Prepared by Evan Dykimching

 RA 5921 Pharmacy Law

 RA 3720 Food Drugs, Devices and Cosmetics Act
 RA 8203 Special Law of Counterfeit Drugs
 RA 6425 Dangerous Drugs Act
 RA 6675 Generics Act
 RA 7432 Senior Citizens Act
 No. 1 Series of 1988 Implementation of Executive Order No. 119, Reorganizing the
Bureau of Food and Drugs, and Department of Health
 No. 5 Series of 1988 Requirements for Labelling Materials of Pharmaceutical Products
 No. 56 Series of 1989 Revised Regulations for the Licensing of Drug Establishments
and Outlets
 Pharmacy Law

 Ammended by EO 174
Objectives:
Standardize PHARMACEUTICAL EDUCATION
Examination for GRADUATES OF PHARMACY schools
Supervision and regulation of PRACTICE OF PHARMACY
 Council of Pharmaceutical Education

Education Secretary (CHAIRMAN) Br. Amin Luistro

 Health Undersecretary
 BFAD Director
 PRC Pharmacy Board Chairman Teresita Manzala
 UP College of Pharmacy Dean
 Dean (representing private pharmacy schools)
 Bona fide Representatives
 PRC Board of Pharmacy:
 Natural-born Filipino citizens
 Registered and practicing  10 years
 Good moral character
 Not a faculty of college of pharmacy at time of appointment
 Member of national pharmacy organization
 Candidacy for Board Examination:
 Filipino citizen
 Good moral character
 Complete internship requirement
 Graduate with degree in pharmacy
 Ratings Required
 General average at least 75%
 No rating below 50% in more than 2 subjects (module)
 Failure to pass in 3 successive attempt  pre-board review course from accredited
college of pharmacy
 Practice of Pharmacy
 MANUFACTURING INTERNSHIP
 COMMUNITY/ HOSPITAL INTERNSHIP
 ACADEME
 R&D
 Requirement to Practice Pharmacy
 At least 21 years of age
 Passed the Board Exams
 Holder of valid certificate of Registration
 “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.”

 A person that introduces a business establishment’s

products to physicians and other healthcare
professionals that prescribe the product
 Preferable graduate of pharmacy
 Registration fee (P20) Renewal (P15)
 Possess credentials issued by the Board
 False representation as pharmacist:
 1000-4000
 6 m & 1d – 4 years

 Suspended/Revoked but continue to practice pharmacy:

 100-500
 30 days – 4 months
 BLOCK BUSTER (P)
Means a place of 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.
 BLOCK BUSTER (P)
Means an establishment where pharmaceuticals,
proprietary medicines or pharmaceutical specialties
are prepared, compounded, standardized and
distributed or sold.
 BLOCK BUSTER (W)
Means and includes every person who acts as a
merchant, broker or agent, who sells or distributes
for resale pharmaceuticals, proprietary medicines or
pharmaceutical specialties
Multiple Choice:
Drug Means:
I. Article recognized in USP
II. Article used for diagnosis, cure and mitigation of diseases
III. Articles intended to affect the structure or function of the body
of man
IV. Devices
a. I and II
b. I and III
c. II and III
d. I, II and III
e. I, II, III and IV
Multiple Choice:
Means any drug, preparation or mixture of drugs marked
under a trade name and intended for the cure, mitigation,
treatment or prevention of diseases in man and animals
I. Pharmaceuticals
II. Proprietary Medicines
III. Pharmaceutical Specialties
a. I and II
b. I and III
c. II and III
d. I, II and III
e. I only
 BLOCK BUSTER (D)
Means instrument, apparatus, or contrivances
including their component parts and accessories
 BLOCK BUSTER (B)
Viruses, sera, toxins and analogous products used
for the prevention or cure of human diseases
 BLOCK BUSTER (P)
Active principle capable of destroying life or
seriously endangering health when applied
externally to the body or introduced internally in
moderate doses
 IDENTIFICATION
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
 IDENTIFICATION
System of words or other systems arbitrarily used to
represent words
 IDENTIFICATION
Characteristics styles or symbols kept from the
knowledge of others or disclosed confidentially to
but one or few
 IDENTIFICATION
Color of label for poisons
 Food Drugs Devices and Cosmetics Act

