Download as pdf or txt
Download as pdf or txt
You are on page 1of 32

REPUBLIC ACT No.

5921 Sixteenth Congress

AN ACT REGULATING THE PRACTICE OF Third Regular Session


PHARMACY AND SETTING STANDARDS OF
PHARMACEUTICAL EDUCATION IN THE Begun and held in Metro Manila, on Monday, the
PHILIPPINES AND FOR OTHER PURPOSES. twenty-seventh day of July, two thousand fifteen.

ARTICLE 1 REPUBLIC ACT No. 10918

Objectives and Implementation An Act Regulating and Modernizing the Practice of


Pharmacy in the Philippines, Repealing for the
Section 1. Objectives. This Act provides for and shall Purpose Republic Act Numbered Five Thousand Nine
govern (a) the standardization and regulation of Hundred Twenty-One (R.A. No. 5921), Otherwise
pharmaceutical education; (b) the examination for Known as the Pharmacy Law
registration of graduates of schools of pharmacy and (c)
the supervision, control and regulation of the practice of Be it enacted by the Senate and House of
pharmacy in the Philippines. Representatives of the Philippine Congress Assembled:

Section 2. Enforcement. For the purposes of Article I


implementing the provisions of this Act, the Council of
Pharmaceutical Education and the Board of Pharmacy General Provisions
are hereby created.
Section 1. Title. - This Act shall be known as the
ARTICLE II "Philippine Pharmacy Act".

The Council of Pharmaceutical Education Section 2. Statement of Policy. - The State recognizes
the vital role of pharmacists in the delivery of quality
Section 3. The Council of Pharmaceutical Education and health care services through the provision of safe,
its composition. The Council of Pharmaceutical effective, and quality pharmaceutical products,
Education shall be composed of the Secretary of pharmaceutical care, drug information, patient medication
Education, Chairman, the Undersecretary of Health counseling, and health promotion. The pharmacists’
Services, the Food and Drug Administrator, the Chairman professional services shall, therefore, be promoted as an
of the Board of Pharmacy, the dean of the College of indispensable component of the total health care system
Pharmacy, University of the Philippines, the dean of a to ensure the physical well-being of the Filipinos.
college of pharmacy, representing duly accredited private
schools of pharmacy, and a representative of the bona Hence, the State shall develop and nurture competent,
fide national pharmaceutical organizations in the productive, morally upright, and well-rounded pharmacists
Philippines. whose standards of professional practice and service
shall be excellent and globally competitive through
It shall be incumbent upon all deans of duly accredited regulatory measures, programs, and activities that
colleges of pharmacy of private colleges and universities promote and sustain their continuing professional
by agreement among themselves to promulgate rules development.
and regulations regarding the selection of one from
among their group to represent them in the said Council Section 3. Objectives. - This Act provides for and shall
and it shall be incumbent upon all presidents of bona fide govern the:
national pharmaceutical organizations in the Philippines
by agreement to promulgate rules and regulations (a) Standardization and regulation of pharmacy
regarding the selection of one from among them to education;
represent them in the said Council.
(b) Administration of licensure examination, registration,
The members of the Council shall hold office until their
successors have been appointed, elected or designated and licensing of pharmacists;
and duly qualified.
(c) Supervision, control, and regulation of the practice of
Section 4. Functions. The functions of the Council of pharmacy in the Philippines;
Pharmaceutical Education shall be:
(d) Development and enhancement of professional
(a) To promulgate rules and regulations relative to competence of pharmacists through continuing
Pharmaceutical Education in the Philippines; professional development, research, and other related
activities; and
(b) To submit such rules and regulations, which shall
have a binding effect, for implementation to the proper (e) Integration of the pharmacy profession.
agencies such as Department of Education, the Board of
Pharmacy, the bona fide national pharmaceutical Section 4. Scope of the Practice of Pharmacy. - A person
organizations in the Philippines and others; is deemed to be practicing pharmacy, within the meaning
of this Act, when with or without a fee, salary, percentage
(c) To recognize and accredit colleges of pharmacy in the or other rewards, paid or given directly or indirectly, shall:
different private colleges and universities; and
(a) Prepare, compound or manufacture, preserve, store,
(d) To approve the accreditation of community or distribute, procure, sell, or dispense, or both, any
prescription pharmacies, pharmaceutical manufacturing pharmaceutical product or its raw materials; or
laboratories and hospital pharmacies for purposes of
pharmacy internship. (b) Render services, such as clinical pharmacy services,
drug information services, regulatory services,
Section 5. Meetings and traveling expenses. The pharmaceutical marketing, medication management, or
Council of Pharmaceutical Education shall meet at least whenever the expertise and technical knowledge of the
once a month for regular business and as often as the pharmacist is required; or
Council may decide. The Chairman and members of the
Council of Pharmaceutical Education shall not be entitled (c) Engage in teaching scientific, technical, or
to any compensation except for traveling expenses in professional pharmacy courses in a school or college of
connection with their official duties as herein provided. pharmacy; or (d) Dispense pharmaceutical products in
situations where supervision of dispensing of
ARTICLE III pharmaceutical products is required; or

The Board of Pharmacy and Examination and (e) Chemical, biological or microbiological analyses and
Registration of Pharmacists assay of pharmaceutical products, food/dietary
supplements, health supplements, and cosmetics; or
Section 6. The Board of Pharmacy and its Composition.
The Board of Pharmacy shall be composed of a (f) Physico-chemical analyses for medical devices used in
Chairman and two members who shall be appointed by aid of administration of pharmaceutical products; or
the President of the Philippines with the consent of the
Commission of Appointments, from a list of nominees (g) Administration of adult vaccines as approved by the
recommended by the Commissioner of Civil Service who Food and Drug Administration (FDA): Provided, That they
shall secure such lists from bona fide professional shall undergo the training on the safe administration of
national organizations of pharmacists which should be adult vaccines and management of adverse event
certified in accordance with Republic Act Numbered Five following immunization (AEFI) for pharmacists and hold a
hundred forty-six. certificate of training issued by an institution duly
accredited by the Professional Regulation Commission
Section 7. Qualification of Board members. To be (PRC); Provided, further, That the safe administration of
appointed a member of the Board of Pharmacy, a person vaccines be part of the higher education curriculum for
shall be: pharmacists; or

