Compilation of Philippine Pharmacy Law

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Table Of Contents
A.O 56………………………………………………………………………… 3
1989 Licensing of Drug Establishment and Outlet
R.A 3720……………………………………………………………………. 18
Food, Drugs and Devices, and Cosmetic Act
R.A 6425……………………………………………………………………. 30
Dangerous Drugs Act of 1972
R.A 6675…………………………………………………………………… 39
Generic Act of 1988
R.A 9125……………………………………………………………………. 42
Northern Sierra Madre Natural Park (NSMNP) Act of 2001
R.A 8203……………………………………………………………………54
Special Law on Counterfeit Drugs
R.A 5921…………………………………………………………………….. 67
The Pharmacy Law
R.A 10918…………………………………………………………………… 75
Philippine Pharmacy Act
R.A 9994…………………………………………………………………….. 91
Expanded Senior Citizens Act of 2001
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ADMINISTRATIVE ORDER
No. 56 s. 1989
SUBJECT : Revised Regulations for the Licensing of Drug Establishments and Outlets
Pursuant to Section 26(a) in relation to Section 21(a) and 11(k) of Republic Act No. 3720, known as the Foods, Drugs and Devices, and Cosmetics
Act as amended by Executive Order No. 175 s. 1987 and consistent with Republic Act No. 6675, known as the Generic Act of 1988, the following
regulations are hereby promulgated governing drug establishments and drug outlets under the Bureau of Food and Drugs (BFAD).
In accordance with Section 3 Paragraphs 5 and 6 of R.A. 6675, any organization, company or business establishments in the pharmaceutical
industry shall fall under the following general classification:
I. Drug Establishment means any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs
or medicines. This is covered by Chapter I below.
II. Drug Outlet means drugstore, pharmacy, and other business establishment which sells drugs or medicines. This is covered by Chapter II
below.
CHAPTER I
Drug Establishment
1. Definition of Different Types of Drug Establishments
1.1 Drug Manufacturer means any establishment engaged in operations involved in the production of a drug, including propagation,
processing, compounding, finishing, filling, packing, repacking, altering, ornamenting and labelling with the end in view of storage,
distribution or sale of the product; provided that for the purpose of this regulation the compounding and filling of prescriptions in
drugstores and hospital pharmacies shall not be considered as production operations.
1.2 Drug Trader means any establishment which is a registered owner of the drug product, procures the raw materials and packaging
components, and provides the production monographs, quality control standards and procedures, but sub-contracts the manufacture
of such product to a licensed manufacturer. In addition, a trader may also engage in distribution, and/or marketing of its products.
1.3 Drug Distributor/Importer means any establishment that imports raw materials, active ingredients and/or finished products for its own
use or for wholesale distribution to other drug establishments or outlets.
1.4 Drug Distributor/Exporter means any drug establishment that exports raw materials, active ingredients and/or finished products to
another country.
1.5 Drug Distributor/Wholesaler means any drug establishment that procures raw materials, active ingredients and/or finished products
from local establishments for local distribution on wholesale basis.
2. Standards and Requirements for License To Operate (LTO)
2.1 General Requirements
2.1.1 Application — any person desiring to operate or establish a drug establishment shall file with the BFAD an application supported by the
following documents:
2.1.1.1 A standard petition form containing among others the name, age, citizenship and a passport size picture (5 x 5 cm.) of the petitioner and
other pertinent circumstances pertaining to the proposed drug establishment including the place where it is to be established.
2.1.1.2 Proof of registration as an establishment, i.e.:

(a) For single proprietorship; an authenticated photocopy of the Certificate of Business Name Registration issued by the Bureau of Domestic
Trade (BDT) of the Department of Trade and Industry.
(b) For partnerships, corporations and other juridical persons; authenticated photocopies of the Certificate of Registration issued by the
Securities and Exchange Commission (SEC) and the Articles of Incorporation or partnership
.
2.1.1.3 A valid Certificate of Registration of the establishment’s Filipino pharmacist issued by the Professional Regulation Commission (PRC).
2.1.1.4 A certificate of attendance to a BFAD-sponsored accredited Seminar on Licensing of Drug Establishments.
2.1.1.5 An Affidavit of Undertaking providing that the applicant shall:

(a) change the establishment’s name if there is already a validly registered name similar to it.
(b) display the duly approved LTO in a conspicuous place within the establishment.
(c) notify BFAD in case of any change in the circumstances described in the application such as: change of location, change of pharmacist,
change in drug products.
2.1.1.6 List of products to be manufactured or distributed identified by their generic names and brand names, if any.
2.1.1.7 An authenticated photocopy of Contract of Lease for the space to be occupied if the applicant does not own it.
2.1.2 A Certificate of continuing compliance with specific technical requirements (to be specified by BFAD according to section 2.2 below).
2.1.3 A Batch Distribution Record Book duly registered with BFAD.
2.1.4. A contingency plan or procedure for a systematic, effective and prompt recall in case any of its products is found violative and ordered
recalled from the market by BFAD.
2.1.5. An orderly and secure system of filing up to date invoices from suppliers and buyers identifying lot numbers or batch numbers of
manufacturer’s stock pursuant to BFAD Memo Circular No. 001 s. 1983.
2.2 Specific Requirements:

Any entity applying for a LTO as a drug manufacturer, drug trader or drug distributor shall be required to demonstrate its capacity to perform
adequately as such in a manner that satisfactorily assures the safety, efficacy and quality of its drug products. It shall be required to conform with the
following relevant standards and requirements specific for each category, in addition to the above general requirements:
2.2.1 Drug Manufacturers
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2.2.1.1 Guidelines on Current Good Manufacturing Practices provided for under A.O No. 220 s. 1974, including location, building and floor plans,
and any additional guidelines issued by BFAD;
2.2.1.2 Minimum standards for pharmaceutical manufacturing equipment/machines described in Annex A;
2.2.1.3 Minimum standards for quality control facilities described in Annex B;
2.2.1.4 If importing raw materials, active ingredients and/or finished products for use in manufacture of drug products, a certificate that the
manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer
meets BFAD standards for local manufacturers. If inspection of the foreign manufacturer by BFAD is necessary, the cost of inspection shall be borne
by the applicant establishment.
2.2.2 Drug Traders

2.2.2.1 A valid contract agreement with a BFAD-Licensed manufacturer containing a stipulation that both the drug trader and the manufacturer are
jointly responsible for the quality of the product;
2.2.2.2 If importing raw materials, active ingredients and/or finished products for the use in the manufacture of drug products, a certificate that the
manufacturer is registered with the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer
meets BFAD standards for local manufacturers. If inspection of the foreign manufacturer by BFAD is necessary, the cost of inspection shall be borne
by the applicant establishment;
2.2.2.3 A description of the production process and quality control procedures to be followed by the contracted manufacturer, jointly certified by
the owner and the pharmacist of the establishment.
2.2.3 Drug Distributors

2.2.3.1 Importers
2.2.3.1.1 Foreign Agency Agreement between the Philippine importer and foreign supplier duly authenticated by the territorial Philippine Consulate.
2.2.3.1.2 A certificate that the manufacturer of the raw material, active ingredient and/or finished product is registered in the country of origin, duly
authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD standards for local manufacturers. If
inspection of the foreign manufacturer is necessary, the cost of inspection shall be borne by the applicant establishment.
2.2.3.1.3 In case of finished products, Certificate of Free Sale of the products in the country of origin, duly authenticated by the territorial Philippine
Consulate and evidence that such certificate is issued in substantial compliance with BFAD standards.
2.2.3.2 Exporters
2.2.3.2.1 A valid contract with BFAD-licensed manufacturer in addition to other requirements set by other competent authorities.
2.2.3.3 Wholesalers
2.2.3.3.1 A valid contract with a BFAD licensed manufacturer, trader or distributor.
2.2.3.3.2 A certification that the products it sells are registered with BFAD.
2.3 Other Additional Requirements
In addition to the above standards and requirements, BFAD in the course of evaluating an application may require other additional documentation or
evidence to satisfactorily ascertain the capability of the drug establishment.
3. Renewal of License To Operate (LTO)
3.1. The License To Operate shall have the following validities for all categories of drug establishments.
3.1.1. Initial Period (Initial Application) 1 year
3.1.2. Subsequent Period (Renewal Application) 2 years
3.2. At least one month prior to the expiration of the LTO, drug establishments shall apply to renew their license.
3.3 In considering the renewal application, BFAD shall ascertain the continued compliance by the establishment with the standards and
requirements stipulated in section 2.1 and 2.2.
3.4 The following grounds shall be basis for non-renewal of LTO:
3.4.1. Failure to comply with BFAD standards and requirements.
3.4.2. Serious, repeated or rampant violation of existing laws, rules and regulations.
3.4.3 Persistent shortcomings in demonstrating a capacity to perform in a manner that satisfactorily assures the safety, efficacy and quality of its
drug products.
4. Administrative Sanctions
4.1 Grounds for Revocation of LTO
4.1.1 Misrepresentation of any material fact in the application for LTO and in any documentation used as basis for issuing the LTO.
4.1.2. For manufacturers and traders: any deficiency in GMP that is likely to result in adulterated, misbranded, substandard or unsafe products
as determined by BFAD. This includes, among others, grossly inadequate premises, lack of key technical and professional personnel, lack of key
equipment in production or quality control, poor or inadequate process control and inadequate or improper documentation of the production process.
4.1.3 For distributors: distribution of fake, misbranded, adulterated or unsafe drug products.
4.1.4 Violation of BFAD standards of quality, efficacy, purity and safety of drug products.
4.1.5. Sale or distribution of antibiotic products without batch certification by BFAD.
4.1.6 Failure to take adequate remedial or corrective measures for deficiencies identified in accordance with requirements of BFAD.
4.1.7 Failure to keep up to date, secure, orderly, and easily inspected records that would indicate continued compliance with standards.
4.2 Grounds for Suspension of LTO
4.2.1 Minor deficiencies in GMP or material management that need to be corrected but are not immediately or likely to result in adulterated,
misbranded, substandard or unsafe products as determined by BFAD. This includes, among others, poor housekeeping, inadequate storage
facilities, lack of minor equipment or requirement, and other minor shortcomings.
4.2.2. Lapses in record keeping of invoices, receipts or distribution records.
4.3 Re-application After Revocation
No establishment whose LTO was revoked may apply for an LTO within 5 years after the revocation of its license.
5. Schedule of Fees
5.1 Upon application for a license to operate as a drug establishment, the following non-refundable fees shall be charged for each application:
Renewal
Initial (good for 2 years)
5.2 If a drug establishment engages in activities belonging to more than one of the above categories, applicant must apply for LTO for each of
the category and pay the corresponding fees.
5.3 Only upon payment of application fees may the application be processed. A surcharge of fifty percent (50%) of the above fees shall be
imposed on applications for renewal filed after the validity of the license has lapsed. Any change in the category of drug establishment or change in
ownership shall require a new application.
CHAPTER II
Drug Outlets
1. Definitions of Different Types of Drug Outlets
1.1 Drugstore, Pharmacy or Botica, including Hospital Pharmacy/Dispensary means a drug outlet where registered drugs, chemical products,
active principles, proprietary medicines or pharmaceutical specialties and dental, medicinal, galenical, or veterinary preparations are
compounded and/or dispensed.
1.2 Retail outlet for non-prescription drugs including nontraditional outlets such as supermarkets and stores, means a drug outlet where
registered non-prescription or over-the-counter (OTC) drugs are sold in their original packages, bottles or containers or in smaller quantities
not in their original containers.
2. Standards and Requirements for License To Operate (LTO)
2.1 General Requirements
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2.1.1.Applications — any person desiring to operate or establish a drug establishment shall file with the BFAD an application supported by the
following documents:
2.1.1.1 A standard petition form containing among others the name, age, citizenship and a passport size (5 x 5 cm) photo of the petitioner and
other pertinent circumstances pertaining to the proposed drug establishment including the place where it is to be established.
2.1.1.2 Proof of registration as an establishment, i.e.:
(a) For single proprietorship, an authenticated photocopy of the Certificate of Business Name Registration issued by the Bureau of Domestic
Trade (BDT) of the Department of Trade and Industry.
(b) For partnership, corporations and other juridical persons; authenticated photocopies of the Certificate of Registration issued by Securities
and Exchange Commission (SEC) and the Articles of Incorporation or Partnership.
2.1.1.3 A valid Certificate of Registration of the establishment’s Filipino pharmacist issued by the Professional Regulation Commission
(PRC).
2.1.1.4 A Certification of Attendance to a BFAD-sponsored/accredited Seminar on Licensing of Drug Outlets.
2.1.1.5 An Affidavit of undertaking providing that the applicant shall:
(a) change the establishments’ name if there is already a validly registered name similar to it.
(b) display the duly approved LTO in a conspicuous place within the establishment.
(c) notify BFAD in case of any change in the circumstances described in the application such as: change of location or change of pharmacist.
2.1.1.6 Tentative list of products intended to be sold using generic names with brand names when applicable.
2.1.1.7 An authenticated photocopy of Contract of Lease of the space to be occupied if the applicant does not own it.
2.2 Specific Requirements:
Any entity applying for a license to operate a drugstore, pharmacy or botica or retail outlet shall be required to demonstrate its capacity to perform
adequately its functions to inform its clientele in accordance with Section 6(d) of R.A. 6675 and sell drugs and medicines, which are safe, effective,
and of good quality to the public. It shall be required to conform with relevant standards and requirements specific for each category, in addition to
the foregoing general requirements.
2.2.1 Drugstores, Pharmacy or Botica
2.2.1.1 Premises
2.2.1.1.1 A signboard in front of the place of business bearing the registered name of the drug store. For hospital pharmacy, the sign
“Pharmacy” is sufficient. For drug outlet selling exclusively non-prescription or Over the Counter (OTC) drug product, the signboard should indicate
so by putting the symbol non-Rx or its equivalent.
2.2.1.1.2 A well-ventilated area not less than 15 sq. m. in floor area with concrete, tile or wooden flooring.
2.2.1.1.3 A place suitable for compounding prescription and for washing and sterilizing bottles (compulsory only for hospital pharmacy).
2.2.1.1.4 A suitable and proper place for the adequate storage of drugs and biological products as specified on the label.
2.2.1.1.5 A suitable cabinet for keeping poisons and/or dangerous drugs.
2.2.1.1.6 An adequate water supply.
2.2.1.2 Reference Books and Documents
2.2.1.2.1 Philippine National Drug Formulary (when available)
2.2.1.2.2 United States Pharmacopeia/National Formulary (USP-NF) (latest edition).
2.2.1.2.3 R.A. 3720, otherwise known as the Foods, Drugs and Devices and Cosmetics Act as amended and relevant implementing rules
and regulations.
2.2.1.2.4 R.A. 6675, Generics Act of 1988 and relevant implementing rules and regulations.
2.2.1.2.5 R.A. 5921 Pharmacy Law, as amended and relevant implementing rules and regulations.
2.2.1.2.6 Remington’s Pharmaceutical Sciences (latest edition).
2.2.1.2.7 Goodman & Gilman — Pharmacological Basis of Therapeutics (latest edition).
2.2.1.3 Record Books Duly Registered with the BFAD
2.2.1.3.1 Prescription Book
2.2.1.3.2 Dangerous Drug Book
2.2.1.3.3 Exempt Preparation Book
2.2.1.3.4 Poisons Book
2.2.1.3.5 Record Book for Selected Non-Prescription Drugs, subject to abuse as determined by BFAD and/or Dangerous Drugs Board
(DDB).
2.2.1.4 Utensils, Apparatus and Other Equipment
2.2.1.4.1 For all drugstores including hospital pharmacies, refrigerator for biologicals and other drug products needing refrigeration.
2.2.1.4.2 For hospital pharmacy only:
2.2.1.4.2.1 Prescription balance of one centigram sensitivity and a set of weights.
2.2.1.4.2.2 Glass volumetric measures a set of not less than six pieces from 15 ml to 1000 ml capacity.
2.2.1.4.2.3 Mortar and pestle — a set of not less than three in assorted sizes.
2.2.1.5 A full-time validly registered pharmacist physically present while the drugstore is open to business.
2.2.1.6 Other Additional Requirements:
2.2.1.6.1 Invoices indicating the lot number or batch number of the manufacturer’s stock pursuant to BFAD Memo. Circular no. 001 s. 1983.
2.2.1.6.2 File of prescription filled, consecutively numbered.
2.2.1.6.3 Dry Seal or Rubber Stamp containing the name and address of the drug outlet.
2.2.1.6.4 Red and White labels indicating name and address of drugstore.
2.2.2 Requirements for a Retail Outlet for Non-Prescription Drugs
2.2.2.1 Premises
2.2.2.1.1 A signboard in front of the place of business bearing the registered name of retail outlet and the symbol non-Rx or equivalent.
2.2.2.1.2 An adequate, well-ventilated area with concrete, tile, or wooden flooring.
2.2.2.1.3 A suitable and proper place for the adequate storage of non-prescription drugs. When there are products sold other than drugs,
an area exclusively for drug products shall be allocated within the premises.
2.2.2.2 Reference Books and Documents
2.2.2.2.1 Philippine National Drug Formulary (when available);
2.2.2.2.2 R.A. 5921, Pharmacy Law and its implementing rules and regulations;
2.2.2.2.3 R.A. 6675, the Generics Act of 1988 and relevant implementing rules and regulations;
2.2.2.2.4 R.A. 3720 as amended or Foods, Drugs and Devices and Cosmetics Act;
2.2.2.3 Record Books as required by BFAD for selected non-prescription drugs subject to abuse as determined by BFAD and/or DDB
2.2.2.4 A full-time validly registered pharmacist physically present while the retail outlet is open for business.
2.2.2.5 Other Additional Requirements
2.2.2.5.1 Invoices indicating the lot number or batch number of the manufacturer’s stock pursuant to BFAD Memo. Circular No. 001 s. 1983.
2.2.2.5.2 Dry seal or Rubber Stamp containing the name and address of the drug outlet.
3. Renewal of License to Operate (LTO)
In case of renewal of LTO the drug outlet must have a history of satisfactory performance, consistent with BFAD standards and requirements,
without any case of serious violation of existing laws, rules and regulations.
4. Administrative Sanctions
4.1 Temporary Closure
Absence of pharmacist on three (3) inspections by BFAD inspector.
4.2 Suspension of License to Operate
4.2.1 Failure to produce invoices and receipts together with lot numbers, expiry dates for the drugs in stock.
4.2.2 Failure to properly record and keep a file of all prescriptions filled in the last two years.
4.2.3 Refusal to allow entry of BFAD inspectors.
4.3 Revocation of License to Operate
4.3.1 Sale or offer for sale of adulterated, misbranded, sub-standard, unregistered, expired and/or unsafe drugs or products marked “Not for
Sale.”
4.3.2 Failure to properly record dangerous drugs as determined by DDB.
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4.3.3 Lack of pharmacist.
4.3.4 Failure to take necessary remedial or corrective measures within the prescribed period as directed by BFAD.
5. Validity
The license to operate shall have the following validities:
Initial Period Validity of
of validity Subsequent
Renewal
Drugstore, Pharmacy or Botica 1 year 2 years
Retail Outlet 1 year 2 years
6. Schedule of Fees

Upon application for a license to operate as a drug outlet, the following non-refundable fees shall be charged for each application:
Renewal
Initial (good for two years)
P500.00 per drugstore, pharmacy
or botica outlet P1,000.00
P200.00 per retail outlet
carrying only OTC drugs P400.00
Only upon payment of application fees may the application be processed. A surcharge of fifty percent (50%) of the above fees shall be imposed on
applications for renewal filed after the validity of the license has lapsed.
SEPARABILITY CLAUSE
In case any provision of this rules and regulations is declared contrary to law or unconstitutional other provisions which are not affected thereby shall
continue to be in force and in effect.
REPEALING CLAUSE
All administrative orders, rules and regulations and other administrative issuances or parts thereof, inconsistent with the provisions of this Regulation
are hereby repealed or modified accordingly.
EFFECTIVITY
This Regulation shall take effect fifteen (15) days after its publication in a newspaper of general circulation. *
* The foregoing Administrative Order was published in the Daily Globe issue of January 17, 1989.
ANNEX “A”
MINIMUM STANDARDS FOR PHARMACEUTICAL MANUFACTURING EQUIPMENT/MACHINES
1.0 General Machinery and Equipment
1.1 Weighing Scale
1.1.1 1 g. sensitivity
1.1.2 1 kg. sensitivity
1.2. Labelling machine
1.3. Coding machine
1.4. Facility for washing and drying bottles
1.5. Laboratory apparatus including measuring glasswares, chemical supplies, filter paper.
2.0. Additional Machine and Equipment needed for each dosage form:
2.1. Liquid/Suspension
2.1.1. Stainless Steel tank with stirrer of appropriate capacity
2.1.2. Jacketed kettle
2.1.3. Homogenizer
2.1.4. Stainless steel pail, assorted sizes
2.1.5. Deionizer or distilling apparatus
2.1.6. Stainless steel storage tank 500 L
2.1.7. Filter assembly
2.1.8. Filling machine
2.1.9. Pilfer-proof capper
2.2. Tablet
2.2.1. Mixer/blender
2.2.2. Mill
2.2.3. Granulator
2.2.4. Drying Oven or fluidized-bed dryer
2.2.5. Sifter/Sieves
2.2.6. Tablet Press
2.2.7. Dust collector/exhaust system
2.2.8. Dehumidifier
2.3 Capsule
2.3.1. Mixer
2.3.2. Dehumidifier
2.3.3. Encapsulating machine
2.3.4. Dust collector/exhaust system
2.4. Powder/Granule Preparation
2.4.1. Blender
2.4.2. Powder filling machine
2.4.3. Tamper-proof machine
2.4.4. Dehumidifier
2.5. Sterile products (Ophthalmic, etc.)
2.5.1. Stainless steel tank with stirrer
2.5.2. Stainless steel storage tank
2.5.3. Membrane filter assembly
2.5.4. Laminar flow system
2.5.5. Filling machine
2.5.6. Capping machine
2.6. Ointment/Cream
2.6.1 Mill
2.6.2 Stainless tank with stirrer, jacketed
2.6.3 Filling machine
2.6.4 Crimper
2.7. Small Volume Parenteral Products
2.7.1. Vial washer/rinser
2.7.2. Pyrogen-free distilling apparatus
2.7.3. Storage tank s.s.
2.7.6. Laminar flow system
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2.7.7. Ampule filter and sealer
2.7.8. Vial filter and sealer/crimper
2.7.9. Filling machine for liquid
2.7.10. Sterilizer/autoclave
2.7.11. Depyrogenating oven
2.8. Large Volume Parenteral Products
2.8.1. Water softener
2.8.2. Carbon filter
2.8.3. Deionizer
2.8.4. Distilling unit
2.8.6. Stainless steel storage tank
2.8.8. Bottle/stopper washer
2.8.9. Laminar flow assembly
2.8.10. Filter and sealer/crimper
2.8.11. Vacuum equipment
2.8.12. Autoclave/sterilizer
2.8.13. Depyrogenating oven
2.9. Penicillin Preparation
2.9.1. Separate areas, separate area and entrance from non-penicillin products.
2.9.2. Separate equipment outlay based on specific dosage form.
2.10. Optional equipment and Machine
2.10.1. Coating Pan )
2.10.2. Mill ) for sugar coated tablet
2.10.3. Polishing Pan )
2.10.4. Sprayer — for film coating
2.10.5. Sachet filler
2.10.6. Strip sealing machine
2.10.7. Blister pack machine
2.10.8. Tablet/capsule Counter
ANNEX “B”
MINIMUM STANDARDS FOR QUALITY CONTROL
FACILITIES
(DRUG MANUFACTURERS)
1.0. GENERAL REQUIREMENTS
1.1 Physico-Chemical Assay
1.1.1. UV spectrophotometer
1.1.2. Fluorphotometer (for vitamin preparation)
1.1.3. Titrimeter
1.1.4. Thin layer chromatography
1.1.5. Analytical balance
1.1.6. pH meter
1.1.7. Drying oven
1.1.8. Oven for stability testing
1.1.9. Water bath
1.1.10. Magnetic stirrer
1.1.11. Mechanical shaker
1.1.12. Pycnometer
1.1.13. Desiccators/vacuum desiccators
1.1.14. Hot plate
1.1.15. Furnace
1.1.16. Glasswares
1.1.16.1. Buret (4)
1.1.16.2. Volumetric flask (6)
1.1.16.3. Separatory funnel (3)
1.1.16.4. Erlenmeyer flask (3)
1.1.16.5. Beaker (assorted sizes, 2 pcs. of each size)
1.1.16.6. Graduated cylinder (assorted sizes, 2 pcs. of each size)
1.1.16.7. Pipette (6)
1.1.16.8. Thermometer (2)
1.1.16.9. Test Tube (24)
1.1.16.10. Funnel (4)
1.1.16.11. Stirring rod (6)
1.1.16.12. Crucible (6)
Laboratory supplies/chemical/reagents/reference standards, etc.

1.2. Biological Assay
1.2.1. Micro Assay
1.2.1.1. Autoclave
1.2.1.2. Centrifuge
1.2.1.3. Colony counter
1.2.1.4. Incubator
1.2.1.5. Refrigerator
1.2.1.6. Bunsen burner
1.2.1.7. Petri Dishes (24 pieces)
1.2.1.8. Microscope
1.2.1.9. Laboratory supplies/glasswares/chemicals/ culture/media etc.
1.2.2. Animal House and Laboratory Animals i.e. mice for safety test; rabbits for pyrogen test
1.3. Reference Books
1.3.1. Latest United States Pharmacopeia/National Formulary
1.3.2. British Pharmacopeia Latest Edition
1.3.3. Remington’s Pharmaceutical Sciences
1.3.4. Merck Index
1.3.5. Drug Reference Manual
1.3.6. BFAD Regulations/Pharmacy Laws
1.3.7. Official Philippine National Drug Formulary
1.4. Optional Requirements
NOTE: If product to be manufactured requires the use of any of the following then it becomes mandatory.
1.4.1. Colorimeter
1.4.2. Column Chromatography
1.4.3. Gas-liquid chromatography
1.4.4. Infrared spectrophotometer
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1.4.5. Polarimeter
1.4.6. Polarograph
1.4.7. High pressure liquid chromatography
1.4.8. Ultra-sonic bath
1.4.9. Kjeldahl assembly
2.0. Additional Requirements based on dosage form to be manufactured
2.1. Tablet Preparation
2.1.1. Disintegration tester
2.1.2. Dissolution rate assembly
2.1.3. Friabilator
2.1.4. Hardness tester
2.1.5. Caliper
2.1.6. Moisture balance
2.1.7. Torsion balance/analytical balance
2.1.8. Melting point apparatus
2.2. Capsule Preparation
2.2.1. Dissolution rate assembly
2.2.3. Melting point apparatus
2.3. Liquid/Suspension
2.3.1. Viscosimeter
2.3.2. Refractometer
2.3.3. Visual inspection assembly
2.3.4. pH meter
2.4. Powder and Granules
2.4.3. See 2.3 requirements for liquid/suspension
2.5. Parenteral
2.5.1. Visual Inspection system
2.5.2. Leaker Test (Set-up) for ampules
2.5.3. Pyrogen test Set-up
2.5.4. Particle counter
2.6. Ointment/Cream
2.6.1. Viscosimeter
2.6.2. pH meter
2.7. Penicillin Preparation
2.7.1. Separate equipment from that of non-penicillin products depending on the dosage form to be manufactured.
PURSUANT TO THE GENERICS ACT OF 1988 AND ITS

IMPLEMENTING GUIDELINES, DOCTORS AND
PHARMACISTS ARE URGED TO BEGIN GENERIC
PRESCRIBING AND DISPENSING TODAY, JUNE 1, 1989
June 1 to August 31 is the designated learning and practice period for all medical, dental, veterinary and pharmaceutical professionals. Beginning
September 1, the Generics Act of 1988 will be in full effect.
GUIDELINES ON PRESCRIBING MEDICINES

BASED ON PRIOR LAWS
* Only validly-registered medical, dental and veterinary practitioners, whether in private practice or employed in a private
institution/corporation or in the government, are authorized to prescribe drugs.
* All prescriptions must contain the name of the prescriber, office address, professional registration number, professional tax receipt
number, patient’s/client’s name, age and sex, and date of prescription.
* For prohibited and regulated drugs, the following are required:
The prescriber must have an S-2 license.
The special Dangerous Board prescription form must be used.
A recording system following pertinent Dangerous Drugs Board regulations must be observed.
ADDITIONAL GUIDELINES ON PRESCRIBING
MEDICINES PURSUANT TO THE
GENERICS ACT OF 1988
* Generic names shall be used in all prescriptions for:
Drugs with a single active ingredient, the generic name of the active ingredient shall be used in prescribing.
Drugs with two or more active ingredients, the generic name of the active ingredients as determined by the Bureau of Food and Drugs shall be used
in prescribing.
* The generic name must be written in full but the salt or chemical form may be abbreviated.
* The generic name of the drug ordered must be clearly written on the prescription immediately after the Rx symbol, or on the order chart.
In addition to the generic name, a brand name may also be indicated. In such cases, the following shall be observed:
* If written on a prescription pad, the brand name enclosed in parenthesis shall be written below the generic name.
* If written on a patient’s chart, the brand name enclosed in parenthesis shall be written after the generic name.
* Only one drug product shall be prescribed on one prescription form.
* In prescribing drugs which need strict precaution in their use, the prescriber must comply with the following:
After the Rx symbol but before the generic name he must write clearly “(List B)”. Refer to attached appendix for details.
The prescriber must ensure that the following information are accurately written on the prescription:
* The generic name of the active ingredient(s) and the specific sat or chemical form.
* The manufacturer.
* The brand name, if so desired.
* The strength or dose level using units of the metric system. Example: 1 grain — 60 mg.
* The delivery mode or delivery system: quick-dissolve, sustained release, etc., and the corresponding appropriate dose frequency or dose
interval.
VIOLATIVE, ERRONEOUS AND IMPOSSIBLE
PRESCRIPTIONS
Violative Prescription
* Where the generic name is not written.
* Where the generic name is not legible and a brand name which is legible is written.
* Where the brand name is indicated and instructions added (such as the phrase “no substitution”) which tend to obstruct, hinder or prevent
proper generic dispensing.
Violative prescription shall not be filled. They shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the
nearest Department of Health Office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to
get the proper prescription.
Erroneous Prescription
* Where the brand name precedes the generic name.
* Where the generic name is the one in parenthesis.
8
* Where the brand name is not in parenthesis.
* Where more than one drug product is prescribed on one prescription form.
Erroneous prescriptions shall not be filled. Such prescriptions shall also be kept and reported by the pharmacist of the drug outlet or any other
interested party to the nearest Department of Health office for appropriate action.
Impossible Prescriptions
* When only the generic name is written but is not legible.
* When the generic name does not correspond to the brand name.
* When both the generic and the brand names are not legible.
* When the drug product prescribed is not registered with the Bureau of Food and Drugs.
Impossible prescriptions shall not be filled. They shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the
nearest Department of Health office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to
get the proper prescription.
In cases of violative, erroneous and impossible prescriptions, the local Department of Health office shall be responsible for giving written notice to
the erring doctor concerned and for transmitting through channels the report for violation/error to the Professional Regulation Commission or to the
fiscal’s office for appropriate action.
GUIDELINES ON DISPENSING OF MEDICINES

BASED ON PRIOR LAWS
* Ethical drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian.
* Non-prescription or over-the-counter drugs may be dispensed even without a written order of a validly-registered physician, dentist or
veterinarian in duly licensed drug outlets. When dispensing over-the-counter drugs without a doctor’s prescription, the pharmacist shall give the
necessary information and direction for use of the drug.
* All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for two years and recorded in a prescription
book duly registered with the Bureau of Food and Drugs which shall be opened for inspection to Food and Drugs Inspectors any time during
business hours of the outlet. The prescription book shall be kept for two years after the last entry.
ADDITIONAL GUIDELINES ON DISPENSING