 Amended by EO 175
 Objectives
 ESTABLISH and ADOPT STANDARDS AND QUALITY
MEASURES
 STRENGTHEN BFAD

For Food Drugs,

Devices and
Cosmetics
 BFAD Functions: BFAD Divisions:
 Administer RA 3720
 SAMPLING  ANALYSIS  • INSPECTION AND
ANALYTICAL DATA  Issue LICENSING DIVISION
CERTIFICATE OF COMPLIANCE
 COLLECT FEES from inspection
• LABORATORY
and analysis DIVISION
 Certify batches of ANTIBIOTICS
 If contains FILTHY/ DECOMPOSED substance
 If manufactured in UNSANITARY conditions
 If composed of POISONOUS or DELETERIOUS substance
 It contains OTHER COLOR aside from permissible one
 If STRENGTH or PURITY FALLS BELOW STANDARD
 If PACKAGING RESULTS TO DECREASE IN QUALITY
 If method is NOT CGMP COMPLIANT
 If FALSE LABELING  Inaccurate statements on labelling
 If used for man and contains NARCOTIC or HYPNOTIC
substance
 If NAME not in OFFICIAL COMPENDIUM
 If Inadequate information for DIRECTION OF USE and
WARNINGS
 If NO PRECAUTION that LIABLE TO DETERIORATION
 If CONTAINER is MISLEADING
 An IMITATION of another drug
 If FOR SALE under a DIFFERENT DRUG NAME
 DANGEROUS DOSAGE in the labelling
 MISBRANDED
• Activities would result to • False LABELLING
decrease in QUALITY OF • Lack necessary information (e.g.
DRUG due to: precaution, warnings)
• Content • Non-prominently placed
• Filth
• Method
• False NAME
• POISONOUS Content • Contains
NARCOTIC/HYPNOTICS
 Misbranded or Adulterated Food, Drugs, or Cosmetics
(Ammended by EO 175)
 1 y- 5 years
 5000-10000
MULTIPLE CHOICE:
Food Means:
I. Articles used for food or drink for man
II. Articles used as component of such article
III. Chewing gum
a. I only
b. I and II only
c. I and III only
d. II and III only
e. I, II and III
 BLOCK BUSTER (C)
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.
 BLOCK BUSTER (L)
Display of written, printed, or graphic matter upon
the immediate container of any article
 BLOCK BUSTER (I)
Does not include package liners
 BLOCK BUSTER (N)
Any drug which 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 labelling thereof
 BLOCK BUSTER (F)
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
 RA 5921 or 3720?
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;
 RA 5921 or 3720?
Manufacture, importation, exportation, sale, offering
for sale, distribution, or transfer of any food, drug,
device or cosmetic that is adulterated or
misbranded.
 RA 5921 or 3720?
Refusal to permit entry of inspection as authorized
hereof or to allow samples to be collected.
 RA 5921 or 3720?
Violations of any provision of the Code of Ethics
which may be adopted as part of the Rules and
Regulations of the Board.
 RA 5921 or 3720?
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.
 RA 5921 or 3720?
Fraud or deceit in the acquisition of the certificate of
registration
 RA 5921 or 3720?
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.
 RA 5921 or 3720?
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
 RA 5921 or 3720?
Acting as a dummy of an alien or of a person who is
not qualified to establish and operate a retail
drugstore
 Special Law on Counterfeit Drugs
 INGREDIENTS • PACKAGING
 Wrong amount
• Fake
 Wrong ingredients
 No active ingredients
• Fake trademark,
imprint or
 Insufficient Quantity
identification mark
 <80% Active
ingredient based on the • Refilled by others
label • Unregistered product
 Manufacturer, exporter or importer
 Seller, distributor, trafficker, broker or donor
 Possessor
 Manager, operator, or lessee of laboratory facilities
 Registered pharmacist
 Manufacture, sale, offering for sale, donation,
distribution, trafficking, brokering, importation,
exportation or possession of counterfeit drugs
 Forging, counterfeiting, simulating or falsely
representing without proper authority of mark, stamp,
tag, label or other identification marks/ devices
required by RA 3720
 Photocopying, duplicating, altering, printing,
transferring, obliterating, or removing of approved
label lawfully belonging to another person for the
purpose of using the label on counterfeit drug.
 Making, selling, or concealing any punch, dye, plate or
other equipment designed to print, imprint, or
reproduce the trademark, trade name or other
identifying mark of another registered producer on any
drug product, device, container, or label without
proper authority form legitimate owners of the
trademark or trade name.
 Fine: P100k – 500k
 Confiscation and destruction of counterfeit drugs
 Closure and Revocation of LTO
 Permanent disqualification of person from owning an
establishment
 POSESSION
 Imprisonment 6m&1d-6 years
 Fine: P100k – 500k