(a) A natural born citizen of the Philippines; (h) Conduct or undertake scientific research in all aspects
(b) A duly registered pharmacist and has been in the involving pharmaceutical products and health care; or
practice of pharmacy for at least ten years;
(i) Provide other services where pharmaceutical
(c) Of good moral character and of recognized standing knowledge is required.
in the pharmaceutical profession;
Activities under paragraphs (a), (b), (c), (d) and (i) are
(d) At the time of appointment, not a member of the exclusive to licensed pharmacists. However, nothing
faculty of any school, college or university offering herein shall be construed as requiring other persons
courses in pharmacy; nor have any direct or indirect carrying out only the activities under paragraphs (e), (f),
pecuniary interests in such school or college of (g) and (h) to be licensed pharmacists, subject to any
pharmacy; and qualification that is imposed by other laws with respect to
such particular activity.
(e) A member of good standing of any bona fide national
pharmaceutical association of the Philippines. All pharmacists are expected to abide by current
standards such as the Philippine Practice Standards for
Section 8. Tenure of office and fees of board members. Pharmacists, Good Laboratory Practice, Good
The Chairman and members of the Board of Pharmacy Distribution Practice, Good Manufacturing Practice and
shall hold office for three years after appointment or until Good Clinical Practice, which are deemed vital in the
their successors shall have been appointed and duly performance of their roles and functions in different
qualified: Provided, That members of the first Board to be practice areas.
appointed after the approval of this Act shall hold office
for the following terms: Chairman for three years, one The Professional Regulatory Board of Pharmacy,
member for two years and one member for one year: hereinafter created, subject to the approval of the PRC,
Provided, further, That any chairman or member may be as provided for by Republic Act No. 8981, otherwise
reappointed for another term of three years but in no known as the "PRC Modernization Act of 2000", and in
case shall be serve continuously for more than six years. consultation with the integrated and accredited
The most senior member of the Board shall automatically professional organization (APO), may modify the
be the Chairman. above-enumerated acts, services, or activities, as the
need arises, in order to conform to the latest trends and
The Chairman and members of the Board shall each developments in the practice of the pharmacy profession:
receive the sum of ten pesos for each applicant Provided, That such modifications are consistent with the
examined regardless of whether or not he is already in enumeration above.
the government service when appointed.
Section 5. Definition of Terms. - As used in this Act:
Section 9. Removal of the Board members. The
chairman or member of the Board may be removed by (a) Accredited professional organization (APO) refers to
the President of the Philippines if found guilty of neglect the duly integrated and accredited professional
of duty, incompetence, malpractice, or unprofessional, organization of registered and licensed pharmacists, of
unethical, immoral, or dishonorable conduct, after having which there shall be only one (1), as prescribed under
been given the opportunity to defend himself in a proper Section 41, Article V of this Act;
administrative investigation. The President may in his
discretion suspend such member under investigation: (b) Adult vaccines refer to cervical cancer, flu (influenza),
Provided, however, That the period of suspension shall pneumococcal, other pre-exposure prophylactic vaccines
not exceed sixty days after which the latter shall be to be administered to patients aged eighteen (18) years
automatically reinstated pending the outcome of the and above, and such other vaccines as may be defined
investigation. by the Department of Health (DOH) in an administrative
issuance;
Section 10. Executive Officer of the Board. The
Commissioner of Civil Service shall be the Executive (c) Adulterated/Deteriorated pharmaceutical products
Officer of the Board and shall conduct the examination refer to pharmaceutical products unfit for human
given by it according to the rules and regulations consumption, following the standards of quality or purity
promulgated by him and approved by the President of the of which, are as those stated in the United States
Philippines. The Secretary of the Board of Examiners in Pharmacopeia/National Formulary and Philippine
accordance with Republic Act Numbered Five hundred Pharmacopeia in its latest edition or any standard
and forty six shall also be the Secretary of the Board. To reference for drugs and medicines which are given official
assist both officials, there shall be appointed from the recognition as well as those provided for in Republic Act
ranking employees of the Board of Examiners, an No. 3720, otherwise known as the "Food, Drug, and
Assistant Secretary, a Legal Officer and a Records Cosmetic Act", as amended, and Republic Act No. 9711,
Officer with compensation of eight thousand eight known as the "Food and Drug Administration Act of
hundred thirty-two pesos, seven thousand two hundred 2009";
thirty-six pesos and five thousand nine hundred
twenty-eight pesos, respectively who may also perform (d) Biopharmaceuticals refer to pharmaceutical products
identical functions for the other existing examination that are used for therapeutic or for in vivo diagnostic
boards. All the records of the Board including purposes, such as vaccines, sera, and drugs derived from
examination papers, minutes of deliberation and records life forms using biotechnology. These include proteins,
of administrative proceedings shall be kept by the nucleic acids, or living microorganisms where the
Secretary of the Board. virulence is reduced and are used for therapeutic or for in
vivo diagnostic purposes;
Section 11. Powers and duties of the Board. The Board
of Pharmacy, conformably with the provisions of this Act (e) Brand name refers to the proprietary name given by
is vested with authority: the manufacturer to distinguish its product from those of
competitors;
(a) To examine applicants for the practice of pharmacy;
(f) Cipher, Code, or Secret Key refers to a method of
(b) To issue certificates of registration or pharmacists. secret writing or use of characteristic style or symbol by
substituting other letter/s or character/s for the letter/s
(c) To reprimand any pharmacist or to suspend or revoke intended, for the purpose of misleading the consumer;
his certificate of registration on the grounds as provided
for in Section thirteen hereof, after a formal administrative (g) Compounding refers to the sum of processes
investigation has been conducted by it. performed by a pharmacist in drug preparation including
the calculations, mixing, assembling, packaging, or
(d) To promulgate from time to time the necessary rules labeling of a drug: (i) as the result of a prescription or drug
and regulations for the effective enforcement of this Act, order by a physician, dentist, or veterinarian; or (ii) for the
subject to the approval of the President upon advice of purpose of, or in relation to, research, teaching, or
the Commissioner of Civil Service; chemical analysis;

(e) To study the conditions affecting the practice of (h) Continuing professional development (CPD) refers to
pharmacy in the Philippines; the inculcation of advanced knowledge, skills, and ethical
values in a post-licensure specialized or in an inter- or
(f) To check the employment of qualified personnel in multidisciplinary field of study for assimilation into
drug stores, hospital pharmacies, drug or pharmaceutical professional practice, self-directed research, and/or
laboratories, cosmetic laboratories and similar lifelong learning;
establishments for which the Board may designate
inspectors from the Board of Pharmacy; and (i) Cosmetics refer to a substance or preparation intended
to be placed in contact with the various external parts of
(g) To encourage the development of botanical gardens the human body or with the teeth and the mucous
and their inspection particularly the propagation of membranes of the oral cavity, with a view exclusively or
Philippine medicinal plants with the cooperation of the mainly to cleaning them, perfuming them, changing their
Department of Agriculture and Natural Resources. appearance and/or correcting body odor, and/or
protecting the body or keeping them in good condition, as
Section 12. Detailmen, requirements, qualifications and defined under Republic Act No. 9711;
fees. Any person who shall be employed as detailman by
any pharmaceutical or drug laboratory or other (j) Counterfeit pharmaceutical products refer to
manufacturers of medical, dental pharmaceutical, pharmaceutical products which do not contain the
biological and veterinary products and by distributors, amounts as claimed; with wrong ingredients; without
dealers or wholesalers of said products, doing business active ingredients; or with insufficient quantity of active
directly or indirectly in the Philippines, shall be required, ingredients, which result in the reduction of the products’
at the beginning of each year, to register with the Board safety, efficacy, quality, strength, or purity. These also
of Pharmacy that he is employed as such. refer to products that are deliberately and fraudulently
mislabeled with respect to identity and/or source or with
(a) An applicant for registration shall be, preferably, a fake packaging, and can apply to both branded and
graduate of a college of pharmacy. generic products, including the following:

There shall be an initial fee of twenty pesos upon (1) The pharmaceutical product itself or the container or
registration and thereafter fifteen pesos shall be charged labeling thereof or any part of such product, container, or
annually for renewal. Upon payment of said fees, the labeling, bearing without authorization; the trademark,
proper credential shall be issued to the applicant. trade name, or other identification marks or imprints or
any likeness to that which is owned or registered in the
(b) It shall be incumbent upon the drug establishments Intellectual Property Office (IPO) in the name of another
referred to in this section to require that detailmen natural or juridical person;
employed or to be employed by them possess the
necessary credentials issued by the Board of Pharmacy (2) A pharmaceutical product refilled in containers bearing
as provided for herein. legitimate labels or marks, without authority; and