TO IMPLEMENT THE GENERICS ACT OF 1988
* All drug outlets are required to practice dispensing of drugs using generic names with some exceptions, modifications or qualifications in
certain cases or circumstances prescribed herein.
Drugstores, boticas, and other drug outlets.
To ensure the informed choice and use of drugs by patient/buyer, the drug outlet is required to:
* Inform the patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding prices. In so
doing, the drug outlet shall not favor or suggest any particular product so that the patient/buyer may fully and adequately exercise his option to
choose.
* For this purpose, all drug outlets shall post in a conspicuous place in their respective establishments a list of drug products using generic
names with their brand names, if any, and their corresponding current prices. A handbook or directory containing the above required information,
readily accessible to the patient/buyer shall be considered substantial compliance.
Hospital Pharmacies The following shall govern generic dispensing in hospital pharmacies, in the case of in-patients only:
* Upon admission, the patient or his/her responsible relative shall indicate in writing whether he/she shall submit to the hospital drug
policies or reserve the option to buy drugs and medicines outside of the hospital pharmacy.
* Hospital pharmacies operating on an acceptable formulary system and pricing policy as determined by the Department of Health, and
using generic terminology in procurement, prescribing, dispensing, and recording of drugs shall be exempted from the following:
* Recording of prescription filled in the prescription book, provided such prescriptions shall be kept in file for two years.
* Individually informing the in-patient/buyer on available generic equivalents and their corresponding prices. However, a handbook or
directory containing the required drug information must be made available in the wards for patients, responsible relatives of patients and professional
staff.
* In dispensing to the buyer, the drug products in the unit dose or products which are not in their original containers but transferred to small
bottles, tin cans, boxes, plastic and/or paper envelopes and the like, the pharmacist shall place legibly on the required drug outlet’s label the
following information:
Name of patient Dosage strength
Generic name of the drug Expiry date
Brand name, if any Directions for use
Manufacturer Name of Pharmacist
The partially-filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore which completes
the filling of the prescription shall keep the prescription in file.
Dispensing prohibited and Regulated Drugs (List) and Drugs Requiring Strict Precautions (List B) (Please see attached Lists)
* In dispensing prohibited and regulated drugs requiring strict precautions in their use, the following shall be observed:
Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription filled.
The order and instructions of the doctor as written on the prescription, must be precisely followed.
Partial filling of prescription for prohibited and regulated drugs (List A) shall not be allowed.
Guidelines on what to do with Violative, Erroneous, and
Impossible Prescriptions
* Violative and impossible prescriptions as defined in A.O. 62 (Generic Prescribing) shall not be filled. The pharmacist shall advise the
prescriber of the problem and/or instruct the customer to get the proper prescription. These violative and impossible prescriptions shall be kept and
reported by the pharmacist or other interested parties to the nearest Department of Health office for appropriate action.
* Erroneous prescription shall be filled, but they shall also be kept and reported to the nearest Department of Health office for appropriate
action.
Violations on the part of Dispensers and Outlets
The following acts or omissions are considered violations of these rules and regulations:
* Imposing a particular brand or product on the buyer.
* Inaccurate dispensing i.e. dispensing a drug product which does not meet the prescription as to any or all the following: active ingredient,
dosage form and strength.
* Failure to post or make accessible the required up-to-date information on drug products.
* Failure to indicate the generic name/official name designated by the Bureau of Food and Drugs and other required information on the
drug outlet’s label of the dispensed drug.
* Failure to record and keep prescriptions filled.
* Failure to report to the nearest Department of Health office cases of violative, erroneous, and/or wrong prescriptions within three months
after receipt of such prescriptions
9
REPUBLIC ACT No. 3720
AN ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY
CREATING THE FOOD AND DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.
CHAPTER I
Title
Section 1. This Act shall be known as the "Food, Drug, and Cosmetic Act."
CHAPTER II
Declaration of Policy
Section 2. It is hereby declared the policy of the State to insure safe and good quality supply of food, drug and cosmetic, and to regulate the
production, sale, and traffic of the same to protect the health of the people.
Section 3. In the implementation of the foregoing policy, the Government shall in accordance with the provisions of this Act:
(a) Establish standards and quality measures for food, drug, and cosmetic.
(b) Adopt measures to insure pure and safe supply of food, drug, and cosmetic in the country.
CHAPTER III
Creation of the Food and Drug Administration
Section 4. To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration in the Department
of Health. Said Administration shall be under the Office of the Secretary and shall have the following functions, powers and duties:
(a) To administer and supervise the implementation of this Act and of the rules and regulations issued pursuant to the same.
(b) To provide for the collection of samples of food, drug and cosmetic.
(c) To analyze and inspect food, drug and cosmetic in connection with the implementation of this Act.
(d) To establish analytical data to serve as basis for the preparation of food, drug and cosmetic standards, and to recommend standards of
identity, purity, quality and fill of container.
(e) To issue certificate of compliance with technical requirements to serve as basis for the issuance of license and spot-check for
compliance with regulations regarding operation of food, drug and cosmetic manufacturers and establishments.
(f) To levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the
provisions of this Act.
(g) To certify batches of anti-biotic and anti-biotic preparations in compliance with the provisions of this Act.
Section 5. The Food and Drug Administration shall have the following Divisions:
(a) Inspection and Licensing Division, which shall have charge of the inspection of food, drug, and cosmetic establishments engaged in
their manufacture and sale.
(b) Laboratory Division, which shall conduct all the tests, analyses and trials of products covered by this Act.
Section 6. The Food and Drug Administration shall have a Food and Drug Administrator who shall be appointed by the Secretary of Health subject
to the Civil Service rules and regulations. The compensation of said official shall be determined by the Secretary of Health.
Section 7. The Secretary of Health shall provide for the additional personnel needed to carry out the functions and duties of the Food and Drug
Administration.
Section 8. The powers, functions and duties of the Division of Food and Drug Testing of the Bureau of Research and Laboratories and the Board of
Food Inspection, all personnel in the Bureau of Health Services who are engaged in food and drug control work, together with all their equipment,
supplies, records, files, personnel and balance of appropriations are transferred to the Food and Drug Administration.
CHAPTER IV
Board of Food and Drug Inspection
Section 9. The Board of Food Inspection is hereby converted into the Board of Food and Drug Inspection which shall consist of:
10
(a) A representative of the Department of Health to be designated by the Secretary of Health, as Chairman;
(b) A representative of the Department of Agriculture and Natural Resources;
(c) A representative of the Department of Commerce and Industry;
(d) An authorized designate of the Commissioner of Customs;
(e) An authorized representative of the Office of the Solicitor-General;
(f) A technical member to be designated by the Food and Drug Administrator with the approval of the Secretary of Health.
(g) The President of the Philippine Medical Association of his authorized representative;
(h) The President of the Philippine Dental Association or his authorized representative; and
(i) The President of the Philippine Pharmaceutical Association or his authorized representative.
Each member of the Board as well as the Board secretary shall receive a per diem of twenty pesos per meeting, hearing or investigation actually
attended, but in no case shall the total per diem exceed two hundred pesos each per month.
It shall be the duty of the Board, conformably with the rules and regulations, to hold hearings and conduct investigations relative to matters touching
the administration of this Act, to investigate processes of food, drug and cosmetic manufacture and to submit reports to the Food and Drug
Administrator, recommending food and drug standards for adoption. Said Board shall also perform such additional functions, properly within the
scope of the administration hereof, as may be assigned to it by the Food and Drug Administrator. The decisions of the Board shall be advisory to the
Food and Drug Administrator.
CHAPTER V
Definitions
Section 10. For the purposes of this Act, the term:
(a) "Board" means the Board of Food and Drug Inspection.
(b) "Secretary" means the Secretary of Health.
(c) "Department" means the Department of Health.
(d) "Person" includes individual, partnership, corporation and association.
(e) "Food" means (1) articles used for food or drink for man, (2) chewing gum, and (3) articles used for components of any such article.
(f) "Drug" means (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United
States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any
function of the body of man or animals; and (4) articles intended for use as a component of any articles specified in clauses (1), (2), or (3),
but not include devices or their components, parts, or accessories.
(g) "Device" means instruments, apparatus, or contrivances, including their components, parts, and accessories, intended (1) for use in
the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals; or (2) to affect the structure or any function of the
body of man or animals.
(h) "Cosmetic" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the
human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended
for use as a component of any such articles.
(i) "Label" means a display of written, printed, or graphic matter upon the immediate container of any article and a requirement made by or
under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied
with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail
package of such article, or is easily legible through the outside container or wrapper.
(j) "Immediate container" does not include package liners.
(k) "Labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2)
accompanying such article.
(l) "New drugs" mean:
(1) any drug the composition of which is such that said drug is not generally recognized, among experts qualified by scientific training and
experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling
thereof.
(2) any drug the composition of which is such that said drug, as a result of investigations to determine its safety for use under such
conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a
material time under such conditions.
(m) If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is misleading
there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or
any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or
11
material with respect to consequences which may result from the use of the article to which the labeling relates under the conditions of use
prescribed in the labeling thereof or under such conditions of use as are customary or usual.
(n) "Food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly,
in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation
intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to
evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.
CHAPTER VI
Prohibited Acts and Penalties
PROHIBITED ACTS
Section 11. The following acts and the causing thereof are hereby prohibited: (a) The manufacture, sale, offering for sale or transfer of any food,
drug, device or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or cosmetic.
(c) The refusal to permit entry or inspection as authorized by Section twenty-seven hereof or to allow samples to be collected.
(d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereof which guaranty or undertaking is false, except by a
person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person
residing in the Philippines from whom he received in good faith the food, drug, device, or cosmetic or the giving of a guaranty or
undertaking referred to in Section twelve (b) which guaranty or undertaking is false.
(e) Forging, counterfeiting, simulating, or falsely representing or without proper authority using any mark, stamp, tag label, or other
identification device authorized or required by regulations promulgated under the provisions of this Act.
(f) The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department or
to the courts when relevant in any judicial proceeding under this Act, any information acquired under authority of Section nine, or
concerning any method or process which as a trade secret is entitled to protection.
(g) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act
with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) and
results in such article being adulterated or misbranded.
(h) The use, on the labeling of any drug or in any advertising relating to such drug, of any representation or suggestion that an application
with respect to such drug is effective under Section twenty-one hereof, or that such drug complies with the provisions of such section.
(i) The use, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with Section
twenty-six hereof.
PENALTIES
Section 12. (a) Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, be subject to imprisonment of not less
than six months and one day, but not more than five years, or a fine of not less than one thousand pesos, or both such imprisonment and fine, in the
discretion of the Court.
(b) No person shall be subject to the penalties of subsection (a) of this section (1) for having sold, offered for sale or transferred any article
and delivered it, if such delivery was made in good faith, unless he refuses to furnish on request of the Board of Food and Drug Inspection
or an officer or employee duly designated by the Secretary, the name and address of the person from whom he purchased or received
such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; (2) for having violated Section
eleven (a) if he established a guaranty or undertaking signed by, and containing the name and address of, the person residing in the
Philippines from whom he received in good faith the article, or (3) for having violated Section eleven (a), where the violation exists
because the article is adulterated by reason of containing a coal-tar color not permissible under regulations promulgated by the Secretary
under this Act, if such person establishes a guaranty or undertaking signed by, and containing the name and address, of the manufacturer
of the coal-tar color, to the effect that such color is permissible, under applicable regulations promulgated by the Secretary under this Act.
(c) Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into the domestic commerce may be
seized and held in custody pending proceedings pursuant to Section twenty-six (d) hereof, without a hearing or court order, when the
Secretary has probable cause to believe from facts found by him or any officer or employee of the Food and Drug Administration that the
misbranded article is dangerous to health, or that the labeling of the misbranded articles is fraudulent, or would be in a material respect
misleading to the injury or damage of the purchaser or consumer.
CHAPTER VII
Definition and Standards for Food
Section 13. Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall,
upon recommendation of the Food and Drug Administrator, promulgate regulations fixing and establishing for any food, under its common or usual
name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, and/or reasonable standards of fill of
container: Provided, That no definition and standard of identity and no standard of quality shall be established for fresh or dried fruits, fresh or dried
vegetables.
ADULTERATED FOOD
Section 14. A food shall be deemed to be adulterated: (a) (1) If it bears or contains any poisonous or deleterious substance which may render it
injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the
quantity of such substance in such food does not ordinarily render it injurious to health;
(2) if it bears or contains any added poisonous or added deleterious substance other then one which is a pesticide chemical in
or a raw agricultural commodity for which tolerances have been established and it conforms to such tolerances;
12
(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food:
(4) if it has been prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or
whereby, it may have been rendered injurious to health;
(5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter;
(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents
injurious to health.
(b) (1) If any valuable constituent has been, in whole or in part, omitted or abstracted therefrom and same has not been substituted by any
healthful equivalent of such constituent;
(2) if any substance injurious to health has been added or substituted;
(3) if damage or inferiority has been concealed in any manner; and
(4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its
quality or strength, or make it appear better or of greater value than it is.
(c) If it bears or contains a coal-tar color other than one which is permissible under existing regulations;
(d) If it is confectionery, and it bears or contains any alcohol or non-nutritive article or substance except harmless coloring, harmless
flavoring, harmless resinous glass less coloring, harmless flavoring, harmless resinous glass not in excess of four-tenths of one per
centum, natural gum and pectin: Provided, That this paragraph shall not apply to any confectionery by reason of its containing less than
one-half of one per centum by volume of alcohol derived solely from the use of flavoring extracts, or to any chewing gum by reason of its
containing harmless non-nutritive masticatory substances;
(e) If it is oleomargarine or margarine or butter and any of the raw material used therein consists in whole or in part of any filthy, putrid or
decomposed substance, or such oleomargarine, margarine or butter is otherwise unfit for food.
MISBRANDED FOOD
Section 15. A food shall be deemed to be misbranded:
(a) If its labeling is false or misleading in any particular;
(b) If it is offered for sale under the name of another food;
(c) If it is an imitation of another food, unless its label bears in types of uniform size and prominence, the word "imitation" and, immediately
thereafter, the name of the food imitated;
(d) If its container is so made, formed, or filled as to be misleading;
(e) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, distributor; and (2)
an accurate statement of the quantity of the contents in terms of weight, measure, numerial count: Provided, That under clause (2) of this
paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed
by the Secretary.
(f) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling),
and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and
use.
(g) If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed unless (1) it conforms
to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and, insofar as may
be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such
food.
(h) If it purports to be or is represented as
(1) A food for which a standard of quality has been prescribed by regulations as provided by Section thirteen, and its quality falls
below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below
such standard; or
(2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by Section
thirteen and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as
such regulations specify, statement that if falls below such standard.
(i) If it is not subject to the provisions of paragraph (g) of this section unless its label bears (1) the common or usual name of the food, if
there be any, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that
spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings and colorings without naming
each: Provided, That to the extent that compliance with the requirements of clause (2) of this paragraph is impracticable or results in
deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.
(j) If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral and
other dietary properties as the Secretary determined to be, and by regulations prescribes as necessary in order fully to inform purchasers
as to its value for such uses.
13
(k) If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that
fact: Provided, That to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be
established by regulations promulgated by the Secretary. The provisions of this paragraph or paragraphs (g) and (i) with respect to
artificial coloring shall not apply in the case of butter, cheese or ice cream.
Emergency Permit Control
Section 16. (a) Whenever the Secretary finds after investigation that the sale or distribution in domestic commerce of any class of food may be
injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered domestic commerce, he shall
promulgate regulations also in accordance with the recommendations of the Food and Drug Administrator providing for the issuance, to
manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the
manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health; and
after the effective date of such regulations, and during such temporary period, no person shall manufacture, sell or offer for sale or transfer any such
food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor or packer holds a
permit issued by the Secretary as provided by such regulations.
(b) The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any
of the conditions of the permit have been violated.
(c) Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which
holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and
denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.
Tolerances for Poisonous Ingredients in Food
COAL-TAR COLOR FOR FOOD
Section 17. (a) Any poisonous or deleterious substance added to any food, shall be deemed to be unsafe except when such substance is required
or cannot be avoided in its production or manufacture. In such case the Secretary shall promulgate, upon recommendation of the Food and Drug
Administrator, regulations limiting the quantity therein to such extent as he finds necessary for the protection of public health, and any quantity
exceeding the limits so fixed shall also be deemed to be unsafe. In determining the quantity of such added substance to be tolerated in different
articles of food the Secretary shall take into account the extent to which the use of such article is required or cannot be avoided in the production or
manufacture of such article and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.
(b) The Secretary shall, upon recommendation of the Food and Drug Administrator, promulgate regulations providing for the listing of coal-
tar colors which are harmless and suitable for use in food.
CHAPTER VIII
Drug and Devices
ADULTERATED DRUGS AND DEVICES
Section 18. A drug or device shall be deemed to be adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid, decomposed substance;
or (2) if it has been prepared, packed, or held under insanitary conditions contaminated with filth or whereby it may have been rendered injurious to
health; or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the
contents injurious to health; or (4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than a permissible one.
(b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from,
or its quality or purity falls below, the standard set forth in such compendium, except that whenever tests or methods of assay as are
prescribed are, in the judgment of the Secretary, insufficient for the making of such determination the Secretary, shall promulgate, upon
recommendation of the Food and Drug Administrator, regulations prescribing appropriate tests or methods of assay in accordance with
which such determination as to strength, quality or purity shall be made. No drug defined in an official compendium shall be deemed to be
adulterated under this paragraph because it differs from the standard of strength, quality or purity in strength, quality, or purity from such
standards is plainly stated on its label.
(c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity of quality falls below, that
which it purports or its represented to possess.
(d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly
or in part therefor.
MISBRANDED DRUGS AND DEVICES
Section 19. A drug or device shall be deemed to be misbranded: (a) If its labeling is false or misleading in any particular.
(b) If in a package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor;
(2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That reasonable
variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the Secretary.
(c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling)
use.
(d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine,
bromal, cannabis, cabromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or
sulfonmethane; or any chemical derivative of such substance, which derivative has been recommended by the Secretary, after
investigation, and by regulations, designated as, habit forming; unless its label bears the name, and quantity or proportion of such
substance or derivative and in juxtaposition therewith the statement "Warning May be habit forming."
(e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or
usual name of the drug, if such there be; and (2) in case it is fabricated from two or more ingredients, the common or usual name of each
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active ingredient, including the quantity, kind, and proportion of any alcohol, and also including whether active or not, the name and
quantity of proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine,
hyoscyamine, arsenic, digitalis, digitalis glucosides mercury, ouabain, strophantin, strychnine, thyroid, or any derivative or preparation of
any such substances, contained therein: Provided, That where compliance with this paragraph in impracticable, exemptions shall, upon
recommendation of the Food and Drug Administrator, be established by regulations promulgated by the Secretary.
(f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions
or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application,
in such manner and form, as necessary for the protection of users: Provided, That where any requirement of clause (1) of this paragraph,
as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall, upon recommendation of the
Food and Drug Administrator, promulgate regulations exempting such drug or device from such requirement.
(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed
therein: Provided, That the method of packing may be modified with the consent of the Secretary.
(h) If it has been found by the Secretary to be a drug liable to determination, unless it is packaged in such form and manner, and its label
bears a statement of such precautions, as the Secretary shall by regulations require as necessary for the protection of the public health.
(i) (1) If it is a drug and its container is so made, formed, or filled as to be misleading; or
(2) if it is an imitation of another drug; or
(3) if it is offered for sale under the name of another drug.
(j) If it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the
labeling thereof.
(k) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, bacitracin, or any other anti-biotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a
certificate of release has been issued pursuant to Section twenty-two (a), and (2) such certificate of release is in effect with respect to such
drug: Provided, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under Section
twenty-one (a), (b) and (c).
EXEMPTION IN CASE OF DRUGS AND DEVICES
Section 20. (a) The Secretary is hereby directed to promulgate regulations exempting from any labeling or packaging requirement of this Act drugs
and devices which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments
other than those where originally processed or packed, on condition that such drugs and devices are not adulterated or misbranded, under the
provisions of this Act upon removal from such processing, labeling, or repacking establishment.
(b) (1) Drugs intended for use by man which:
(A) are habit-forming
(B) because of its toxicity or other potentiality for harmful effect, or the method of its use is not safe for use except
under the supervision of a practitioner licensed by law to administer such drug;
(C) are new drugs whose application are limited to investigational use shall be dispensed only (1) upon a written
prescription of a practitioner licensed by law to administer such drug, or (2) upon an oral prescription of such
practitioner which is reduced promptly to writing and filed by the pharmacist, or (3) by refilling any such written or oral
prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is
reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this
paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.
(2) Any drug dispensed by filling or refilling a written prescription of a practitioner licensed by law to administer such drug shall
be exempt from the requirements of Section nineteen, except paragraphs (a), (1), (2) and (3), and the packaging requirements
of paragraphs (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and
date of the prescription or of its filling, the name of prescriber, and, if stated in the prescription the name of the patient, and the
directions of use and cautionary statements, if any, contained in such prescription.
(3) The Secretary may by regulation remove drugs subject to Section nineteen (d) and Section twenty-one from the
requirements of Subsection (b) (1) of this Section, when such requirements are not necessary for the protection of the public
health.
(4) A drug which is subject to subsection (b) (1) of this section shall be deemed to be misbranded if at any time prior to
dispensing, its label fails to bear the statement "Caution: Food, Drug and Cosmetics Law prohibits dispensing without
prescription." A drug to which subsection (b) (1) of this Section does not apply shall be deemed to be misbranded if at any time
prior to dispensing, its label bears the caution statement quoted in the preceding sentence.
NEW DRUGS
Section 21. (a) No person shall manufacture, sell, offer for the sale or transfer any new drug, unless an application filed pursuant to subsection (b) is
effective with respect to such drug.
(b) Any person may file with the Secretary, thru the Food and Drug Administration, an application with respect to any drug subject to the
provisions of subsection (a). Such persons shall permit to the Secretary thru the Food and Drug Administration as a part of the application
(1) full reports of investigations which have been made to show whether or not such drug is safe for use; (2) a full list of the articles used
as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in and the
facilities and controls used for the manufacture, processing, and packing of such drug; (5) such samples of such drug and of the articles
used as components hereof as the Secretary may require; and (6) specimens of the labeling proposed to be used for such drug.
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(c) Within one hundred and eighty days after the filing of an application under this subsection, or such additional period as may be agreed
upon by the Secretary and the applicant, the Secretary shall either (1) approve the application if he then finds that none of the grounds for
denying approval specified in subsection (d) applies, or (2) give the applicant notice of an opportunity for a hearing before the Secretary
under subsection (d) on the question whether such application is approvable.
(d) If the Secretary finds, after due notice to the applicant and giving him an opportunity for a hearing, that (1) the investigation, reports of
which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably
applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed
labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is
safe for use under such conditions; (3) the methods used in, and the facilities and controls used for the manufacture, processing, and
packing of such drug are inadequate to preserve its identity, strength, quality, and purity; or (4) upon the basis of the information submitted
to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient
information to determine whether such drug is safe for use under such conditions; or (5) evaluated on the basis of the information
submitted to him as part of the application, and any other information before him with respect to such drug, there is a lack of substantial
evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or
suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts, such labeling is false or misleading in any
particular; he shall issue an order refusing to approve the application.
(e) The effectiveness of an application with respect to any drug shall, after due notice and opportunity for hearing to the applicant, by order
of the Secretary be suspended if the Secretary finds (1) that clinical experience, tests by new methods, or tests by methods not deemed
reasonably applicable when such application became effective show that such drug is unsafe for use under the conditions of use upon the
basis of which the application became effective, or (2) that the application contains any untrue statement of a material fact. The order shall
state the findings upon which it is based.
(f) An order refusing to permit an application with respect to any drug to become effective shall be revoked whenever the Secretary finds
that the facts so require.
(g) The Secretary shall promulgate regulations for exempting from the operation of this section drugs intended solely for investigational
use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
CHAPTER IX
Certification of Drugs containing Penicillin, Streptomycin, Chlortetracycline, Chloramphenicol or Bacitracin.
Section 22. (a) The Secretary, pursuant to regulations promulgated by him shall provide for the certification of batches of drugs composed wholly or
partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any anti-biotic drug, or any derivative thereof. A batch
of such drug shall be certified if such drug has such characteristics of identity, strength, quality and purity, as the Secretary prescribes in such
regulations as necessary to adequately insure safety and efficacy of use, but shall not otherwise be certified. Prior to the effective date of such
regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the
safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as
to such batch and as to portions thereof. For purposes of this section and of Section nineteen (k), the term "anti-biotic drug" means any drug
intended for use by man containing any quantity of any chemical substance which is produced by micro-organism and which has the capacity to
inhibit or destroy micro-organism in dilute solution (including the chemically synthesized equivalent of any such substance).
(b) Whenever in the judgment of the Secretary, the requirements of this section and of Section nineteen (k) with respect to any drug or
class of drugs are not necessary to insure safety and efficacy of use, the Secretary shall promulgate regulations exempting such drug or
class of drugs from such requirements.
(c) The Secretary shall promulgate regulations exempting from the requirement of this section and of Section nineteen (k), (1) drugs which
are to be stored, processed labeled, or repacked at establishments other than those where manufactured, on condition that such drugs
comply with all such requirements upon removal from such establishments; (2) drugs which conform to applicable standards of identity,
strength, quality, and purity prescribed by these regulations and are intended for use in manufacturing other drugs; and (3) drugs which
are intended for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs.
CHAPTER X
Cosmetics
ADULTERATED COSMETICS
Section 23. A cosmetic shall be deemed to be adulterated: (a) If it bears or contains any poisonous or deleterious substances which may render it
injurious to users under the conditions of use prescribed in the labeling thereof, or under the conditions of use as are customary or usual: Provided,
That this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuous displayed thereon: "Caution: This
product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions
should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness", and the labeling of which
bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term "hair dye" shall not include
eyelash dyes or eyebrow dyes.
(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
(c) If it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it
may have been rendered injurious to health.
(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to
health.
(e) If it is not a hair dye and it bears or contains a coal-tar color other than one which is permissible.
MISBRANDED COSMETIC
Section 24. A cosmetic shall be deemed to be misbranded:
(a) If its labeling is false or misleading in any particular.
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(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and
(2) an accurate statement of the quantity of the contents in terms of weight, measure, of numerical count: Provided, That under reasonable
variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the Secretary.
(c) If any word, statement, or other information required by or under authority of this Act, to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling)
use.
(d) If its container is so made, formed, or filled as to be misleading.
REGULATIONS MAKING EXEMPTIONS
Section 25. The Secretary shall promulgate regulations exempting from any labeling requirements of this Act cosmetic which are, in accordance
with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally
processed or packed, on condition that such cosmetics are not adulterated or misbranded under the provisions of this Act upon removal from such
processing, labeling, repacking establishment.
CHAPTER XI
General Administration Provisions, Regulations, Hearings and Institution of Criminal Action
Section 26. (a) Except as otherwise provided in this section, the Secretary of Health shall, upon recommendation of the Food and Drug
Administrator, issue rules and regulations as may be necessary to enforce effectively the provisions of this Act.
(b) The Commissioner of Customs, the Commissioner of Internal Revenue and the Secretary of Health shall jointly prescribe regulations
for the efficient enforcement of the provisions of Section thirty, except as otherwise provided therein. Such regulations shall be
promulgated upon the recommendation of the Food and Drug Administrator and shall take effect at such time, after due notice, as the
Secretary of Health shall determine.
(c) Hearings authorized or required by this Act shall be conducted by the Board of Food and Drug Inspection which shall submit its
recommendation to the Food and Drug Administrator.
(d) When it appears to the Food and Drug Administrator from the report of the Food and Drug Laboratory that any article of food or any
drug, or cosmetic secured pursuant to Section twenty-eight of this Act is adulterated or misbranded, he shall cause notice thereof to be
given to the person or persons concerned and such person or persons shall be given an opportunity to be heard before the Board of Food
and Drug Inspection and to submit evidence impeaching the correctness of the finding or charge in question.
(e) When a violation of any provisions of this Act comes to the knowledge of the Food and Drug Administrator of such character that a
criminal prosecution ought to be instituted against the offender, he shall certify the facts to the Secretary of Justice through the Secretary
of Health, together with the chemist's report, the findings of the Board of Food and Drug Inspection, or other documentary evidence on
which the charge is based.
(f) Nothing in this Act shall be construed as requiring the Food and Drug Administrator to certify for prosecution pursuant to sub-paragraph
(e) hereof, minor violations of this Act whenever he believes that public interest will be adequately served by a suitable written notice or
warning.
FACTORY INSPECTION
Section 27. (a) For purposes of enforcement of this Act, officers or employees duly designated by the Secretary, upon presenting appropriate
credentials to the owner, operator, or agent in charge, are authorized (1) to enter, at reasonable hours, any factory, warehouse, or establishment in
which food, drugs, devices or cosmetics are manufactured, processed, packed or held, for introduction into domestic commerce or are held after
such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics, in domestic commerce; and (2) to
inspect, in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials,
containers, and labeling therein.
Section 28. (a) If the officer or employee making any such inspection of a factory, warehouse or other establishment has obtained any sample in the
course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge
a receipt describing the samples obtained.
(b) Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer
or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purpose of ascertaining
whether such food consists in whole or in part of any filthy, putrid or decomposed substance, or is otherwise unfit for food, a copy of the results of
such analysis shall be furnished promptly to the owner, operator, or agent in charge.
PUBLICITY
Section 29. (a) The Secretary may cause to be disseminated information regarding food, drugs, devices, or cosmetics in situations involving, in the
opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this Section shall be construed to prohibit the
Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.
CHAPTER XII
Imports and Exports
Section 30. (a) The Commissioner of Customs shall cause to be delivered to the Food and Drug Administration samples taken at random from every
incoming shipment of food, drugs, devices, and cosmetics which are being imported or offered for import into the Philippines giving notice thereof to
the owner or consignee. The quantity of such samples shall be fixed by regulation issued by the Secretary. If it appears from the examination of such
samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions, or (2) such article is forbidden
or restricted from sale in the country in which it was produced or from which it was produced or from which it was exported, or (3) such article is
adulterated, misbranded, or in violation of Section twenty-one, then the Food and Drug Administrator shall so inform the Commissioner of Customs
and such article shall be refused admission, except as provided in subsection (b) of this section. The Commissioner of Customs shall then cause the
destruction of any such article refused admission unless such article is exported, under regulations prescribed by the Commissioner of Customs,
within ninety days of the date of notice of such refusal or within such additional time as may be permitted pursuant to such regulations. If the food,
drugs, devices, and cosmetics being imported or offered for import into the Philippines arrives at a port of entry other than Manila, the collection of
17
such samples shall be the responsibility of the Regional Health Director having jurisdiction over the port of entry and such samples shall be
forwarded to the Food and Drug Administration.
(b) Pending decision as to the admission of an article being imported or offered for import, the Commissioner of Customs may authorize
delivery of such article to the owner or consignee upon execution by him of a good and sufficient bond providing for the payment of such
liquidated damages in the event of default as may be required pursuant to regulations of the Commissioner of Customs. If it appears to the
Secretary that an article included within the provisions of clause (3) of subsection (a) of this section can, by relabeling or other action, be
brought into compliance with the Act or rendered other than a food, drug, device, or cosmetic, final determination as to admission of such
article may be deferred, and upon filing to timely written application by the owner or consignee, and the execution by him of a bond as
provided in the preceding provisions of this subsection, the Secretary may, in accordance with regulations, authorize the applicant to
perform such relabeling or other actions specified in such authorization with regulations (including destruction or export of rejected articles
or portions thereof, as may be specified in the Secretary's authorization). All such relabeling or other action pursuant to such authorization
shall be in accordance with regulations and be under the supervision of an office or employee of the Bureau of Customs designated by the
Commissioner of Customs and a duly authorized representative of the Food and Drug Administrator.
(c) All expenses (including travel, per diem or subsistence, and salaries) of officers or employees of the Philippines in connection with the
destruction provided for in subsection (a) of this section and the supervision of the relabeling or other action authorized under the
provisions of subsection (b) of this section, the amount of such expenses to be determined in accordance with regulations, and all
expenses in connection with the storage, cargo, or labor with respect to any article refused admission under subsection (a) of this section,
shall be paid by the owner or consignee, and in default of such payment, shall constitute a lien against any future importations made by
such owner or consignee.
(d) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this Act if it (1)
conforms with the specifications of the foreign purchaser, (2) is not conflict with laws of the country to which it is intended for export, and
(3) is labelled on the outside of the shipping package to show that it is intended for export. But if such article is sold or offered for sale in
domestic commerce, this subsection shall not exempt it from any of the provisions of this Act.
CHAPTER XIII
Financing
Section 31. The amount of one million pesos is hereby appropriated from any funds in the National Treasury not otherwise appropriated to augment
the funds transferred to this Office under Section eight for the implementation of this Act. All income derived from fees authorized in Section Four of
this Act shall accrue to the General Fund.
CHAPTER XIV
Repealing Clause and Effectivity
Section 32. If any provision of this Act or the application of such provision to any person or circumstance is held invalid, the remainder of this Act or
the application of such provision to other persons of circumstances should not be affected thereby.
Section 33. Section eleven hundred and nine to Section eleven hundred twenty-nine of the Administrative Code, and such other laws, executive
orders, rules and regulations inconsistent with the provisions of this Act are repealed.
Section 34. This Act shall take effect upon its approval.
Approved: June 22, 1963.
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REPUBLIC ACT No. 6425 April 4, 1972
THE DANGEROUS DRUGS ACT OF 1972
Section 1. Short Title. This Act shall be known and cited as "The Dangerous Drugs Act of 1972."
ARTICLE I
Definition of terms
Section 2. Definitions. As used in this Act, the term:
(a) "Administer" refers to the act of introducing any dangerous drug into the body of any person, with or without his knowledge, by
injection, ingestion or other means or of committing any act of indispensable assistance to a person in administering a dangerous drug to
himself;
(b) "Board" refers to the Dangerous Drugs Board created under Section 35, Article VIII of this Act;
(c) "Centers" refers to any of the treatment and rehabilitation centers for drug dependents referred to in Section 34, Article VII of this Act;
(d) "Cultivate or culture" means the act of knowingly planting, growing, raising or permitting the planting, growing or raising of any plant
which is the source of a prohibited drug;
(e) "Dangerous drugs" refers to either:
(1) "Prohibited drug," which includes opium and its active components and derivatives, such as heroin and morphine; coca leaf and its
derivatives, principally cocaine; alpha and beta eucaine; hallucinogenic drugs, such as mescaline, lysergic acid diethylamide (LSD) and
other substances producing similar effects; Indian hemp and its derivates; all preparations made from any of the foregoing; and other
drugs, whether natural or synthetic, with the physiological effects of a narcotic drug; or
(2) "Regulated drug," which includes self-inducing sedatives, such as secobarbital, phenobarbital, pentobarbital, barbital, amobarbital and
any other drug which contains a salt or a derivative of a salt of barbituric acid; any salt, isomer or salt of an isomer, of amphetamine, such
as benzedrine or dexedrine, or any drug which produces a physiological action similar to amphetamine; and hypnotic drugs, such as
methaqualone or any other compound producing similar physiological effects;
(f) "Deliver" refers to a person's act of knowingly passing a dangerous drug to another, personally or otherwise, and by any means, with or
without consideration;
(g) "Drug dependence" means a state of psychic or physical dependence, or both, on a dangerous drug, arising in a person following
administration or use of that drug on a periodic or continuous basis;
(h) "Employee" of a prohibited drug den, dive or resort includes the caretaker, helper, watchman, lookout and other persons employed by
the operator of a prohibited drug den, dive or resort where any prohibited drug is administered, delivered, distributed, sold or used, with or
without compensation, in connection with the operation thereof;