 Cause ILLNESS
 12y-15 y
 Fine: P100k – 500k

 Cause DEATH
 Life Imprisonment
 Fine: P500k- 5M
 BLOCK BUSTER (C)
Medicinal products with the correct ingredients but
not in the amounts as provided on the label
 BLOCK BUSTER (B)
Any act of facilitating the disposal or sale of
counterfeit drugs
 BLOCK BUSTER (B)
Any entity, whether a single proprietorship,
partnership, or corporation engaged in or doing
business in the Philippines
 BLOCK BUSTER (O)
Any person or group of persons who is the
registered owner of a license to operate a business
or business undertaking in the Philippines.
 BLOCK BUSTER (R)
Private dwelling or abode where a person lives,
either as owner or lessee
 BLOCK BUSTER (C)
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
• The Dangerous Drugs Act (6425)
• Comprehensive Dangerous Drugs Act (RA 9165)
 DANGEROUS DRUGS:
 Prohibited Drugs  OPIUM and its derivative
 Regulated Drugs  SEDATIVE and HYPNOTIC drugs
 Importation
 Sale
 Manufacture
DANGEROUS
 Possession DRUGS
 Cultivation
 Use
 Unnecessary prescription
 10g – other dangerous drugs; marijuana resin
 50g - methamphetamine HCl or “Shabu”
 500g - marijuana
 Penalty for people importing dangerous drug to
Philippines
 Life imprisonment to death;
 Fine: 500k-10M
 Penalty for planting dangerous drugs- Death
 S1 – Retailer of Drug Preparations exempted from special prescription or those
containing controlled chemicals
 S2- Physician
 S3 – Retailer
DANGEROUS
 S4 – Wholesaler/ Trader
 S5C – Manufacturer/Distributor
DRUGS OR
 S5D – Bulk Depot/ Storage facilities CONTROLLED
 S5E- Exporter CHEMICALS
 S5I- Importer
 BLOCK BUSTER (I)
Illegal cultivation, culture, delivery, administration,
dispensation, manufacture, sale, trading,
transportation, distribution, importation,
exportations
 BLOCK BUSTER (C)
Mental condition characterized by the periodic or
constantly repeated consumption of this substance
and whose characteristics vary depending upon
kind of the taken chemical
 BLOCK BUSTER (P)
To discard at a licensed or authorized facility in
accordance with all applicable laws and regulations
not reused or sold.
 BLOCK BUSTER (D,D,R)
A place where any dangerous drug and/or
controlled precursor and essential chemical is
administered, delivered, stored for illegal purposes,
distributed, sold or used in any form.
 PDEA
stands for?
• Generics Act
Objectives
 USE GENERIC TERMINOLOGY
 ADEQUATE SUPPLY, USAGE and SCIENTIFIC BASIS
OF GENERIC DRUGS
 MINIMIZE DUPLICATION IN MEDICATION with
potential ADVERSE DRUG REACTION
• Components of the National Drug Policy
• Quality Assurance of Drugs
• Rational Use of Drugs by Health Professionals an Consumers
• National Self-Sufficiency in Pharmaceuticals
• Rationalization of the DOH’s Procurement Program
• Generic Prescribing
• Generic name is used in all prescriptions
• Written in full but salt may be abbreviated
• Brand name (if written), in parentheses and written under the
generic name
• Generic Dispensing
• Dispensing the patient’s choice from among generic equivalents
• WHAT TO DO?!?!
• Inform patient of all available drug products generically
equivalent to prescribed drug
• All drug outlets post in a visible place list of generic names with
brand names
• ERRONEOUS
PRESCRIPTION • WHAT TO DO?
• Brand name precedes generic • FILL
name
• Generic name is the one in • Keep and report to nearest
parentheses DOH office
• Brand name not in parentheses
• VIOLATIVE • WHAT TO DO?
PRESCRIPTIONS
• Generic name not written • DO NOT FILL
• Generic name no legible (Brand • Keep and report to nearest
name Legible is written) DOH office
• “No Substitution” written on • Pharmacist advise prescriber
prescription
• IMPOSSIBLE PRESCRIPTIONS
• Generic name written but not • WHAT TO DO?
legible
• DO NOT FILL
• Generic name does not correspond
to brand name • Keep and report to nearest
• Both Generic name and Brand name DOH office
not legible
• Pharmacist advise prescriber
• Drug not registered in BFAD