For purposes of this section, a detailman is one who (3) A pharmaceutical product which contains no amount
represents any duly authorized manufacturer, dealer, of or a different active ingredient; or less than eighty
distributor, representative or wholesaler of drugs, percent (80%) of the active ingredient it purports to
pharmaceuticals, biologic products and devices, whose possess, as distinguished from an adulterated drug
primary duty is to introduce or reacquaint a product or including reduction or loss of efficacy due to expiration;
products prepared, distributed or made by said
manufacturers, dealer, distributor, representative or (k) Dangerous drugs refer to those listed in the: (1)
wholesaler to the physician, dentist, pharmacist, Schedules annexed to the 1961 Single Convention on
veterinarian or any other qualified person and which Narcotic Drugs, as amended by the 1972 Protocol; (2)
forms part of their program for promotion by describing its Schedules annexed to the 1971 Single Convention on
use, composition, action, dosage, administration, Psychotropic Substances; and (3) Annex of Republic Act
contra-indication, advantages and other salient No. 9165, otherwise known as the "Comprehensive
information relative to said drug, pharmaceutical, Dangerous Drugs Act of 2002", and its amendments;
biological product or device.
(l) Dispensing refers to the sum of processes performed
Section 13. Grounds for reprimand, suspension or by a pharmacist from reading, validating, and interpreting
revocation of registrant certificate. Any of the following prescriptions; preparing; packaging; labeling; record
shall be sufficient ground for reprimanding a pharmacist, keeping; dose calculations; and counseling or giving
or for suspending or revoking his certificate of information, in relation to the sale or transfer of
registration: pharmaceutical products, with or without a prescription or
medication order;
(a) Conviction by a court of competent jurisdiction of any
violation as penalized in sections forty and forty-one (m) Drugs refer to pharmaceutical products that pertain to
hereof; chemical compounds or biological substances, other than
food, intended for use in the treatment, prevention, or
(b) Immoral or dishonorable conduct which includes diagnosis of disease in humans or animals, including the
conviction by a competent court of any criminal offense following:
involving moral turpitude;
(1) Any article recognized in the official United States
(c) Fraud or deceit in the acquisition of the certificate of Pharmacopeia/National Formulary, Homeopathic
registration; Pharmacopeia of the United States of America, Philippine
Pharmacopeia, Philippine National Drug Formulary,
(d) Gross negligence, ignorance or incompetence in the British Pharmacopoeia, European Pharmacopoeia,
practice of his profession resulting in the injury damage Japanese Pharmacopoeia, and any official compendium
or death of another; or any supplement to them;

(e) Malpractice, including aiding or abetting the (2) Any article intended for use in diagnosis, cure,
commission of criminal abortion or sex crimes through mitigation, treatment, or prevention of disease of man or
illegal compounding, dispensing or sale of abortive or sex animals;
drugs as the case may be;
(3) Any article, other than food, intended to affect the
(f) Acting as a dummy of an alien or of a person who is structure or any function of the human body or animals;
not qualified to establish and operate a retail drugstore;
(4) Any article intended for use, as a component of
(g) Addiction to alcoholic beverage or to any articles, specified in clauses (1), (2) and (3), not including
habit-forming drug rendering him incompetent to practice devices or their components, parts and accessories; and
his profession;
(5) Herbal or traditional drugs as defined in Republic Act
(h) Insanity; No. 9502;

(i) False or extravagant or unethical advertisements (n) Emergency cases refer to life-threatening situations
wherein other things than his name, profession, limitation where a patient needs immediate medical attention and
of practice, office and home address and the like are treatment, including the occurrence of epidemic or natural
mentioned; and calamities;

(j) Violations of any provision of the Code of Ethics which (o) Expiration date refers to the end date when the
may be adopted as part of the Rules and Regulations of manufacturer can guarantee that a product possesses its
the Board. claimed potency, efficacy, quality, and safety; after which
its sale or distribution is prohibited;
Section 14. Administrative Investigation. Administrative
investigations shall be conducted by all the members of (p) Filling refers to the act of dispensing or providing
the Board sitting en banc. The existing rules of evidence medicines in accordance with a prescription or medication
shall be observed as far as practicable during order;
administrative investigations.
(q) Food/Dietary supplements refer to processed food
If the Board, by majority vote of the members, shall find products intended to supplement the diet that bears or
that the charges are sustained by evidence adduced, it contains one (1) or more of the following dietary
may at its discretion reprimand the respondent or revoke ingredients: vitamins, minerals, herbs, or other botanicals,
or suspend his certificate of registration. In case of amino acids, and dietary substances to increase the total
suspension, it shall be for a period of not more than six daily intake in amounts conforming to the latest
months. Where the certificate of registration has been Philippine-recommended energy and nutrient intakes or
revoked as herein provided, the Board may, after the internationally agreed minimum daily requirements. It
expiration of six months and upon application, issue a usually is in the form of capsules, tablets, liquids, gels,
new certificate of registration in place of a revoked powders, or pills and not represented for use as a
certificate without the necessity of undergoing any conventional food or as the sole item of a meal or diet or
examination if the respondent in the meanwhile has replacement of drugs and medicines, as defined under
conducted himself in an exemplary manner. Republic Act No. 9711;