(i) "Indian hemp," otherwise known as "Marijuana," embraces every kind and class of the plant cannabis sativa L. from which the resin has
not been extracted, including cannabis americana, hashish, bhang, guaza, churrus and ganjah, and embraces every kind, class and
character of Indian hemp, whether dried or fresh, flowering or fruiting tops of the pistillate plant, and all its geographic varieties, whether as
a reefer, resin, extract, tincture or in any form whatsoever;
(j) "Manufacture" means the production, preparation, compounding or processing of a dangerous drug either directly or indirectly or by
extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and
chemical synthesis, and shall include any packaging or repackaging of such substance or labeling or relabelling of its container; except
that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance by a duly authorized
practitioner as an incident to his administration or dispensing of such drug or substance in the course of his professional practice;
(k) "Narcotic drug" refers to any drug which produces insensibility, stupor, melancholy or dullness of mind with delusions and which may
be habit-forming, and shall include opium, opium derivatives and synthetic opiates;
(l) "Opium" refers to the coagulated juice of the opium poppy (papaver somniferum) and embraces every kind and class of opium, whether
crude or prepared; the ashes or refuse of the same; narcotic preparations thereof or therefrom; morphine or any alkaloid of opium;
preparations in which opium, morphine or any alkaloid of opium enters as an ingredient; opium poppy straw; and leaves or wrappings of
opium leaves, whether prepared for use or not;
(m) "Pusher" refers to any person who sells, administers, delivers, or gives away to another, on any terms whatsoever, or distributes,
dispatches in transit or transports any dangerous drug or who acts as a broker in any of such transactions, in violation of this Act;
(n) "School" includes any university, college, or institution of learning, regardless of the course or courses it offers;
(o) "Sell" means the act of giving a dangerous drug, whether for money or any other material consideration;
(p) "Use" refers to the act of injecting, intravenously or intramuscularly, or of consuming, either by chewing, smoking, sniffing, eating,
swallowing, drinking, or otherwise introducing into the physiological system of the body, any of the dangerous drugs.
ARTICLE II
Prohibited Drugs
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Section 3. Importation of Prohibited Drugs. The penalty of imprisonment ranging from fourteen years and one day to life imprisonment and a fine
ranging from fourteen thousand to thirty thousand pesos shall be imposed upon any person who, unless authorized by law, shall import or bring into
the Philippines any prohibited drug.
Section 4. Sale, Administration, Delivery, Distribution and Transportation of Prohibited Drugs. The penalty of imprisonment ranging from twelve
years and one day to twenty years and a fine ranging from twelve thousand to twenty thousand pesos shall be imposed upon any person who,
unless authorized by law, shall sell, administer, deliver, give away to another, distribute, dispatch in transit or transport any prohibited drug, or shall
act as a broker in any such transactions. In case of a practitioner, the additional penalty of the revocation of his license to practice his profession
shall be imposed. If the victim of the offense is a minor, the maximum of the penalty shall be imposed.
Should a prohibited drug involved in any offense under this Section, be the proximate cause of the death of a victim thereof, the penalty of life
imprisonment to death and a fine ranging from twenty thousand to thirty thousand pesos shall be imposed upon the pusher.
Section 5. Maintenance of a Den, Dive or Resort for Prohibited Drug Users. The penalty of imprisonment ranging from twelve years and one day to
twenty years and a fine ranging from twelve thousand to twenty thousand pesos shall be imposed upon any person or group of persons who shall
maintain a den, dive or resort where any prohibited drug is used in any form.
The maximum of the penalty shall be imposed in every case where a prohibited drug is administered, delivered or sold to a minor who is allowed to
use the same in such place.
Should a prohibited drug be the proximate cause of the death of a person using the same in such den, dive or resort, the penalty of life imprisonment
to death and a fine ranging from twenty thousand to thirty thousand pesos shall be imposed on the maintainer.
Section 6. Employees and Visitors of Prohibited Drug Den. The penalty of imprisonment ranging from two years and one day to six years and a fine
ranging from two thousand to six thousand pesos shall be imposed upon:
(a) Any employee of a prohibited drug den, dive or resort; and
(b) Any person who, not being included in the provisions of the next preceding, paragraph, shall knowingly visit any prohibited drug den,
dive or resort.
Section 7. Manufacture of Prohibited Drugs. The penalty of life imprisonment to death and a fine ranging from twenty thousand to thirty thousand
pesos shall be imposed upon any person who, unless authorized by law, shall engage in the manufacture of any prohibited drug.
Section 8. Possession or Use of Prohibited Drugs. The penalty of imprisonment ranging from six years and one day to twelve years and a fine
ranging from six thousand to twelve thousand pesos shall be imposed upon any person who, unless authorized by law, shall possess or use any
prohibited drug, except Indian hemp as to which the next following paragraph shall apply.
The penalty of imprisonment ranging from six months and one day to six years and a fine ranging from six hundred to six thousand pesos shall be
imposed upon any person who, unless authorized by law, shall possess or use Indian hemp.
Section 9. Cultivation of Plants Which are Sources of Prohibited Drugs. The penalty of imprisonment ranging from fourteen years and one day to life
imprisonment and a fine ranging from fourteen thousand to thirty thousand pesos shall be imposed upon any person who shall cultivate or culture
Indian hemp, opium poppy ( papaver somniferum) and other plants from which any prohibited drug may be manufactured.
The land on which any of said plants is cultivated or cultured shall be confiscated and escheated to the State, unless the owner thereof can prove
that he did not know of such cultivation or culture despite the exercise of due diligence on his part.
Section 10. Records of Prescriptions, Sales, Purchases, Acquisitions and/or Deliveries of Prohibited Drugs. The penalty of imprisonment ranging
from one year and one day to six years and a fine ranging from one thousand to six thousand pesos shall be imposed upon any pharmacist,
physician, dentist, veterinarian, manufacturer, wholesaler, importer, distributor, dealer or retailer who violates or fails to comply with the provisions of
Section 25 of this Act, if the violation or failure involves a prohibited drug.
The additional penalty of the revocation of his license to practice his profession, in case of a practitioner, or of his or its business license, in case of a
manufacturer, seller, importer, distributor or dealer, shall be imposed.
Section 11. Unlawful Prescription of Prohibited Drugs. The penalty of imprisonment ranging from eight years and one day to twelve years and a fine
ranging from eight thousand to twelve thousand pesos shall be imposed upon any person who, unless authorized by law, shall make or issue a
prescription or any other writing purporting to be a prescription for any prohibited drug.
Section 12. Unnecessary Prescription of Prohibited Drugs. The penalty of imprisonment ranging from four years and one day to twelve years and a
fine ranging from four thousand to twelve thousand pesos and the additional penalty of the revocation of his license to practice shall be imposed
upon any physician or dentist who shall prescribe any prohibited drug for any person whose physical or physiological conditions does not require the
use thereof.
Section 13. Possession of Opium Pipe and Other Paraphernalia for Prohibited Drugs. The penalty of imprisonment ranging from six months and one
day to four years and a fine ranging from six hundred to four thousand pesos shall be imposed upon any person who, unless authorized by law, shall
possess or have under his control any opium, pipe, equipment, instrument, apparatus or other paraphernalia fit or intended for smoking, consuming,
administering, injecting, ingesting or otherwise using opium or any other prohibited drug.
The possession of such opium pipe, equipment, instrument, apparatus or other paraphernalia, fit or intended for any of the purposes enumerated in
this Section shall be prima facie evidence that the possessor has smoked, consumed, administered to himself, injected, ingested or used a
prohibited drug.
ARTICLE III
Regulated Drugs
Section 14. Importation of Regulated Drugs. The penalty of imprisonment ranging from six years and one day to twelve years and a fine ranging
from six thousand to twelve thousand pesos shall be imposed upon any person who, unless authorized by law, shall import or bring any regulated
drug into the Philippines.
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Section 15. Sale, Administration, Dispension, Delivery, Transportation and Distribution of Regulated Drugs. The penalty of imprisonment ranging
from six years and one day to twelve years and a fine ranging from six thousand to twelve thousand pesos shall be imposed upon any person who,
unless authorized by law, shall sell, dispense, deliver, transport or distribute any regulated drug. In case of a practitioner, the maximum of the
penalty herein prescribed and the additional penalty of the revocation of his license to practice his profession shall be imposed.
Section 16. Possession or Use of Regulated Drugs. The penalty of imprisonment ranging from six months and one day to four years and a fine
ranging from six hundred to four thousand pesos shall be imposed upon any person who shall possess or use any regulated drug without the
corresponding license or prescription.
Section 17. Records of Prescriptions, Sales, Purchases, Acquisitions and/or Deliveries of Regulated Drugs. The penalty of imprisonment ranging
from six months and one day to four years and a fine ranging six hundred to four thousand pesos shall be imposed upon any pharmacist, physician,
dentist, veterinarian, manufacturer, wholesaler, importer, distributor, dealer or retailer who violates or fails to comply with the provisions of Section 25
of this Act, if the violation or failure involves a regulated drug.
Section 18. Unlawful Prescription of Regulated Drugs. The penalty of imprisonment ranging from four years and one day to eight years and a fine
ranging from four thousand to eight thousand pesos shall be imposed upon any person who, unless authorized by law, shall make or issue a
prescription for any regulated drug.
Section 19. Unnecessary Prescription of Regulated Drugs. The penalty of imprisonment ranging from six months and one day to four years and a
fine ranging from six hundred to four thousand pesos and the additional penalty of the revocation of his license to practice shall be imposed upon
any physician or dentist who shall prescribe any regulated drug for any person whose physical or physiological condition does not require the use
thereof.
ARTICLE IV
Provisions of Common Application to Offenses Penalized under Articles II and III
Section 20. Confiscation and Forfeiture of the Proceeds or Instruments of the Crime. Every penalty imposed for the unlawful importation, sale,
administration, delivery, transportation or manufacture of dangerous drugs, the cultivation of plants which are sources of prohibited drugs and the
possession of any opium pipe and other paraphernalia for prohibited drugs shall carry with it the confiscation and forfeiture, in favor of the
Government, of the proceeds of the crime and the instruments or tools with which it was committed, unless they are the property of a third person
not liable for the offense, but those which are not of lawful commerce shall be ordered destroyed. Dangerous drugs and plant-sources of prohibited
drugs so confiscated and forfeited in favor of the Government shall be turned over to the Board for safe-keeping and proper disposal.
Section 21. Attempt and Conspiracy. The same penalty prescribed by this Act for the commission of the offense shall be imposed in case of any
attempt or conspiracy to commit the same in the following cases:
a) importation of dangerous drugs;
b) sale, administration, delivery, distribution and transportation of dangerous drugs;
c) maintenance of a den, diver or resort for prohibited drug users;
d) manufacture of dangerous drugs; and
e) cultivation or culture of plants which are sources of prohibited drugs.
Section 22. Additional Penalty if Offender is an Alien. In addition to the penalties therein prescribed, any alien who violates any of the provisions of
Articles II and III of this Act shall be deported without further proceedings immediately after service of sentence.
Section 23. Criminal Liability of Officers of Partnerships, Corporations, Associations and other Juridical Persons; Liability in Cases Where Vehicles,
Vessels or Aircraft or Other Instruments are used to Commit a Crime. In case any violation of this Act is committed by a partnership, corporation,
association or any juridical person, the partner, president, director or manager who consents to or knowingly tolerates such violation shall be held
criminally liable as a co-principal.
The penalty provided for the offense under this Act shall be imposed upon the partner, president, director, manager, officer or stockholder who
knowingly authorizes, tolerates or consents to the use of a vehicle, vessel, or aircraft as an instrument in the importation, sale, delivery, distribution
or transportation of dangerous drugs, or to the use of their equipment, machines or other instruments in the manufacture of any dangerous drug, if
such vehicle, vessel, aircraft, equipment or other instrument is owned by or under the control or supervision of the partnership, corporation,
association or juridical entity to which they are affiliated.
Section 24. Penalty for Government Officials and Employees and Officers and Members of Police Agencies and the Armed Forces.The maximum
penalties provided for in Sections 3, 4, 5, 6, 8, 9, 11 and 12 of Article II and Sections 14, 15, 16, and 19 of Article III shall be imposed if those found
guilty of any of the said offenses are government officials, employees or officers, including members of police agencies and the armed forces.
Section 25. Records Required of Pharmacists, Physicians, Veterinarians or Dentists Dispensing or Prescribing Dangerous Drugs, and of Importers,
Manufacturers, Wholesalers, Distributors, Dealers and Retailers of Dangerous Drugs. (a) Every pharmacist dealing in dangerous drugs shall
maintain and keep an original record of sales, purchases, acquisitions and deliveries of dangerous drugs, indicating therein the license number and
address of the pharmacist; the name, address and license of the manufacturer, importer or wholesaler from whom dangerous drugs have been
purchased; the quantity and name of the dangerous drugs so purchased or acquired; the date of acquisition or purchase; the name, address and
class A residence certificate number of the buyer; the serial number of the prescription and the name of the doctor, dentist, veterinarian or
practitioner issuing the same; the quantity and name of the dangerous drug so sold or delivered; and the date of sale or delivery.
A certified true copy of such record covering a period of three calendar months, duly signed by the pharmacist or the owner of the drug store or
pharmacy, shall be forwarded to the city or municipal health officer within fifteen days following the last day of every quarter of each year.
The city or municipal health officer shall forward such records to the Board within fifteen (15) days from receipt thereof.
(b) A physician, dentist, veterinarian or practitioner authorized to prescribe any dangerous drug shall issue the prescription therefor in one
original and two duplicate copies. The original, after the prescription has been filled, shall be retained by the pharmacist for a period of one
year from the date of sale or delivery of such drug. One copy shall be retained by the buyer or by the person to whom the drug is delivered
until such drug is consumed, while the second copy shall be retained by the person issuing the prescription.
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For purposes of this Act, all prescriptions issued by physicians, dentists, veterinarians or practitioners shall be made out on forms
exclusively issued by and obtained from the Board. Such forms shall be made of a special kind of paper and shall be distributed in such
quantities and contain such information and other data as the Board may, by rules and regulations, require. Such forms shall not be issued
by the Board or any of its employees except to license physicians, dentists, veterinarians and practitioners in such quantities, as the Board
may authorize. In such emergency cases, however, as the Board may specify in the public interest, prescriptions need not be
accomplished on such forms. The prescribing physician, dentist, veterinarian or practitioner shall, within three days after issuing such
prescription, inform the Board of the same in writing. No prescription once issued may be refilled.
(c) All manufacturers, wholesalers, distributors, importers, dealers and retailers of dangerous drugs shall keep a record of all sales,
purchases, acquisitions and deliveries of dangerous drugs, the names, addresses and licenses of the persons from whom the dangerous
drugs were purchased or acquired or to whom such drugs were sold or delivered, the name and quantity of the drugs and the date of the
transaction.
Section 26. Penalty for a Person Importing Dangerous Drugs by Making Use of a Diplomatic Passport. The penalty of life imprisonment and a fine of
thirty thousand pesos shall be imposed upon any person who, unless authorized under this Act, shall import or bring into the Philippines any
dangerous drug by making use of a diplomatic passport, diplomatic facilities, or any other means involving his official status intended to facilitate the
unlawful entry of dangerous drugs. In addition, the diplomatic passport shall be confiscated and canceled.
Section 27. Criminal Liability of Possessor or User of Dangerous Drugs During Social Gatherings. The maximum of the penalties provided for in
Section 8, Article II and Section 16, Article III of this Act shall be imposed upon any person found possessing or using any dangerous drug during a
party or at a social gathering or in a group of at least five persons possessing or using such drugs.
ARTICLE V
Educational Measures
Section 28. Heads, Supervisors and Teachers of Schools. For the purpose of enforcing the provisions of Articles II and III of this Act, all school
heads, supervisors and teachers shall be deemed to be persons in authority and, as such, are hereby vested with the power to apprehend, arrest, or
cause the apprehension or arrest of any person who shall violate any of the said provisions. They shall be considered as persons in authority if they
are in the school or within its immediate vicinity, or beyond such immediate vicinity if they are in attendance at any school or class function in their
official capacity as school heads, supervisors or teachers.
Any teacher or school employees who discovers or finds that any person in the school or within its immediate vicinity is violating any provision of
Articles II and III of this Act shall have the duty to report the violation to the school head or supervisor who shall, in turn, report the matter to the
proper authorities. Failure to report in either case shall, after due hearing, constitute sufficient cause for disciplinary action.
Section 29. Dangerous Drugs as Part of School Curricula.Instruction on the adverse effects of dangerous drugs, including their legal, social and
economic implications, shall be integrated into the existing curricula of all public and private schools, whether general, technical, vocational or agro-
industrial.
The Secretary of Education shall promulgate such rules and regulations as may be necessary to carry out the provisions hereof and, with the
assistance of the Board, shall cause the publication and distribution of materials on dangerous drugs to students and the general public.
ARTICLE VI
Rehabilitative Confinement and Suspension of Sentence
Section 30. Voluntary Submission of a Drug Dependent to Confinement, Treatment and Rehabilitation by the Dependent Himself or Through His
Parent, Guardian or Relative. If a drug dependent voluntarily submits himself for confinement, treatment and rehabilitation in a center and complies
with such conditions therefor as the Board may, by rules and regulations, prescribe, he shall not be criminally liable for any violation of Section 8,
Article II and Section 16, Article III of this Act.
The above exemption shall be extended to a minor who may be committed for treatment and rehabilitation in a government center upon sworn
petition of his parent, guardian or relative within the fourth civil degree of consanguinity or affinity, in that order. Such petition may be filed with the
Court of First Instance of the province or city where the minor resides and shall set forth therein his name and address and the facts relating to his
dependency. The court shall set the petition for hearing and give the drug dependent concerned an opportunity to be heard. If, after such hearing,
the facts so warrant in its judgment, the court shall order the drug dependent to be examined by two physicians accredited by the Board. If both
physicians conclude, after examination, that the minor is not a drug dependent, the court shall enter an order discharging him. If either physician
finds him to be a dependent, the court shall conduct a hearing and consider all relevant evidence which may be offered. If the court makes a finding
of drug dependency, it shall issue an order for his commitment to a center designated by the court for treatment and rehabilitation under the
supervision of the Board.
When, in the opinion of the person committed or of his parent, guardian or relative, or of the Board, such person is rehabilitated, any of the above
parties may file a sworn petition for his release with the Court of First Instance which ordered the commitment. If, after due hearing, the court finds
the petition to be well-founded, it shall forthwith order the release of the person so committed.
Should the drug dependent, having voluntarily submitted himself to confinement, treatment and rehabilitation in, or having been committed to a
center upon petition of the proper party, escape therefrom, he may resubmit himself for confinement within one week from the date of his escape, or
his parent, guardian or relative may, within the same period, surrender him for recommitment. If, however, the drug dependent does not resubmit
himself for confinement or he is not surrendered for recommitment, as the case may be, the Board may file a sworn petition for his recommitment.
Upon proof of previous commitment or of his voluntary submission to confinement, treatment and rehabilitation, the court shall issue an order for
recommitment. If, subsequent to such recommitment, he should escape again, he shall no longer be exempt from criminal liability for use or
possession of any dangerous drug.
The judicial and medical records pertaining to any drug dependent's confinement or commitment under this Section shall be confidential and shall
not be used against him for any purpose except to determine how many times he shall have voluntarily submitted himself to confinement, treatment
and rehabilitation or been committed or recommitted to a center.
Section 31. Compulsory Submission of a Drug Dependent to Treatment and Rehabilitation After Arrest. If a person charged with an offense is found
by the fiscal or by the court, at any stage of the proceedings, to be a drug dependent, the fiscal or the court, as the case may be, shall suspend all
further proceedings and transmit copies of the record of the case to the Board.
In the event the Board determines, after medical examination, that public interest requires that such drug dependent be committed to a government
center for treatment and rehabilitation, it shall file a petition for his commitment with the Court of First Instance of the province or city where he
resides. The court shall take judicial notice of the prior proceedings in the case and shall proceed to hear the petition. If the court finds him to be a
drug dependent, it shall order his commitment to a government center for treatment and rehabilitation. The head of said center shall submit to the
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court every four months, or as often as the court may require, a written report on the progress of the treatment. If the dependent is rehabilitated, as
certified by the center and the Board, he shall be returned to the court which committed him, for his discharge therefrom.
Thereafter, his prosecution for any offense punishable by law shall be instituted or shall continue, as the case may be. In case of conviction, the full
period of his prior detention and of his confinement for treatment and rehabilitation shall be deducted from the period of the penalty imposed on him
and he shall serve sentence only for the remainder thereof.
Section 32. Suspension of Sentence for First Offense of a Minor. If an accused less than twenty-one years of age who is found guilty of violating
Section 8, Article II and Section 16, Article III of this Act has not been previously convicted of violating any provision of this Act or of the Revised
Penal Code or placed on probation as herein provided, the court may defer sentence and place him on probation under the supervision of the Board
or its agents and under such conditions as the court may impose for a period ranging from six months to one year. If the accused violates any of the
conditions of his probation, the court shall pronounce judgment of conviction and he shall serve sentence as in any other criminal case. If, however,
he does not violate any condition of his probation, then upon the expiration of the designated period, the court shall discharge him and dismiss the
proceedings.
If the court finds that such accused is a drug dependent, it shall commit him to a center for treatment and rehabilitation under the supervision of the
Board. Upon certification of his rehabilitation by the Board, the court shall enter an order discharging him.
A confidential record of the proceedings shall be kept by the Department of Justice and shall not be used for any other purpose except as a record to
be used in determining whether or not a person accused under the provisions of this Act is a first offender.
Upon dismissal of the proceedings against him, the court shall enter an order to expunge all official records (other than the confidential record to be
retained by the Department of Justice) relating to his case. Such an order, which shall be kept confidential, shall restore the accused to his status
prior to the case. He shall not be held thereafter, under any provision of law, to be guilty of perjury or of concealment or misrepresentation by reason
of his failure to acknowledge the case or recite any fact related thereto in response to any inquiry made of him for any purpose.
In the case of minors under sixteen year of age at the time of the commission of any offense penalized under this Act, the provisions of Article 80 of
the Revised Penal Code shall apply, without prejudice to the application of the provisions of this Section.
Section 33. Violation of Confidential Nature of Records. The penalty of imprisonment ranging from six months and one day to six years and a fine
ranging from six hundred to six thousand pesos shall be imposed upon any person who, having official custody of, or access to the confidential
records referred to in Sections 30 and 32 of this Act, or anyone who, having gained possession of such records, whether lawfully or not, reveals their
contents to any person other than those charged with the prosecution of offenses under this Act or with its implementation.
ARTICLE VII
Treatment and Rehabilitation of Drug Dependents
Section 34. Treatment and Rehabilitation Center for Drug Dependents. The existing Treatment and Rehabilitation Center for Drug Dependents at
Tagaytay City shall continue to be operated and maintained by the National Bureau of Investigation under the supervision and funding of the Board.
In addition thereto, the Board shall encourage and assist in the establishment, operation and maintenance of private centers. The Tagaytay center
shall constitute the nucleus of such centers as may be created, authorized and/or accredited under this Act.
ARTICLE VIII
Dangerous Drugs Board
Section 35. Creation and Composition of the Board. There is hereby created a Dangerous Drugs Board which shall be composed of nine members.
Three members who shall possess adequate training and experience in the field of dangerous drugs or in law, medicine, criminology, psychology or
social work, shall be appointed by the President of the Philippines with the consent of the Commission on Appointments. The President shall
designate a chairman from among the three appointive members who shall serve for six years. Of the two other members, one shall serve for four
years and the other for two years. Thereafter, the persons appointed to succeed such members shall hold office for a term of six years and until their
successors shall have been duly appointed and qualified. The remaining six shall be ex-officio members, as follows:
(a) the Secretary of Justice or his representative;
(b) the Secretary of National Defense or his representative;
(c) the Secretary of Health or his representative;
(d) the Secretary of Education or his representative;
(e) the Secretary of Finance or his representative; and
(f) the Secretary of the Department of Social Welfare or his representative.
The Director of the National Bureau of Investigation shall be the permanent consultant of the Board.
The chairman shall receive a compensation of twenty-four thousand pesos per annum. The two other members who are appointed by the President
of the Philippines shall each receive a compensation of eighteen thousand pesos per annum.
The Board shall meet at the call of the chairman or of the two other members appointed by the President of the Philippines. The presence of five
members shall constitute a quorum.
The Board may constitute an executive committee, to be composed of the chairman and two other members, which shall have the duty of carrying
into effect the policies and decisions of the Board and shall meet as often as necessary, at the discretion of the chairman.
When public interest so requires, the executive committee may act for and in behalf of the Board, and its decisions shall be valid unless revoked by
the Board at its next regular or special meeting.
The Chief of the Narcotics Section of the National Bureau of Investigation shall be the ex-officio executive director of the Board. He shall be the
administrative officer of the Board and shall perform such other duties as may be assigned to him by it.
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Section 36. Powers and Duties of the Board. The Board shall:
(a) Promulgate such rules and regulations as may be necessary to carry out the purposes of this Act, including the manner of safekeeping,
disposition, burning or condemnation of dangerous drugs under its charge and custody, and prescribe administrative remedies or
sanctions for the violation of such rules and regulations;
(b) Take charge and custody of all dangerous drugs seized, confiscated by or surrendered to any national, provincial or local law
enforcement agency, if no longer needed for purposes of evidence in court;
(c) Develop educational programs based on factual information and disseminate the same to the general public, for which purpose the
Board shall endeavor to make the general public aware of the hazards of dangerous drugs by providing, among others, literature, films,
displays or advertisements, and by coordinating with all institutions of learning as well as with all national and local law enforcement
agencies in planning and conducting its educational campaign programs;
(d) Provide law enforcement officers, school authorities and personnel of centers with special training in dangerous drugs control;
(e) Conduct scientific, clinical, social, psychological, physical and biological researches on dangerous drugs;
(f) Draw up, in consultation and in coordination with the various agencies involved in drugs control, treatment and rehabilitation, both
public and private, a national treatment and rehabilitation program for drug dependents; and call upon any department, office, bureau,
institution or agency of the Government to render such assistance as it may require, or coordinate with it or with other such entities, to
carry out such program as well as such other activities as it may undertake pursuant to the provisions of this Act;
(g) Receive all donations for the purpose of carrying out the objectives of this Act;
(h) Subject to the civil service law and the rules and regulations issued thereunder, appoint such technical, administrative and other
personnel as may be necessary for the effective implementation of this Act;
(i) Receive, gather, collate and evaluate all information on the importation, exportation, production, manufacture, sale, stocks, seizures of
and the estimated need for dangerous drugs, for which purpose of the Board may require from any official, instrumentality or agency of the
Government or any private persons or enterprises dealing in, or engaged in activities having to do with, dangerous drugs such data or
information as it may need to implement this Act;
(j) Relay information regarding any violation of this Act to law enforcement agencies to effect the apprehension of offenders and the
confiscation of dangerous drugs and transmit evidence to the proper court;
(k) Conduct eradication programs to destroy wild or illicit growth of plants from which dangerous drugs may be extracted;
(l) Authorize, pursuant to the provisions of this Act, the importation, distribution, prescription dispensing and sale of, and other lawful acts
in connection with, dangerous drugs of such kind and quantity as it may deem necessary according to the medical and research needs of
the country, which authorization shall be required by the Commissioner of Internal Revenue as a basis for the issuance of licenses and
permits for such purposes in accordance with Republic Act No. 953;
(m) Encourage, assist and accredit private centers, promulgating rules and regulations setting minimum standards for their accreditation to
assure their competence, integrity and stability;
(n) Prescribe and promulgate rules and regulations governing the establishment of such centers as it may deem necessary, after
conducting a feasibility study thereof;
(o) Provide appropriate rewards to informers who are instrumental in the discovery and seizure of dangerous drugs and in the
apprehension of violators of this Act;
(p) Gather and prepare detailed statistics on the importation, exportation, manufacture, stocks, seizures of and estimated need for
dangerous drugs and such other statistical data on said drugs as may be periodically required by the United Nations Narcotics Drug
Commission, the World Health Organization and other international organizations in consonance with international commitments.
ARTICLE IX
Appropriation, Management of Funds and Annual Report
Section 37. Appropriation. In order to carry out the objectives of this Act, the sum of twelve million pesos is hereby appropriated out of any funds in
the National Treasury not otherwise appropriated from the effectivity of this Act until June 30, 1973. Thereafter, such sums as may be necessary to
carry out the provisions of this Act shall be included in subsequent annual General Appropriations Acts.
All income derived from fines authorized in this Act and all unclaimed and forfeited sweepstakes prizes in the Philippine Charity Sweepstakes Office
are hereby constituted as special funds for the implementations of this Act: Provided, That as least 50% of all funds from the latter source shall be
reserved for assistance to accredited and deserving private rehabilitation centers: Provided,further, That all such fines and unclaimed and forfeited
prizes shall be turned over to the Board by the Philippine Charity Sweepstakes Office within 30 days after they are collected or declared forfeited, as
the case may be.
Section 38. Management of Funds Under this Act; Annual Report by the Board. The Board shall manage the funds as it may deem proper for the
attainment of the objectives of this Act. The chairman of the Board shall submit to the President of the Philippines and to the presiding officers of
both houses of Congress, within fifteen days from the opening of the regular session, an annual report on the dangerous drugs situation in the
country which shall include a detailed account of the programs and projects undertaken, statistics on crimes related to dangerous drugs, expenses
incurred pursuant to the provisions of this Act, recommended remedial legislation, if needed, and such other relevant facts as it may deem proper to
cite.
ARTICLE X
Jurisdiction Over Dangerous Drug Cases
Section 39. Jurisdiction of the Circuit Criminal Court. The Circuit Criminal Court shall have exclusive original jurisdiction over all cases involving
offenses punishable under this Act.
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The preliminary investigation of cases filed under this Act shall be resolved within a period of seven (7) days from the date of termination of the
preliminary investigation. Where a prima facie case is established, the corresponding information shall be filed in court within twenty-four (24) hours.
Decision on said cases shall be rendered within a period of fifteen (15) days from the date of submission of the case.
Section 40. Reclassification, Additions or Removal of Any Drug from the List of Dangerous Drugs. The Board shall give notice to the general public
of the reclassification, additional to or removal from the list of any drug by publishing such notice in any newspaper of general circulation once a
week for two consecutive weeks.
The effect of such reclassification, addition or removal shall be as follows:
(1) In case a prohibited drug is reclassified as regulated, the penalties for violations of this Act involving the latter shall, in case of
conviction, be imposed in all pending criminal prosecutions;
(2) In case a regulated drug is reclassified as prohibited, the penalties for violations of this Act involving regulated drugs shall, in case of
conviction, be imposed in all pending criminal prosecutions:
(3) In case of the addition of a new drug to the list of dangerous drugs, no criminal liability involving the same under this Act shall arise
until after the lapse of fifteen (15) days from the last publication of such notice; and
(4) In case of removal of a drug from the list of dangerous drugs, all pending criminal prosecutions involving such a drug under this Act
shall forthwith be dismissed.
ARTICLE XI
Final Provisions
Section 41. Separability Clause. If for any reason any section or provision of this Act, or any portion thereof, or the application of such section,
provision or portion thereof to any person, group or circumstances is declared invalid or unconstitutional, the remainder of this Act shall not be
affected by such declaration.
Section 42. Repealing Clause. Articles one hundred ninety, one hundred ninety-one, one hundred ninety-two, one hundred ninety-three and one
hundred ninety-four of Act Numbered Thirty-eight hundred and fifteen, otherwise known as the Revised Penal Code, are hereby repealed; and the
provisions of such other laws, executive or administrative orders, rules and regulations, or parts thereof, inconsistent with the provisions of this Act;
are hereby repealed or modified accordingly.
Section 43. Effectivity. This Act shall take effect upon its approval.
Approved: March 30, 1972
REPUBLIC ACT No. 6675 September 13, 1988
AN ACT TO PROMOTE, REQUIRE AND ENSURE THE PRODUCTION OF AN ADEQUATE SUPPLY, DISTRIBUTION, USE AND ACCEPTANCE
OF DRUGS AND MEDICINES IDENTIFIED BY THEIR GENERIC NAMES
Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:
Section 1. Title – This Act shall be known as the "Generics Act of 1988."
Section 2. Statement of Policy – It is hereby declared the policy of the State:
To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and
promotion, prescription and dispensing of drugs;
To ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to
indigent patients;
To encourage the extensive use of drugs with generic names through a rational system of procurement and distribution;
To emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of their
therapeutic effectiveness; and
To promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions.
Section 3. Definition of Terms – The following terms are herein defined for purposes of this Act:
(1) "Generic Name or Generic Terminology" is the identification of drugs and medicines by their scientifically and internationally recognize
active ingredients or by their official generic name as determined by the Bureau of Food and Drugs of the Department of Health.
(2) "Active Ingredient" is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product.
(3) "Chemical Name" is the description of the chemical structure of the drug or medicine and serves as the complete identification of a
compound.
(4) "Drug Product" is the finished product form that contains the active ingredients, generally but not necessarily in association with
inactive ingredients.
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(5) "Drug Establishment" is any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs
or medicines.
(6) "Drug Outlets" means drugstores, pharmacies, and any other business establishments which sell drugs or medicines.
(7) "Essential Drugs List" or "National Drug Formulary" is a list of drugs prepared and periodically updated by the Department of Health on
the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria. It shall consist of a core list and a
complementary list.
(8) "Core List" is a list of drugs that meets the health care needs of the majority of the population.
(9) "Complementary List" is a list of alternative drugs used when there is no response to the core essential drug or when there is
hypersensitivity reaction to the core essential drug or when for one reason or another, the core essential drug cannot be given.
(10) "Brand Name" is the proprietary name given by the manufacturer to distinguish its product from those of competitors.
(11) "Generic Drugs" are drugs not covered by patent protection and which are labeled solely by their international non-proprietary or
generic name.
Section 4. The Use of Generic Terminology for Essential Drugs and Promotional Incentives. – (a) In the promotion of the generic names for
pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drugs List to be prepared
within one hundred eighty (180) days from approval of this Act and updated quarterly by the Department of Health on the basis of health conditions
obtaining in the Philippines as well as on internationally accepted criteria.
(b) The exclusive use of generic terminology in the manufacture, marketing and sales of drugs and medicines, particularly those in the Essential
Drugs List, shall be promoted through such a system of incentives as the Board of Investments jointly with the Department of Health and other
government agencies as may be authorized by law, shall promulgate in accordance with existing laws, within one hundred eighty (180) days after
approval of this Act.
Section 5. Posting and Publication – The Department of Health shall publish annually in at least two (2) newspapers of general circulation in the
Philippines the generic names, and the corresponding brand names under which they are marketed, of all drugs and medicines available in the
Philippines.
Section 6. Who Shall Use Generic Terminology - (a) All government health agencies and their personnel as well as other government agencies
shall use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing and administering of drugs and
medicines.
(b) All medical, dental and veterinary practitioners, including private practitioners, shall write prescriptions using the generic name. The brand name
may be included if so desired.
(c) Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall
indicate prominently the generic name of the product. In the case of brand name products, the generic name shall appear prominently and
immediately above the brand name in all product labels as well as in advertising and other promotional materials.
(d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores, shall
inform any buyer about any and all other drug products having the same generic name, together with their corresponding prices so that the buyer
may adequately exercise, his option.
Within one (1) year after approval of this Act, the drug outlets referred to herein, shall post in conspicuous places in their establishments, a list of
drug products with the same generic name and their corresponding prices.
Section 7. Provision on Quality, Manufacturer’s Identity and Responsibility – In order to assure responsibility for drug quality in all instances,
the label of all drugs and medicines shall have the following: name and country of manufacture, dates of manufacture and expiration. The quality of
such generically labeled drugs and medicines shall be duly certified by the Department of Health.
Section 8. Required Production – Subject to the rules and regulations promulgated by the Secretary of Health, every drug manufacturing company
operating in the Philippines shall be required to produce, distribute and make available to the general public the medicine it produces, in the form of
generic drugs.
Section 9. Rules and Regulations – The implementation of the provisions of this Act shall be in accordance with the rules and regulations to be
promulgated by the Department of Health. Rules and regulations with penal sanctions shall be promulgated within one hundred eighty (180) days
after approval of this Act and shall take effect fifteen (15) days after publication in the Official Gazette or in two (2) newspapers of general circulation.
Section 10. Authority to Import – Within three (3) years from the effectivity of this Act, extendible by the President for another two (2) years and
during periods of critical shortage and absolute necessity, the Department of Health is hereby authorized to import raw materials of which there is a
shortage for the use of Filipino-owned or controlled drug establishments to be marketed and sold exclusively under generic nomenclature. The
President may authorize the importation of raw materials tax and duty-free. The Secretary of Health shall ensure that the imported raw materials are
allocated fairly and efficiently among Filipino-owned or controlled drug establishments. He shall submit to the Office of the President and to
Congress a quarterly report on the quantity, kind and value of the raw materials imported.
Section 11. Education Drive – The Department of Health jointly with the Department of Education, Culture and Sports, Philippine Information
Agency and the Department of Local Government shall conduct a continuous information campaign for the public and a continuing education and
training for the medical and allied medical professions on drugs with generic names as an alternative of equal efficacy to the more expensive brand
name drugs. Such educational campaign shall include information on the illnesses or symptoms which each generically named drug is supposed to
cure or alleviate, as well as its contraindications. The Department of Health with the assistance of the Department of Local Government and the
Philippine Information Agency shall monitor the progress of the education drive, and shall submit regular reports to Congress.
Section 12. Penalty – A) Any person who shall violate Section 6(a) or 6(b) of this Act shall suffer the penalty graduated hereunder, viz:
(a) for the first conviction, he shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the
Professional Regulation Commission.
26
(b) for the second conviction, the penalty of fine in the amount of not less than two thousand pesos (P2,000.00) but not exceeding five
thousand pesos (5,000.00) at the discretion of the court.
(c) for the third conviction, the penalty of fine in the amount of not less than five thousand pesos (P5,000.00) but not exceeding then
thousand pesos (P10,000.00) and suspension of his license to practice his profession for thirty (30) days at the discretion of the court.
(d) for the fourth and subsequent convictions, the penalty of fine of not less than ten thousand pesos (P10,000.00) and suspension of his
license to practice his profession for one year or longer at the discretion of the court.
B) Any juridical person who violates Section 6(c), 6(d), 7 or 8 shall suffer the penalty of a fine of not less than five thousand pesos (P5,000.00) nor
more than ten thousand pesos (P10,000.00) and suspension or revocation of license to operate such drug establishment or drug outlet at the
discretion of the Court: Provided,That its officers directly responsible for the violation shall suffer the penalty of fine and suspension or revocation of
license to practice profession, if applicable, and by imprisonment of not less than six (6) months nor more than one (1) year or both fine and
imprisonment at the discretion of the Court: and Provided, further, That if the guilty party is an alien, he shall be ipso facto deported after service of
sentence without need of further proceedings. C) The Secretary of Health shall have the authority to impose administrative sanctions such as
suspension or cancellation of license to operate or recommend suspension of license to practice profession to the Professional Regulation
Commission as the case may be for the violation of this Act. Section 13. Separability Clause – If any provision of this Act is declared invalid, the
remainder or any provision hereof not affected thereby shall remain in force and effect.
Section 14. Repealing Clause – The provisions of any law, executive order, presidential decree or other issuances inconsistent with this Act are
hereby repealed or modified accordingly.
Section 15. Effectivity – This Act shall take effect fifteen (15) days after its complete publication in the Official Gazette or two (2) newspapers of
general circulation.
Approved,
(Sgd.) RAMON V. MITRA (Sgd.) JOVITO R. SALONGA