 Violation of Use of Generic Names
Reprimand by PRC
 NLT 2k
 5k-10k & 30 day suspension of license
 10k or more and 1 year or more suspension of license
 BLOCK BUSTER (A)
Chemical component responsible for the claimed
therapeutic effect of the pharmaceutical product
 BLOCK BUSTER (C)
Description of the chemical structure of the drugs
and medicine and serves as the complete
identification of the compound
 BLOCK BUSTER (D)
Finished product form that contains the active
ingredients, generally but not necessarily in
association with inactive ingredients
 BLOCK BUSTER (D)
Organization or company involved in the
manufacture, importation, repacking and/or
distribution of drugs or medicines
 BLOCK BUSTER (E/N)
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 in
the internationally accepted criteria.
 BLOCK BUSTER (C)
List of drugs that meet the health care needs of
majority
 BLOCK BUSTER (C)
List of alternative drugs used wherein no response
to core list or hypersensitivity to core list
 BLOCK BUSTER (B)
Proprietary name given by the manufacture to
distinguish its product from those of competitors
 BLOCK BUSTER (G)
Also known as non-proprietary name
• Senior Citizens Act (RA 7432)
• Expanded Senior Citizens Act (RA 9994)
SENIOR CITIZENS:
• Resident of the Philippines
• >/= 60 years old
• 20% Discount from all establishments
OSCA Stands
for?
 BLOCK BUSTER (S)
Resident citizen of the Philippines at least sixty (60)
years old
 BLOCK BUSTER (G)
Branch of medical science devoted to the study of
biological and physical changes and diseases of the
old age
 BLOCK BUSTER (L)
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
travellers.
 BLOCK BUSTER (M)
Refers to hospital services, professional services
necessary for diagnosis or treatment of illness or
injury
Age Requirement to Practice Pharmacy 21 y/o
Internship hours 960 hours
Board of Pharmacy is composed of a 2 members
chariman and ____ members
Years chairman and members of the Board of 3 years
Pharmacy hold office after appointment
Administrative investigation to all members 6 months
of the Board of Pharmacy: In case of
suspension, it shall be in a period of not more
than:
Book of Poison is kept for _____ years 5 years
Dangerous Drug Prescription kept for _____ 1 year
years
Duration where Secretary approve or give 180 days
the applicant notice of an opportunity for a
hearing after filling of an application for
License and registration of drugs or devices
Duration when re-application for LTO may be 5 years
done after revocation
Duration where confiscated dangerous drug 24 hours
shall be submitted to PDEA
Alcohol limit test for quality control NMT 10%
requirements
Validity of the initial registration for herbal 1 year
and tradition drugs
Initial License to Operate a drug 1 year
establishment Validity
Renewal of License to Operate a drug 2 years
establishment
# of people to check critical step in 2 individuals
production process
Age Requirement to Practice Pharmacy
?
Internship hours
?
Board of Pharmacy is composed of a
chairman and ____ members
?
Years chairman and members of the Board of
Pharmacy hold office after appointment
?
Administrative investigation to all members
of the Board of Pharmacy: In case of
?
suspension, it shall be in a period of not more
than:
Book of Poison is kept for _____ years
?
Dangerous Drug Prescription kept for _____
years
?
Duration where Secretary approve or give
the applicant notice of an opportunity for a
?
hearing after filling of an application for
License and registration of drugs or devices
Duration when re-application for LTO may be
done after revocation
?
Duration where confiscated dangerous drug
shall be submitted to PDEA
?
Alcohol limit test for quality control
requirements
?
Validity of the initial registration for herbal
and tradition drugs
?
Initial License to Operate a drug
establishment Validity
?
Renewal of License to Operate a drug
establishment
?
# of people to check critical step in
production process
?