Section 15. Procedure and rules. The Board of (r) Generic name refers to the scientifically and
Pharmacy upon receipt of a formal complaint under oath internationally recognized name of the active ingredients,
against any pharmacist, shall furnish the latter a copy of as approved by the FDA pursuant to Republic Act No.
the complaint which he shall answer within ten days from 6675, otherwise known as the "Generics Act of 1988";
receipt hereof. If the Board of Pharmacy, after careful
study of the records, finds that there is a valid grounds to (s) Health supplement refers to any product that is used
the charge it shall conduct a formal investigation setting to maintain, enhance and improve the healthy function of
the dates of hearing thereof. For this purpose, a the human body and contains one (1) or more or a
subpoena or subpoena duces tecum may be issued by combination of the following: (1) herbal fatty adds,
the Chairman of the Board. The proceedings shall at all enzymes, probiotics, and other bioactive substances; and
times be recorded. The investigation shall be terminated (2) substances derived from natural sources, induding
and resolved within ninety days from the time of the first animal, plant, mineral, and botanical materials in the form
date of hearing has been set and heard. of extracts, isolates, concentrates, metabolites, synthetic
sources of substances mentioned in (1) and (2). It is
Section 16. Right of respondent. The respondent presented in dosage forms or in small unit doses such as
pharmacist shall be entitled to be heard by himself or be capsules, tablets, powder, liquids and it shall not include
represented by counsel; to have a speedy and public any sterile preparations (i.e. injectibles, eyedrops);
hearing to confront and to cross-examine witnesses
against him; to summon and present witnesses in his (t) Household remedies refer to any preparation
behalf; and to any other process for the protection of his containing pharmaceutical substances of common or
individual or civil rights. ordinary use to relieve common physical ailments and
which may be dispensed without a medical prescription in
Section 17. Appeal from judgment. The decision of the original packages, bottles or containers, of which the
Board of Pharmacy shall automatically become final thirty nomenclature has been duly approved by the FDA;
days from notice to respondent, unless the latter after
receipt of the decision and within the same period has (u) Institutional pharmacies refer to pharmacies of
appealed to the President of the Philippines. institutions, organizations, and/or corporations that
provide a range of pharmaceutical services, given
Section 18. Candidate for board examination. A exclusively to the employees and/or their qualified
candidate for the board examination in Pharmacy shall dependents;
have the following qualifications:
(v) Internship program refers to a supervised practical
(a) He shall be a natural-born citizen of the Philippines; experience that is required to be completed for licensure
as a registered pharmacist;
(b) He shall be of good moral character;
(w) Label refers to a display of written, printed, or graphic
(c) He shall have completed an Internship Program which matter on the immediate container of any article;
shall consist of at least nine hundred sixty hours, one-half
of which shall be spent equally distributed in a (x) Labeling materials refer to all labels and other written,
prescription pharmacy, a pharmaceutical manufacturing printed, or graphic matter: (1) upon any item or any of its
laboratory and a hospital pharmacy duly accredited by containers or wrappers; or (2) accompanying any such
the Council of Pharmacy and the rest of the hours of item;
internship shall be spent in any or all of the said
establishments at the choice of the candidate. (y) Medical device refers to any instrument, apparatus,
implement, machine, appliance, implant, in vitro reagent
For this purpose, the above-mentioned prescription or calibrator, software, material or other similar or related
pharmacy, pharmaceutical manufacturing laboratory and article intended by the manufacturer to be used alone, or
hospital pharmacy shall keep a separate record of in combination, for human beings, for one (1) or more of
Pharmacy students who have undergone said internship the specific purposes of: diagnosis, prevention,
program directly under their control and as a result monitoring, treatment, or alleviation of disease; diagnosis,
thereof shall issue the proper certificate of said hours of monitoring, treatment, or alleviation of or compensation
internship. It shall also be the duty of said establishments for an injury; investigation, replacement, modification or
to submit annually a complete report of the names of support of the anatomy of a physiological process;
those who have undergone training under their supporting or sustaining life; preventing infection; control
supervision and the corresponding number of hours of of conception; disinfection of medical devices; and
internship credit of each of the pharmacy students to their providing information for medical or diagnostic purposes
respective colleges or school and to the Board of by means of in vitro examination of specimens derived
Pharmacy for proper accreditation; and from the human body. This device does not achieve its
primary intended action in or on the human body by
(d) He shall have graduated with a degree of Bachelor of pharmacological, immunological, or metabolic means, but
Science in Pharmacy or with an equivalent degree from a which may be assisted in its intended function by such
school, college or university duly accredited by the
Council of Pharmaceutical Education after satisfactorily means, as defined under Republic Act No. 9711;
completing a standard pharmacy course of not less than
five academic years. (z) Medical mission refers to an activity conducted on
normal circumstances of an individual or a group of health
Section 19. Scope of Examination. The pharmacist care practitioners to provide health services outside the
examination shall consist of both theoretical and practical hospital, clinic, and health care facility premises as
examinations. The theoretical examination shall include differentiated from humanitarian missions and relief
subjects in Chemistry, Biological Sciences and operations which is conducted during emergency
Pharmacy. situations such as calamity, war, or natural and
man-made disasters;
The Chemistry subjects shall include (1) General,
Inorganic, Pharmaceutical and Physical Chemistry, (2) (aa) Medicines refer to drugs in their appropriate dosage
Organic and Medicinal or Pharmaceutical Chemistry, (3) forms, with assured quality, safety and efficacy for
Qualitative, Quantitative and Drug Assaying. The humans or animals, or both;
Biological Science subjects shall include (4) Physiology
and Biochemistry, (5) Microbiology and Public Health, (6) (bb) Medical representative or professional service
Pharmacology and Toxicology. The Pharmacy subjects representative refers to one who represents any duly
shall include (7) Botany and Pharmacognosy, (8) General authorized manufacturer, distributor, trader, and
Pharmacy, (9) Compounding and Dispensing, (10) wholesaler of pharmaceutical products and whose
Physical and Manufacturing Pharmacy, (11) Pharmacy primary duty is to promote their products to duly licensed
Administration, and (12) Pharmaceutical Jurisprudence health professionals;
and Ethics. The subjects shall be weighted as follows:
Chemistry, thirty per cent; Biological Science, twenty per (cc) Nontraditional outlets refer to entities licensed by
cent; Pharmacy, fifty per cent. appropriate government agencies to dispense
over-the-counter medicines based on an approved list;
The practical examination shall consist of (1)
Identification and Analysis of Drugs, (2) Preparation of (dd) Online pharmacy services refer to pharmaceutical
Official Pharmaceuticals, (3) Compounding and services of a duly licensed pharmaceutical outlet done
Dispensing of Prescriptions and Fixing of Prices of over the internet;
Prescriptions, and (4) Manufacturing Pharmacy and
Quality Control. The practical examination shall be (ee) Over-the-counter (OTC) medicines refer to medicines
weighted as follows: Identification and Analysis of Drugs, used for symptomatic relief of minor ailments and which
thirty per cent; Compounding of Official Pharmaceutical may be dispensed without a prescription;
Preparations, Dispensing and Fixing of Price of
Prescription and Manufacturing Pharmacy and Quality (ff) Pharmaceutical establishments refer to entities
Control, seventy per cent. licensed by appropriate government agencies, and which
are involved in the manufacture, importation, exportation,
It shall be the duty of the Board of Pharmacy to prepare repacking, and distribution of pharmaceutical products to
the schedules of the theoretical and practical pharmaceutical outlets;
examinations and the syllabus of each subject to be
given two months before the dates of the examination (gg) Pharmaceutical manufacturers refer to
wherein they are to be used. establishments engaged in any or all operations involved
in the production of pharmaceutical products including the
Section 20. Ratings required. In order to pass the preparation, processing, compounding, formulating, filling,
examination, a candidate must obtain on the basis of one packaging, repackaging, altering, ornamenting, finishing
hundred per cent a general average of seventy-five per and labeling, preparatory to their storage, sale, or
cent or over in both the theoretical and practical distribution, except the compounding and filling of
examinations, with no ratings below fifty per cent in more prescriptions in pharmaceutical outlets;
than two subjects in the theoretical examinations:
Provided, That any candidate who passed in the (hh) Pharmaceutical marketing refers to any activity
theoretical examination but failed in the practical undertaken, organized, or sponsored by a pharmaceutical
examination, may, upon taking a re-examination, repeat establishment or outlet which is directed at promoting its
only the practical examination and vice-versa: Provided,
further, That any candidate who fails to pass the product;
theoretical or practical examination in three successive
attempts shall not be admitted in the fourth examination (ii) Pharmaceutical outlets refer to entities licensed by
unless be could present to the Board a certification that appropriate government agencies, and which are involved
he had enrolled and undergone within the year in compounding and/or dispensing and selling of
preceding, a pre-board review course from a duly pharmaceutical products directly to patients or end-users;
accredited college of Pharmacy.
(jj) Pharmaceutical products refer to drugs, medicines,
Section 21. Holding of examination. Examination for biologicals, pharmaceutical and biopharmaceutical
registration to practice pharmacy in the Philippines shall products/specialties, veterinary products, veterinary
be given twice a year in the City of Manila and biologies and veterinary medicinal products;
environment as the Board of Pharmacy may fix.
(kk) Pharmacist refers to a health professional who has
Section 22. Fees for examination and registration. The been registered and issued a valid Certificate of
Board of Pharmacy shall charge for each applicant for Registration (COR) and Professional Identification Card
examination the sum of fifty pesos, and after passing the (PIC) by the PRC and the Professional Regulatory Board
Board examinations, for each certificate of registration of Pharmacy;
twenty pesos; and for each duplicate registration
certificate, ten pesos. All fees shall be paid to the cashier (ll) Pharmacist-only OTC medicines refer to
of the Board of Examiners and all expenses, including over-the-counter medicines classified by appropriate
the fees of the Board members shall be disbursed by him government agencies to be obtained only from a licensed
from such funds. pharmacist, with mandatory pharmacist’s advice on their
selection and proper use;
ARTICLE IV
(mm) Pharmacy aides refer to persons who assist the
Practice of Pharmacy pharmacists in the different aspects of pharmacy
operation based on established standard operating
Section 23. Definition of practice of pharmacy. A person procedures and processes, with very minimal degree of
shall be deemed to be practicing pharmacy within the independence or decision making and without direct
meaning of this Article, who shall, for fee, salary, interaction with patients:
percentage or other reward paid or given directly to
himself or indirectly through another, prepare or (nn) Pharmacy assistants refer to persons who assist the
manufacture, analyze, assay, preserve, store, distribute pharmacists in different aspects of pharmacy operation
or sell any medicine, drug, chemicals, cosmetics, based on established standard operating procedures and
pharmaceuticals, devices or contrivances used in processes, with a minimum degree of independence or
pursuance thereof; or render pharmaceutical service in decision making and may have supervised interaction
any office or drug and cosmetic establishment where with patients;
scientific, technological or professional knowledge of
Pharmacy is applied; or engage in teaching scientific, (oo) Pharmacy technicians refer to persons who assist in
technological or professional pharmacy subject in a compounding and dispensing of medicines in community,
college of pharmacy; or conduct or undertake scientific hospital, institutional and industrial settings or engaged in
pharmaceutical research for biological and bacteriological other activities under the supervision of the pharmacist as
testings and examinations. described in Section 39, Article IV of this Act;