Speaker of the House of Representatives President of the Senate
This Act which is a consolidation of Senate Bill NO. 453 and House Bill No. 10900 was finally passed by the Senate and the House of
Representatives on August 25, 1988 and August 31, 1988, respectively.
(Sgd.) QUIRINO D. ABAD SANTOS, JR. (Sgd.) EDWIN P. ACOBA

Secretary General Secretary of Senate
House of Represenatives
Approved: September 13, 1988
(Sgd.) CORAZON C. AQUINO
President of the Philippines
REPUBLIC ACT NO. 9125 April 22, 2001
OF ISABELA AS A PROTECTED AREA AND ITS PERIPHERAL AREAS AS BUFFER ZONES, PROVIDING FOR ITS MANAGEMENT AND FOR
OTHER PURPOSES
ARTICLE I
TITLE, POLICIES AND OBJECTIVES
Section 1. Title. - This Act shall be known as the "Northern Sierra Madre Natural Park (NSMNP) Act of 2001."
Section 2. Declaration of Policy. - Considering the unique biological and ecological importance of the Northern Sierra Madre as the widest remaining
tropical rainforest in the Island of Luzon; owing to its rich and diverse ecosystems spanning from coral reefs and seagrass beds to mangroves and
beach forests, ultramafic forests, forests over limestone, lowland dipterocarps to montane forests; recognizing its status as home to a variety of
endemic species of plants and animals such as the rare Philippine Eagle, cloud rat and jade vine, and threatened and endangered species like the
pawikan and estuarine crocodile; and because of its aesthetic, historical, cultural and economic importance to the country, it is hereby declared the
policy of the State to secure the protection, preservation and rehabilitation of the Northern Sierra Madre Mountain Range within the Province of
Isabela, its communities, their culture and their way of life insofar as they are in harmony with nature and do not alter the ecological systems and the
magnitude of biological diversity of the area. In so doing, the State shall ensure the protection and conservation of biodiversity of the NSMNP
through sustainable and participatory development, to advance and protect the interests of its legitimate inhabitants and honor customary laws in
27
accordance with Republic Act No. 7586 or the National Integrated Protected Areas System (NIPAS) Act of 1992 and Republic Act No. 8371 or the
Indigenous Peoples Rights Act of 1997, as well as international conventions to which the Philippines is a signatory.
Section 3. Definitions.-
"Biodiversity" shall refer to the variety and variability among all living organisms and the ecological complexes in which they
a
occur.
"Bioprospecting" shall refer to the research, collection and utilization of biological and genetic resources, for purposes of
b applying the knowledge derived therefrom to make or modify products or processes and their derivatives for scientific,
agricultural, industrial and other applications.
"Buffer zone" shall refer to identified areas outside the boundaries of and immediately adjacent to the NSMNP pursuant to
c
Section 5 hereof that need special development control in order to avoid or minimize harm to the protected area.
"By-product" shall refer to any part taken from wild species such as, but not limited to, hides, antlers, feathers, fur, teeth,
d claws, internal organs, eggs, guano, roots, trunk, branches, leaves, stems, flowers and any other item produced out of or
utilizing wildlife or any of its parts.
"CITES" shall refer to the Convention on International Trade of Endangered Species of wild flora and fauna including all its
e
appendices referring to the lists of species differentially regulated therein.
"Collection" shall refer to the act of gathering, harvesting or catching wildlife, or the taking of any of its parts, derivatives or
f
by-products.
"Commercial" shall refer to market sale in volume or value in excess of that required to maintain a basic subsistence for
g
workers and their dependents.
"Consultation" shall refer to a meeting or dialogue with the concerned or affected individuals, agencies and organizations
h within and outside the NSMNP designed to identify and resolve issues and problems affecting them in relation to the
protection, conservation and sustainable development of the NSMNP.
i "DENR" shall refer to the Department of Environment and Natural Resources.
"Derivatives" shall refer to anything extracted from wild species such as, but not limited to, blood, oils, saliva, musks, resin,
j
gum, seeds, spores, pollen and the like.
"Endangered species" shall refer to species or subspecies whose populations are in danger of extinction and whose survival
k
is unlikely if the causal factors continue operating.
"Endemic species" shall refer to species or subspecies which has limited distribution, often within the geographical limits of
l
the State.
"Exotic species" shall refer to species or subspecies which do not naturally occur within the biogeographic region of the
m
NSMNP at present or in historical time.
"Exploration" shall refer to searching or prospecting for mineral resources, as defined by law, by geological, geochemical or
n geophysical surveys, remote sensing, test pitting, trenching, drilling, shaft sinking, tunneling or any other means for the
purpose of determining the existence, extent, quantity and quality thereof and the feasibility of mining them for profit.
"Exploitation" shall refer to any mode of use, extraction, development, utilization or disposition of resources, for whatever
o
purpose, whether commercial or otherwise.
p "Habitat" shall refer to an area inhabited by wildlife in the natural state.
"ICCs/IPs" shall refer to Indigenous Cultural Communities/Indigenous Peoples as defined in the IPRA, specifically the Agtas,
q
Paranan and Kalinga within the NSMNP.
"Indigenous species" shall refer to native Philippine species and/or subspecies with an existing or historical natural
r
occurrence and distribution within the NSMNP and its buffer zones.
s "IPRA" shall refer to the Indigenous Peoples Rights Act or Republic Act No. 8371 and its pertinent rules and regulations.
t "Kaingin" shall refer to the slash and burn of vegetation to clear land for agricultural purposes.
u "Large-scale infrastructure projects" shall refer to major port facilities, major highways, tall edifices, major dams, and the like.
"Multiple-use zone" shall refer to areas where settlement, traditional and/or sustainable land use, including agriculture,
v agroforestry, extraction activities and other income generating or livelihood activities may be allowed to the extent prescribed
in the management plan.
"Natural park" shall refer to a relatively large area not materially altered by human activity where extractive resource use and
w large-scale infrastructure projects are not allowed in its strict protection zones and maintained to protect outstanding natural
and scenic areas of national or international significance for educational, scientific and recreational use.
"NIPAS Act" shall refer to the National Integrated Protected Areas System Act of 1992 or Republic Act No. 7586, and its
x
pertinent rules and regulations.
"Nongovernment organization (NGO)" shall refer to any civic, development, conservation or philanthropic, non-stock, nonÂ-
y
profit organization, duly registered, having by-laws, a democratically elected representation and multi-sectoral in character.
"Non-renewable resources" shall refer to those resources within the NSMNP and its buffer zones, the natural replenishment
z
rate of which is not known.
aa "PASu" shall refer to the Protected Area Superintendent.
bb "PAMB" shall refer to the Protected Area Management Board.
"People's organization (PO)" shall refer to any organized group of people residing within the NSMNP and its buffer zones
cc
formed to advance the interests of the sector they represent.
"Protected area" shall refer to identified portions of land and water set aside by reason of their unique physical and biological
dd significance, managed to enhance biological diversity and protected against destructive human exploitation, and unless the
context otherwise provides, shall refer to the NSMNP.
"Protected species" shall refer to any plant or animal that is declared 'protected' under Philippine laws, rules and regulations.
This shall also include all plants and animals listed under CITES, the Bonn Convention on Migratory Animals, those specified
ee
under the red-list categories of the International Union for the Conservation of Nature (IUCN), and those species which may
not be considered threatened elsewhere but are in danger of extinction within the NSMNP as determined by the PAMB.
"Quarrying" shall refer to the process of extracting, removing and disposing quarry resources, as defined by law, found on or
ff
underneath the surface of private or public land.
"Recreation zones" shall refer to areas of high recreational, tourism, educational or environmental awareness values where
gg sustainable eco-tourism, recreational, conservation, education or public awareness activities may be allowed as prescribed in
the management plan.
"Special use zones" shall refer to areas containing existing installations of national significance such as telecommunication
hh
facilities, irrigation canals or electric power lines.
"Sustainable use" shall refer to the use of components of biological diversity in a way and at a rate that does not lead to the
decline of the species used and not causing permanent or long-term diminishment or qualitative degradation of biological
ii
species, ecological functions or of other resources extracted or disturbed, thereby maintaining its potential to meet the needs
and aspirations of the present and future Filipino generations.
"Strict protection zones" shall refer to areas with high biodiversity value which shall be closed to all human activity except for
jj
scientific studies and/or ceremonial or religious use by ICCs/IPs.
"Tenured migrants" shall refer to individuals and households within the NSMNP who have actually and continuously occupied
kk
such areas for five (5) years prior to March 10,1997 and are substantially dependent therein for subsistence.
"Traditional" shall refer to using no power machinery resource in extraction process and consistent with historically customary
ll
techniques of production.
28
"Wildlife" shall refer to wild forms and varieties of flora and fauna, including captive-bred or propagated individuals, parts,
mm
derivatives and by-products thereof.
"Zones" shall refer to the divisions within the NSMNP into levels of protection and permitted use of natural resources such as
nn strict protection zone, sustainable use zone, restoration zone, habitat management zone, multiple-use zone, cultural zone,
recreational zone and special use zone, as provided under existing rules and regulations.
Section 4. Declaration and Scope. - Pursuant to and in accordance with the NIPAS Act, the Northern Sierra Madre Mountain Range within the
Province of Isabela is hereby declared and established as a protected area and part of the National Integrated Protected Areas System under the
category of a natural park as defined herein. It shall be referred to as the Northern Sierra Madre Natural Park (NSMNP) and its boundaries shall be
as follows:
Beginning at a point marked 1 on the map which is a point located at the boundary of the provinces of Isabela and Cagayan,
POINT LONGITUDE LATITUDE

1 122 - 11'23" 17 - 32'23"
2 122 - 11'15" 17 - 31'16"
3 122 - 10'14" 17 - 29'43"
4 122 - 10'35" 17 - 28'26"
5 122 - 11'22" 17 - 28'44"
6 122 - 12'19" 17 - 28'02"
7 122 - 12'27" 17 - 25'51"
8 122 - 11'37" 17 - 26'21"
9 122 - 10'18" 17 - 26'57"
10 122 - 09'21" 17 - 28'38"
11 122 - 08'58" 17 - 30'32"
12 122 - 07'47" 17 - 32'01"
13 122 - 05'10" 17 - 32'21"
14 122 - 02'21" 17 - 32'21"
15 122 - 59'31" 17 - 32'20"
16 121 - 59'21" 17 - 30'31"
17 121 - 59'39" 17 - 28'41"
18 122 - 00'45" 17 - 26'47"
19 122 - 00'19" 17 - 24'28
20 121 - 59'55" 17 - 22'27
21 122 - 00'08" 17 - 20'26
22 122 - 00'58" 17 - 19'01
23 122 - 03'16" 17 - 18'13"
24 122 - 02'24" 17 - 16'25
25 122 - 02'44" 17 - 14'15"
26 122 - 03'06" 17 - 12'39
27 122 - 03'12" 17 - 10'52
28 122 - 04'55" 17 - 09'33
29 122 - 06'56" 17 - 10'21
30 122 - 07'17" 17 - 08'19"
31 122 - 07'43" 17 - 06'05
32 122 - 09'04" 17 - 04'46
33 122 - 09'21" 17 - 02'40
34 122 - 09'19" 17 - 00'39
35 122 - 09'19" 16 - 59'27
36 122 - 10'39" 16 - 59'18"
37 122 - 12'11" 16 - 58'25
38 122 - 12'06" 16 - 56'09
39 122 - 12'37" 16 - 54'20
40 122 - 11'10" 16 - 52'49
41 122 - 11'40" 16 - 21'28
42 122 - 12'52" 16 - 49'05
43 122 - 11'21" 16 - 48'16"
44 122 - 10'53" 16 - 46'29
45 122 - 10'47" 16 - 44'17"
46 122 - 11'55" 16 - 42'19"
47 122 - 12'34" 16 - 40'26
48 122 - 12'44" 16 - 37'56
49 122 - 14'41" 16 - 38'37
50 122- 16'19" 16 - 39'36
51 122 - 17'26" 16 - 38'50
52 122 - 19'42" 16 - 38'54
53 122- 21'09" 16 - 39'21
54 122 - 23'58" 16 - 39'21
55 122 - 25'18" 16 - 41'27
56 122 - 26'45" 16 - 43'40
57 122 - 28'03" 16 - 45'53
58 122 - 28'51" 16 - 48'21
59 122 - 29'49" 16 - 50'46
60 122 - 30'20" 16 - 53'18"
61 122 - 31'11" 16 - 55'45
62 122 - 30'59" 16 - 58'24
63 122 - 32'40" 16 - 59'59
64 122 - 33'47" 17 - 02'21
65 122 - 34'16" 17 - 04'44
29
66 122 - 33'59" 17 - 07'10"
67 122 - 32'58" 17 - 09'29
68 122 - 30'55" 17 -10'58
69 122 - 28'24" 17 -10'03
70 122 - 28'11" 17 - 11'60"
71 122 - 29'13" 17 - 14'23
72 122 - 28'60" 17 - 17'03
73 122 - 27'55" 17 - 19'24
74 122 - 26'33" 17 - 21'28
75 122 - 24'29" 17 - 23'15"
76 122 - 21'57" 17 - 24'14
77 122 - 19'33" 17 - 23'01
78 122 - 17'39" 17 - 24'36
79 122 - 16'22" 17 - 26'51
80 122 - 14'57" 17 - 29'06
81 122 - 14'35" 17 - 31'44
containing an approximate land area of two hundred eighty-seven thousand and eight hundred sixty-one hectares (287,861 has.) and coastline
water area of seventy-one thousand and six hundred twenty-five hectares (71,625 has.).
All existing land-use and resource-use permits within the NSMNP and its buffer zones, as provided herein, shall be reviewed and shall not be
renewed upon their expiration unless consistent with the management plan as provided herein and upon approval by the PAMB. Extractive
resource-use within the NSMNP shall not be deemed to include sustainable extraction by indigenous cultural communities or indigenous peoples
and tenured migrants.
Section 5. Buffer Zones. - Buffer zones of not more than one (1) kilometer wide from the boundaries of the NSMNP, except those bordering the
Province of Cagayan, are hereby established. The municipal water boundary stretch along the boundary of the protected area is likewise hereby
established as a buffer zone.
The buffer zones are established for the purpose of providing an extra layer of protection around the protected area in which restrictions can apply
but where sustainable resource management strategies involving local communities and the private sector can assist in repelling threats to the
protected area. Such buffer zones shall be managed according to the management plan as herein provided.
ARTICLE II
MANAGEMENT PLAN AND ZONING
Section 6. Management of the NSMNP and its Buffer Zones. - The management and administration of the NSMNP and its buffer zones shall be
vested with the PAMB, as herein provided. The management of zones to be established within the NSMNP shall be consultative and participatory.
Section 7. Management Plan. - Within one (1) year from the effectivity of this Act and in accordance with the general management planning strategy
as provided for in the NIPAS Act, there shall be a management plan to be prepared by the office of the PASu in coordination with the local
communities, ICCs/IPs and experts with socioeconomic, anthropological and ecological experience in the area. It shall contain, among others:
(a)A period of applicability for twenty-five (25) years subject to periodic review every three (3) years;
(b)Goals and objectives of management in support of Section 2 hereof;
(c)Key management issues such as, but not limited to, issuance of tenurial instruments; issuance, screening and approval of all
development and land-use activities within the NSMNP and its buffer zones; and adequate protection and restoration of endangered
species and fragile ecosystems;
(d)Site management strategy including, but not limited to, establishment of clear and simplified guidelines on activities, consistent with the
NIPAS Act and this Act, that shall be allowed within the zones;
(e)Major management activities such as, but not limited to, enforcement of laws, habitats and wildlife management, sustainable use
management, infrastructure development and maintenance, fire prevention and pest and disease control;
(f)Zoning in accordance with Section 9 hereof;
(g)Mechanisms for the protection of the occupants therein in the exercise of their rights;
(h)Regulations for sustainable, ecologically sound use of non-protected species of flora and fauna and their habitats; harvesting, hunting
and trapping with respect to the protection of fragile habitats, wild animal breeding seasons, roosting and feeding sites; and
(i)Sustainable livelihood activities.
The management plan shall be consistent with the nature of the NSMNP as a protected area under the category of a natural park. It shall be
reviewed and approved by the PAMB and certified to by the DENR Secretary that it conforms to all laws and rules and regulations issued by the
DENR. The management plan shall not be revised nor modified except by prior consultation with the PAMB and in accordance with the procedure
herein set forth.
Before the expiration of the initial management plan, there shall be a successor plan to be prepared by the office of the PASu in the same manner as
the procedure and principles herein set forth and in accordance with the general management planning strategy as provided in the NIPAS Act. A
year before the expiration of the management plan, the PASu shall cause the publication of notices for comments and suggestions on the successor
plan in a newspaper of local circulation and the posting of such notices in the provincial, municipal and barangay halls and in three (3) other
conspicuous areas frequented by the public. The successor plan to the management plan shall be made available for public perusal at the office and
sub-offices of the PASu and the DENR provincial office.
Section 8. Integration of the Management Plan into Local Government Development Plans. - Local government units shall participate in the
management of the NSMNP and its buffer zones through their representation in the PAMB. To ensure that the future development of the Province of
30
Isabela and Region II takes place in accordance with this Act, the provisions herein shall be incorporated into the barangay, municipal and provincial
development plans of Isabela and the regional development plan of Region II as part of the environmental concerns of the province and the region.
Local government units shall likewise ensure that their ordinances pertaining to the environment are consistent with this Act and the management
plan, as herein provided.
Section 9. Zoning. - Zones shall be established within the NSMNP and its buffer zones giving primary consideration to the preservation and
conservation of all life forms while according respect to the traditional areas used and recognized by ICCs/IPs. Zoning shall also take into account
the tenurial and livelihood concerns of other communities and must ensure the efficient protection of habitats, fragile ecosystems and unique areas.
All primary (old growth) forests within the NSMNP, including portions which have been previously declared as alienable and disposable, shall be
classified as strict protection zones and shall be free from all forms of logging or exploitation, whether commercial or otherwise. However, portions of
primary forests may be classified as sustainable use zones. Strict protection zones shall also be established where necessary for the preservation of
biodiversity including, but not limited to, the survival of rare and endangered species.
The establishment and management of zones must involve the community concerned by undertaking such steps as dialogue, community-based
management approach, and land and resource-use mapping.
Multiple-use zones shall be validated on the ground, demarcated on maps, and monumented in the field with the assistance of communities and
agencies concerned.
ARTICLE III
THE PROTECTED AREA MANAGEMENT BOARD
Section 10. The Protected Area Management Board. - There is hereby created a Protected Area Management Board (PAMB) which shall be the
sole policy-making and permit-granting body of the NSMNP and its buffer zones.
In addition to the powers enumerated in the NIPAS Act, the PAMB shall decide by a majority vote and shall have the following powers and functions:
(a)Issue rules and regulations in accordance with the management plan to prohibit and regulate acts that may be prejudicial to the
NSMNP and its buffer zones pursuant to the policy declarations herein set forth.
(b)Issue land and resource-use permits and all the necessary permits within the NSMNP and its buffer zones in accordance with the
management plan and consistent with the nature of the NSMNP as a natural park. This authority may be delegated by the PAMB to the
PASu upon prior determination of the conditions and qualifications necessary for the issuance therefor;
(c)Establish criteria and set fees for the issuance of permits for the activities regulated by this Act or the management plan. The PAMB
shall only issue permits taking into consideration ecological and sustainability factors based on the policies provided in Sections 2 and 9 of
this Act;
(d)Adopt rules of procedure for the conduct of business, including the creation of committees to which the PAMB's powers may be
delegated;
(e)Control and supervise the office of the PASu;
(f)Deputize, through the PASu, individuals for the enforcement of the laws, rules and regulations governing conduct within the NSMNP and
its buffer zones, and prescribe the necessary qualifications therefor;
(g)Accept donations, approve proposals for funding, budget allocations and exercise accountability over all funds that may accrue to the
NSMNP;
(h)Coordinate with the appropriate agencies of the government; and
(i)Retain legal counsel to defend cases against the PAMB and the office of the PASu whenever they are sued in connection with the
performance of their duties under this Act.
The DENR, through the regional executive director (RED), shall ensure that the PAMB acts within the scope of its powers and functions. In case of
conflict between administrative orders issued by the DENR pursuant to the NIPAS Act and the resolutions issued by the PAMB, the DENR Secretary
shall decide whether to apply the rule or withdraw its application within the NSMNP.
Section 11. Composition. - The PAMB shall be composed of:
(a)The RED of the DENR Region II as chairperson;
(b)The provincial environment and natural resources officer (PENRO) of Isabela;
(c)All the mayors of the coastal or eastern municipalities of Maconacon, Divilacan, Palanan and Dinapigue and the western municipalities
of San Mariano, Ilagan, Tumauini, Cabagan andSan Pablo. Each mayor may appoint a regular duly authorized representative whenever
he/she cannot personally attend any of the PAMB meetings;
(d)The provincial planning and development officer of Isabela;
(e)All the chairpersons of the association of barangay captains for the coastal or eastern municipalities of Maconacon, Divilacan and
Palanan, except Dinapigue; and one (1) barangay captain to be chosen from among the heads of each barangay within the NSMNP from
the western municipalities of San Mariano, Ilagan, Tumauini, Cabagan and San Pablo;
(f)One (1) representative from the sangguniang kabataan to be chosen from among the chairpersons of each of the municipalities within
the NSMNP;
(g)Three (3) representatives from NGOs operating within the NSMNP, chosen from among themselves;
31
(h)Four (4) representatives from POs from within the NSMNP, chosen from among themselves;
(i)Twelve (12) ICC/IP representatives, eight (8) directly from the coastal or eastern municipalities comprised of three (3) ICC/IP
representatives from Palanan, two (2) each from Maconacon and Divilacan, and one (1) from Dinapigue; and four (4) from the western
municipalities of San Mariano, Ilagan, Tumauini, Cabagan and San Pablo, chosen directly from among the ICCs/IPs; and
(j)One (1) representative from the women's sector to be chosen from among the accredited women's organizations.
In addition to actual and necessary travelling and subsistence expenses incurred in the performance of their duties, PAMB members shall be entitled
to honorarium and insurance coverage in attending PAMB or other PAMB committee meetings. These expenses shall be included in the budget for
the NSMNP.
Section 12. The Executive Committee. - There shall be an executive committee (Execom) within the PAMB to whom the PAMB may delegate some
of its powers and functions. It shall be composed of:
(a)The RED of the DENR Region II as chair, or the RTD-EMPAS as his representative;
(b)One (1) of the NGO representatives as vice chair;
(c)One (1) of the ICC/IP representatives;
(d)One (1) of the PO representatives;
(e)The representative from the women's sector;
(f)One (1) mayor from the eastern municipalities and one (1) mayor from the western municipalities; or their respective representatives;
and
(g)One (1) barangay captain from the coastal or eastern municipalities, and the barangay captain representing the western municipalities.
The PAMB may create other committees within the Board.
The PAMB en banc shall hold regular meetings at least twice a year. However, the Execom may meet on a more regular basis to discuss regular
day-to-day affairs and other matters delegated by the PAMB.
Section 13. Terms of Office. - Except for government officials who shall serve ex officio, each PAMB member shall serve for a term of five (5)
years: Provided, That he/she remains connected with the sector he/she is supposed to represent. Whenever a vacancy occurs during the term of a
member who does not represent the government, a new member shall be chosen in the same manner as the original selection
process: Provided, That he/she shall only serve for the remaining term.
Section 14. Removal from Office. - A PAMB member may be removed, for cause and upon majority vote, on the following grounds:
(a)More than three (3) consecutive unexcused absences in regular PAMB en banc meetings;
(b)Commission of any of the prohibited acts as provided in this Act, the NIPAS Act or other rules and regulations governing protected
areas and protected species;
(c)Graft and corruption; and
(d)Conviction of any criminal offense.
Section 15. The Office of the PASu. - There shall be an office of the Protected Area Superintendent (PASu) within the DENR to be headed by the
PASu who shall serve as the chief operating DENR officer of the entire NSMNP and its buffer zones. The PASu and his/her staff shall reside within
the protected area and establish an office, or if necessary, sub-offices within the NSMNP and its buffer zones in order to implement this Act.
The PASu shall have full responsibility for the protection of land, water, wildlife and other resources within the NSMNP. As such, he shall have the
following duties and responsibilities in addition to those provided under existing laws and regulations:
(a)Prepare the management plan and its successor plans as herein provided;
(b)Serve as secretariat to the PAMB with the duty to provide the PAMB with all the information necessary to make appropriate decisions
for the implementation of this Act;
(c)Hire and supervise the necessary personnel to support operations as the budget may allow;
(d)Establish a productive partnership with local communities, including groups supporting the achievement of the goals and objectives of
this Act;
(e)Develop and implement park information, education and visitor programs;
(f)Enforce the laws, rules and regulations and PAMB resolutions relevant to the protected area and its buffer zones, and assist in the
prosecution of offenses;
(g)Monitor all activities within the NSMNP and its buffer zones in conformity with the management plan; and
(h)Perform such other functions as the PAMB may assign.
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ARTICLE IV
ANCESTRAL LANDS AND DOMAINS AND TENURED MIGRANTS
Section 16. Ancestral Lands and Domains. - The rights of ICCs/IPs in the NSMNP to their lands and domains shall be fully recognized. Traditional
property regimes exercised by ICCs/ IPs in accordance with their customary laws shall govern the relationship of all individuals within their
communities with respect to all land and other resources found within the ancestral lands and domains traditionally used by them.
The provisions of this Act shall be construed liberally in favor of the ICCs/IPs in accordance with the preservation and conservation objectives of the
NSMNP and its resources. Nothing herein shall be construed to impair or diminish prior and existing rights currently enjoyed by the IPs/ICCs as
provided by existing laws.
Section 17. Tenured Migrants. - Whenever practicable, tenured migrant communities of more than five (5) households occupying contiguous lots
shall be provided tenurial rights over their current habitation sites. However, if despite the foregoing, these areas are subsequently identified as
crucial for conservation, tenured migrants shall, after due consultation, be offered alternative sites within the appropriate zones or buffer zones with
preference over non-tenured migrants: Provided, That provisions for their transfer shall be undertaken using humanitarian considerations including
payment of compensation, providing tenure to alternative land and facilities of equivalent standard, and other measures to reach agreement with the
affected tenured migrants.
In all other cases, the grant of tenurial rights must take into account the need to promote clustering and to avoid unnecessary displacement. In areas
where tenurial instruments are granted, appropriate use zones shall be established for the purpose of maintaining non-commercial livelihood
activities.
Lands used as homelots or farmlots shall preferably be held by individual household. Lands currently used on a communal basis shall not be held
individually.
Tenurial instruments shall not be issued solely on the basis of tax declaration receipts but must be supported by indisputable evidence of permanent
land-use from five (5) years before 10 March 1997, such as:
(a)Cultivated trees at their fruit-bearing stage;
(b)Physical structures in the area indicating prolonged occupancy;
(c)Certification from the barangay captain or any two (2) respected members of the nearest community attesting to occupancy; and
(d)Other relevant data (e.g. previous census reports) that may be accepted by the PAMB.
Existing land title instruments shall be reviewed by the PASu and endorsed by the PAMB to the DENR regional office for validation or reversion.
All persons who fail to qualify as tenured migrants including transient farmers shall be allowed to gather and collect whatever they have planted
within five (5) years from the effectivity of this Act. Any transfer of non-tenured migrants from the NSMNP shall be undertaken using humanitarian
considerations.
Section 18. Contracts Involving Lands within the NSMNP and its Buffer Zones. - Any purchase, sale, encumbrance, mortgage, usufruct, or any form
of disposition, alienation or transfer of rights involving lands within the NSMNP shall be restricted solely among tenured migrants and ICCs/IPs;
otherwise, it shall be void.
Lease of lands within the NSMNP to persons not otherwise qualified to hold lands may only take place in multiple-use zones, recreation and special
use zones: Provided, That the use thereof is consistent with Section 2 of this Act and in accordance with the management plan.
ARTICLE V
UTILIZATION OF RESOURCES AND FACILITIES
Section 19. Utilization of Resources. - Except for protected species or whenever detrimental to the ecosystem, the use of resources derived from
the NSMNP by tenured migrants and ICCs/IPs for their domestic needs or for their subsistence shall not be restricted: Provided, however, That
livelihood activities requiring the use of these resources shall be allowed only when sustainable, consistent with the management plan, and after
prior PAMB approval. Only non-timber forest products can be used for livelihood purposes.
The PAMB is authorized to impose regulatory measures such as hunting moratoriums, closed hunting seasons and other restrictions on the use of
resources within the NSMNP and its buffer zones to ensure the sustainability of species and ecosystems: Provided, That these will not pose a threat
to the food security of the ICCs/IPs or other tenured migrants directly dependent therein for their subsistence: Provided, further, That these
restrictions shall be made upon due consultation with the ICCs/IPs and tenured migrants.
Any exploration, exploitation or utilization of non-renewable resources within the NSMNP for commercial purposes or by non-tenured migrants or
non-ICCs/IPs shall not be allowed.
Energy projects within the NSMNP shall be allowed only through an act of Congress except energy from wind, sun, waves and water
sources: Provided, That in all instances, the primary beneficiaries shall be residents of the NSMNP and its buffer zones: Provided, further, That it
shall undergo the Environmental Impact Assessment (EIA) system as provided by law and: Provided, finally, That the PAMB has endorsed the
project.
Commercial exploitation of water resources within the NSMNP shall require prior PAMB approval, must be in accordance with the management plan,
and should undergo the EIA system.
Section 20. Existing Facilities within the NSMNP. - Within ninety (90) days from the effectivity of this Act, all existing commercial facilities within the
NSMNP or its buffer zones with a total capitalization in excess of Fifty thousand pesos (P50,000) shall submit to the PAMB through the PASu the
following information:
(a)Potential for disturbance of protected species and their habitat, reproductive cycle, nesting and feeding grounds and migratory paths;
(b)Noise levels at all stages of operation;
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(c)Emissions and effluent at all stages of operation;
(d)Energy requirements and sources of energy; and
(e)Requirements of water supply and sources of water.
Based on these submissions, the PAMB with the assistance of the DENR, shall determine whether the existence of such facility/ ies and its future
plans and operations will be detrimental to the NSMNP and its buffer zones.
Failure to submit the required information shall constitute a violation of this Act. The PAMB may prescribe further conditions for the operation of the
facility to ensure that it does not contradict the management objectives of the NSMNP. If any of such conditions are violated, a fine of Five thousand
pesos (P5,000) for every day of violation shall be imposed upon the owners of said facility but not to exceed a total of Four hundred fifty thousand
pesos (P450,000). At anytime whenever necessary, the PAMB through the PASu or other government entities shall cause the cessation and
demolition of the facility at the cost of its owners.
Existing facilities allowed to remain within the NSMNP or its buffer zones shall be charged a fee by the PAMB, which shall not be more than two
percent (2%) of the annual gross income of the facility.
ARTICLE VI
PROHIBITED ACTS AND PENALTIES
Section 21. Prohibited Acts. - The following acts shall be prohibited within the NSMNP and its buffer zones, in addition to the prohibited acts as
provided in the NIPAS Act and its pertinent rules and regulations:
(a)Hunting, collecting, catching, capture, wounding, killing, destroying or possessing anywhere within the NSMNP or its buffer zones any
protected species of plant or animal or their by-products or derivatives without prior PAMB approval;
(b)Hunting, collecting, catching, capture, wounding, killing or destroying anywhere within the NSMNP or its buffer zones any other species
of plant or animal or their by-products or derivatives the trade of which is regulated by the PAMB, without prior PAMB approval;
(c)Bioprospecting without obtaining prior PAMB approval and the prior and informed consent of ICCs/IPs in accordance with existing
guidelines;
(d)Transporting within or outside the NSMNP or its buffer zones any protected species of plant or animal or their by-products or derivatives
from the NSMNP and its buffer zones without the necessary transport permit from the PAMB;
(e)The deliberate disturbance of protected species or their habitats, reproductive cycle, roosting and feeding grounds, and migratory
paths;
(f)Cutting, gathering, collecting or removal of timber or other forest products without prior PAMB permit: Provided, That any permit issued
shall be valid for only one (1) year at a time and given only to: (i) tenured migrants within sustainable, monitored and controlled quotas,
and (ii) for scientific purposes necessary for protected area management in accordance with existing guidelines;
(g)Establishment or introduction of exotic species within the NSMNP with allelophatic effect or those detrimental to endemic species, or
without prior PAMB approval;
(h)Exploration, exploitation or extraction, drilling or prospecting for minerals or resources, or engages in quarrying within the NSMNP or its
buffer zones;
(i)Destroying, excavating, vandalizing or in any manner damaging any natural formation on land or sea, burial or religious/ spiritual sites,
artifacts, objects belonging to ICCs/IPs and other objects of natural and scenic value;
(j)Possession or use of blasting caps, explosives or cyanide anywhere within the NSMNP or its buffer zones;
(k)Possession or use of chainsaws and band saws without a prior permit from the PAMB: Provided, That permits may only be issued for
multiple-use and buffer zones;
(l)Use of motorized equipment anywhere within the strict protection zone of the NSMNP without a prior permit from the PAMB.
(m)Construction or maintains any kind of road, edifice, facility or any infrastructure project within the NSMNP without a prior permit from
the PAMB: Provided, That no PAMB permit can be issued unless:
(1)the PAMB has been fully informed of the project or undertaking and its environmental consequences through consultative
process;
(2)all other legal requirements have been complied with; and
(3)the project is consistent with the nature of the NSMNP as a protected area natural park.
(n)Occupation of any portion of land inside the NSMNP without a permit from the PAMB. Clearing, construction of residence or any
introduction of improvements shall constitute prima facie evidence of occupation or settlement;
(o)Alteration, removal, destruction of boundary marks or signs;
(p)Engaging in kaingin or in any manner causing a forest fire inside the NSMNP or its buffer zones;
(q)Fishing anywhere within the NSMNP without prior permit from the PAMB;
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(r)Fishing within the NSMNP using spear and submerged underwater breathing apparatus, trawling equipment or gillnets of more than one
hundred meters (100 m.) in total length or any other equipment prohibited under Republic Act No. 8550 or the Fisheries Code of 1998;
(s)Destruction or in any manner damaging coral reefs except in cases of emergency;
(t)Introduction, disposal, dumping or causing to be dumped into the NSMNP or its buffer zones any waste material, including but not
limited to, non-biodegradable, toxic, nuclear, hazardous and other prohibited substances; and
(u)Violation of any rules and regulations provided in the management plan or any resolution reached by the PAMB in the exercise of its
adjudicative functions.
Section 22. Penalties. -
(a)For any violation of the provisions of Section 21 hereof, a fine of not less than Five thousand pesos (P5,000) but not more than Five
hundred thousand pesos (P500,000) and/or imprisonment of not less than one (1) year but not more than six (6) years shall be imposed.
(b)Any provision to the contrary notwithstanding, commission of any unlawful act as provided under Section 22(a) herein shall carry the
penalty of imprisonment of six (6) years and one (1) day to twelve (12) years, and a minimum fine of One million pesos (P1,000,000) in
case the species involved is listed under CITES Appendix I, Seven hundred fifty thousand pesos (P750,000) for species listed under
CITES Appendix II, and Five hundred thousand pesos (P500,000) for all threatened species, in addition to the accessory penalties
provided in the immediately succeeding paragraph.
(c)Commission of any of the foregoing acts shall likewise carry the accessory penalties of eviction from the NSMNP or its buffer zones,
payment of damages for rehabilitation and restoration, and the forfeiture of all equipment, devices, weapons or any other instrument or
tool used in the commission of the offense. Any resource found in the possession of the offender shall also be forfeited. Pending the
outcome of the case, any resource confiscated shall be immediately turned over to the PAMB for proper disposal and the proceeds thereof
deposited in a trust fund. However, in no case shall any confiscated or rescued protected animal species be sold or in any manner
disposed of but shall be immediately turned over to the PASu office for release in its natural habitat. Valuation of the damage to the
NSMNP and its buffer zones shall take into account biodiversity and conservation considerations as well as aesthetic, socioeconomic
values, and rehabilitation and restoration costs. Failure to comply with this provision shall constitute an offense under this subsection.
(d)A fine of not less than One hundred thousand pesos (P100,000) but not more than Five hundred thousand pesos (P500,000) and/or
imprisonment of not less than one (1) year but not more than six (6) years shall be imposed upon any public officer or officer of the law
who shall unjustifiably refuse or refrain from instituting prosecution or shall tolerate the commission of the abovementioned offenses.
Conviction of this offense shall carry the accessory penalty of perpetual disqualification from public office.
(e)A fine of not less than One hundred pesos (P100) but not more than One thousand pesos (P1,000), or community service from one (1)
day to one (1) week, or both, shall be imposed on anyone who enters into the strict protection zone of the NSMNP without prior PAMB
permit.
Section 23. Exemptions.- Members of ICCs/IPs who commit any of the abovementioned acts in the exercise of their customary laws, traditional
rights, and traditional cultural spiritual practices without having been adequately informed of restricting rules and regulations for the NSMNP by the
PAMB shall be exempt.
Except for protected species, the certified customs and traditional practices of ICCs/IPs when sustainable and carried out with traditional tools and
equipment are also allowable activities over which the above prohibitions shall not apply.
All activities contained in the management plan and such other measures as are necessary for protection, preservation and protected area
management as certified by the PAMB and the DENR Secretary and those undertaken by the PASu or those deputized by the PAMB shall likewise
be exempt.
Section 24. Special Prosecutor. - Within thirty (30) days from the effectivity of this Act, the Department of Justice (DOJ) shall designate a special
prosecutor to whom all cases of violation of protected area laws, rules and regulations within the NSMNP and its buffer zones shall be assigned. The
special prosecutor shall coordinate with the PAMB and the PASu in the performance of his/her duties and assist in the training of wardens and
rangers in arrest and criminal procedure.
The PAMB may appoint a private prosecutor on a case-to-case basis to assist the public prosecutor in the enforcement of protected area laws.
ARTICLE VII
PROCEEDS, FEES AND APPROPRIATIONS
Section 25. Integrated Protected Areas Fund (IPAF). - There is hereby established a trust fund to be known as the Integrated Protected Areas Fund
(IPAF) for purposes of financing projects of the system. All incomes generated from the operation of the system or management of wild flora and
fauna in the NSMNP shall accrue to the fund. These income shall be derived from fees from permitted sale and export of flora and fauna and other
resources from the protected area and its buffer zones other than protected species as may be set by the DENR and the PAMB, proceeds from
lease of multiple-use areas, contributions from industries and facilities directly benefiting from the protected area and such other fees and incomes
derived from the operation of the protected area.
The fund may be augmented by grants, donations, endowment from various sources, domestic or foreign for purposes related to their
functions: Provided, That the fund shall be deposited as a special account in the national treasury and disbursements therefrom shall be made
solely for the protection, maintenance, administration and management of the system, and duly approved projects endorsed by the PAMB in
accordance with existing accounting and budgeting rules and regulations: Provided, further, That no amount shall be disbursed for the operating
expenses of the Department and other concerned agencies.
Section 26. Appropriations. - The Secretary of the DENR shall include in its program the implementation of this Act, the funding of which shall be
charged against the IPAF constituted under this Act and from appropriations authorized in the annual General Appropriations Act.
ARTICLE VIII
TRANSITORY AND MISCELLANEOUS PROVISIONS
Section 27. Construction. - The provisions of this Act shall be construed liberally in favor of tenured migrants and ICCs/IPs and in consideration of
the protection and conservation of biodiversity. The NIPAS Act shall have suppletory effect in the implementation of this Act.
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Section 28. Transitory Provisions. - In order to ensure the sustainability and recovery of biodiversity and to develop sustainable livelihood
opportunities for tenured migrants, the DENR shall henceforth cease to issue concessions, licenses, permits, clearances, compliance documents or
any other instrument that allows exploitation of resources within the NSMNP until the management plan shall have been put into effect.
Pending the organization of a new PAMB in accordance with this Act, the incumbent PAMB members shall continue to hold office until a new PAMB
has been convened.
Section 29. Separability Clause. - If, for any reason, any part or section of this Act is declared unconstitutional or invalid, such other parts not
affected thereby shall remain in full force and effect.
Section 30. Repealing Clause. - All laws, decrees, proclamations, rules and regulations inconsistent with the provisions of this Act are hereby
repealed or modified accordingly.
Section 31. Effectivity Clause. - This Act shall be translated in Filipino and Ilocano. It shall be published once a week for three (3) consecutive
weeks in a newspaper of general circulation readily available in the areas in and around the NSMNP and its buffer zones. It shall likewise be
conspicuously posted simultaneously in the provincial, municipal and barangay halls within the NSMNP, as well as in three (3) other places
frequented by the public. Fifteen (15) days after the last publication and posting, this Act shall have full force and effect.
Approved,
(Sgd.) AQUILINO Q. PIMENTEL JR. (Sgd.) FELICIANO BELMONTE JR.

President of the Senate Speaker of the House of Representatives
This Act which is a consolidation of House Bill No. 12809 and Senate Bill No. 2237 was finally passed by the House of Representatives and Senate
on February 5, 2001 and February 8, 2001, respectively.
(Sgd.) LUTGARDO B. BARBO (Sgd.) ROBERTO NAZARENO

Secretary of Senate Secretary General
House of Representatives
Approved: APR 22 2001
(Sgd.) GLORIA MACAPAGAL-ARROYO
[REPUBLIC ACT NO. 8203]

AN ACT OF PROHIBITING COUNTERFEIT DRUGS, PROVIDINGPENALTIES FOR VIOLATIONS AND APPROPRIATING
FUNDS THEREFOR

SECTION 1. Title – This Act shall be known as the"Special Law on Counterfeit Drugs."

SECTION 2. Declaration of Policy - It is hereby the policy of the State to protect and promote the right to health of the people and instill health
consciousness among them as provided in Section 15 Article 11 of the Constitution.

It is also further declared the policy of the State that in order to safeguard the health of the people, the State shall provide for their protection
against counterfeit drugs.
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SECTION 3. Definition of Terms – For purposesof this Act, the terms:

(a) Drugs shall refer to any chemical compound orbiological substance, other than
food, intendedfor use in the treatment, prevention or diagnosisof disease in man or animals, including but not limited to:

(1) any article recognized in the official United States Pharmacopoeia – National Formulary (USP-NF), official HomeopathicPharmacopoeia of the United
States, Philippines National Drug Formulary, British Pharmacopoeia, any NationalCompendium or any supplement to any ofthem;

(2) any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;

(3) any article other than food intended to affect the structure or any function of the body of man or animals;

(4) any article intended for use as a componentof any articles specified in clauses (1), (2), (3) not including devices or their components, parts, or
accessories; and

(5) herbal and/or traditional drugs which arearticles of plant or animal origin used in folk medicine which are:

(a) recognized in the Philippine NationalDrug Formulary; (b) intended for use in the treatment or cure or mitigation of disease
symptoms, injury or body defect inman; (c) other than food, intended toaffect the structure or any function of the body of man;
(d) in finished or ready-to-use dosage form; and (e) intended for useas a component of any of the articles specified in clauses
(a), (b), (c) and (d).
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(b) Counterfeit drug/medicine refers to medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients,
without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, strength or
purity. It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to
both branded and generic products. It shall also refer to:

1) the drug itself or the container or labelingthereof or any part of such drug,container or labeling bearing withoutauthorization the trademark, trade
name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology
Transfer (BPTTT) in the name of another natural or juridical person;

2) a drug product refilled in containers by unauthorized persons if the legitimate labels or marks are used;

3) an unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical
records;

4) a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as
distinguished from an adulterated drug including reduction or loss or efficacy due to expiration.

(c) Brokering shall refer to any act of facilitating the disposal or sale or counterfeit drugs, including acts ofagency.

(d) Bureau shall refer to the Bureau of Food and Drugs (BFAD) of the Department of Health (DOH).

(e) Department shall refer to the Departmentof Health

(f) Business establishment shall refer to any entity, whether a single proprietorship,partnership, or corporation engaged in ordoing business in the
Philippines.

(g) Owner shall refer to a person or group of persons who is the registered owner of a license to operate a business or businessundertaking in the
Philippines or the branch manager or operator, licensee, franchisee, or any person acting on behalf of he corporate entity.

(h) Residence shall refer to a private dwelling or abode where a person lives, either asowner or lessee, or usurfructuaryincluding, for purposes of this
Act, its yard, garage, storage rooms or premises.

SECTION 4 Prohibited Acts. – The following actsare declared unlawful and therefore prohibited;

a) The manufacture, sale, or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation or possession of
counterfeit drugs as defined in Section 3 hereof not otherwise covered by Republic Act No. 3720, as amended. The presence or availability of such
counterfeit drugs within the premises of any entity engaged in the sale, manufacture or distribution of drugs
and/or pharmaceuticalproducts or in a private residence, or in publicor private

10

vehicle, or in the premises not covered by a valid license to operate from the Bureau, shall constitute a prima facie evidence of violation
of this Act: Provided, however, That this presumption shall not apply to the legitimate owners of trademarks, trade names or
otheridentifying marks, or the legitimate or authorized representatives or agents of such owners who have in their possession counterfeit
drugs which bear the trademarks, trade names or marks if they can show the sales invoices or official receipts evidencing their purchase
from a drugstore, manufacturer or distributor suspected by them of dealing in counterfeit drugs involving the trademarks, trade names
and other similar identifying marks registered in their names: Provided, further, That such counterfeit products shall be reported and
immediately turned over to the Bureau: Provided, finally, That compliance with the preceding provision shall be made within a
reasonable period from the date of purchase of such counterfeit drugs as indicated in the salesinvoice, official receipt, or other similar
documents abovementioned to the time the counterfeit drugs are reported and turned over to the Bureau;
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b) Possession of any such counterfeit drugs. However, any person found in possession of counterfeit drugs, in violation of this subsection, shall be
exempted from liability under the provisions of this Act after:

1) presentation of sales invoices, official receipts or other legally acceptable documents evidencing his purchase thereof from a drugstore, distributor,
manufacturer, hospital pharmacy or dispensary; or any other person or place duly licensed to sell and/or dispense drugs or medicines and indicating
therein the batch and lot numbers, as well as the expiry dates of such drugs; or

2) presentation of certificates and other documents evidencing the importation or exportation of the counterfeit drugs found in his possession as
required by existing laws, including those documents required in the preceding paragraph covering the commercial transactions involving counterfeit
drugs.

In both cases, the subject counterfeit drugsmust not on their face appear to be as such, or do not bear any marking or any patently
unusual characteristic sufficient to arouse thesuspicion of a reasonable and prudent person that such drugs are
counterfeit. Furthermore, the amount or volume of counterfeit drugs held is such that it does not negate or is inconsistent with the
averment that the same are for personal use, notwithstanding the presentation by the possessor of medical records and other similar
documents accompanying and justifying the use of such drugs;

c) Forging, counterfeiting, simulating or falsely representing, or without proper authority, using any mark, stamp, tag, label or other identification mark
or device authorized or required by Republic Act No. 3720, as amended,and/or the regulations promulgated under this Act;

d) Photocopying, duplicating, altering, printing, transferring, obliterating or removing the approved label or any part thereof, lawfully belonging to
another person, for the purpose of using such label or a part thereof on any counterfeit drug: Provided, That if the person who committed any of the
acts enumerated in this paragraph and the person who used thelabels produced thereby are not one and the same person and the former had
knowledge of the purpose for which the labels are intended, the former shall also be liable under this Act notwithstanding the failure of the latter to
achieve the intended purposes; and

e) Making, selling, or concealing any punch, dye, plate or any other equipment or instrument designed to print, imprint or reproduce the trademark,
trade name or other identifying mark of another registered producer or any likenessthereof, upon

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any drug product or device or its container orlabel without authority from the legitimateowners of the trademark or trade name.

SECTION 5. Parties Liable - The followingpersons shall be liable for violation(s) of this Act:

a) the manufacturer, exporter or importer of the counterfeit drugs and their agents: Provided, That the agents shall be liable only upon proof of actual or
constructive knowledge that the drugs are counterfeit;

b) the seller, distributor, trafficker, broker or donor and their agents, upon proof of actual or constructive knowledge that the drugs sold, distributed,
offered or donated are counterfeit drugs;

c) the possessor of counterfeit drugs as provided inSection 4 (b) hereof;

d) the manager, operator or lessee of the laboratory or laboratory facilities used in the manufacture of counterfeit drugs;

e) the owner, proprietor, administrator or manager of the drugstore, hospital pharmacy or dispensary, laboratory or other outlets or premises where the
counterfeit drug is found who induces, causes or allows the commission of any act herein prohibited;

f) the registered pharmacist of the outlet where the counterfeit drug is sold or found,
who sells ordispenses such drug to a third party and who hasactual or constructive knowledge that said drug is counterfeit; and

g) should the offense be committed by a juridical person the president, general manager, the managing partner, chief operating officer or the person
who directly induces, causes or knowinglyallows the commission of the offense shall be penalized.

SECTION 6. Administrative Proceedings.- TheBureau is hereby further authorized to undertake the following administrative actions:

a) upon verified information on the existence ofsuspected counterfeit drugs in the possession of any manufacturer, seller or distributor, the duly
authorized officers of the bureau or any officer deputized by the Bureau for the purpose shall segregate, seal and after having obtained a valid
search warrant from a competent court, seize such counterfeit drugs and take them into custody: Provided, That in case the suspected counterfeit
drugs are found in a private residence, as defined in Section 3 of this Act or inother premises not covered by a valid license tooperate issued by the
Bureau, the duly authorized officer of the Bureau or deputized officer
thereof shall secure a search warrant forthe purpose of seizing and taking into custody such suspected counterfeit drugs;

b) if, after the appropriate examination of the samples by the Bureau, the seized drugs are determined or found to be counterfeit, the Bureau shall,
within (15) days from their seizure, issue an order directing the preventive closure of the business establishment for a period not exceeding thirty
(30) days. Thereafter, administrative proceedings shall be initiated bythe Bureau against the parties concerned where
they shall have the opportunity to be heard andpresent evidence on their behalf; and

c) to ensure the effective enforcement of theforegoing, the Bureau may enlist the assistanceof the national or local law enforcement agencies.

10

SECTION 7. Administrative Sanctions – Upon finding that the drugs examined are
counterfeit andthe determination of the parties liable thereof, theBureau shall impose any or all of the following sanctions:
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a) permanent closure of the establishmentconcerned and the revocation of its license to business;

b) a fine of not less than One hundred thousand pesos (P100,000) but not more than Five hundred thousand pesos (P500,000);

c) upon order of the Court, forfeiture, confiscation,and destruction of products found to be counterfeited and the equipment, instruments, and other
articles used in violation of this Act;

d) filing of an appropriate proceedings against the registered pharmacist with the
ProfessionalRegulations Commission for cancellation ofprofessional license;

e) filing of criminal charges against the violator (s), which can be instituted independently from the administrative case: Provided, That the dismissal of
the criminal case shall not lift the closure order, except when it is a dismissal on the merits or for lack of basis: Provided, further, That the withdrawal
of the private criminal complaint shall not be a ground for the dismissal of the administrative proceedings; and

f) permanent disqualification of the person concerned, whether natural or juridical, from owning or operating an establishment engaged in any business
activity under the supervision of the Bureau.

SECTION 8. Penalties. – The commission of anyof the acts prohibited under Sections 4 and 6 of thisAct shall be punished by:

a) imprisonment of not less than six (6) months andone (1) day; but not more than six
(6) years for more possession of counterfeitdrugs as provided for in Section 4(b) hereof; or

b) imprisonment of six (6) years and one (1) day,but not more than ten (10) years or a
fine of notless than One hundred thousand pesos(P100,000) but not more than Five hundred thousand pesos (P500,000) or both such imprisonment
and fine at the discretion of thecourt in any other case mentioned in Section 4hereof; or

c) imprisonment of not less than six (6) months andone (1) day, but not more than two
(2) years and four (4) months if the counterfeitdrug is intended for animals; or

d) imprisonment of not less than six (6) years andone (1) day but not more than ten
(10) years for any manufacturer, seller or distributor who shall conceal, substitute,
disposeor destroy any drug as may have been segregatedand sealed by the Bureau
or who shall break,alter or tamper any mark or seal used by theBureau to identify
those segregated drugs asprovided for under Section 6(a) of this Act. Anyother
person who breaks, alters or tampers anymark or seal used by the Bureau to
identify thesegregated drugs shall suffer the penalty of notless than six (6) months
and one (1) day, but notmore than six (6) years imprisonment; or

e) if, as a result of the use of the drug found to be counterfeit, the illness sought to be
cured isaggravated or physical injury or suffering resultstherefrom, a punishment of imprisonment from twelve (12 years to fifteen (15) years and a
fine ranging from One hundred thousand pesos (P100,000) to Five hundred thousand pesos (P500,000) shall be meted out; or

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f) should a counterfeit drug be the proximate cause of death of a victim, who
unknowingly purchasedand took a counterfeit drug, the penalty of life imprisonment and a fine of Five hundred thousand pesos (P500,000) to Five
million pesos(P5,000,000) shall be imposed.

In case any act prohibited in Section 4 hereof isalso punishable under other laws, the offender shall, if warranted by the evidence, be
prosecuted under the law prescribing the highest penalty.

SECTION 9. Appropriations – The amountnecessary to carry out the provisions of this
Act shallbe included in the General Appropriations Act for theyear following its enactment and every year thereafter.

SECTION 10. Implementation – The Bureau of Food and Drugs of the Department of
Health ishereby authorized to administer and supervise theimplementation of this Act.

SECTION 11. Implementing Rules and Regulations. – Within ninety (90) days from the
approval of this Act, the Bureau of Food and Drugs,in consultation with the Department of
Health, shallpromulgate the rules and regulations implementingthe provisions of this Act.
The implementing rulesand regulations issued pursuant to this section shalltake effect
thirty (30) days after its publication in two(2) national newspapers of general circulation.

SECTION 12. Separability Clause – If, for anyreason, any portion or provision of this Act
issubsequently declared unconstitutional or invalid,such declaration shall not nullify the other portions or provisions hereof.

SECTION 13. Repealing Clause. – all laws,decrees, executive or administrative orders, rules or regulations inconsistent with the provisions of
this Act are hereby or modified accordingly.

SECTION 14. Effectivity. – This Act shall takeeffect fifteen (15) days after its publication in at leasttwo (2) national newspapers of general
circulation.
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Approved,
(Sgd) JOSE DE VENECIA, JR.(Sgd)NEPTALI A. GONZALES
Speaker of the HousePresident ofthe Senate of Representatives

This Act, which is a consolidation of Senate Bill NO. 1284 and House Bill No. 5666 was finally passed by the Senate and the House
of Representatives on August 27, 1996 and August 22, 1996, respectively.
(Sgd) ROBERTO P. NAZARENO(Sgd)HEZEL P. GACUTAN
Secretary GeneralSecretary of theSenate House of Representatives
Approved: September 4, 1996
(Sgd) FIDEL V. RAMOS

RULES AND REGULATIONS IMPLEMENTING REPUBLIC ACT NO. 8203 OTHERWISE KNOWN AS
THE SPECIAL LAW ON COUNTERFEIT DRUGS
AUTHORITY

Pursuant to Section 11 of Republic Act No. 8203 otherwise known as the Special Law on Counterfeit Drugs, the following rules and regulations
are hereby promulgated in consultation with the Secretary of Health.
RULE I
INTERPRETATION ANDDEFINITION OF TERMS
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Section 1. Short Title. These rules and regulationsshall be cited as "IRR of R.A. 8203."

Section 2. Construction. The words and phrasesused in these rules shall be interpreted
to givemeaning to the provisions of R.A. 8203 in order tosafeguard the health of the people and to protect them from counterfeit drugs.

Section 3. Definition of Terms. In addition tothe terms defined by Section 3 of R.A. 8203, and for purposes of these regulations, the term --

(a) "Bureau or BFAD" shall refer to the Bureau ofFood and Drugs
(b) "Constructive Knowledge" as here applied shall mean, that by exercise of reasonable care, one would have known the fact or suspect that the
drug product he or she has sold or in possession of is counterfeit, such as but not limited to the knowledge that the drug was not covered by any
sales invoice or evidence of delivery of purchase from a BFAD license drug establishment.
(c) "FDRO" shall mean Food and Drug RegulationOfficer
(d) "LICD" shall mean Legal, Information andCompliance Division of the BFAD
(e) "Life saving drugs" shall refer to drugproducts indicated for life threatening condition(s)
(f) "LSD" shall mean Laboratory Services Division ofBFAD
(g) "PSD" shall mean Product Services Division ofBFAD
(h) "Unregistered imported drug product" asdistinguished from counterfeit drug defined under Section 3 of R.A., shall refer to unregistered imported
drug product without a registered counterpart brand in the Philippines. If the unregistered imported drug product has a registered counterpart
brand in the Philippines, their product shall be considered counterfeit.

RULE II PROHIBITED ACTS
Section 1. Prohibited Acts. The acts prohibited ordeclared unlawful under Section 4 of
R.A. 8203 are adopted as the same acts that areprohibited by these rules and therefore punishable by the administrative sanctions herein
prescribed.

Section 2. Parties Liable. The parties who are liable under Section of R.A. 8203 are likewise made liable under these rules.
RULE III
MONITORING OF COUNTERFEITDRUGS
Section 1. Procedure of MonitoringCounterfeit Drugs in the Market

(a) The Food and Drugs Regulation Officers (FDROs)in the course of their inspection of a
factory,warehouse, establishment or vehicle, finished orraw materials, containers and

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labeling therein upon the authority conferred by Section 27 of R.A. 3720 as amended,
shall furtherdetermine during such inspection, whether thedrug products therein found are counterfeit or not. For the effective
implementation of R.A. 8203, thesaid inspection shall be without prior notice in anyplace within the Philippines to prevent the parties liable
from concealing them and avoiding inspection.
(b) If upon such inspection, the FDRO shall suspect certain stocks as counterfeit drugs, the FDRO shall conduct an inventory, segregate and seal the
suspected stocks, and collect samples for examination as to the drug products' geniunenessand authenticity.
(c) The FDRO shall require the owner or the representative of the inspected establishment or outlet to produce the sales invoice, delivery receipts or
documents covering the suspected counterfeitdrugs. The FDRO shall only acknowledge andrecognize invoices or documents that have been issued
by a BFAD licensed manufacturer, trader, distributor, wholesaler or importer with the lot number and expiry date of the drug product(s) indicated
therein.
(d) Immediately upon return to his/her office, the FDRO concerned shall submit the samples to either the LSD or PSD for their examination or
evaluation. The examination or evaluation shall be for the purpose of determining the authenticity and/or geniuneness of the said samples.

Section 2. Duration In the Conduct of Examination. The BFAD shall have twenty (20)
working days to determine the genuineness andauthenticity of the product.

Section 3. When There Is No Need ForLaboratory Testing. When the geniuneness of the product can be determined by the mere physical
examination of the product or the labeling thereof, the PSD shall conduct the examination or evaluation of the same. The result of the
physical examinationshall be reduced into a certification of findings.

The Regulation Division I may also require the registered brand-owner of the suspected counterfeit drug to certify whether or not the suspected
drug product has been manufactured, imported and/or distributed by them; or whether they own the Lot Number and Expiry Date of the same
suspected drug product. The certification issued by the registered brand-owner shall be supported by the batch, production and
distribution records. However, the brand-owner's certification shall be validated by the PSD for evidentiary purposes.

Section 4. When To Refer To LICD For Investigation. When the result of examination
shall confirm the suspicion of the FDRO that in factthe drug product is counterfeit, the
LSD or PSD shallforward the result of examination to the LICD for amotu proprio investigation. Otherwise, the result of the examination shall be
released to the Regulation Division concerned.

Section 5. When The Product Is Found Not Counterfeit. When the result of the examination reveals that the sample collected is genuine, the
PSD or LSD shall forward the report of examination or evaluation to the FDRO through his/her division chief.
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If the sealed and segregated products are within the Metro Manila area, the Regulation Division concerned shall, within sixteen (16) working
hours from receipt of such report, notify the outlet or the communication available. However, only a FDRO can unseal the suspected product
before it can be released for sale or distribution to legitimate commerce.

When the segregated and sealed products are located outside the Metro Manila area, the Regulation Division concerned shall send a notice to
release the products to the Food and Drug Section having territorial jurisdiction over the same through the Regional Director within sixteen (16)
working hours from receipt of the notice. The FDRO assigned in the said province shall, within sixteen 916) hours from receipt of the notice,
unseal the suspected drugs for distribution to legitimate commerce

Section 6. Accreditation of Complaint Desk. Upon application by an interested
pharmaceuticalassociation. BFAD shall accredit complaint desks thatmay be established

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by any pharmaceutical organization or association.The desk shall receive and refer verifiable letter of complaint or information from any of its
members about counterfeit drug products. Any letter ofcomplaint or information referred to BFAD by such complaint desk shall be processed in
accordance with Section 2 of Rule IV hereof.

Section 7. Possession Of Counterfeit Drugs byOwners Of Trademarks, Trade Names Or Other Identifying Marks; When to
Report. Owners of trademarks, trade names or other identifying marks, or their authorized agents who have in their possession counterfeit drug
product involving their own trademark, trade name or other identifying marks, shall report in writing and turn over the said counterfeit drugs to the
BFAD within ten (10) days from the time of purchase or acquisition of such drugs as indicated in the sale invoices or official receipt or
other similar documents. The salesinvoice, official receipts or other similar documents shall be attached to the said report on counterfeit drugs.
Failure to comply with this section will give rise to the presumption of violation as provided under Section 4(a) of R.A. 8203.
RULE IV
PROCEDURE IN THE FILING OFADMINISTRATIVE COMPLAINT

Section 1. Where to File the Complaint. Any person may file a complaint whether in an affidavit or letter form with the BFAD LIC or in any
BFAD Accredited Complaint Desk as provided for in Section 8 Rule II of this Order.

Section 2. Complaint Filed By A Registered Brand Owner. A drug establishment or a
registered brand owner may file an administrativeaction against any person or
establishment for anyacts in violation of R.A. 8203 in the form of anaffidavit of complaint.

Section 3. Contents of the Complaint Affidavit. The affidavit of complaint of theregistered brand owner shall state--

(a) name of the product, the lot numbers and expiry date of the products he shall allege as counterfeit;
(b) name and address of the person and/or drugestablishment or company he shall name as party-respondent;
(c) specific acts that he shall allege as having beencommitted by the party-respondent;
(d) remedy or relief or action he shall intend BFAD totake.

The affidavit of complaint shall be accompanied bysamples of counterfeit drug products duly marked for identification purposes.

Section 4. Complaint Filed By A Consumer, A Physician Prescriber and Other InterestedParty. A consumer, physician-
prescriber or otherinterested party other than the registered brand owner may file a letter of complaint or information about a suspected
counterfeit drug product. His lettershall state--

(a) the name of the suspected product;
(b) the source or the name and address of the personfrom whom he/she acquired the said suspected drug product;
(c) the mode of his acquisition, and
(d) the reason or fact giving rise to the suspicion thatthe drug product is counterfeit.

Section 5. When The Consumer, Physician Prescriber Or Interested Party May File An Affidavit Of Complaint And Not a Letter of
Complaint. When the consumer, physician- prescriber or the interested party is in possession of evidence to prove that the product is
counterfeit andan act in violation of R.A. 8203 has been committed,he/she shall instead file an affidavit of complaint stating --

10

(a) the name and address of the person who hascommitted the act of violation of R.A. 8203; and
(b) the specific acts committed.

He/she shall submit and offer the evidence in his/her possession specifically including the sample of the counterfeit drug product or the container
of such product he shall allege as counterfeit. Such anaffidavit of complaint shall be processed inaccordance with Section 3 of the Rule IV hereof.

RULE V ADMINISTRATIVEPROCEEDINGS

Section 1. When Initiated by BFAD FDROs. When the administrative action is initiated by
FDRO,the FDRO shall submit a report of violation to theLICD.

(a) Upon receipt of the report of violation and when such report is found proper in form and substance, the LICD shall immediately preparethe formal
charge in the form of a memorandumof evidence. The memorandum of evidence shallcontain a statement giving the party-respondent fifteen (15)
days within which to file his position paper and submit evidence contrary to that which was found, or
justifying the acts inviolation of R.A. 8203, failing in which, the casewill considered submitted for resolution based upon the evidence found and
presented to him in the same memorandum of evidence.
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(b) If the party-respondent is a drug establishment, outlet or a business establishment, the memorandum of evidence shall be accompanied by a
preventive closure order for thirty (30) days from receipt of the order.
(c) If the position paper filed by the respondent shall raise no factual issue that necessitates a trial, the case will be considered submitted for resolution.
(d) If the position paper will raise factual issues necessitating a trial, or the respondent moves for a hearing to confront the witnesses upon which the
memorandum of evidence was instituted, a hearing will be conducted.
(e) In the hearing, upon motion of the Respondent, the witnesses upon which the memorandum of evidence had been issued will be called to affirm the
documentary evidence and their reports, if any. The party-respondent shall be given the opportunity to confront or cross-examine the said witnesses.
(f) After such affirmation and cross-examination, the party-respondent shall be given
another ten(10) days to supplement his position paper or tomanifest his intention to present evidence in support of his position paper, if he shall so
intend.

In the case the part-respondent manifests hi intention to present evidence in support of his
position paper, the continuation of the hearing shallbe conducted. Otherwise, the case shall be considered submitted for resolution based on
evidence on record.

The administrative proceedings shall be completed and terminated within thirty (30)-day period; otherwise, if such proceedings cannot be
completedwithin the thirty (30)-day period from notice, an order lifting the preventive closure shall be issued without prejudice to the resolution of
the administrative case.

Section 2. Procedure When A Complaint Is Based On A Letter Of Complaint Or Information.

(a) Upon receipt of the letter of complaint or information about a suspected counterfeit drug, and upon a preliminary finding that there is sufficient basis
to conduct an investigation, the letter of complaint or information will be assigned to an FDRO for verification.
(b) If the information is verified that in fact the drug product is counterfeit and that a person, a drug outlet, or business establishment or drug
establishment has committed acts in violation ofR.A. 8203, a memodrandum of evidence shall be

10

issued and the administrative proceedings provided for in Section 1 hereof shall be instituted.

Section 3. Procedure When A Complaint is Initiated By a Drug Establishment OrRegistered Brand Owner.

(a) Upon receipt of the complaint and a finding that the complaint is proper in form and substance, the party-respondent shall be summoned to answer
within fifteen (15) days from receipt thereof.
(b) The party-respondent shall file an answer and not a motion to dismiss except when the subject matter of complaint is not within the administrative
jurisdiction of the BFAD.
(c) The hearing of the case shall be summary innature and that direct testimonies of
thewitnesses shall be reduced to an affidavit whichshall be submitted within three
(3) days before the date of hearing.

Section 4. Decision. Administrative cases underR.A. 8203 and these implementing rules
andregulations shall be decided by the Director of BFADwithin thirty (3) days from the date it shall bedeemed submitted for decision.

Section 5. Finality of Decisions/Resolutions. Decisions and resolutions shall be final and
executoryafter the lapse of fifteen (15) days from receipt ofparties or from notice.

RULE VI APPEAL

Section 1. Motion For Reconsideration; When And When Not Allowed. No motion for reconsideration from an interlocutory order shall be
allowed. Only one motion for reconsideration fromthe final resolution or decision shall be allowed andonly upon the grounds that --

(a) the resolution is not supported by substantialevidence; and
(b) the conduct of the administrative investigation isattended with irregularity.

Section 2. Appeal; When. The aggrieved partymay appeal the decision of the BFAD
Director withinfifteen (15) days from receipt thereof to the Secretaryof Health.

Section 3. Grounds For Appeal. No appeal shall be given due course on the following grounds --

(a) Abuse of discretion;
(b) Decision is not supported by substantial evidence;or
(c) Irregularity in the conduct of investigation.

Section 4. How Made. A party who intends to appeal the decision of the BFAD Director shall file anotice of appeal with the BFAD. The BFAD
shall forward the records of the case to the Office of the Secretary within fifteen (15) days from receipt of the notice of appeal.

Section 5. Execution Pending Appeal. The appeal when filed by a respondent shall not stay the execution of the decision, unless a bond in the
amount of One Hundred Thousand Pesos (PHP 100,000.00), which is the minimum administrative fine imposable, is posted.

RULE VII ADMINISTRATIVESANCTIONS

Section 1. Minimum Penalty. An administrative fine of not less than of One Hundred
Thousand Pesos(PHP 100,000.00) but not more than of FiveHundred Thousand Pesos (PHP 500,000.00) shall be the minimum administrative
penalty.
10
43

Section 2.. Medium Penalty. An administrative fine of not less than of Three Hundred Thousand Pesos (PHP 300,000.00) but not more than of
Five Hundred Thousand Pesos (PHP 500,000.00) and permanent closure of establishment as well as the revocation of its license to do business
shall be the medium administrative penalty

Section 3. Maximum Penalty. An administrative fine of not less than of Three Hundred Thousand Pesos (PHP 300,000.00) but not more than of
Five Hundred Thousand Pesos (PHP 500,000.00) and permanent closure of establishment concerned as well as the revocation of its license to
do business shall be the maximum administrative penalty
Section 4. Accessory Penalties.

(a) Upon order of the court, all administrative sanctions shall be accompanied by forfeiture, confiscation and destruction of product found to be
counterfeit and the equipment, instrument and other articles used in violation of R.A. 8203
(b) Permanent disqualification of the person concerned, whether natural or juridical, from owning or operating an establishment engaged in any
business activity under the supervision of the Bureau shall be imposed together with the maximum administrative penalty.

Section 5. Proceedings Against theRegistration of a Pharmacist. If the offenseshall be committed with the actual or constructive knowledge
of the registered pharmacist, the administrative sanction that shall be imposed shall be accompanied by the filing of certificate of violation for
the appropriate proceeding against said pharmacist with the Professional Regulation Commission to cancel her/his professional license.

Section 6. When to File Criminal Charges.Criminal charges shall be filed against the party liable when the evidence found by BFAD is
considered sufficient to establish a probable cause and the drugproducts involved are life saving or if the drugproducts are not life saving, the
volume or number of the drug products subject to the case will manifest the criminal intent to the party liable to introduce into commerce
counterfeit drug products. This, however, shall not preclude any interested party from initiating a criminal action against the party liable
independent of BFAD.

Section 7. When the Minimum Penalty Shall be Applied. The minimum administrative penalty shall be imposed when the counterfeit drug
products subject of the case are not life saving drugs and the volume of the said products is not worth more than (PHP 100,000.00); or the
number of drug product subject of the case it not more than three brands or generic products.