However, persons performing executive managerial or (pp) Philippine Practice Standards for Pharmacists refer
administrative functions and their subordinate personnel to the established national framework for quality
employed in the pharmaceutical laboratories referred to standards and guidelines of the practice of pharmacy that
in the second paragraph of Section twenty-seven hereof respond to the needs of the people who require the
shall not be considered for purposes of this definition, pharmacists’ services to provide optimal, evidence-based
considered persons in the practice of pharmacy. care as formulated by the integrated APO and approved
by the Professional Regulatory Board of Pharmacy;
Section 24. Prerequisite for the practice of pharmacy. No
person shall engage in the practice of pharmacy in the (qq) Physician’s samples refer to medicines given to
Philippines unless he is at least twenty-one years of age, health professionals for promotional purposes only;
has satisfactorily passed the corresponding examination
given by the Board of Pharmacy, and is a holder of a (rr) Prescription/Ethical medicines refer to medicines
valid certificate of registration duly issued to him by said which can only be dispensed by a pharmacist to a patient,
Board. upon the presentation of a valid prescription from a
physician, dentist, or veterinarian and for which a
Section 25. Sale of medicine, pharmaceuticals, drugs pharmacist’s advice is necessary;
and devices. No medicine, pharmaceutical, or drug of
whatever nature and kind or device shall be (ss) Refilling of a prescription refers to the act of
compounded, dispensed, sold or resold, or otherwise be dispensing the remaining balance of medicines ordered in
made available to the consuming public except through a the prescription;
prescription drugstore or hospital pharmacy, duly
established in accordance with the provisions of this Act. (tt) Referral refers to the process wherein a pharmacist
provides consultative services and conducts preliminary
Pharmaceutical, drug or biological manufacturing assessment of symptoms and refers the patient to a
establishments, importers and wholesalers of drugs, physician or other health care professional;
medicines, or biologic products are authorized to sell
their products only at wholesale to duly established retail (uu) Referral registry refers to the record book maintained
drugstore or hospital pharmacies. by pharmacists, listing the patients referred to different
health facilities for further diagnosis;
Section 26. Markings and inhibition to the sale of drug
samples. No sample of any drug, biological product, (vv) Refresher program refers to a prescribed study
device or proprietary medicine, given or intended to be program in an accredited school of pharmacy; and
given for free to the physician and other qualified person
by any manufacturer or distributor of its representative or (ww) Telepharmacy services refer to pharmaceutical
detailman as part of its program or promotion, may be services of a duly licensed pharmaceutical outlet done
sold. through the use of telephone, teleconferencing, or
facsimile.
The statement "Sample, not for sale" shall appear
conspicuously on the container, package or carton of the Article II
drug or device to be given.
The Professional Regulatory Board of Pharmacy
Section 27. Pharmacist required and compensation.
Every pharmacy, drugstore or hospital pharmacy whether Section 6. Creation of the Professional Regulatory Board
owned by the government or a private person or firm of Pharmacy. - There is hereby created a Professional
shall at all times when open for business be under the Regulatory Board of Pharmacy, hereinafter called the
personal and immediate supervision of a registered Board, under the administrative control and supervision of
pharmacist: Provided, That no pharmacist shall have the PRC, to be composed of a Chairperson and two (2)
personal supervision of more than one such members, to be appointed by the President of the
establishment. In cases where a drug establishment Philippines from a list of three (3) recommendees for each
operates in more than one shift, each shift must be under position ranked in the order of preference and submitted
the supervision and control of a registered pharmacists. by the PRC from a list of five (5) nominees submitted for
each position by the duly integrated APO of pharmacists.
Drug or pharmaceutical laboratories or similar
establishments engaged in the repackaging, manufacture Section 7. Qualifications of the Chairperson and
or sale of drugs, biologic products and pharmaceutical Members of the Board. - The Chairperson and members
products in quantities greatly in excess of the therapeutic of the Board, at the time of nomination, must:
doses of each substance; such processes involving the
(a) Be a citizen of the Philippines and a resident for at
preparation, quality control or repackaging of said
least five (5) years;
products shall for each respective operation be under the
direct and immediate supervision of a registered
(b) Be a duly registered and licensed pharmacist in the
pharmacist, or, in the sale of pharmaceuticals, medicines
Philippines, preferably a holder of a masteral degree in
and drugs at wholesale, such business shall be
conducted under the immediate supervision of a Pharmacy, or its equivalent;
registered pharmacist practicing only in such
establishment. (c) Have been in the active practice of pharmacy for the
past ten (10) years;
Every pharmacist employed as such in any of the
establishments mentioned in this section whose (d) Have not been convicted of a crime involving moral
capitalization is not less than ten thousand pesos shall turpitude;
receive, notwithstanding any provisions of law to the
contrary, a minimum compensation similar to that of (e) Be a member in good standing of the APO for at least
government pharmacists. five (5) years, but not an officer or trustee thereof; and

Section 28. Display of certificate required. It shall be the (f) At the time of appointment, must neither be a member
duty of every pharmacist engaged in the practice of of the faculty nor an administrative officer of any school,
pharmacy either on his own account or under the employ college or university offering degree programs in
of another, to display his certificate of registration in a pharmacy nor has any direct or indirect pecuniary interest
prominent and conspicuous place in pharmacy, or connection in any review center or similar institution.
drugstore, hospital pharmacy or drug establishment
which he operates or in which he is employed. No Section 8. Powers, Functions, and Responsibilities of the
pharmacist shall with his knowledge allow his certificate Board. - The Board shall exercise the following powers,
of registration to be displayed in such establishments functions, and responsibilities:
when he is not actually employed or operating therein in
his professional capacity. (a) Administer and implement the provisions of this Act;