Section 8. When the Medium Penalty Shall beImposed. The medium administrative penalty shall be imposed when the counterfeit drug
products subject of the case are not life saving drugs and the volume of the said products is not worth (PHP 100,000.00) but not
exceeding One Million Pesos(PHP 1,000,000.00) or the number of counterfeitdrug products is more than three brands or generic products.

Section 9. When the Maximum Penalty Shallbe Imposed. The maximum administrative
penaltyshall be imposed when the counterfeit drug productsare life saving drugs
regardless of the volume; or thevolume of the counterfeit drug products is worthmore than One Million Pesos (PHP 1,000,000.00)

RULE VIII FINALPROVISIONS

Section 1. Separability If, for any reason, any part or provision of these rules and regulations shall be held to be unconstitutional or invalid, other
parts or provision hereof which are not affected thereby shall continue to be in full force and affect.
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Section 2. Prospectivity. The administrativesanctions herein imposed shall not apply to acts committed prior to October 26, 1996 or the effective
of the law R.A. 8203.

Section 3. Amendments. These rules andregulations may be amended, modified or
supplemented when effective implementation andenforcement of R.A. 8203 would require.
Section 4. Effectivity. This Order shall take effectthirty days after its publication in two
(2) newspapers of general circulation.
(Sgd) QUINTIN L. KINTANAR,M.D., Ph.D., CESO I
Director
(Sgd) CARMENCITA NORIEGA-REODICA,MD, MPH., CESO II
Secretary of Health
Date of Issuance:November 19, 1996
44

AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING STANDARDS OF PHARMACEUTICAL EDUCATION IN THE
PHILIPPINES AND FOR OTHER PURPOSES.
ARTICLE 1
Objectives and Implementation
Section 1. Objectives. This Act provides for and shall govern (a) the standardization and regulation of pharmaceutical education; (b) the examination
for registration of graduates of schools of pharmacy and (c) the supervision, control and regulation of the practice of pharmacy in the Philippines.
Section 2. Enforcement. For the purposes of implementing the provisions of this Act, the Council of Pharmaceutical Education and the Board of
Pharmacy are hereby created.
ARTICLE II
The Council of Pharmaceutical Education
Section 3. The Council of Pharmaceutical Education and its composition. The Council of Pharmaceutical Education shall be composed of the
Secretary of Education, Chairman, the Undersecretary of Health Services, the Food and Drug Administrator, the Chairman of the Board of
Pharmacy, the dean of the College of Pharmacy, University of the Philippines, the dean of a college of pharmacy, representing duly accredited
private schools of pharmacy, and a representative of the bona fide national pharmaceutical organizations in the Philippines.
It shall be incumbent upon all deans of duly accredited colleges of pharmacy of private colleges and universities by agreement among themselves to
promulgate rules and regulations regarding the selection of one from among their group to represent them in the said Council and it shall be
incumbent upon all presidents of bona fide national pharmaceutical organizations in the Philippines by agreement to promulgate rules and
regulations regarding the selection of one from among them to represent them in the said Council.
45
The members of the Council shall hold office until their successors have been appointed, elected or designated and duly qualified.
Section 4. Functions. The functions of the Council of Pharmaceutical Education shall be:
(a) To promulgate rules and regulations relative to Pharmaceutical Education in the Philippines;
(b) To submit such rules and regulations, which shall have a binding effect, for implementation to the proper agencies such as Department
of Education, the Board of Pharmacy, the bona fide national pharmaceutical organizations in the Philippines and others;
(c) To recognize and accredit colleges of pharmacy in the different private colleges and universities; and
(d) To approve the accreditation of community or prescription pharmacies, pharmaceutical manufacturing laboratories and hospital
pharmacies for purposes of pharmacy internship.
Section 5. Meetings and traveling expenses. The Council of Pharmaceutical Education shall meet at least once a month for regular business and as
often as the Council may decide. The Chairman and members of the Council of Pharmaceutical Education shall not be entitled to any compensation
except for traveling expenses in connection with their official duties as herein provided.
ARTICLE III
The Board of Pharmacy and Examination and Registration of Pharmacists
Section 6. The Board of Pharmacy and its Composition. The Board of Pharmacy shall be composed of a Chairman and two members who shall be
appointed by the President of the Philippines with the consent of the Commission of Appointments, from a list of nominees recommended by the
Commissioner of Civil Service who shall secure such lists from bona fide professional national organizations of pharmacists which should be
certified in accordance with Republic Act Numbered Five hundred forty-six.
Section 7. Qualification of Board members. To be appointed a member of the Board of Pharmacy, a person shall be:
(a) A natural born citizen of the Philippines;
(b) A duly registered pharmacist and has been in the practice of pharmacy for at least ten years;
(c) Of good moral character and of recognized standing in the pharmaceutical profession;
(d) At the time of appointment, not a member of the faculty of any school, college or university offering courses in pharmacy; nor have any
direct or indirect pecuniary interests in such school or college of pharmacy; and
(e) A member of good standing of any bona fide national pharmaceutical association of the Philippines.
Section 8. Tenure of office and fees of board members. The Chairman and members of the Board of Pharmacy shall hold office for three years after
appointment or until their successors shall have been appointed and duly qualified: Provided, That members of the first Board to be appointed after
the approval of this Act shall hold office for the following terms: Chairman for three years, one member for two years and one member for one
year: Provided, further, That any chairman or member may be reappointed for another term of three years but in no case shall be serve continuously
for more than six years. The most senior member of the Board shall automatically be the Chairman.
The Chairman and members of the Board shall each receive the sum of ten pesos for each applicant examined regardless of whether or not he is
already in the government service when appointed.
Section 9. Removal of the Board members. The chairman or member of the Board may be removed by the President of the Philippines if found
guilty of neglect of duty, incompetence, malpractice, or unprofessional, unethical, immoral, or dishonorable conduct, after having been given the
opportunity to defend himself in a proper administrative investigation. The President may in his discretion suspend such member under
investigation: Provided, however, That the period of suspension shall not exceed sixty days after which the latter shall be automatically reinstated
pending the outcome of the investigation.
Section 10. Executive Officer of the Board. The Commissioner of Civil Service shall be the Executive Officer of the Board and shall conduct the
examination given by it according to the rules and regulations promulgated by him and approved by the President of the Philippines. The Secretary
of the Board of Examiners in accordance with Republic Act Numbered Five hundred and forty six shall also be the Secretary of the Board. To assist
both officials, there shall be appointed from the ranking employees of the Board of Examiners, an Assistant Secretary, a Legal Officer and a Records
Officer with compensation of eight thousand eight hundred thirty-two pesos, seven thousand two hundred thirty-six pesos and five thousand nine
hundred twenty-eight pesos, respectively who may also perform identical functions for the other existing examination boards. All the records of the
Board including examination papers, minutes of deliberation and records of administrative proceedings shall be kept by the Secretary of the Board.
Section 11. Powers and duties of the Board. The Board of Pharmacy, conformably with the provisions of this Act is vested with authority:
(a) To examine applicants for the practice of pharmacy;
(b) To issue certificates of registration or pharmacists.
(c) To reprimand any pharmacist or to suspend or revoke his certificate of registration on the grounds as provided for in Section thirteen
hereof, after a formal administrative investigation has been conducted by it.
(d) To promulgate from time to time the necessary rules and regulations for the effective enforcement of this Act, subject to the approval of
the President upon advice of the Commissioner of Civil Service;
(e) To study the conditions affecting the practice of pharmacy in the Philippines;
(f) To check the employment of qualified personnel in drug stores, hospital pharmacies, drug or pharmaceutical laboratories, cosmetic
laboratories and similar establishments for which the Board may designate inspectors from the Board of Pharmacy; and
46
(g) To encourage the development of botanical gardens and their inspection particularly the propagation of Philippine medicinal plants with
the cooperation of the Department of Agriculture and Natural Resources.
Section 12. Detailmen, requirements, qualifications and fees. Any person who shall be employed as detailman by any pharmaceutical or drug
laboratory or other manufacturers of medical, dental pharmaceutical, biological and veterinary products and by distributors, dealers or wholesalers of
said products, doing business directly or indirectly in the Philippines, shall be required, at the beginning of each year, to register with the Board of
Pharmacy that he is employed as such.
(a) An applicant for registration shall be, preferably, a graduate of a college of pharmacy.
There shall be an initial fee of twenty pesos upon registration and thereafter fifteen pesos shall be charged annually for renewal. Upon
payment of said fees, the proper credential shall be issued to the applicant.
(b) It shall be incumbent upon the drug establishments referred to in this section to require that detailmen employed or to be employed by
them possess the necessary credentials issued by the Board of Pharmacy as provided for herein.
For purposes of this section, a detailman is one who represents any duly authorized manufacturer, dealer, distributor, representative or wholesaler of
drugs, pharmaceuticals, biologic products and devices, whose primary duty is to introduce or reacquaint a product or products prepared, distributed
or made by said manufacturers, dealer, distributor, representative or wholesaler to the physician, dentist, pharmacist, veterinarian or any other
qualified person and which forms part of their program for promotion by describing its use, composition, action, dosage, administration, contra-
indication, advantages and other salient information relative to said drug, pharmaceutical, biological product or device.
Section 13. Grounds for reprimand, suspension or revocation of registrant certificate. Any of the following shall be sufficient ground for reprimanding
a pharmacist, or for suspending or revoking his certificate of registration:
(a) Conviction by a court of competent jurisdiction of any violation as penalized in sections forty and forty-one hereof;
(b) Immoral or dishonorable conduct which includes conviction by a competent court of any criminal offense involving moral turpitude;
(c) Fraud or deceit in the acquisition of the certificate of registration;
(d) Gross negligence, ignorance or incompetence in the practice of his profession resulting in the injury damage or death of another;
(e) Malpractice, including aiding or abetting the commission of criminal abortion or sex crimes through illegal compounding, dispensing or
sale of abortive or sex drugs as the case may be;
(f) Acting as a dummy of an alien or of a person who is not qualified to establish and operate a retail drugstore;
(g) Addiction to alcoholic beverage or to any habit-forming drug rendering him incompetent to practice his profession;
(h) Insanity;
(i) False or extravagant or unethical advertisements wherein other things than his name, profession, limitation of practice, office and home
address and the like are mentioned; and
(j) Violations of any provision of the Code of Ethics which may be adopted as part of the Rules and Regulations of the Board.
Section 14. Administrative Investigation. Administrative investigations shall be conducted by all the members of the Board sitting en banc. The
existing rules of evidence shall be observed as far as practicable during administrative investigations.
If the Board, by majority vote of the members, shall find that the charges are sustained by evidence adduced, it may at its discretion reprimand the
respondent or revoke or suspend his certificate of registration. In case of suspension, it shall be for a period of not more than six months. Where the
certificate of registration has been revoked as herein provided, the Board may, after the expiration of six months and upon application, issue a new
certificate of registration in place of a revoked certificate without the necessity of undergoing any examination if the respondent in the meanwhile has
conducted himself in an exemplary manner.
Section 15. Procedure and rules. The Board of Pharmacy upon receipt of a formal complaint under oath against any pharmacist, shall furnish the
latter a copy of the complaint which he shall answer within ten days from receipt hereof. If the Board of Pharmacy, after careful study of the records,
finds that there is a valid grounds to the charge it shall conduct a formal investigation setting the dates of hearing thereof. For this purpose, a
subpoena or subpoena duces tecum may be issued by the Chairman of the Board. The proceedings shall at all times be recorded. The investigation
shall be terminated and resolved within ninety days from the time of the first date of hearing has been set and heard.
Section 16. Right of respondent. The respondent pharmacist shall be entitled to be heard by himself or be represented by counsel; to have a
speedy and public hearing to confront and to cross-examine witnesses against him; to summon and present witnesses in his behalf; and to any other
process for the protection of his individual or civil rights.
Section 17. Appeal from judgment. The decision of the Board of Pharmacy shall automatically become final thirty days from notice to respondent,
unless the latter after receipt of the decision and within the same period has appealed to the President of the Philippines.
Section 18. Candidate for board examination. A candidate for the board examination in Pharmacy shall have the following qualifications:
(a) He shall be a natural-born citizen of the Philippines;
(b) He shall be of good moral character;
(c) He shall have completed an Internship Program which shall consist of at least nine hundred sixty hours, one-half of which shall be
spent equally distributed in a prescription pharmacy, a pharmaceutical manufacturing laboratory and a hospital pharmacy duly accredited
by the Council of Pharmacy and the rest of the hours of internship shall be spent in any or all of the said establishments at the choice of
the candidate.
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For this purpose, the above-mentioned prescription pharmacy, pharmaceutical manufacturing laboratory and hospital pharmacy shall keep
a separate record of Pharmacy students who have undergone said internship program directly under their control and as a result thereof
shall issue the proper certificate of said hours of internship. It shall also be the duty of said establishments to submit annually a complete
report of the names of those who have undergone training under their supervision and the corresponding number of hours of internship
credit of each of the pharmacy students to their respective colleges or school and to the Board of Pharmacy for proper accreditation; and
(d) He shall have graduated with a degree of Bachelor of Science in Pharmacy or with an equivalent degree from a school, college or
university duly accredited by the Council of Pharmaceutical Education after satisfactorily completing a standard pharmacy course of not
less than five academic years.
Section 19. Scope of Examination. The pharmacist examination shall consist of both theoretical and practical examinations. The theoretical
examination shall include subjects in Chemistry, Biological Sciences and Pharmacy.
The Chemistry subjects shall include (1) General, Inorganic, Pharmaceutical and Physical Chemistry, (2) Organic and Medicinal or Pharmaceutical
Chemistry, (3) Qualitative, Quantitative and Drug Assaying. The Biological Science subjects shall include (4) Physiology and Biochemistry, (5)
Microbiology and Public Health, (6) Pharmacology and Toxicology. The Pharmacy subjects shall include (7) Botany and Pharmacognosy, (8)
General Pharmacy, (9) Compounding and Dispensing, (10) Physical and Manufacturing Pharmacy, (11) Pharmacy Administration, and (12)
Pharmaceutical Jurisprudence and Ethics. The subjects shall be weighted as follows: Chemistry, thirty per cent; Biological Science, twenty per cent;
Pharmacy, fifty per cent.
The practical examination shall consist of (1) Identification and Analysis of Drugs, (2) Preparation of Official Pharmaceuticals, (3) Compounding and
Dispensing of Prescriptions and Fixing of Prices of Prescriptions, and (4) Manufacturing Pharmacy and Quality Control. The practical examination
shall be weighted as follows: Identification and Analysis of Drugs, thirty per cent; Compounding of Official Pharmaceutical Preparations, Dispensing
and Fixing of Price of Prescription and Manufacturing Pharmacy and Quality Control, seventy per cent.
It shall be the duty of the Board of Pharmacy to prepare the schedules of the theoretical and practical examinations and the syllabus of each subject
to be given two months before the dates of the examination wherein they are to be used.
Section 20. Ratings required. In order to pass the examination, a candidate must obtain on the basis of one hundred per cent a general average of
seventy-five per cent or over in both the theoretical and practical examinations, with no ratings below fifty per cent in more than two subjects in the
theoretical examinations: Provided, That any candidate who passed in the theoretical examination but failed in the practical examination, may, upon
taking a re-examination, repeat only the practical examination and vice-versa: Provided, further, That any candidate who fails to pass the theoretical
or practical examination in three successive attempts shall not be admitted in the fourth examination unless be could present to the Board a
certification that he had enrolled and undergone within the year preceding, a pre-board review course from a duly accredited college of Pharmacy.
Section 21. Holding of examination. Examination for registration to practice pharmacy in the Philippines shall be given twice a year in the City of
Manila and environment as the Board of Pharmacy may fix.
Section 22. Fees for examination and registration. The Board of Pharmacy shall charge for each applicant for examination the sum of fifty pesos,
and after passing the Board examinations, for each certificate of registration twenty pesos; and for each duplicate registration certificate, ten pesos.
All fees shall be paid to the cashier of the Board of Examiners and all expenses, including the fees of the Board members shall be disbursed by him
from such funds.
ARTICLE IV
Practice of Pharmacy
Section 23. Definition of practice of pharmacy. A person shall be deemed to be practicing pharmacy within the meaning of this Article, who shall, for
fee, salary, percentage or other reward paid or given directly to himself or indirectly through another, prepare or manufacture, analyze, assay,
preserve, store, distribute or sell any medicine, drug, chemicals, cosmetics, pharmaceuticals, devices or contrivances used in pursuance thereof; or
render pharmaceutical service in any office or drug and cosmetic establishment where scientific, technological or professional knowledge of
Pharmacy is applied; or engage in teaching scientific, technological or professional pharmacy subject in a college of pharmacy; or conduct or
undertake scientific pharmaceutical research for biological and bacteriological testings and examinations.
However, persons performing executive managerial or administrative functions and their subordinate personnel employed in the pharmaceutical
laboratories referred to in the second paragraph of Section twenty-seven hereof shall not be considered for purposes of this definition, considered
persons in the practice of pharmacy.
Section 24. Prerequisite for the practice of pharmacy. No person shall engage in the practice of pharmacy in the Philippines unless he is at least
twenty-one years of age, has satisfactorily passed the corresponding examination given by the Board of Pharmacy, and is a holder of a valid
certificate of registration duly issued to him by said Board.
Section 25. Sale of medicine, pharmaceuticals, drugs and devices.No medicine, pharmaceutical, or drug of whatever nature and kind or device shall
be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public except through a prescription drugstore or
hospital pharmacy, duly established in accordance with the provisions of this Act.
Pharmaceutical, drug or biological manufacturing establishments, importers and wholesalers of drugs, medicines, or biologic products are authorized
to sell their products only at wholesale to duly established retail drugstore or hospital pharmacies.
Section 26. Markings and inhibition to the sale of drug samples. No sample of any drug, biological product, device or proprietary medicine, given or
intended to be given for free to the physician and other qualified person by any manufacturer or distributor of its representative or detailman as part
of its program or promotion, may be sold.
The statement "Sample, not for sale" shall appear conspicuously on the container, package or carton of the drug or device to be given.
Section 27. Pharmacist required and compensation. Every pharmacy, drugstore or hospital pharmacy whether owned by the government or a
private person or firm shall at all times when open for business be under the personal and immediate supervision of a registered
pharmacist: Provided, That no pharmacist shall have personal supervision of more than one such establishment. In cases where a drug
establishment operates in more than one shift, each shift must be under the supervision and control of a registered pharmacists.
Drug or pharmaceutical laboratories or similar establishments engaged in the repackaging, manufacture or sale of drugs, biologic products and
pharmaceutical products in quantities greatly in excess of the therapeutic doses of each substance; such processes involving the preparation, quality
control or repackaging of said products shall for each respective operation be under the direct and immediate supervision of a registered pharmacist,
or, in the sale of pharmaceuticals, medicines and drugs at wholesale, such business shall be conducted under the immediate supervision of a
registered pharmacist practicing only in such establishment.
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Every pharmacist employed as such in any of the establishments mentioned in this section whose capitalization is not less than ten thousand pesos
shall receive, notwithstanding any provisions of law to the contrary, a minimum compensation similar to that of government pharmacists.
Section 28. Display of certificate required. It shall be the duty of every pharmacist engaged in the practice of pharmacy either on his own account or
under the employ of another, to display his certificate of registration in a prominent and conspicuous place in pharmacy, drugstore, hospital
pharmacy or drug establishment which he operates or in which he is employed. No pharmacist shall with his knowledge allow his certificate of
registration to be displayed in such establishments when he is not actually employed or operating therein in his professional capacity.
Section 29. Responsibility for quality of drugs. In cases of drugs, pharmaceuticals or poisons sold in their original packings, the seal of which has
not been broken or tampered with, the liability that may arise because of their quality and purity , rests upon the manufacturer or in his absence,
upon the importer, the distributor, representative or dealer who was responsible for their distribution or sale.
It shall be unlawful for any reason, whoever, to manufacture, prepare, sell or administer any prescription, drug, pharmaceutical or poison under any
fraudulent name, direction or pretense or to adulterate any drug, pharmaceutical, medicine or poison so used, sold or offered for sale. Any drug,
pharmaceutical, medicine or poison shall be held to be adulterated or deteriorated within the meaning of this section if it differs from the standard of
quality or purity given in the United States Pharmacopoeia or National Formulary, both in their latest edition or, in lieu thereof, in any standard
reference for drugs and medicines given official recognition; and those which fall within the meaning as provided for in the Food, Drug and Cosmetic
Act, (Republic Act Numbered Thirty-seven hundred twenty).
Section 30. Filling and refilling of prescription. No prescription shall be filled or compounded except by a registered pharmacist in the employ of the
drugstore or pharmacy. It shall be incumbent upon the pharmacist so compounding or filling the prescription to see to it that every component of the
prescription called for metes the standard or purity and quality given in the standard references. Students undergoing pharmaceutical internship may
assist said pharmacist in the compounding and dispensing of the prescription called for.
No prescription shall be refilled except upon express order of the person so prescribing.
Section 31. Label of dispensed medicine. Upon every box, bottle, or other package containing medicine sold or dispensed by a pharmacist based
on prescription, there shall be pasted, affixed or imprinted a seal of label bearing, among others, the name and address of pharmacy; the names and
quantities of the ingredients; required doses thereof, its expiration date if any; the name of the prescriber, date and the number of prescription; and
the direction for its use.
Every prescription, which in its preparation, contains any quantity of a drug which is habit-forming, or a derivative of such drug, shall have in the label
attached to the container the added statement "Warning may be habit forming.
Every prescription for external use filled in the drugstore shall bear a red label showing in black ink the components of such prescription and the
words "For external use only" at the bottom of the label.
Section 32. Record books for prescription. All prescriptions dispersed in the drugstore shall be recorded in the book kept for the purpose indicating
therein, among others, the name of the manufacturer, the original stock, lot and control numbers of the main ingredients of the prescriptions, which
book shall be open to inspection by the proper authorities at any time of the day when the pharmacy is open to the public and must be preserved for
a period of not less than two years the last entry in it has been made. All prescription shall be attached to said book for prescriptions and numbered
consecutively and shall be preserved for the same length of time as the prescription book.
Section 33. Inhibition against use of cipher or unusual terms in prescriptions and prescription switching. No pharmacist shall compound or dispense
prescriptions, recipes or formulas which are written in ciphers, codes or secret keys or in which they are employed unusual names of drugs which
differ from the names ordinarily used for such drugs in standard pharmacopoeias or formularies.
No pharmacist dispensing or compounding prescriptions shall substitute the drug or drugs called for in the prescription with any other drug or
substance or ingredient without prior consultation with, and a written consent of, the person prescribing.
Section 34. Provisions relative to dispensing of violent poisons.Every pharmacist who dispenses, sells or otherwise delivers any of the violent
poisons intended for medicinal use, to wit: arsenical preparations, phosphorus; corrosive sublimate; atropine, strychnine, or any of their salts,
hycocyanic acid or any of its salts; oil of bitter almonds containing hydrocyanic acid or prassic acid; oil of mirbane (Nitro-benzene); and such other
poisonous substances which may from time to time be classified under this category by the Food and Drug Administration; shall do so only upon
prescription of a duly licensed physician, dentist or veterinarian. He shall make or cause to be made in a separate book, kept for the purpose, an
entry stating the date of each sale and the name and address of the purchaser, the name and quantity of the poison sold and the purpose for which
it was claimed to be purchased, before delivering it to the purchaser.
No prescription, the prescribed dose of which contains a dangerous quantity of poison, shall be filled without first consulting the prescribing authority
and verifying the prescription. The pharmacist before delivery of such poison to the purchaser shall acquaint the latter of its poisonous character.
The pharmacist shall also affix to every box, bottle or other package containing any dangerous or poisonous drug, another label of red paper upon
which shall be printed in large letters the word "Poison" and a vignette representing a skull and bones before delivering it to the purchaser.
No poison specified in this section shall be sold or otherwise delivered to any person less than eighteen years of age or who is mentally deranged or
under the influence of liquor or one who is apparently addicted to opiate and other habit-forming drugs.
The books kept for the purpose of recording the sale of violent poisons shall be open at all times to the inspection of the proper authorities, and
every such book shall be preserved for at least five years after the last entry in it has been made.
Should any of the poisons above-stated be intended for purposes other than medicinal, the same may be sold without a prescription by the
pharmacist but the other requirements of this section must be complied with.
Section 35. Provisions relative to dispensing of less violent poisons. Every pharmacist who dispenses, sells or delivers any poison which is less
violent in category as classified by the Food and Drug Administration may do so even without the prescription of a physician and its sale may be
recorded in the poison book. The other requirements as provided for in Section thirty-four hereof, however, shall be complied with.
Section 36. Receptacle for poisonous drugs. The poisonous drugs specified in Section thirty-four and thirty-five hereof shall be kept in a cabinet to
be provided in every pharmacy carrying such drugs in stock and the same shall be kept securely-locked when not in use.
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Section 37. Provisions relative to dispensing of abolifecients or anti-conceptional substances and devices. No drug or chemical product or device
capable of provoking abortion or preventing conception as classified by the Food and Drug Administration shall be delivered or sold to any person
without a proper prescription by a duly licensed physician.
The pharmacist in charge of a drug store or pharmacy after filling a prescription containing abortive or anti-conceptional substance or devices shall
record in a separate register book for abortives and anti-conceptionals, the following data;
(a) Number and date of the prescription;
(b) Name and address of the physician;
(c) Name, quantity and manufacturer of the drug;
(d) Name and address of the purchaser;
(e) Date of filling the prescription; and
(f) Signature of the pharmacist filling the prescription.
Section 38. Provisions relative to dispensing of potent drugs. Every pharmacist who dispenses, sells or delivers any drug, which falls under the
classification of the Food and Drug Administration as potent drugs shall do so only upon prescription of a duly licensed physician, dentist or
veterinarian.
Section 39. Requirements for the opening and operation of drugstores and pharmacies. The minimum requirements necessary for the opening and
operation of drugstores and pharmacies shall be in accordance with the rules and regulations to be prescribed by the Food and Drug Administration
in accordance with the provisions of this Act. Only natural-born Filipino citizens who are registered pharmacists can apply for the opening of a retail
drugstore.
Section 40. Penal provisions. Any person who shall violate any of the provisions of Sections twelve, twenty-four, twenty-five, twenty-six, twenty-
seven and twenty-nine of this Act or any person who shall make false representation to procure a registration certificate as pharmacist for himself or
for another; or any person who shall allow anyone in his employ who is not a registered pharmacist to engage in the practice of pharmacy; or any
person who shall falsely display within the establishment the certificate of registration of a pharmacist who is not actually and regularly employed
therein as such or to act as a dummy for any alien or an unqualified person for the purpose of opening and operating a retail drugstore; shall, upon
conviction thereof, be sentenced to a fine of not less than one thousand pesos but not exceeding four thousand pesos or to an imprisonment of not
less than six months and one day but not more than four years, in the discretion of the court.
Section 41. Other penalties. Any pharmacist who shall violate any of the provisions of Sections twenty-eight, thirty, thirty-one, thirty-two, thirty-three,
thirty-four, thirty-five, thirty-seven and thirty-eight of this Act or any pharmacist after his certificate of registration has been lawfully suspended or
revoked, who continues to engage in the practice of pharmacy, shall, upon conviction thereof, be sentenced to a fine of not less than one hundred
pesos but shall not exceed five hundred pesos or to an imprisonment of not less than thirty days but not more than four months, in the discretion of
the court.
Any person other than citizens of the Philippines having been found guilty of any violation as provided for in this and the preceding section shall,
after having paid the fine or having served his sentence or both when so required be also subject to deportation.
Section 42. Definition of terms. For purposes of this Act, the term (a) "Pharmacy" or "Drug Store" means a place or establishment where drugs,
chemical products, active principles of drugs, pharmaceuticals, proprietary medicines or pharmaceutical specialties, devices, and poisons are sold at
retail and where medical, dental and veterinary prescriptions are compounded and dispensed.
(b) "Drug or Pharmaceutical Laboratory" or Pharmaceutical Manufacturing Laboratory" means an establishment where pharmaceuticals,
proprietary medicines or pharmaceutical specialties are prepared, compounded, standardized and distributed or sold.
(c) "Wholesaler" means and includes every person who acts as a jobber, merchant, broker or agent, who sells or distributes for resale
pharmaceuticals, proprietary medicines or pharmaceutical specialties.
(d) "Person" means and includes an individual, partnership, corporation or association.
(e) "Drug" means (1) articles recognized in the official United States Pharmacopoeia, official Hemeopathic Pharmacopoeia of the United
States or official National Formulary, or any of their supplements; (2) articles intended for use in the diagnosis, cure, mitigation, treatment,
or prevention of disease in man or animals; (3) articles (other than food) intended to effect the structure or any function of the body of man
or animals; and (4) articles intended for use as a component of any articles specified in clauses (1), (2), or (3), but not include devices or
their components, parts or accessories.
(f) "Pharmaceuticals", "Proprietary Medicines" or "Pharmaceutical Specialties" means any drug, preparation or mixture of drugs marked
under a trade name and intended for the cure, mitigation or prevention of disease in man or animals.
(g) "Device" means instruments, apparatus or contrivances including their components, parts and accessories, intended (1) for use in the
diagnosis, cure, mitigation, treatment or prevention of disease in man or animals; or
(2) to effect the structure or any function of the body of man or animals.
(h) "Biologic Products" are viruses, sera, toxins and analogous products used for the prevention or cure of human diseases.
(i) "Poison" is any drug, active principle, or preparation of the same, capable of destroying life or seriously endangering health when
applied externally to the body or introduced internally in moderate doses.
(j) "Cipher" means a method of secret writing that substitutes other letters or characters for the letter intended or transposes the letter after
arranging them in blocks or squares.
(k) "Code" means a system of words or other symbols arbitrarily used to represent words.
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(l) "Secret Keys" means a characteristics style or symbols kept from the knowledge of others or disclosed confidentially to but one of few.
Section 43. Final Provisions. To carry out the provisions of this Act, there is hereby authorized to be appropriated, out of any funds in the National
Treasury not otherwise appropriated, the sum of thirty thousand pesos within the fiscal year of the approval hereof. Thereafter, such funds as are
necessary for the maintenance and operation of the Board of Pharmacy and of the Council of Pharmaceutical Education shall be included in the
annual General Appropriations Act.
Section 44. Repealing clause. The following are hereby repealed: Sections seven hundred seventeen to seven hundred fifty-seven inclusive,
Sections two thousand six hundred seventy-five to two thousand six hundred seventy-seven inclusive of the Revised Administrative Code, as
amended; and such other laws or part of laws, executive orders, administrative orders; circulars, regulations and memoranda inconsistent or
incompatible with this Act.
Section 45. Separability of provisions. If any part, section or provision of this Act shall be held invalid or unconstitutional, no other part, section or
provision thereof shall be affected thereby.
Section 46. Effectivity. This Act shall take effect upon its approval.
Approved: June 21, 1969
An Act Regulating and Modernizing the Practice of Pharmacy in the Philippines, Repealing for the Purpose Republic Act Numbered Five
Thousand Nine Hundred Twenty-One (R.A. No. 5921), Otherwise Known as the Pharmacy Law
Be it enacted by the Senate and House of Representatives of the Philippine Congress Assembled:
Article I
General Provisions
Section 1. Title. - This Act shall be known as the "Philippine Pharmacy Act".
Section 2. Statement of Policy. - The State recognizes the vital role of pharmacists in the delivery of quality health care services through the
provision of safe, effective, and quality pharmaceutical products, pharmaceutical care, drug information, patient medication counseling, and health
promotion. The pharmacists’ professional services shall, therefore, be promoted as an indispensable component of the total health care system to
ensure the physical well-being of the Filipinos.
Hence, the State shall develop and nurture competent, productive, morally upright, and well-rounded pharmacists whose standards of professional
practice and service shall be excellent and globally competitive through regulatory measures, programs, and activities that promote and sustain their
continuing professional development.
Section 3. Objectives. - This Act provides for and shall govern the:
(a) Standardization and regulation of pharmacy education;
(b) Administration of licensure examination, registration, and licensing of pharmacists;
(c) Supervision, control, and regulation of the practice of pharmacy in the Philippines;
(d) Development and enhancement of professional competence of pharmacists through continuing professional development, research,
and other related activities; and
(e) Integration of the pharmacy profession.
Section 4. Scope of the Practice of Pharmacy. - A person is deemed to be practicing pharmacy, within the meaning of this Act, when with or without
a fee, salary, percentage or other rewards, paid or given directly or indirectly, shall:
(a) Prepare, compound or manufacture, preserve, store, distribute, procure, sell, or dispense, or both, any pharmaceutical product or its
raw materials; or
(b) Render services, such as clinical pharmacy services, drug information services, regulatory services, pharmaceutical marketing,
medication management, or whenever the expertise and technical knowledge of the pharmacist is required; or
(c) Engage in teaching scientific, technical, or professional pharmacy courses in a school or college of pharmacy; or (d) Dispense
pharmaceutical products in situations where supervision of dispensing of pharmaceutical products is required; or
(e) Chemical, biological or microbiological analyses and assay of pharmaceutical products, food/dietary supplements, health supplements,
and cosmetics; or
(f) Physico-chemical analyses for medical devices used in aid of administration of pharmaceutical products; or
(g) Administration of adult vaccines as approved by the Food and Drug Administration (FDA): Provided, That they shall undergo the
training on the safe administration of adult vaccines and management of adverse event following immunization (AEFI) for pharmacists and
hold a certificate of training issued by an institution duly accredited by the Professional Regulation Commission (PRC); Provided,
further,That the safe administration of vaccines be part of the higher education curriculum for pharmacists; or
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(h) Conduct or undertake scientific research in all aspects involving pharmaceutical products and health care; or
(i) Provide other services where pharmaceutical knowledge is required.
Activities under paragraphs (a), (b), (c), (d) and (i) are exclusive to licensed pharmacists. However, nothing herein shall be construed as requiring
other persons carrying out only the activities under paragraphs (e), (f), (g) and (h) to be licensed pharmacists, subject to any qualification that is
imposed by other laws with respect to such particular activity.
All pharmacists are expected to abide by current standards such as the Philippine Practice Standards for Pharmacists, Good Laboratory Practice,
Good Distribution Practice, Good Manufacturing Practice and Good Clinical Practice, which are deemed vital in the performance of their roles and
functions in different practice areas.
The Professional Regulatory Board of Pharmacy, hereinafter created, subject to the approval of the PRC, as provided for by Republic Act No. 8981,
otherwise known as the "PRC Modernization Act of 2000", and in consultation with the integrated and accredited professional organization (APO),
may modify the above-enumerated acts, services, or activities, as the need arises, in order to conform to the latest trends and developments in the
practice of the pharmacy profession: Provided, That such modifications are consistent with the enumeration above.
Section 5. Definition of Terms. - As used in this Act:
(a) Accredited professional organization (APO) refers to the duly integrated and accredited professional organization of registered and
licensed pharmacists, of which there shall be only one (1), as prescribed under Section 41, Article V of this Act;
(b) Adult vaccines refer to cervical cancer, flu (influenza), pneumococcal, other pre-exposure prophylactic vaccines to be administered to
patients aged eighteen (18) years and above, and such other vaccines as may be defined by the Department of Health (DOH) in an
administrative issuance;
(c) Adulterated/Deteriorated pharmaceutical products refer to pharmaceutical products unfit for human consumption, following the
standards of quality or purity of which, are as those stated in the United States Pharmacopeia/National Formulary and Philippine
Pharmacopeia in its latest edition or any standard reference for drugs and medicines which are given official recognition as well as those
provided for in Republic Act No. 3720, otherwise known as the "Food, Drug, and Cosmetic Act", as amended, and Republic Act No. 9711,
known as the "Food and Drug Administration Act of 2009";
(d) Biopharmaceuticals refer to pharmaceutical products that are used for therapeutic or for in vivo diagnostic purposes, such as vaccines,
sera, and drugs derived from life forms using biotechnology. These include proteins, nucleic acids, or living microorganisms where the
virulence is reduced and are used for therapeutic or for in vivo diagnostic purposes;
(e) Brand name refers to the proprietary name given by the manufacturer to distinguish its product from those of competitors;
(f) Cipher, Code, or Secret Key refers to a method of secret writing or use of characteristic style or symbol by substituting other letter/s or
character/s for the letter/s intended, for the purpose of misleading the consumer;
(g) Compounding refers to the sum of processes performed by a pharmacist in drug preparation including the calculations, mixing,
assembling, packaging, or labeling of a drug: (i) as the result of a prescription or drug order by a physician, dentist, or veterinarian; or (ii)
for the purpose of, or in relation to, research, teaching, or chemical analysis;
(h) Continuing professional development (CPD) refers to the inculcation of advanced knowledge, skills, and ethical values in a post-
licensure specialized or in an inter- or multidisciplinary field of study for assimilation into professional practice, self-directed research,
and/or lifelong learning;
(i) Cosmetics refer to a substance or preparation intended to be placed in contact with the various external parts of the human body or with
the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing
their appearance and/or correcting body odor, and/or protecting the body or keeping them in good condition, as defined under Republic
Act No. 9711;
(j) Counterfeit pharmaceutical products refer to pharmaceutical products which do not contain the amounts as claimed; with wrong
ingredients; without active ingredients; or with insufficient quantity of active ingredients, which result in the reduction of the products’
safety, efficacy, quality, strength, or purity. These also refer to products that are deliberately and fraudulently mislabeled with respect to
identity and/or source or with fake packaging, and can apply to both branded and generic products, including the following:
(1) The pharmaceutical product itself or the container or labeling thereof or any part of such product, container, or labeling,
bearing without authorization; the trademark, trade name, or other identification marks or imprints or any likeness to that which
is owned or registered in the Intellectual Property Office (IPO) in the name of another natural or juridical person;
(2) A pharmaceutical product refilled in containers bearing legitimate labels or marks, without authority; and
(3) A pharmaceutical product which contains no amount of or a different active ingredient; or less than eighty percent (80%) of
the active ingredient it purports to possess, as distinguished from an adulterated drug including reduction or loss of efficacy due
to expiration;
(k) Dangerous drugs refer to those listed in the: (1) Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by
the 1972 Protocol; (2) Schedules annexed to the 1971 Single Convention on Psychotropic Substances; and (3) Annex of Republic Act No.
9165, otherwise known as the "Comprehensive Dangerous Drugs Act of 2002", and its amendments;
(l) Dispensing refers to the sum of processes performed by a pharmacist from reading, validating, and interpreting prescriptions; preparing;
packaging; labeling; record keeping; dose calculations; and counseling or giving information, in relation to the sale or transfer of
pharmaceutical products, with or without a prescription or medication order;
(m) Drugs refer to pharmaceutical products that pertain to chemical compounds or biological substances, other than food, intended for use
in the treatment, prevention, or diagnosis of disease in humans or animals, including the following:
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(1) Any article recognized in the official United States Pharmacopeia/National Formulary, Homeopathic Pharmacopeia of the
United States of America, Philippine Pharmacopeia, Philippine National Drug Formulary, British Pharmacopoeia, European
Pharmacopoeia, Japanese Pharmacopoeia, and any official compendium or any supplement to them;
(2) Any article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease of man or animals;
(3) Any article, other than food, intended to affect the structure or any function of the human body or animals;
(4) Any article intended for use, as a component of articles, specified in clauses (1), (2) and (3), not including devices or their
components, parts and accessories; and
(5) Herbal or traditional drugs as defined in Republic Act No. 9502;
(n) Emergency cases refer to life-threatening situations where a patient needs immediate medical attention and treatment, including the
occurrence of epidemic or natural calamities;
(o) Expiration date refers to the end date when the manufacturer can guarantee that a product possesses its claimed potency, efficacy,
quality, and safety; after which its sale or distribution is prohibited;
(p) Filling refers to the act of dispensing or providing medicines in accordance with a prescription or medication order;
(q) Food/Dietary supplements refer to processed food products intended to supplement the diet that bears or contains one (1) or more of
the following dietary ingredients: vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances to increase the total
daily intake in amounts conforming to the latest Philippine-recommended energy and nutrient intakes or internationally agreed minimum
daily requirements. It usually is in the form of capsules, tablets, liquids, gels, powders, or pills and not represented for use as a
conventional food or as the sole item of a meal or diet or replacement of drugs and medicines, as defined under Republic Act No. 9711;
(r) Generic name refers to the scientifically and internationally recognized name of the active ingredients, as approved by the FDA
pursuant to Republic Act No. 6675, otherwise known as the "Generics Act of 1988";
(s) Health supplement refers to any product that is used to maintain, enhance and improve the healthy function of the human body and
contains one (1) or more or a combination of the following: (1) herbal fatty adds, enzymes, probiotics, and other bioactive substances; and
(2) substances derived from natural sources, induding animal, plant, mineral, and botanical materials in the form of extracts, isolates,
concentrates, metabolites, synthetic sources of substances mentioned in (1) and (2). It is presented in dosage forms or in small unit doses
such as capsules, tablets, powder, liquids and it shall not include any sterile preparations (i.e. injectibles, eyedrops);
(t) Household remedies refer to any preparation containing pharmaceutical substances of common or ordinary use to relieve common
physical ailments and which may be dispensed without a medical prescription in original packages, bottles or containers, of which the
nomenclature has been duly approved by the FDA;
(u) Institutional pharmacies refer to pharmacies of institutions, organizations, and/or corporations that provide a range of pharmaceutical
services, given exclusively to the employees and/or their qualified dependents;
(v) Internship program refers to a supervised practical experience that is required to be completed for licensure as a registered
pharmacist;
(w) Label refers to a display of written, printed, or graphic matter on the immediate container of any article;
(x) Labeling materials refer to all labels and other written, printed, or graphic matter: (1) upon any item or any of its containers or wrappers;
or (2) accompanying any such item;
(y) Medical device refers to any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings, for one (1)
or more of the specific purposes of: diagnosis, prevention, monitoring, treatment, or alleviation of disease; diagnosis, monitoring,
treatment, or alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy of a
physiological process; supporting or sustaining life; preventing infection; control of conception; disinfection of medical devices; and
providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
This device does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic
means, but which may be assisted in its intended function by such means, as defined under Republic Act No. 9711;
(z) Medical mission refers to an activity conducted on normal circumstances of an individual or a group of health care practitioners to
provide health services outside the hospital, clinic, and health care facility premises as differentiated from humanitarian missions and relief
operations which is conducted during emergency situations such as calamity, war, or natural and man-made disasters;
(aa) Medicines refer to drugs in their appropriate dosage forms, with assured quality, safety and efficacy for humans or animals, or both;
(bb) Medical representative or professional service representative refers to one who represents any duly authorized manufacturer,
distributor, trader, and wholesaler of pharmaceutical products and whose primary duty is to promote their products to duly licensed health
professionals;
(cc) Nontraditional outlets refer to entities licensed by appropriate government agencies to dispense over-the-counter medicines based on
an approved list;
(dd) Online pharmacy services refer to pharmaceutical services of a duly licensed pharmaceutical outlet done over the internet;
(ee) Over-the-counter (OTC) medicines refer to medicines used for symptomatic relief of minor ailments and which may be dispensed
without a prescription;
(ff) Pharmaceutical establishments refer to entities licensed by appropriate government agencies, and which are involved in the
manufacture, importation, exportation, repacking, and distribution of pharmaceutical products to pharmaceutical outlets;
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(gg) Pharmaceutical manufacturers refer to establishments engaged in any or all operations involved in the production of pharmaceutical
products including the preparation, processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing
and labeling, preparatory to their storage, sale, or distribution, except the compounding and filling of prescriptions in pharmaceutical
outlets;
(hh) Pharmaceutical marketing refers to any activity undertaken, organized, or sponsored by a pharmaceutical establishment or outlet
which is directed at promoting its product;
(ii) Pharmaceutical outlets refer to entities licensed by appropriate government agencies, and which are involved in compounding and/or
dispensing and selling of pharmaceutical products directly to patients or end-users;
(jj) Pharmaceutical products refer to drugs, medicines, biologicals, pharmaceutical and biopharmaceutical products/specialties, veterinary
products, veterinary biologies and veterinary medicinal products;
(kk) Pharmacist refers to a health professional who has been registered and issued a valid Certificate of Registration (COR) and
Professional Identification Card (PIC) by the PRC and the Professional Regulatory Board of Pharmacy;
(ll) Pharmacist-only OTC medicines refer to over-the-counter medicines classified by appropriate government agencies to be obtained only
from a licensed pharmacist, with mandatory pharmacist’s advice on their selection and proper use;
(mm) Pharmacy aides refer to persons who assist the pharmacists in the different aspects of pharmacy operation based on established
standard operating procedures and processes, with very minimal degree of independence or decision making and without direct
interaction with patients:
(nn) Pharmacy assistants refer to persons who assist the pharmacists in different aspects of pharmacy operation based on established
standard operating procedures and processes, with a minimum degree of independence or decision making and may have supervised
interaction with patients;
(oo) Pharmacy technicians refer to persons who assist in compounding and dispensing of medicines in community, hospital, institutional
and industrial settings or engaged in other activities under the supervision of the pharmacist as described in Section 39, Article IV of this
Act;
(pp) Philippine Practice Standards for Pharmacists refer to the established national framework for quality standards and guidelines of the
practice of pharmacy that respond to the needs of the people who require the pharmacists’ services to provide optimal, evidence-based
care as formulated by the integrated APO and approved by the Professional Regulatory Board of Pharmacy;
(qq) Physician’s samples refer to medicines given to health professionals for promotional purposes only;
(rr) Prescription/Ethical medicines refer to medicines which can only be dispensed by a pharmacist to a patient, upon the presentation of a
valid prescription from a physician, dentist, or veterinarian and for which a pharmacist’s advice is necessary;
(ss) Refilling of a prescription refers to the act of dispensing the remaining balance of medicines ordered in the prescription;
(tt) Referral refers to the process wherein a pharmacist provides consultative services and conducts preliminary assessment of symptoms
and refers the patient to a physician or other health care professional;
(uu) Referral registry refers to the record book maintained by pharmacists, listing the patients referred to different health facilities for
further diagnosis;
(vv) Refresher program refers to a prescribed study program in an accredited school of pharmacy; and
(ww) Telepharmacy services refer to pharmaceutical services of a duly licensed pharmaceutical outlet done through the use of telephone,
teleconferencing, or facsimile.
Article II
The Professional Regulatory Board of Pharmacy
Section 6. Creation of the Professional Regulatory Board of Pharmacy. - There is hereby created a Professional Regulatory Board of Pharmacy,
hereinafter called the Board, under the administrative control and supervision of the PRC, to be composed of a Chairperson and two (2) members, to
be appointed by the President of the Philippines from a list of three (3) recommendees for each position ranked in the order of preference and
submitted by the PRC from a list of five (5) nominees submitted for each position by the duly integrated APO of pharmacists.
Section 7. Qualifications of the Chairperson and Members of the Board. - The Chairperson and members of the Board, at the time of nomination,
must:
(a) Be a citizen of the Philippines and a resident for at least five (5) years;
(b) Be a duly registered and licensed pharmacist in the Philippines, preferably a holder of a masteral degree in Pharmacy, or its
equivalent;
(c) Have been in the active practice of pharmacy for the past ten (10) years;
(d) Have not been convicted of a crime involving moral turpitude;
(e) Be a member in good standing of the APO for at least five (5) years, but not an officer or trustee thereof; and
(f) At the time of appointment, must neither be a member of the faculty nor an administrative officer of any school, college or university
offering degree programs in pharmacy nor has any direct or indirect pecuniary interest or connection in any review center or similar
institution.
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Section 8. Powers, Functions, and Responsibilities of the Board. - The Board shall exercise the following powers, functions, and responsibilities:
(a) Administer and implement the provisions of this Act;
(b) Promulgate rules and regulations, administrative orders, and issuances necessary to carry out the provisions of this Act;
(c) Prepare licensure examination questions, score, and rate the examinations and submit the results thereof to the PRC. The Board shall
prepare, adopt, issue, or amend the syllabi or tables of specifications of the subjects in the licensure examination, in consultation with the
academe and the Commission on Higher Education (CHED);
(d) Recommend the issuance, suspension, revocation, or reinstatement of the COR, PIC or Special/Temporary Permits (STP) for the
practice of pharmacy;
(e) Administer oaths in accordance with the provisions of this Act;
(f) Regulate and monitor the practice of pharmacy in the Philippines, including the practice of subprofessional services such as pharmacy
technicians, pharmacy assistants, aides, and other medicine handlers, as described in this Act; adopt measures that may be deemed
proper for the enhancement of the profession and the maintenance of high professional, academic, ethical, and technical standards; and
conduct ocular inspection of pharmaceutical establishments and higher education institutions (HEIs), in coordination with concerned
government agencies;
(g) Promulgate and prescribe the Pharmacists’ Code of Ethics, Code of Technical Standards and Guidelines for the Professional Practice
of the Pharmacy Profession, in coordination with the APO;
(h) Represent the pharmacy profession in all fora involving concerns and issues related to pharmaceutical products and the practice of
pharmacy;
(i) Investigate cases arising from violations of this Act, the rules and regulations promulgated pursuant thereto, the Pharmacists’ Code of
Ethics, Code of Technical Standards and Guidelines for the Professional Practice of the Pharmacy Profession, and other Board issuances;
issue summons, subpoena ad testificandum and subpoena duces tecum to secure the attendance of witnesses or production of
documents, or both, and other evidence necessary for such investigation or hearing; and render decision thereon which shall, unless
appealed to the PRC, become final and executory after fifteen (15) days from receipt of notice of judgment or decision;
(j) Delegate the he aring or investigation of administrative cases filed before the Board, except where the issue or question involves the
practice of the profession, in which case, the hearing shall be presided over by at least one (1) member of the Board, to be assisted by a
Legal or Hearing Officer of the PRC;
(k) Conduct, through the Legal Officers of the PRC, summary proceedings on minor violations of this Act, the General Instruction to the
Examinees, including the implementing rules and regulations issued by the Board, and to render summary judgment thereon which shall,
unless appealed to the PRC, become final and executory after fifteen (15) days from receipt of notice of judgment or decision;
(l) Issue and promulgate guidelines on CPD, in coordination with the APO;
(m) Recommend the accreditation of the standardized training programs for and certifications of medical representatives or professional
service representatives, pharmacy technicians, pharmacy assistants, pharmacy aides and other medicine handlers covered in Section 39,
Article IV of this Act. The Board shall promulgate the criteria and guidelines in the accreditation of training programs and certifications as
described above, in coordination with the APO and with other concerned government agencies;
(n) Accredit Specialty Boards of Pharmacy based on the criteria that it shall establish and prescribe; and
(o) Perform and discharge such other functions and responsibilities, as may be deemed implied, incidental, and necessary, to preserve the
integrity of the pharmacy licensure examination and to enhance and upgrade the practice of the pharmacy profession in the country.
Section 9. Term of Office of the Members of the Board. - The Chairperson and members of the Board shall hold office for a term of three (3) years
from the date of appointment or until their successors shall have been qualified and appointed. They may be reappointed in the same office for
another term of three (3) years immediately after the expiry of their term; Provided, That no member of the Board shall hold office for more than two
(2) terms or not more than six (6) years; Provided, further, That the first Board appointed under this Act shall hold these terms cf office: the
Chairperson for three (3) years, the first member for two (2) years, and the second member for one (1) year; Provided, finally, That an appointee to a
vacancy shall serve only the unexpired portion of the term of office. The Chairperson and members of the Board shall duly take their oath of office
before a duly authorized officer.
Section 10. Compensation and Allowances of the Board. - The Chairperson and members of the Board shall receive compensation and allowances
comparable to the compensation and allowances received by the members of the other existing professional regulatory boards under the PRC, as
provided for in the General Appropriations Act.
Section 11. Grounds for Suspension or Removal from Office of the Chairperson or Member of the Board. - The President of the Philippines may,
upon recommendation of the PRC and after due process, suspend or remove the Chairperson or any member of the Board on any of the following
grounds:
(a) Gross neglect, incompetence, or dishonesty in the discharge of duty;
(b) Involvement in the manipulation, tampering, or rigging of the licensure examination, its questions or results, or both, and in the
disclosure of classified and confidential information pertaining to the licensure examination;
(c) Conviction of an offense involving moral turpitude by a court of competent jurisdiction; and
(d) Unprofessional, unethical, immoral, or dishonorable conduct.
The PRC, in the conduct of investigation, shall be guided by Sections 7 and 15 of Republic Act No. 8981, the existing rules on administrative
investigation, and the Rules of Court.
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Section 12. Custodian of its Records, Secretariat and Support Services. - All records of the Board, pertaining to the applications for examinations,
administrative and other investigative hearings conducted by the Board, shall be under the custody of the PRC. The PRC shall designate a
Secretary who shall provide the Board with secretariat and other support services to implement the provisions of this Act.
Article III
Examination, Registration, and Licensure
Section 13. Licensure Examination Requirement. - Unless exempted therefrom, all applicants for registration for the practice of pharmacy shall be
required to pass a licensure examination, as provided for in this Act and Section 7(d) of Republic Act No. 8981.
Section 14. Qualifications for the Licensure Examination. - An applicant for the Pharmacists’ Licensure Examination shall establish to the
satisfaction of the Board that the following qualifications are met:
(a) A citizen of the Philippines or of a foreign country which has a law or policy on reciprocity for the practice of the pharmacy profession;
(b) Of good moral character and reputation;
(c) A degree holder of Bachelor of Science in Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of
learning in a foreign country duly recognized by the CHED; and
(d) Has completed an internship program approved by the Board, pursuant to such guidelines as may hereinafter be promulgated, in
consultation with the duly recognized associations of pharmacy schools and the CHED.
Section 15. Scope of Examination. - The Pharmacists’ Licensure Examination shall cover the following subjects on Pharmacy Science and Practice,
Inorganic Pharmaceutical Chemistry, Organic Pharmaceutical Chemistry, Qualitative and Quantitative Pharmaceutical Chemistry, Pharmacognosy
and Plant Chemistry, Pharmaceutical Biochemistry, Microbiology and Parasitology, Physical Pharmacy, Biopharmaceutics, Pharmacology and
Toxicology, Manufacturing, Quality Assurance and Instrumentation, Pharmaceutical Calculations, Drug Delivery Systems, Hospital Pharmacy,
Clinical Pharmacy, Dispensing and Medication Counseling, Pharmaceutical Administration and Management, Public Health, Legal Pharmacy, and
Ethics.
The Board, subject to the approval of the PRC, may introduce relevant changes on the subject areas, format, and content of the examination, as well
as on the relative weight attributed to each examination subject, as the need arises, and in consultation with the duly recognized associations of
pharmacy schools and the CHED.
Section 16. Holding of Examination. - The Pharmacists’ Licensure Examination shall be given two (2) times a year in places and dates as the PRC
may designate in the Resolution providing for the master schedule of all licensure examinations pursuant to Section 7(d) of Republic Act No. 8981.
Section 17. Ratings in the Licensure Examination. - In order to be registered and licensed as a pharmacist, a candidate must obtain a general
weighted average of seventy-five percent (75%), with no rating lower than fifty percent (50%) in any of the subjects.
An applicant who failed in the licensure examination for the third (3rd) time shall not be allowed to take the next succeeding examinations without
having undertaken a refresher program in a duly accredited institution. The Board shall issue guidelines on the refresher program requirement.
Section 18. Report of Rating. - The Board shall submit to the PRC the ratings obtained by each candidate within three (3) working days after the last
day of the examination, unless extended for just cause.Upon the release of the results of the examination, the PRC shall send by mail the rating
obtained by each examinee at the given address using the mailing envelope submitted during the examination.
Section 19. Oath of Profession. - All successful candidates in the licensure examination shall take their oath of profession before any member of the
Board, officer of the PRC, or any person authorized by law to administer oaths, prior to entering the practice of the pharmacy profession.
Section 20. Issuance of Certificate of Registration and Professional Identification Card. - A COR as a pharmacist shall be issued to those who
passed the licensure examination, subject to compliance with the registration requirements and payment of the prescribed fees. The COR shall bear
the registration number, the date of its issuance, and the signatures of the Chairperson of the PRC and the members of the Board, stamped with the
official seals of the PRC and of the Board, certifying that the person named therein is entitled to the practice of the profession, with all the privileges
appurtenant thereto. This COR shall remain in full force and effect until suspended or revoked in accordance with this Act.
A PIC bearing the registration number and dates of its issuance and expiry, duly signed by the Chairperson of the PRC, shall likewise be issued to
every registrant, upon payment of the prescribed fees. The PIC shall be renewed every three (3) years, upon presentation of the Certificate of Good
Standing (COGS) from the APO and proof of completion of the CPD requirements.
Section 21. Foreign Reciprocity. - Unless the country or state of which the foreign pharmacist is a subject or citizen, specifically permits Filipino
pharmacists to practice within its territorial limits on the same basis as the subjects or citizens of the said foreign country or state under reciprocity
and under international agreements, no foreigner shall be admitted to licensure examinations, given a COR to practice as pharmacist nor be entitled
to any of the privileges under this Act.
Section 22. Practice Through Special/Temporary Permit (STP). - The practice of pharmacy in the Philippines shall be limited to natural persons only
and shall be governed by the provisions of Republic Act No. 8981 and other issuances pertinent thereto: Provided, That any foreign citizen who has
gained entry in the Philippines to perform professional services within the scope of the practice of pharmacy, including the following: (a) being a
consultant in foreign-funded or assisted projects of the government; (b) being engaged or employed by a Filipino employer or establishment; (c)
providing free services in humanitarian missions: and (d) being a visiting faculty member in any field or specialty in pharmacy shall, before assuming
such duties, functions and responsibilities, secure an STP from the Board and the PRC, under the following conditions:
(1) The person is an internationally renowned pharmacist or expert in a field or specialty of pharmacy;
(2) The person is engaged in the provision of a professional service which is determined to be necessary due to lack of Filipino specialist
or expert; and
(3) The person is required to work with a Filipino counterpart, a natural person who is a registered and licensed pharmacist.
Section 23. Grounds for Non-registration. - The Board shall not register any successful examinee who has been:
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(a) Convicted of an offense involving moral turpitude by a court of competent jurisdiction;
(b) Summarily adjudged by the Board as guilty for misrepresentation or falsification of documents in connection with the application for
examination or for violation of the General Instructions to Examinees;
(c) Found guilty of immoral or dishonorable conduct by the Board;
(d) Medically proven to be addicted to any drug or alcohol by a medical or drug testing facility accredited by the government; and
(e) Declared of unsound mind by a court of competent jurisdiction.
In refusing the registration, the Board shall give a written statement setting forth the reasons therefor and shall file a copy thereof in its records.
Should ground (d) be proven to be no longer existent, the Board shall issue a Board Resolution allowing the issuance of such COR.
Section 24. Reissuance of Revoked Certificate of Registration, Replacement of Lost or Damaged Certificate of Registration, Professional
Identification Card or Special/Temporary Permit. - The Board may, upon petition, reinstate or reissue a revoked COR after the expiration of two (2)
years from the date of its revocation. The Board may, in its discretion, require the applicant to take another licensure examination. The petitioner
shall prove to the Board that there is a valid reason for such reinstatement. For the grant of the petition, the Board shall issue a Board Resolution, to
be approved by the PRC.
A duplicate copy of the COR for display in Category B establishments may be issued. Replacement of lost or damaged COR, PIC or STP may be
issued in accordance with the pertinent rules that shall be issued thereon.
Article IV
Regulation of the Practice of Pharmacy
Section 25. Vested Rights; Automatic Registration. - All pharmacists registered before the effectivity of this Act shall automatically be registered
hereunder, subject to compliance as to future requirements.
The CORs, PICs or STPs held by such persons in good standing shall have the same force and effect, as though they were issued on or after the
effectivity of this Act.
Section 26. Affixing RPh After a Registered Pharmacist’s Name. - Only duly registered and licensed pharmacists shall have the right to affix to one’s
name, the title "Registered Pharmacist" or "RPh".
Section 27. Indication of Information. - A pharmacist shall be required to indicate the serial numbers, the date of expiry of the pharmacist’s PIC and
APO Certificate of Membership on all pertinent documents signed by him/her.
Section 28. Registry of Pharmacists. - The Board and the PRC shall prepare and maintain a registry of the names, residences or office addresses,
or both, status of registration and area of practice of all registered pharmacists, which shall be updated annually, in coordination with the APO. This
registry shall be made available to the public upon inquiry or request, subject to such guidelines that shall be established therefor.
Section 29. Display of Certificate of Registration. - It shall be the duty of every pharmacist engaged in the practice, whether in private or under the
employ of another, to display the original copy of one’s COR in a prominent and conspicuous place in the drug establishment in which one is
employed in a professional capacity as pharmacist. When employed in establishments under Category B, as defined in Section 31 of this Act, the
duplicate copy of the pharmacist’s COR shall also be displayed therein. - No pharmacist shall knowingly allow the COR to be displayed in an
establishment where one is not ctually employed as a professional pharmacist.
Section 30. Dispensing/Sale of Pharmaceutical Products. - No pharmaceutical product, of whatever nature and kind, shall be compounded,
dispensed, sold or resold, or otherwise be made available to the consuming public, except through a retail drug outlet duly licensed by the FDA.
Prescription drugs and pharmacist-only OTC medicines shall be dispensed only by a duly registered and licensed pharmacist, except in emergency
cases, where the services of a registered and licensed pharmacist are not available: Provided, That a report shall be made to the supervising
pharmacist within twenty-four (24) hours after the occurrence of the emergency so that product recording in the prescription books can be done.
Compounding and dispensing shall be done only by duly registered and licensed pharmacists, in accordance with current Good Manufacturing
Practice, laboratory practice, Philippine Practice Standards for Pharmacists and dispensing guidelines. A registered and licensed pharmacist may
refuse to compound, dispense or sell drugs and pharmaceutical products, if not in accordance with this Act and the abovementioned standards.
Licensed manufacturers, importers, distributors, and wholesalers of pharmaceutical products are authorized to sell their products only to duly
licensed pharmaceutical outlets.
Section 31. Pharmacist Requirement. - Establishments/outlets which are required to employ and/or retain and maintain the professional services of
duly registered and licensed pharmacists shall be classified as follows:
(a) Category A – Pharmaceutical establishments/outlets where the direct and immediate control and supervision of a duly registered and
licensed pharmacist is required, per establishment, whether in-store or online, including:
(1) Pharmaceutical establishments/outlets selling or otherwise making available to the consuming public prescription/ethical
medicines, combination products (medical device and drugs) classified as drugs according to the primary intended mode of
action, pharmacist-only OTC medicine, whether owned by the government or by a private person or firm, whether sold at
wholesale or retail;
(2) Establishments involved in the manufacture, importation, exportation, distribution, and sale of combination products (medical
device and drugs) classified as drugs according to the primary intended mode of action;
(3) Departments/Divisions/Units of pharmaceutical laboratories, pharmaceutical manufacturing laboratories, or other