Section 29. Responsibility for quality of drugs. In cases (b) Promulgate rules and regulations, administrative
of drugs, pharmaceuticals or poisons sold in their original orders, and issuances necessary to carry out the
packings, the seal of which has not been broken or provisions of this Act;
tampered with, the liability that may arise because of their
(c) Prepare licensure examination questions, score, and
quality and purity , rests upon the manufacturer or in his
rate the examinations and submit the results thereof to
absence, upon the importer, the distributor,
the PRC. The Board shall prepare, adopt, issue, or
representative or dealer who was responsible for their
amend the syllabi or tables of specifications of the
distribution or sale.
subjects in the licensure examination, in consultation with
It shall be unlawful for any reason, whoever, to the academe and the Commission on Higher Education
manufacture, prepare, sell or administer any prescription, (CHED);
drug, pharmaceutical or poison under any fraudulent
(d) Recommend the issuance, suspension, revocation, or
name, direction or pretense or to adulterate any drug,
reinstatement of the COR, PIC or Special/Temporary
pharmaceutical, medicine or poison so used, sold or
Permits (STP) for the practice of pharmacy;
offered for sale. Any drug, pharmaceutical, medicine or
poison shall be held to be adulterated or deteriorated
(e) Administer oaths in accordance with the provisions of
within the meaning of this section if it differs from the
this Act;
standard of quality or purity given in the United States
Pharmacopoeia or National Formulary, both in their latest (f) Regulate and monitor the practice of pharmacy in the
edition or, in lieu thereof, in any standard reference for Philippines, including the practice of subprofessional
drugs and medicines given official recognition; and those services such as pharmacy technicians, pharmacy
which fall within the meaning as provided for in the Food, assistants, aides, and other medicine handlers, as
Drug and Cosmetic Act, (Republic Act Numbered described in this Act; adopt measures that may be
Thirty-seven hundred twenty). deemed proper for the enhancement of the profession
and the maintenance of high professional, academic,
Section 30. Filling and refilling of prescription. No
ethical, and technical standards; and conduct ocular
prescription shall be filled or compounded except by a
inspection of pharmaceutical establishments and higher
registered pharmacist in the employ of the drugstore or
education institutions (HEIs), in coordination with
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 concerned government agencies;
standard or purity and quality given in the standard
references. Students undergoing pharmaceutical (g) Promulgate and prescribe the Pharmacists’ Code of
internship may assist said pharmacist in the Ethics, Code of Technical Standards and Guidelines for
compounding and dispensing of the prescription called the Professional Practice of the Pharmacy Profession, in
for. coordination with the APO;

No prescription shall be refilled except upon express (h) Represent the pharmacy profession in all fora
order of the person so prescribing. involving concerns and issues related to pharmaceutical
products and the practice of pharmacy;
Section 31. Label of dispensed medicine. Upon every
box, bottle, or other package containing medicine sold or (i) Investigate cases arising from violations of this Act, the
dispensed by a pharmacist based on prescription, there rules and regulations promulgated pursuant thereto, the
shall be pasted, affixed or imprinted a seal of label Pharmacists’ Code of Ethics, Code of Technical
bearing, among others, the name and address of Standards and Guidelines for the Professional Practice of
pharmacy; the names and quantities of the ingredients; the Pharmacy Profession, and other Board issuances;
required doses thereof, its expiration date if any; the issue summons, subpoena ad testificandum and
name of the prescriber, date and the number of subpoena duces tecum to secure the attendance of
prescription; and the direction for its use. witnesses or production of documents, or both, and other
evidence necessary for such investigation or hearing; and
Every prescription, which in its preparation, contains any render decision thereon which shall, unless appealed to
quantity of a drug which is habit-forming, or a derivative the PRC, become final and executory after fifteen (15)
of such drug, shall have in the label attached to the days from receipt of notice of judgment or decision;
container the added statement "Warning may be habit
forming. (j) Delegate the he aring or investigation of administrative
cases filed before the Board, except where the issue or
Every prescription for external use filled in the drugstore question involves the practice of the profession, in which
shall bear a red label showing in black ink the case, the hearing shall be presided over by at least one
components of such prescription and the words "For (1) member of the Board, to be assisted by a Legal or
external use only" at the bottom of the label. Hearing Officer of the PRC;

Section 32. Record books for prescription. All (k) Conduct, through the Legal Officers of the PRC,
prescriptions dispersed in the drugstore shall be recorded summary proceedings on minor violations of this Act, the
in the book kept for the purpose indicating therein, General Instruction to the Examinees, including the
among others, the name of the manufacturer, the original implementing rules and regulations issued by the Board,
stock, lot and control numbers of the main ingredients of and to render summary judgment thereon which shall,
the prescriptions, which book shall be open to inspection unless appealed to the PRC, become final and executory
by the proper authorities at any time of the day when the after fifteen (15) days from receipt of notice of judgment
pharmacy is open to the public and must be preserved or decision;
for a period of not less than two years the last entry in it
has been made. All prescription shall be attached to said (l) Issue and promulgate guidelines on CPD, in
book for prescriptions and numbered consecutively and coordination with the APO;
shall be preserved for the same length of time as the
prescription book. (m) Recommend the accreditation of the standardized
training programs for and certifications of medical
Section 33. Inhibition against use of cipher or unusual representatives or professional service representatives,
terms in prescriptions and prescription switching. No pharmacy technicians, pharmacy assistants, pharmacy
pharmacist shall compound or dispense prescriptions, aides and other medicine handlers covered in Section 39,
recipes or formulas which are written in ciphers, codes or Article IV of this Act. The Board shall promulgate the
secret keys or in which they are employed unusual criteria and guidelines in the accreditation of training
names of drugs which differ from the names ordinarily programs and certifications as described above, in
used for such drugs in standard pharmacopoeias or coordination with the APO and with other concerned
formularies. government agencies;

No pharmacist dispensing or compounding prescriptions (n) Accredit Specialty Boards of Pharmacy based on the
shall substitute the drug or drugs called for in the criteria that it shall establish and prescribe; and
prescription with any other drug or substance or
ingredient without prior consultation with, and a written (o) Perform and discharge such other functions and
consent of, the person prescribing. responsibilities, as may be deemed implied, incidental,
and necessary, to preserve the integrity of the pharmacy
Section 34. Provisions relative to dispensing of violent licensure examination and to enhance and upgrade the
poisons. Every pharmacist who dispenses, sells or practice of the pharmacy profession in the country.
otherwise delivers any of the violent poisons intended for
medicinal use, to wit: arsenical preparations, phosphorus; Section 9. Term of Office of the Members of the Board. -
corrosive sublimate; atropine, strychnine, or any of their The Chairperson and members of the Board shall hold
salts, hycocyanic acid or any of its salts; oil of bitter office for a term of three (3) years from the date of
almonds containing hydrocyanic acid or prassic acid; oil appointment or until their successors shall have been
of mirbane (Nitro-benzene); and such other poisonous qualified and appointed. They may be reappointed in the
substances which may from time to time be classified same office for another term of three (3) years
under this category by the Food and Drug Administration; immediately after the expiry of their term; Provided, That
shall do so only upon prescription of a duly licensed no member of the Board shall hold office for more than
physician, dentist or veterinarian. He shall make or cause two (2) terms or not more than six (6) years; Provided,
to be made in a separate book, kept for the purpose, an further, That the first Board appointed under this Act shall
entry stating the date of each sale and the name and hold these terms cf office: the Chairperson for three (3)
address of the purchaser, the name and quantity of the years, the first member for two (2) years, and the second
poison sold and the purpose for which it was claimed to member for one (1) year; Provided, finally, That an
be purchased, before delivering it to the purchaser. appointee to a vacancy shall serve only the unexpired
portion of the term of office. The Chairperson and
No prescription, the prescribed dose of which contains a members of the Board shall duly take their oath of office
dangerous quantity of poison, shall be filled without first before a duly authorized officer.
consulting the prescribing authority and verifying the
prescription. The pharmacist before delivery of such Section 10. Compensation and Allowances of the Board.
poison to the purchaser shall acquaint the latter of its - The Chairperson and members of the Board shall
poisonous character. receive compensation and allowances comparable to the
compensation and allowances received by the members
The pharmacist shall also affix to every box, bottle or of the other existing professional regulatory boards under
other package containing any dangerous or poisonous the PRC, as provided for in the General Appropriations
drug, another label of red paper upon which shall be Act.
printed in large letters the word "Poison" and a vignette
representing a skull and bones before delivering it to the Section 11. Grounds for Suspension or Removal from
purchaser. Office of the Chairperson or Member of the Board. - The
President of the Philippines may, upon recommendation
No poison specified in this section shall be sold or of the PRC and after due process, suspend or remove the
otherwise delivered to any person less than eighteen Chairperson or any member of the Board on any of the
years of age or who is mentally deranged or under the following grounds:
influence of liquor or one who is apparently addicted to
opiate and other habit-forming drugs. (a) Gross neglect, incompetence, or dishonesty in the
discharge of duty;
The books kept for the purpose of recording the sale of
violent poisons shall be open at all times to the inspection (b) Involvement in the manipulation, tampering, or rigging
of the proper authorities, and every such book shall be of the licensure examination, its questions or results, or
preserved for at least five years after the last entry in it both, and in the disclosure of classified and confidential
has been made. information pertaining to the licensure examination;

Should any of the poisons above-stated be intended for (c) Conviction of an offense involving moral turpitude by a
purposes other than medicinal, the same may be sold court of competent jurisdiction; and
without a prescription by the pharmacist but the other
requirements of this section must be complied with. (d) Unprofessional, unethical, immoral, or dishonorable
conduct.
Section 35. Provisions relative to dispensing of less
violent poisons. Every pharmacist who dispenses, sells The PRC, in the conduct of investigation, shall be guided
or delivers any poison which is less violent in category as by Sections 7 and 15 of Republic Act No. 8981, the
classified by the Food and Drug Administration may do existing rules on administrative investigation, and the
so even without the prescription of a physician and its Rules of Court.
sale may be recorded in the poison book. The other
requirements as provided for in Section thirty-four hereof, Section 12. Custodian of its Records, Secretariat and
however, shall be complied with. Support Services. - All records of the Board, pertaining to
the applications for examinations, administrative and
Section 36. Receptacle for poisonous drugs. The other investigative hearings conducted by the Board, shall
poisonous drugs specified in Section thirty-four and be under the custody of the PRC. The PRC shall
thirty-five hereof shall be kept in a cabinet to be provided designate a Secretary who shall provide the Board with
in every pharmacy carrying such drugs in stock and the secretariat and other support services to implement the
same shall be kept securely-locked when not in use. provisions of this Act.

Section 37. Provisions relative to dispensing of Article III


abolifecients or anti-conceptional substances and
devices. No drug or chemical product or device capable Examination, Registration, and Licensure
of provoking abortion or preventing conception as
classified by the Food and Drug Administration shall be Section 13. Licensure Examination Requirement. -
delivered or sold to any person without a proper Unless exempted therefrom, all applicants for registration
prescription by a duly licensed physician. for the practice of pharmacy shall be required to pass a
licensure examination, as provided for in this Act and
The pharmacist in charge of a drug store or pharmacy Section 7(d) of Republic Act No. 8981.
after filling a prescription containing abortive or
anti-conceptional substance or devices shall record in a Section 14. Qualifications for the Licensure Examination.
separate register book for abortives and - An applicant for the Pharmacists’ Licensure Examination
anti-conceptionals, the following data; shall establish to the satisfaction of the Board that the
following qualifications are met:
(a) Number and date of the prescription;
(a) A citizen of the Philippines or of a foreign country
(b) Name and address of the physician; which has a law or policy on reciprocity for the practice of
the pharmacy profession;
(c) Name, quantity and manufacturer of the drug;
(b) Of good moral character and reputation;
(d) Name and address of the purchaser;
(c) A degree holder of Bachelor of Science in Pharmacy
(e) Date of filling the prescription; and or its equivalent degree conferred by an HEI in the
Philippines or an institution of learning in a foreign country
(f) Signature of the pharmacist filling the prescription. duly recognized by the CHED; and

Section 38. Provisions relative to dispensing of potent (d) Has completed an internship program approved by the
drugs. Every pharmacist who dispenses, sells or delivers Board, pursuant to such guidelines as may hereinafter be
any drug, which falls under the classification of the Food promulgated, in consultation with the duly recognized
and Drug Administration as potent drugs shall do so only associations of pharmacy schools and the CHED.
upon prescription of a duly licensed physician, dentist or
veterinarian. Section 15. Scope of Examination. - The Pharmacists’
Licensure Examination shall cover the following subjects
Section 39. Requirements for the opening and operation on Pharmacy Science and Practice, Inorganic
of drugstores and pharmacies. The minimum Pharmaceutical Chemistry, Organic Pharmaceutical
requirements necessary for the opening and operation of Chemistry, Qualitative and Quantitative Pharmaceutical
drugstores and pharmacies shall be in accordance with Chemistry, Pharmacognosy and Plant Chemistry,
the rules and regulations to be prescribed by the Food Pharmaceutical Biochemistry, Microbiology and
and Drug Administration in accordance with the Parasitology, Physical Pharmacy, Biopharmaceutics,
provisions of this Act. Only natural-born Filipino citizens Pharmacology and Toxicology, Manufacturing, Quality
who are registered pharmacists can apply for the opening Assurance and Instrumentation, Pharmaceutical
of a retail drugstore. Calculations, Drug Delivery Systems, Hospital Pharmacy,
Clinical Pharmacy, Dispensing and Medication
Section 40. Penal provisions. Any person who shall Counseling, Pharmaceutical Administration and
violate any of the provisions of Sections twelve, Management, Public Health, Legal Pharmacy, and Ethics.
twenty-four, twenty-five, twenty-six, twenty-seven and
twenty-nine of this Act or any person who shall make The Board, subject to the approval of the PRC, may
false representation to procure a registration certificate introduce relevant changes on the subject areas, format,
as pharmacist for himself or for another; or any person and content of the examination, as well as on the relative
who shall allow anyone in his employ who is not a weight attributed to each examination subject, as the
registered pharmacist to engage in the practice of need arises, and in consultation with the duly recognized
pharmacy; or any person who shall falsely display within associations of pharmacy schools and the CHED.
the establishment the certificate of registration of a
pharmacist who is not actually and regularly employed Section 16. Holding of Examination. - The Pharmacists’
therein as such or to act as a dummy for any alien or an Licensure Examination shall be given two (2) times a year
unqualified person for the purpose of opening and in places and dates as the PRC may designate in the
operating a retail drugstore; shall, upon conviction Resolution providing for the master schedule of all
thereof, be sentenced to a fine of not less than one licensure examinations pursuant to Section 7(d) of
thousand pesos but not exceeding four thousand pesos Republic Act No. 8981.
or to an imprisonment of not less than six months and
one day but not more than four years, in the discretion of Section 17. Ratings in the Licensure Examination. - In
the court. order to be registered and licensed as a pharmacist, a
candidate must obtain a general weighted average of
Section 41. Other penalties. Any pharmacist who shall seventy-five percent (75%), with no rating lower than fifty
violate any of the provisions of Sections twenty-eight, percent (50%) in any of the subjects.
thirty, thirty-one, thirty-two, thirty-three, thirty-four,
thirty-five, thirty-seven and thirty-eight of this Act or any An applicant who failed in the licensure examination for
pharmacist after his certificate of registration has been the third (3rd) time shall not be allowed to take the next
lawfully suspended or revoked, who continues to engage succeeding examinations without having undertaken a
in the practice of pharmacy, shall, upon conviction refresher program in a duly accredited institution. The
thereof, be sentenced to a fine of not less than one Board shall issue guidelines on the refresher program
hundred pesos but shall not exceed five hundred pesos requirement.
or to an imprisonment of not less than thirty days but not
more than four months, in the discretion of the court. Section 18. Report of Rating. - The Board shall submit to
the PRC the ratings obtained by each candidate within
Any person other than citizens of the Philippines having three (3) working days after the last day of the
been found guilty of any violation as provided for in this examination, unless extended for just cause.Upon the
and the preceding section shall, after having paid the fine release of the results of the examination, the PRC shall
or having served his sentence or both when so required send by mail the rating obtained by each examinee at the
be also subject to deportation. given address using the mailing envelope submitted
during the examination.
Section 42. Definition of terms. For purposes of this Act,
the term (a) "Pharmacy" or "Drug Store" means a place Section 19. Oath of Profession. - All successful
or establishment where drugs, chemical products, active candidates in the licensure examination shall take their
principles of drugs, pharmaceuticals, proprietary oath of profession before any member of the Board,
medicines or pharmaceutical specialties, devices, and officer of the PRC, or any person authorized by law to
poisons are sold at retail and where medical, dental and administer oaths, prior to entering the practice of the
veterinary prescriptions are compounded and dispensed. pharmacy profession.