establishments with processes involving the preparation, manufacture, assay, regulation, product research and development,
quality control, repacking, importation, exportation, distribution, sale or transfer of pharmaceutical products in quantities greatly
in excess of single therapeutic doses; and
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(4) Government units, including local government, city, first to third class municipal health units, nongovernment organizations
and/or associations involved in the procurement, distribution, dispensing and storage of pharmaceutical products;
(b) Category B – Pharmaceutical establishments/outlets where the supervision and oversight of a duly registered and licensed pharmacist
is required under pertinent provisions of law, including:
(1) Retail outlets selling household remedies and OTC drugs as differentiated from the pharmacist-only OTC medicines;
(2) Satellite institutional pharmacies providing medicines solely to employees of their respective companies or the employees’
qualified dependents, or both; or members of a duly registered organization or institution;
(3) Fourth, fifth and sixth class municipal health units involved in the procurement, distribution, dispensing, and storage of
pharmaceutical products;
(4) Institutions providing telepharmacy services; and
(5) Nontraditional outlets of pharmaceutical products: Provided, That no prescription medicines and pharmacist-only OTC
medicines are sold.
The FDA, in coordination with the Board, and the approval of the PRC, may add to, delete, reclassify, or modify the above list of establishments, as
the need arises, in order to keep pace with the developments in the pharmacy practice.
A pharmacist working in a Category A establishment may be allowed to simultaneously work or render pharmacy services in Category B
establishments, the maximum number of hours of which shall be determined, in accordance with such guidelines as may be established therefor by
the Board, in coordination with the FDA, and other agencies, establishments, institutions, and regulatory bodies.
Procurement, storage, distribution, or dispensing of any pharmaceutical product in the national government and local government units shall be
made only under the supervision of a duly registered and licensed pharmacist.
All units or sub-units of establishments, institutions, and regulatory bodies whether government or private with functions and activities that are
exclusive for pharmacists, as defined in Section 4, paragraphs (a), (b), (c), (d) and (i), shall be headed and managed by a qualified duly registered
and licensed pharmacist: Provided,That an appointment in government service shall comply with the provisions of other pertinent laws.
Section 32. Responsibility for Quality of Pharmaceutical Products. - It shall be the duty of a duly licensed and registered pharmacist of a
pharmaceutical establishment and outlet to ensure that all pharmaceutical products conform to standards of safety, quality and efficacy, as provided
for in this Act and other pertinent rules and regulations and issuances. Owners, managers, or pharmacists in charge of the operation of
pharmaceutical establishments and outlets shall be held jointly responsible for nonconformance with these standards.
It shall be unlawful for any person to manufacture, prepare, sell, or dispense any pharmaceutical product under a fraudulent name, or pretense or to
adulterate any pharmaceutical product offered for sale.
In cases of pharmaceutical products sold in their original package, the seal of which has not been broken or tampered with, the liability that may
arise because of their quality and purity rests upon the manufacturer or importer, the distributor, representative, or dealer who is responsible for their
distribution or sale.
Section 33. Filling and Partial Filling of Prescription. - All prescriptions and pharmacist-only OTC medicines shall be filled, compounded and
dispensed only by a registered and licensed pharmacist, in accordance with the Philippine Practice Standards for Pharmacists, Dispensing
Guidelines and other standards pertaining to purity, safety and quality. Completely filled prescriptions should be surrendered to the pharmacist for
recording.
Partial filling of prescription less than the total quantity indicated in the prescription shall be allowed, subject to dispensing guidelines as provided in
the immediately preceding paragraph. It is the responsibility of the pharmacist dispensing the last quantity completing the prescription to keep the
prescription according to proper prescription recording guidelines.
Prescription medicines may be dispensed only by a duly registered and licensed pharmacist and only with a valid prescription of a physician, dentist,
or veterinarian.
Section 34. Physician’s Sample. - Pharmaceutical products given or intended to be given free to any health professional by a manufacturer or
distributor or its professional service representative as part of its program or promotion shall not be sold to any pharmaceutical outlet or the
consuming public.
The statement "Sample, Not for Sale", or its equivalent, shall appear conspicuously on the primary and secondary packaging of the drug or
combination products (medical device and drug) classified as drug according to the primary intended mode of action to be given. It shall be unlawful
to remove, erase, deface or mark the original labels of samples.
Pharmaceutical products classified as antimicrobials, including anti-TB medicines and other classifications of medicines, as may be prescribed by
the FDA, shall not be given or distributed as physician’s samples.
Section 35. Prohibition Against the Use of Cipher, Codes, or Unusual Terms in Prescriptions and Prescription Substitution. - Pharmacists shall not
compound or dispense prescriptions, recipes, or formulas which are written in ciphers, codes or secret keys or prescriptions of pharmaceutical
products with unusual names which differ from those in standard pharmacopeias or formularies.
The pharmacist dispensing or compounding prescriptions shall not substitute the medicine called for in the prescription with any other drug,
substance or ingredient, without prior consultation with, and written consent of the person prescribing, except in accordance with Republic Act No.
6675, as amended, otherwise known as the "Generics Act of 1988", and other pertinent laws and regulations.
Section 36. Label of Dispensed Medicines. - Upon every box, bottle, or package of medicines compounded or dispensed by a registered and
licensed pharmacist based on prescription, there shall be pasted, affixed, or imprinted a seal or label bearing, among others, the name of patient and
generic name of drug; brand name, if any, strength, expiry date, directions for use; and name and address of pharmacy, name of the doctor, the
dispensing pharmacist and other requirements prescribed in the Philippine Practice Standards for Pharmacists and Dispensing Guidelines, Republic
Act No. 9502, otherwise known as the "Universally Accessible Cheaper and Quality Medicines Act of 2008", its implementing rules and regulations
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and such other guidelines that may be promulgated by the Board. Auxiliary labels containing special pharmacists" instructions for the patient shall be
required as prescribed for dangerous drugs, external-use-only drugs, drugs with special storage and administration instructions and such other
drugs as may be required by law.
Section 37. Recording of Patient Medication Profile. - All prescriptions dispensed in the pharmacy shall be recorded in an appropriate recording
system indicating therein, among other things, the name and address of the patient, name of prescribes generic name and brand, dosage strength,
quantity of drug and initials of pharmacist. It shall be open for inspection by the representatives of the Board or the FDA, or both, at any time of the
day, when the pharmacy is open, and must be kept for a period of not less than two (2) years after the last entry.
All required information on dangerous drugs dispensed by a pharmacy shall be recorded in the Dangerous Drugs Book or an equivalent recording
system as required by Republic Act No. 9165 and other applicable laws and issuances.
All referrals such as tuberculosis patients undertaken by the pharmaceutical outlets shall be recorded in the Referral Registry and shall be open for
inspection by the Board, or representative of the Department of Health (DOH) or the FDA, or both, at any time of the day when the pharmacy is
open, and must be kept for a period of not less than two (2) years after the last entry.
Section 38. Requirements for the Opening and Operation of Retail Pharmaceutical Outlet or Establishment. - The opening of a retail pharmaceutical
outlet or establishment shall be subject to requirements provided for in this Act and the rules and regulations prescribed by the FDA.
The application for the opening and operation of a retail drug outlet or other similar business establishments shall not be approved, unless applied
for by a Filipino registered and licensed pharmacist, either as owner or as pharmacist-in-charge, pursuant to the provisions of this Act.
Section 39. Handling of Pharmaceutical Products by Persons Other Than a Pharmacist. - For the purpose of this section, persons handling
pharmaceutical products, other than the pharmacist, which shall include pharmacy owners who are non-pharmacists, medical representatives or
professional service representatives, pharmacy support personnel, pharmacy technicians, pharmacy assistants, pharmacy aides, persons who
assist pharmacists in any part of a pharmacy operation, or any other person performing functions involved in the handling of pharmaceutical
products, shall be duly certified by appropriate government agencies after undergoing an accredited training program.
No person, except pharmacy graduates, shall be allowed to render such services without undergoing a comprehensive standardized training
program: Provided, That the job description is defined in the implementing rules and regulations of this Act.
Section 40. Administration of Adult Vaccines. - In addition to the requirement provided in Section 4, paragraph (g) of this Act, licensed and trained
pharmacist who shall administer adult vaccines shall ensure that the vaccine to be administered shall have a doctor’s prescription which is not more
than seven (7) days old and submit a monthly vaccination report and AEFI report to DOH regional offices using the prescribed form.
Article V
Accredited Professional Organization
Section 41. The Integrated and Accredited Professional Organization (APO) of Pharmacists. - The pharmacy profession shall be integrated into one
(1) national organization registered with the Securities and Exchange Commission (SEC) which shall be recognized by the Board and the PRC as
the one and only integrated and accredited professional organization of pharmacists.
A pharmacist duly registered with the Board shall automatically become a member of the integrated and accredited professional organization of
pharmacists, and shall receive the benefits and privileges appurtenant thereto upon payment of the required fees and dues.
Membership in the integrated APO shall not be a bar to membership in other associations of pharmacists.
Section 42. Membership to the Integrated and Accredited Professional Organization. - All registered pharmacists must be members of the APO and
must maintain membership throughout the duration of the practice of the profession. The PIC shall not be renewed if the requirements for
membership with the APO are not met including credit units for attendance to duly accredited CPD.
All pharmacy support personnel must be registered as affiliate members of the APO and must likewise maintain membership throughout the duration
of employment in pharmaceutical establishments and outlets.
Section 43. Specialty Boards in Various Areas of Pharmacy Practice. - Specialty Boards in various areas of pharmacy practice shall be created,
subject to accreditation by the Board and the PRC. The Board shall issue guidelines in the accreditation of specialty boards in various areas of
pharmacy practice, which shall include the standards of practice within different specialties, qualifications, and requirements for the certification of
practitioners under each specialty, among others.
Article VI
Violations, Administrative Sanctions, and Procedures
Section 44. Revocation or Suspension of the Certificate of Registration and Cancellation of Special/Temporary Permit.— The Board shall have the
power, upon notice and hearing, to revoke or suspend the COR of a registered pharmacist or to cancel an STP of a foreign pharmacist on any of the
following grounds:
(a) Violation of any provision of this Act, its rules and regulations, the Pharmacists’ Code of Ethics, Code of Technical Standards for the
Professional Practice of the Pharmacy Profession, Code of Good Governance and all other guidelines, policies and regulatory measures
of the Board and/or the PRC relating to the practice of the pharmacy profession;
(b) Conviction of an offense involving moral turpitude by a court of competent jurisdiction;
(c) Unprofessionalism, immorality, malpractice, incompetence, gross negligence, or imprudence in the practice of the profession;
(d) Fraud or deceit in the acquisition of the COR, PIC or STP, or renewal thereof;
(e) Allowing the COR to be used or displayed in establishments where the pharmacist is not actually employed and practicing;
(f) Addiction to alcoholic beverages or to any habit-forming drug rendering a pharmacist incompetent to practice the profession as
provided for in Section 23 hereof;
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(g) Aiding or abetting the illegal practice of a non-registered and licensed person;
(h) Insanity or any mental disorder that would render the person incompetent to practice pharmacy;
(i) False, extravagant, or unethical advertisements and endorsements of pharmaceutical products, pharmaceutical outlets and
establishments where the pharmacist’s name or the pharmacist’s professional organization and similar information, or both, are used;
(j) Manufacture, sale, offering for sale of counterfeit, spurious, substandard and falsified pharmaceutical products and committing other
acts in violation of Republic Act No. 9165 and Republic Act No. 8203, otherwise known as the "Special Law on Counterfeit Drugs";
(k) Illegal manufacture, sale, possession, dispensing of dangerous drugs and other acts in violation of Republic Act No. 9165, and other
applicable laws and issuances;
(l) Committing acts in violation of Section 6 of Presidential Decree No. 881, entitled "Empowering the Secretary of Health to Regulate the
Labeling, Sale and Distribution of Hazardous Substances" and Section 11 of Republic Act No. 3720, as amended;
(m) Practicing pharmacy with a suspended COR or expired PIC;
(n) Unauthorized dispensing of pharmaceutical products through unregistered online services or direct selling businesses; and
(o) Being found guilty of immoral, unprofessional, or dishonorable conduct by the Board.
Article VII
Penal Provisions
Section 45. Penal Provisions. - Any person who shall commit any of the following acts shall, upon conviction, be sentenced to pay a fine of not less
than two hundred fifty thousand pesos (₱250.000.00), but not exceeding five hundred thousand pesos (₱500.000.00) or imprisonment of not less
than one (1) year and one (1) day but not more than six (6) years, or both, at the discretion of the court:
(a) Commission of any act in violation of Sections 30 and 31 of this Act;
(b) Allowing the display of one’s COR in a pharmaceutical establishment where the pharmacist is not employed and practicing;
(c) Displaying of the pharmacist’s COR by pharmacy owners/operators in a pharmaceutical establishment where the pharmacist is not
employed and practicing;
(d) Dispensing or allowing the dispensing or offering for sale of prescription drugs or pharmaceutical products in a place not licensed by
the FDA as a pharmaceutical outlet;
(e) Dispensing of prescription and pharmacist-only OTC pharmaceutical products by a person other than those under the direct and
immediate supervision of a duly registered and licensed pharmacist;
(f) Allowing the dispensing of prescription and pharmacist-only OTC pharmaceutical products, without the direct and immediate
supervision of a duly registered and licensed pharmacist;
(g) Compounding and dispensing not in accordance with current Good Manufacturing Practice, Good Laboratory Practice and Philippine
Practice Standards for Pharmacists, and such other standards and guidelines issued by the Board;
(h) Selling of prescription and pharmacist-only OTC drugs by manufacturers, importers, and wholesalers to unlicensed pharmaceutical
outlets and other establishments;
(i) Substituting prescription drugs which are not generically equivalent to what was on the prescription, without the consent of the
prescriber or not in accordance with Republic Act No. 6675;
(j) Forcing, coercing, or intimidating a duly registered and licensed pharmacist to compound or dispense medical and pharmaceutical
products in violation of the provisions of this Act;
(k) Preparing and compounding of pharmaceutical products in quantities greatly in excess of single therapeutic doses, without the
presence and supervision of a duly registered and licensed pharmacist;
(l) Noncompliance with the labeling requirements for dispensed medicines by a pharmaceutical outlet;
(m) Manufacturing and selling of pharmaceutical products under fraudulent name or address, or both;
(n) Adulterating and misbranding of pharmaceutical products;
(o) Manufacturing and selling of unsafe, substandard and counterfeit pharmaceutical products;
(p) Operating an unlicensed pharmaceutical outlet such as online pharmacy service or direct selling not authorized by the FDA;
(q) Operating a Category A establishment which opens for business without a duly registered and licensed pharmacist;
(r) Operating a Category B establishment without the supervision and oversight of a duly registered and licensed pharmacist;
(s) Practicing pharmacy with an expired, suspended or revoked license;
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(t) Filling and refilling of prescription and pharmacist-only OTC pharmaceutical products by a person other than a duly registered and
licensed pharmacist without the direct and immediate supervision;
(u) Dispensing prescription drugs and pharmacist-only OTC drugs by rural health units without the supervision of a duly registered and
licensed pharmacist; and
(v) All other acts or omissions analogous to the foregoing.
Section 46. Other Penalties. - Any person who shall commit any of the following acts shall, upon conviction, be sentenced to pay a fine of not less
than one hundred thousand pesos (₱100,000.00), but not exceeding two hundred thousand pesos (₱200,000.00) or imprisonment of not less than
thirty (30) days but not more than one (1) year, or both, at the discretion of the court:
(a) Affixing of the title "RPh" by a person who is not a duly registered and licensed pharmacist;
(b) Practicing the pharmacy profession in the Philippines without a valid COR, PIC or STP;
(c) Non-indication of a pharmacist of his/her COR and professional tax receipt numbers in official documents requiring such information;
(d) Refusal to display the COR of the pharmacist in a prominent and conspicuous place in the establishment and outlet where the
pharmacist is employed and practicing;
(e) Noncompliance by a duly registered and licensed pharmacist with the requirements on the filling of prescription;
(f) Noncompliance by a duly registered and licensed pharmacist on the requirements for partially-filled prescription;
(g) Selling of physician’s samples;
(h) Distribution of antimicrobials, including anti-TB drugs and other product classification as may be prohibited by law as physician’s
samples;
(i) Removal, erasure and alteration of mark or label of physician’s sample;
(j) Use of cipher, codes, or secret keys or unusual names or terms in prescriptions;
(k) Filling of prescriptions where cipher, codes, or secret keys or unusual names or terms are used;
(l) Noncompliance with labeling requirements for dispensed medicines;
(m) Noncompliance with the requirements on the keeping of record books by a pharmaceutical outlet;
(n) Employment of personnel in a pharmacy or pharmaceutical operation without the required training and certification;
(o) Refusal of a non-pharmacist owner/operator of a pharmaceutical outlet to undergo training and certification;
(p) Refusal by the owner/operator to allow and require duly registered and licensed pharmacists and pharmacy support personnel to
undergo CPD, training and certification;
(q) Rendering dispensing-related services by non-pharmacists in a pharmaceutical outlet without undergoing the required training and
certification;
(r) Dispensing pharmaceutical products in medical missions without the supervision of a duly registered and licensed pharmacist;
(s) Noncompliance with the required training and certification of professional service or medical representatives or professional service
representatives, pharmacy technicians, pharmacy assistants, pharmacy aides, pharmacy clerks, and other medicine handlers of
pharmaceutical products. Both the medical representatives or professional service representatives, pharmacy technicians, pharmacy
assistants, pharmacy aides, pharmacy clerks, or medicine handlers and the pharmaceutical establishment and outlet emploving any such
individual shall be held jointly liable; and
(t) Violation of any provision of this Act and its rules and regulations not aforementioned above. Any person, other than the citizens of the
Philippines, having been found guilty of any violation as provided for in this section and the preceding section shall, after having paid the
fine or having served the sentence, or both, when so adjudged, shall also be subject to immediate deportation.
The penalties and liabilities herein provided shall be without prejudice to other sanction/s that may be imposed for violation of other applicable laws,
policies, rules and regulations.
The owner/operator of the pharmaceutical establishments/outlets and the duly registered and licensed pharmacists/pharmacy support personnel are
jointly liable for the willful violation of any provision of this Act.
Article VIII
Final Provisions
Section 47. Enforcement. - It shall be the primary duty of the Board and the PRC to effectively enforce the provisions of this Act. All duly constituted
law enforcement agencies and officers of the national, provincial, city or municipal government or of any political subdivision thereof shall ensure the
effective enforcement and implementation of the provisions of this Act.
Section 48. Appropriations. - The Chairperson of the PRC shall immediately include in its programs the implementation of this Act, the funding of
which shall be charged against their current years’ appropriations and thereafter, in the annual General Appropriations Act.1âwphi1
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Section 49. Transitory Provisions. - The incumbent Chairperson and members of the Board shall, in an interim capacity, continue to function as
such until the Chairperson and members of the new Board, created under this Act, shall have been appointed and qualified.
Section 50. Implementing Rules and Regulations. - Within one hundred twenty (120) days after the approval of this Act, the Board, subject to the
approval by the PRC, and in consultation with the APO, shall formulate and issue the rules and regulations to implement the provisions of this Act.
Section 51. Separability Clause. - If any clause, provision, paragraph or part hereof shall be declared unconstitutional or invalid, such declaration
shall not affect, invalidate, or impair the other provisions otherwise valid and effective.
Section 52. Repealing Clause. - Republic Act No. 5921, as amended, is hereby repealed. AH other laws, presidential decrees, executive orders and
other administrative issuances or parts thereof which are contrary to or inconsistent with the provisions of this Act are hereby repealed, amended, or
modified accordingly.
Section 53. Effectivity. - This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in a newspaper of general
circulation.
Approved,
FRANKLIN M. DRILON
President of the Senate
FELICIANO BELMONTE, JR.