(b) "Drug or Pharmaceutical Laboratory" or Section 20. Issuance of Certificate of Registration and
Pharmaceutical Manufacturing Laboratory" means an Professional Identification Card. - A COR as a pharmacist
establishment where pharmaceuticals, proprietary shall be issued to those who passed the licensure
medicines or pharmaceutical specialties are prepared, examination, subject to compliance with the registration
compounded, standardized and distributed or sold. requirements and payment of the prescribed fees. The
COR shall bear the registration number, the date of its
(c) "Wholesaler" means and includes every person who issuance, and the signatures of the Chairperson of the
acts as a jobber, merchant, broker or agent, who sells or PRC and the members of the Board, stamped with the
distributes for resale pharmaceuticals, proprietary official seals of the PRC and of the Board, certifying that
medicines or pharmaceutical specialties. the person named therein is entitled to the practice of the
profession, with all the privileges appurtenant thereto.
(d) "Person" means and includes an individual, This COR shall remain in full force and effect until
partnership, corporation or association. suspended or revoked in accordance with this Act.
(e) "Drug" means (1) articles recognized in the official A PIC bearing the registration number and dates of its
United States Pharmacopoeia, official Hemeopathic issuance and expiry, duly signed by the Chairperson of
Pharmacopoeia of the United States or official National the PRC, shall likewise be issued to every registrant,
Formulary, or any of their supplements; (2) articles upon payment of the prescribed fees. The PIC shall be
intended for use in the diagnosis, cure, mitigation, renewed every three (3) years, upon presentation of the
treatment, or prevention of disease in man or animals; (3) Certificate of Good Standing (COGS) from the APO and
articles (other than food) intended to effect the structure proof of completion of the CPD requirements.
or any function of the body of man or animals; and (4)
articles intended for use as a component of any articles Section 21. Foreign Reciprocity. - Unless the country or
specified in clauses (1), (2), or (3), but not include state of which the foreign pharmacist is a subject or
devices or their components, parts or accessories. citizen, specifically permits Filipino pharmacists to
practice within its territorial limits on the same basis as
(f) "Pharmaceuticals", "Proprietary Medicines" or the subjects or citizens of the said foreign country or state
"Pharmaceutical Specialties" means any drug, under reciprocity and under international agreements, no
preparation or mixture of drugs marked under a trade foreigner shall be admitted to licensure examinations,
name and intended for the cure, mitigation or prevention given a COR to practice as pharmacist nor be entitled to
of disease in man or animals. any of the privileges under this Act.
(g) "Device" means instruments, apparatus or Section 22. Practice Through Special/Temporary Permit
contrivances including their components, parts and (STP). - The practice of pharmacy in the Philippines shall
accessories, intended (1) for use in the diagnosis, cure, be limited to natural persons only and shall be governed
mitigation, treatment or prevention of disease in man or by the provisions of Republic Act No. 8981 and other
animals; or issuances pertinent thereto: Provided, That any foreign
citizen who has gained entry in the Philippines to perform
(2) to effect the structure or any function of the body of professional services within the scope of the practice of
man or animals. pharmacy, including the following: (a) being a consultant
in foreign-funded or assisted projects of the government;
(h) "Biologic Products" are viruses, sera, toxins and (b) being engaged or employed by a Filipino employer or
analogous products used for the prevention or cure of establishment; (c) providing free services in humanitarian
human diseases. missions: and (d) being a visiting faculty member in any
field or specialty in pharmacy shall, before assuming such
(i) "Poison" is any drug, active principle, or preparation of
duties, functions and responsibilities, secure an STP from
the same, capable of destroying life or seriously
the Board and the PRC, under the following conditions:
endangering health when applied externally to the body
or introduced internally in moderate doses. (1) The person is an internationally renowned pharmacist
or expert in a field or specialty of pharmacy;
(j) "Cipher" means a method of secret writing that
substitutes other letters or characters for the letter (2) The person is engaged in the provision of a
intended or transposes the letter after arranging them in professional service which is determined to be necessary
blocks or squares. due to lack of Filipino specialist or expert; and

(k) "Code" means a system of words or other symbols (3) The person is required to work with a Filipino
arbitrarily used to represent words. counterpart, a natural person who is a registered and
licensed pharmacist.
(l) "Secret Keys" means a characteristics style or symbols
kept from the knowledge of others or disclosed Section 23. Grounds for Non-registration. - The Board
confidentially to but one of few. shall not register any successful examinee who has been:

Section 43. Final Provisions. To carry out the provisions (a) Convicted of an offense involving moral turpitude by a
of this Act, there is hereby authorized to be appropriated, court of competent jurisdiction;
out of any funds in the National Treasury not otherwise
appropriated, the sum of thirty thousand pesos within the (b) Summarily adjudged by the Board as guilty for
fiscal year of the approval hereof. Thereafter, such funds misrepresentation or falsification of documents in
as are necessary for the maintenance and operation of connection with the application for examination or for
the Board of Pharmacy and of the Council of violation of the General Instructions to Examinees;
Pharmaceutical Education shall be included in the annual
General Appropriations Act. (c) Found guilty of immoral or dishonorable conduct by
the Board;
Section 44. Repealing clause. The following are hereby
repealed: Sections seven hundred seventeen to seven (d) Medically proven to be addicted to any drug or alcohol
hundred fifty-seven inclusive, Sections two thousand six by a medical or drug testing facility accredited by the
hundred seventy-five to two thousand six hundred government; and
seventy-seven inclusive of the Revised Administrative
Code, as amended; and such other laws or part of laws, (e) Declared of unsound mind by a court of competent
executive orders, administrative orders; circulars, jurisdiction.
regulations and memoranda inconsistent or incompatible
with this Act. In refusing the registration, the Board shall give a written
statement setting forth the reasons therefor and shall file
Section 45. Separability of provisions. If any part, section a copy thereof in its records. Should ground (d) be proven
or provision of this Act shall be held invalid or to be no longer existent, the Board shall issue a Board
unconstitutional, no other part, section or provision Resolution allowing the issuance of such COR.
thereof shall be affected thereby.
Section 24. Reissuance of Revoked Certificate of
Section 46. Effectivity. This Act shall take effect upon its Registration, Replacement of Lost or Damaged Certificate
approval. of Registration, Professional Identification Card or
Special/Temporary Permit. - The Board may, upon
Approved: June 21, 1969 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

(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 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;

(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;

(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

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

President of the Philippines

You might also like