Speaker of the House of Representatives
This Act was passed by the House of Representatives as House Bill No. 5616 on May 23, 2016 and adopted by the Senate as an amendment to
Senate Bill No. 2436 on May 30, 2016.
OSCAR G. YABES
Secretary of the Senate
MARILYN B. BARUA-YAP
Secretary General
House of Representatives
Approved: July 21, 2016
(Sgd.) BENIGNO S. AQUINO, III

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AN ACT GRANTING ADDITIONAL BENEFITS AND PRIVILEGES TO SENIOR CITIZENS, FURTHER AMENDING REPUBLIC ACT NO. 7432, AS
AMENDED, OTHERWISE KNOWN AS "AN ACT TO MAXIMIZE THE CONTRIBUTION OF SENIOR CITIZENS TO NATION BUILDING, GRANT
BENEFITS AND SPECIAL PRIVILEGES AND FOR OTHER PURPOSES"
Be it enacted by the Senate and House of Representatives of the Philippine Congress Assembled:
Section 1. Title. - This Act Shall be known as the "Expanded Senior Citizens Act of 2010."
Section 2. Section 1 of Republic Act No. 7432, as amended by Republic Act No. 9257, otherwise known as the "Expanded Senior Citizens Act of
2003", is hereby further amended to read as follows:
"SECTION 1. Declaration of Policies and Objectives. - As provided in the Constitution of the Republic of the Philippines, it is the declared policy of
the State to promote a just and dynamic social order that will ensure the prosperity and independence of the nation and free the people from poverty
through policies that provide adequate social services, promote full employment, a rising standard of living and an improved quality of life. In the
Declaration of Principles and State Policies in Article II, Sections 10 and 11, it is further declared that the State shall provide social justice in all
phases of national development and that the State values the dignity of every human person and guarantees full respect for human rights.
"Article XIII, Section 11 of the Constitution provides that the Sate shall adopt an integrated and comprehensive approach to health development
which shall endeavor to make essential goods, health and other social services available to all the people at affordable cost. There shall be priority
for the needs of the underprivileged, sick, elderly, disabled, women and children. Article XV, Section 4 of the Constitution Further declares that it is
the duty of the family to take care of its elderly members while the State may design programs of social security for them.
"Consistent with these constitutional principles, this Act shall serve the following objectives:
"(a) To recognize the rights of senior citizens to take their proper place in society and make it a concern of the family,
community, and government;
"(b) To give full support to the improvement of the total well-being of the elderly and their full participation in society, considering
that senior citizens are integral part of Philippine society;
"(c) To motivate and encourage the senior citizens to contribute to nation building;
"(d) To encourage their families and the communities they live with to reaffirm the valued Filipino tradition of caring for the senior
citizens;
"(e) To provide a comprehensive health care and rehabilitation system for disabled senior citizens to foster their capacity to
attain a more meaningful and productive ageing; and
"(f) To recognize the important role of the private sector in the improvement of the welfare of senior citizens and to actively seek
their partnership.
"In accordance with these objectives, this Act shall:
"(1) establish mechanisms whereby the contributions of the senior citizens are maximized;
"(2) adopt measures whereby our senior citizens are assisted and appreciated by the community as a whole;
"(3) establish a program beneficial to the senior citizens, their families and the rest of the community they serve: and
"(4) establish community-based health and rehabilitation programs for senior citizens in every political unit of society."
Section 3. Section 2 of Republic Act No. 7432, as amended by Republic Act No. 9257, otherwise known as the Expanded Senior Citizens Act of
SEC. 2. Definition of terms. - For purposes of this Act, these terms are defined as follows:
"(a) Senior citizen or elderly refers to any resident citizen of the Philippines at least sixty (60) years old;
"(b) Geriatrics refer to the branch of medical science devoted to the study of the biological and physical changes and the
diseases of old age;
"(c) Lodging establishment refers to a building, edifice, structure, apartment or house including tourist inn, apartelle, motorist
hotel, and pension house engaged in catering, leasing or providing facilities to transients, tourists or travelers;
"(d) Medical Services refer to hospital services, professional services of physicians and other health care professionals and
diagnostics and laboratory tests that the necessary for the diagnosis or treatment of an illness or injury;
"(e) Dental services to oral examination, cleaning, permanent and temporary filling, extractions and gum treatments, restoration,
replacement or repositioning of teeth, or alteration of the alveolar or periodontium process of the maxilla and the mandible that
are necessary for the diagnosis or treatment of an illness or injury;
"(f) Nearest surviving relative refers to the legal spouse who survives the deceased senior citizen: Provided, That where no
spouse survives the decedent, this shall be limited to relatives in the following order of degree of kinship: children, parents,
siblings, grandparents, grandchildren, uncles and aunts;
"(g) Home health care service refers to health or supportive care provided to the senior citizen patient at home by licensed
health care professionals to include, but not limited to, physicians, nurses, midwives, physical therapist and caregivers; and
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"(h) Indigent senior citizen, refers to any elderly who is frail, sickly or with disability, and without pension or permanent source of
income, compensation or financial assistance from his/her relatives to support his/her basic needs, as determined by the
Department of Social Welfare and development (DSWD) in consultation with the National Coordinating and Monitoring Board."
Section 4 Section 4 of Republic Act No. 7432, as amended by Republic Act No. 9257, otherwise known as the "Expanded Senior Citizens Act of
"SEC. 4. Privileges for the Senior Citizens. -
The senior citizens shall be entitled to the following:
"(a) the grant of twenty percent (20%) discount and exemption from the value -added tax (VAT), if applicable, on the sale of the following goods and
services from all establishments, for the exclusive use and enjoyment or availment of the senior citizen
"(1) on the purchase of medicines, including the purchase of influenza and pnuemococcal vaccines, and such other essential
medical supplies, accessories and equipment to be determined by the Department of Health (DOH).
"The DOH shall establish guidelines and mechanism of compulsory rebates in the sharing of burden of discounts among
retailers, manufacturers and distributors, taking into consideration their respective margins;
"(2) on the professional fees of attending physician/s in all private hospitals, medical facilities, outpatient clinics and home health
care services;
"(3) on the professional fees of licensed professional health providing home health care services as endorsed by private
hospitals or employed through home health care employment agencies;
"(4) on medical and dental services, diagnostic and laboratory fees in all private hospitals, medical facilities, outpatient clinics,
and home health care services, in accordance with the rules and regulations to be issued by the DOH, in coordination with the
Philippine Health Insurance Corporation (PhilHealth);
"(5) in actual fare for land transportation travel in public utility buses (PUBs), public utility jeepneys (PUJs), taxis, Asian utility
vehicles (AUVs), shuttle services and public railways, including Light Rail Transit (LRT), Mass Rail Transit (MRT), and Philippine
National Railways (PNR);
"(6) in actual transportation fare for domestic air transport services and sea shipping vessels and the like, based on the actual
fare and advanced booking;
"(7) on the utilization of services in hotels and similar lodging establishments, restaurants and recreation centers;
"(8) on admission fees charged by theaters, cinema houses and concert halls, circuses, leisure and amusement; and
"(9) on funeral and burial services for the death of senior citizens;
"(b) exemption from the payment of individual income taxes of senior citizens who are considered to be minimum wage earners in accordance with
Republic Act No. 9504;
"(c) the grant of a minimum of five percent (5%) discount relative to the monthly utilization of water and electricity supplied by the public
utilities: Provided, That the individual meters for the foregoing utilities are registered in the name of the senior citizen residing therein: Provided,
further, That the monthly consumption does not exceed one hundred kilowatt hours (100 kWh) of electricity and thirty cubic meters (30 m3) of
water: Provided, furthermore, That the privilege is granted per household regardless of the number of senior citizens residing therein;
"(d) exemption from training fees for socioeconomic programs;
"(e) free medical and dental services, diagnostic and laboratory fees such as, but not limited to, x-rays, computerized tomography scans and blood
tests, in all government facilities, subject to the guidelines to be issued by the DOH in coordination with the PhilHealth;
"(f) the DOH shall administer free vaccination against the influenza virus and pneumococcal disease for indigent senior citizen patients;
"(g) educational assistance to senior citizens to pursue post secondary, tertiary, post tertiary, vocational and technical education, as well as short-
term courses for retooling in both public and private schools through provision of scholarships, grants, financial aids, subsides and other incentives
to qualified senior citizens, including support for books, learning materials, and uniform allowances, to the extent feasible: Provided, That senior
citizens shall meet minimum admission requirements;
"(h) to the extent practicable and feasible, the continuance of the same benefits and privileges given by the Government Service Insurance System
(GSIS), the Social Security System (SSS) and the PAG-IBIG, as the case may be, as are enjoyed by those in actual service;
"(i) retirement benefits of retirees from both the government and the private sector shall be regularly reviewed to ensure their continuing
responsiveness and sustainability, and to the extent practicable and feasible, shall be upgraded to be at par with the current scale enjoyed by those
in actual service;
"(j) to the extent possible, the government may grant special discounts in special programs for senior citizens on purchase of basic commodities,
subject to the guidelines to be issued for the purpose by the Department of Trade and Industry (DTI) and the Department of Agriculture (DA);
"(k) provision of express lanes for senior citizens in all commercial and government establishments; in the absence thereof, priority shall be given to
them; and
"(l) death benefit assistance of a minimum of Two thousand pesos (Php2, 000.00) shall be given to the nearest surviving relative of a deceased
senior citizen which amount shall be subject to adjustments due to inflation in accordance with the guidelines to be issued by the DSWD.1avvphi1
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"In the availment of the privileges mentioned above, the senior citizen, or his/her duly authorized representative, may submit as proof of his/her
entitled thereto any of the following:
"(1) an identification card issued by the Office of the Senior Citizen Affairs (OSCA) of the place where the senior citizen resides:
Provided, That the identification card issued by the particular OSCA shall be honored nationwide;
"(2) the passport of the senior citizen concerned; and
"(3) other documents that establish that the senior citizen is a citizen of the Republic and is at least sixty (60) years of age as
further provided in the implementing rules and regulations.
"In the purchase of goods and services which are on promotional discount, the senior citizen can avail of the promotional discount or the discount
provided herein, whichever is higher.
"The establishment may claim the discounts granted under subsections (a) and (c) of this section as tax deduction based on the cost of the goods
sold or services rendered: Provided, That the cost of the discount shall be allowed as deduction from gross income for the same taxable year that
the discount is granted: Provided, further, That the total amount of the claimed tax deduction net of VAT, if applicable, shall be included in their gross
sales receipts for tax purposes and shall be subject to proper documentation and to the provisions of the National Internal Revenue Code (NICR), as
amended."
Section 5. Section 5 of the same Act, as amended, is hereby further amended to read as follows:
"SEC. 5. Government Assistance. - The government shall provide the following:
"(a) Employment
"Senior citizens who have the capacity and desire to work, or be re-employed, shall be provided information and matching services to enable them
to be productive members of society. Terms of employment shall conform with the provisions of the Labor Code, as amended, and other laws, rules
and regulations.
"Private entities that will employ senior citizens as employees, upon the effectivity of this Act, shall be entitled to an additional deduction from their
gross income, equivalent to fifteen percent (15%) of the total amount paid as salaries and wages to senior citizens, subject to the provision of
Section 34 of the NIRC, as amended: Provided, however, That such employment shall continue for a period of at least six (6) months: Provided,
further, That the annual income of the senior citizen does not exceed the latest poverty threshold as determined by the National Statistical
Coordination Board (NSCB) of the National Economic and Development Authority (NEDA) for that year.
"The Department of Labor and Employment (DOLE), in coordination with other government agencies such as, but not limited to, the Technology and
Livelihood Resource Center (TLRC) and the Department of Trade and Industry (DTI), shall assess, design and implement training programs that will
provide skills and welfare or livelihood support for senior citizens.
"(b) Education
"The Department of Education (DepED), the Technical Education and Skills Development Authority (TESDA) and the Commission on Higher
Education (CHED), in consultation with nongovernmental organizations (NGOs) and people's organizations (POs) for senior citizens, shall institute
programs that will ensure access to formal and nonformal education.
"(c) Health
"The DOH, in coordination with local government units (LGUs), NGOs and POs for senior citizens, shall institute a national health program and shall
provide an integrated health service for senior citizens. It shall train community-based health workers among senior citizens and health personnel to
specialize in the geriatric care and health problems of senior citizens.
"The national health program for senior citizens shall, among others, be harmonized with the National Prevention of Blindness Program of the DOH.
"Throughout the country, there shall be established a "senior citizens' ward" in every government hospital. This geriatric ward shall be for the
exclusive use of senior citizens who are in need of hospital confinement by reason of their health conditions. However, when urgency of public
necessity purposes so require, such geriatric ward may be used for emergency purposes, after which, such "senior citizens' ward" shall be reverted
to its nature as geriatric ward.
"(d) Social Services
"At least fifty percent (50%) discount shall be granted on the consumption of electricity, water, and telephone by the senior citizens center and
residential care/group homes that are government-run or non-stock, non-profit domestic corporation organized and operated primarily for the
purpose of promoting the well-being of abandoned, neglected, unattached, or homeless senior citizens, subject to the guidelines formulated by the
DSWD.
"(1) "self and social enhancement services" which provide senior citizens opportunities for socializing, organizing, creative
expression, and self-improvement;
"(2) "after care and follow-up services" for citizens who are discharged from the homes or institutions for the aged, especially
those who have problems of reintegration with family and community, wherein both the senior citizens and their families are
provided with counseling;
"(3) "neighborhood support services" wherein the community or family members provide caregiving services to their frail, sick, or
bedridden senior citizens; and
"(4) "substitute family care " in the form of residential care or group homes for the abandoned, neglected, unattached or
homeless senior citizens and those incapable of self-care.
"(e) Housing
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"The national government shall include in its national shelter program the special housing needs of senior citizens, such as establishment of housing
units for the elderly.
"(f) Access to Public Transport
"The Department of Transportation and Communications (DOTC) shall develop a program to assist senior citizens to fully gain access to public
transport facilities.
"(g) Incentive for Foster Care
"The government shall provide incentives to individuals or nongovernmental institution caring for or establishing homes, residential communities or
retirement villages solely for, senior citizens, as follows:
"(1) realty tax holiday for the first five (5) years starting from the first year of operation; and
"(2) priority in the construction or maintenance of provincial or municipal roads leading to the aforesaid home, residential
community or retirement village.
"(h) Additional Government Assistance
"(1) Social Pension
"Indigent senior citizens shall be entitled to a monthly stipend amounting to Five hundred pesos (Php500.00) to augment the
daily subsistence and other medical needs of senior citizens, subject to a review every two (2) years by Congress, in
consultation with the DSWD.
"(2) Mandatory PhilHealth Coverage
"All indigent senior citizens shall be covered by the national health insurance program of PhilHealth. The LGUs where the
indigent senior citizens resides shall allocate the necessary funds to ensure the enrollment of their indigent senior citizens in
accordance with the pertinent laws and regulations.
"(3) Social Safety Nets
"Social safety assistance intended to cushion the effects of economics shocks, disasters and calamities shall be available for senior citizens. The
social safety assistance which shall include, but not limited to, food, medicines, and financial assistance for domicile repair, shall be sourced from
the disaster/calamity funds of LGUs where the senior citizens reside, subject to the guidelimes to be issued by the DSWD."
Section 6. Section 6 of the same Act, as amended, is heeby further amended to read as follows:
SEC. 6. The Office for Senior Citizens Affairs (OSCA). - There shall be established in all cities and municipalities an OSCA to be headed by a senior
citizen who shall be appointed by the mayor for a term of three (3) years without reappointment but without prejudice to an extension if exigency so
requires. Said appointee shall be chosen from a list of three (3) nominees as recommended by a general assembly of senior citizens organizations
in the city or municipality.
"The head of the OSCA shall be appointed to serve the interest of senior citizens and shall not be removed or replaced except for reasons of death
permanent disability or ineffective performance of his duties to the detriment of fellow senior citizens.
"The head of the OSCA shall be entitled to receive an honorarium of an amount at least equivalent to Salary Grade 10 to be approved by the LGU
concerned.
"The head of the OSCA shall be assisted by the City Social Welfare and Development officer or by the Municipal Social Welfare and Development
Officer, in coordination with the Social Welfare and Development Office.
"The Office of the Mayor shall exercise supervision over the OSCA relative to their plans, activities and programs for senior citizens. The OSCA shall
work together and establish linkages with accredited NGOs Pos and the barangays in their respective areas.
"The OSCA shall have the following functions:
"(a) To plan, implement and monitor yearly work programs in pursuance of the objectives of this Act;
"(b) To draw up a list of available and required services which can be provided by the senior citizens;
"(c) To maintain and regularly update on a quarterly basis the list of senior citizens and to issue national individual identification
cards, free of charge, which shall be valid anywhere in the country;
"(d) To serve as a general information and liason center for senior citizens;
"(e) To monitor compliance of the provisions of this Act particularly the grant of special discounts and privileges to senior
citizens;
"(f) To report to the mayor, any individual, establishments, business entity, institutions or agency found violating any provision of
this Act; and
"(g) To assist the senior citizens in filing complaints or charges against any individual, establishments, business entity,
institution, or agency refusing to comply with the privileges under this Act before the Department of Justice (DOJ), the Provincial
Prosecutor's Office, the regional or the municipal trial court, the municipal trial court in cities, or the municipal circuit trial court."
66
"SEC. 10. Penalties. - Any person who refuses to honor the senior citizen card issued by this the government or violates any provision of this Act
shall suffer the following penalties:
"(a) For the first violation, imprisonment of not less than two (2) years but not more than six (6) years and a fine of not less than
Fifty thousand pesos (Php50,000.00) but not exceeding One hundred thousand pesos (Php100,000.00);
"(b) For any subsequent violation, imprisonment of not less than two (2) years but not more than six (6) years and a fine of not
less than One Hundred thousand pesos (Php100,000.00) but not exceeding Two hundred thousand pesos (Php200,000.00);
and
"(c) Any person who abuses the privileges granted herein shall be punished with imprisonment of not less than six (6) months
and a fine of not less than Fifty thousand pesos (Php50,000.00) but not more than One hundred thousand pesos
(Php100,000.00).
"If the offender is a corporation, partnership, organization or any similar entity, the officials thereof directly involved such as the president, general
manager, managing partner, or such other officer charged with the management of the business affairs shall be liable therefor.
"If the offender is an alien or a foreigner, he/she shall be deported immediately after service of sentence.
"Upon filing of an appropriate complaint, and after due notice and hearing, the proper authorities may also cause the cancellation or revocation of
the business permit, permit to operate, franchise and other similar privileges granted to any person, establishment or business entity that fails to
abide by the provisions of this Act."
"SEC. 11. Monitoring and Coordinating Mechanism. - A National Coordinating and Monitoring Board shall be established which shall be composed
of the following:
"(a) Chairperson - the Secretary of the DSWD or an authorized representative;
"(b) Vice Chairperson - the Secretary of the Department of the Interior and Local Government (DILG) or an authorized
representative; and
"(c) Members:
"(1) the Secretary of the DOJ or an authorized representative;
"(2) the Secretary of the DOH or an authorized representative;
"(3) the Secretary of the DTI or an authorized representative; and
(4) representatives from five (5) NGOs for senior citizens which are duly accredited by the DSWD and have service
primarily for senior citizens. Representatives of NGOs shall serve a period of tree (3) years.
"The Board may call on other government agencies, NGOs and Pos to serve as resource persons as the need arises. Resource person have no
right to vote in the National Coordinating and Monitoring Board."
Section 9. Implementing Rules and Regulations. - Within sixty (60) days from theeffectivity of this Act, the Secretary of the DSWD shall formulate
and adopt amendments to the existing rules and regulations implementing Republic Act No. 7432, as amended by Republic Act No. 9257, to carry
out the objectives of this Act, in consultation with the Department of Finance, the Department of Tourism, the Housing and Urban Development
Coordinating Council (HUDCC), the DOLE, the DOJ, the DILG, the DTI, the DOH, the DOTC, the NEDA, the DepED, the TESDA, the CHED, and
five (5) NGOs or POs for the senior citizens duly accredited by the DSWD. The guidelines pursuant to Section 4(a)(i) shall be established by the
DOH within sixty (60) days upon the effectivity of this Act.
Section 10. Appropriations. - The Necessary appropriations for the operation and maintenance of the OSCA shall be appropriated and approved by
the LGUs concerned. For national government agencies, the requirements to implement the provisions of this Act shall be included in their
respective budgets: Provided, That the funds to be used for the national health program and for the vaccination of senior citizens in the first year of
the DOH and thereafter, as a line item under the under the DOH budget in the subsequent General Appropriations Act (GAA): Provided, further, That
the monthly social pension for indigent senior citizens in the first year of implementation shall be added to the regular appropriations of the DSWD
budget in the subsequent GAA.
Section 11. Repealing Clause. - All law, executive orders, rules and regulations or any part hereof inconsistent herewith are deemed repealed or
modified accordingly.
Section 12. Separability Clause. - If any part or provision of this Act shall be declared unconstitutional and invalid, such 18 declaration shall not
invalidate other parts thereof which shall remain in full force and effect.
Section 13. Effectivity. - This Act shall take effect fifteen (15) days its complete publication n the Official Gazette or in at least two (2) newspapers of
general circulation, whichever comes earlier.
Approved
(Sgd.) PROSPERO C. NOGRALES (Sgd.) JUAN PONCE ENRILE

Speaker of the House of Representatives President of the Senate
67
This Act which is a consolidation of Senate Bill No. 3561 and House Bill No. 6390 was finally passed by the Senate and the House of
Representatives on January 27, 2010.
(Sgd.) MARILYN B. BARUA-YAP (Sgd.) EMMA LIRIO-REYES

Secretary General Secretary of Senate
House of Represenatives
Approved: FEB 15, 2010
(Sgd.) GLORIA MACAPAGAL-ARROYO
68

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1

2. Standards and Requirements for License To Operate (LTO)

2.1 General Requirements

2.1.1.2 Proof of registration as an establishment, i.e.:

2.1.1.5 An Affidavit of Undertaking providing that the applicant shall:

2.2 Specific Requirements:

2.2.2 Drug Traders

2.2.3 Drug Distributors

2. Standards and Requirements for License To Operate (LTO)

2.1 General Requirements

6. Schedule of Fees

Laboratory supplies/chemical/reagents/reference standards, etc.

PURSUANT TO THE GENERICS ACT OF 1988 AND ITS

GUIDELINES ON PRESCRIBING MEDICINES

GUIDELINES ON DISPENSING OF MEDICINES

ADDITIONAL GUIDELINES ON DISPENSING

(b) A representative of the Department of Agriculture and Natural Resources;

(c) A representative of the Department of Commerce and Industry;

(d) An authorized designate of the Commissioner of Customs;

(e) An authorized representative of the Office of the Solicitor-General;

Section 10. For the purposes of this Act, the term:

(a) "Board" means the Board of Food and Drug Inspection.

(b) "Secretary" means the Secretary of Health.

(c) "Department" means the Department of Health.

(d) "Person" includes individual, partnership, corporation and association.

(j) "Immediate container" does not include package liners.

(l) "New drugs" mean:

(b) The adulteration or misbranding of any food, drug, device, or cosmetic.

(2) if any substance injurious to health has been added or substituted;

(3) if damage or inferiority has been concealed in any manner; and

Section 15. A food shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular;

(b) If it is offered for sale under the name of another food;

(d) If its container is so made, formed, or filled as to be misleading;

(h) If it purports to be or is represented as

Emergency Permit Control

Tolerances for Poisonous Ingredients in Food

COAL-TAR COLOR FOR FOOD

ADULTERATED DRUGS AND DEVICES

MISBRANDED DRUGS AND DEVICES

(2) if it is an imitation of another drug; or

(3) if it is offered for sale under the name of another drug.

EXEMPTION IN CASE OF DRUGS AND DEVICES

(b) (1) Drugs intended for use by man which:

(A) are habit-forming

(b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.

Section 24. A cosmetic shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular.

(d) If its container is so made, formed, or filled as to be misleading.

REGULATIONS MAKING EXEMPTIONS

Section 34. This Act shall take effect upon its approval.

Approved: June 22, 1963.

THE DANGEROUS DRUGS ACT OF 1972

Section 2. Definitions. As used in this Act, the term:

(e) "Dangerous drugs" refers to either:

(a) Any employee of a prohibited drug den, dive or resort; and

a) importation of dangerous drugs;