FIFTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES —)
FIRST REGULAR SESSION )

HOUSE OF REPRESENTATIVES

Introduced by Representative Rufus B. Rodriguez and
Representative Maximo B, Rodriguez, Jr.

House Bill No.__ 3389

EXPLANATORY NOTE

The provision of safe, affordable, and effective medicines is regarded by the
government as crucial to the delivery of comprehensive quality health care. The
enactment of the Generics Law in 1988 which promoted use of generic drugs, the
Cheaper Medicines Law (R.A. 9502) which provides for better access to affordable
medicines and the FDA Act (R.A. 9711) which is expected to make possible a well-
manned, well-equipped regulatory agency to ensure the quality of registered drug
products, are some of the significant milestone policies towards the pursuit of better
health for the majority of Filipinos. However, the fact remains that all services
associated with the prescription, dispensing and use of medicines have to be
improved and enhanced to guarantee that consumers and patients get the most out
of the medicines they buy, given limited resources.

Studies have shown that the growing number of people who self-medicate,
those who failed to comply with their medication regimen, and those who did not
receive any guidance from their health care providers are the ones who suffer the
most from the detrimental consequences of medication errors.

It is therefore high time to focus on one health professional group directly in
charge of the handling and dispensing of prescription and over-the-counter
medicines — the pharmacists — in order to help the public attain better health
outcomes through the use of their medicines.


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The Pharmacy Law (Republic Act 5921) is the existing law governing the
education and practice of pharmacists in the Philippines since its enactment in 1969.
In view of the rapid progress in medical science and technology and the
developments in pharmacy profession itself, this law has to be updated to serve its
purpose. The new pharmacy bill being proposed has provisions that will adjust
pharmacy services to address the ever-evolving health needs of the Filipino people.
In addition, this proposal aims to raise the standards of pharmacy practice and
education to address the perceived poor quality of pharmacy services in the country.

It is envisioned that with the proposed legislation, pharmacists, as responsible
members on the health care team, would be more conscientious of their role in

providing better services, thereby helping our countrymen attain better treatment and
satisfaction with the health care delivery system of the country.

In view of the above, the immediate passage of this bill is earnestly sought.

RUFUS B. RODRIGUEZ

Me.

MAXIMO B/ RODRIGUEZ, JR.


FIFTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES —)
FIRST REGULAR SESSION )

HOUSE OF REPRESENTATIVES

Introduced by Representative Rufus B, Rodriguez and
Representative Maximo B. Rodriguez, Jr.

3389

House Bill No.

AN ACT
REGULATING THE PRACTICE OF PHARMACY IN THE PHILIPPINES,
REPEALING FOR THE PURPOSE REPUBLIC ACT NO. 5921, THE PHARMACY
LAW, AS AMENDED, AND FOR OTHER PURPOSES.

Be it enacted by the Senate and House of Representatives of the Philippines in
Congress assembled.

ARTICLE |
GENERAL PROVISIONS

Section 1. - Title. - This Act shall be known as the “Philippine Pharmacy Act of
2010”,

Sec. 2. - Statement of Policy. The state recognizes the vital role of pharmacists in
quality healthcare delivery through their services in providing safe, effective, and
quality drugs or medicines; drug information, patient medication counseling, and
health promotion. The pharmacists’ professional service shall, therefore, be
promoted as a component of the total healthcare system, which shall ensure the
physical well-being of the Filipinos.

Hence, the state shall develop and nurture competent, productive, morally
upright, and well-rounded pharmacists whose standards of professional practice and
service shall be excellent, qualitative, world-class and internationally recognized,
globally competitive through regulatory measures, programs, and activities that
foster their continuing professional development.

Sec. 3. ~ Objectives. - This Act provides for, and shall govern:

(a) the standardization and regulation of pharmacy education,

(b) the examination for registration of graduates of schools and colleges of
pharmacy,

(c) the supervision, control, and regulation of the practice of pharmacy in the
Philippines

(d) the enhancement of professional competence through continuing professional
development, research, and other related activities and

(e) the integration of the pharmacy profession.


Sec. 4, - Definition of Terms. - For purposes of this Act, the term:

(@) Biologic Products are microorganisms, sera, toxins and similar products used
for the prevention or cure of human diseases.

(0) Brand Name means the proprietary or trade name given by the manufacturer
to distinguish its product from those of the competitors.

(c) Cipher means a method of secret writing that substitutes other letters or
characters for the letter intended or transpose the letter after arranging them
in blocks or squares.

(d) Code means a system of words or other symbols arbitrarily used to represent
words.

(e) Compounding is the preparation, mixing, assembling, packaging, or labeling
of a drug (i) as the result of a prescription or drug order by a physician,
dentist, optometrist, or veterinarian, based on the said practitioner-patient-
pharmacist relationship in the course of professional practice, or (ii) for the
purpose of, or in relation to, research, teaching, or chemical analysis and not
for sale or dispensing

(f) Cosmetics are (i) products intended to be applied, poured, sprinkled, or
sprayed on, introduced into, or otherwise applied to the human body, or any
part thereof for cleansing, beautifying, promoting attractiveness or improving
the appearance, or (ji) ingredients or other substances intended for use as a
component of any such product.

(g) Counterfeit drug/medicine/pharmaceutical refers to medicinal products with
the correct ingredients but not in the amounts as provided, wrong ingredient,
without active ingredients, with insufficient quantity of active ingredient, which
result in the reduction of the drug's safety, efficacy, quality, strength or purity.
It is a drug that is deliberately and fraudulently mislabeled with respect to
identity and/or source or with fake packaging, and can apply to both branded
and generic products. It shall also refer to:

() the drug itself or the container or labeling thereof or any part of such
drug, container, or labeling bearing without authorization the
trademark, trade name or other identification mark or imprint or any
likeness to that which is owned or registered in the Bureau of Patent,
Trademark and Technology Transfer (BPTTT) in the name of another
natural or juridical person;

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

(ii) an imported drug product not registered with the Food and Drug
Administration (FDA), except drugs brought in the country for personal
use as confirmed and justified by accompanying medical records; and

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

(h) Dangerous drugs include those listed in the Schedules annexed to the 1961
Single Convention on Narcotic Drugs as amended by the 197 Protocol, and in
the Schedules annexed to the 1971 Single Convention on Psychotropic
‘Substances as enumerated in the attached annex in Republic Act No. 9165,
which is an integral part of the Act.

()) Devices refers to any instrument, apparatus, implement, machine, implant, in
vitro reagent or calibrator, software, material or other similar or related article:

(a) intended by the manufacturer to be used, along or in combination,
for human beings for one or more of the specific purpose(s) of:


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diagnosis, prevention, monitoring, treatment, alleviation of

diseases
ji, diagnosis, monitoring, treatment, alleviation of or
compensation for an injury

ili, investigation, replacement or modification or support of the
anatomy of a physiological process,

iv. supporting or sustaining life,

v. control of conception,

vi. disinfection of medical devices,

vii. providing information for medical or diagnostic purposes by
means of an in vitro examination of specimen derived from
the human body; and

(b) which does not achieve its primary intended action in or on the
human body by pharmacological, immunological or metabolic means,
but which may be assisted in their intended function by such means

() Dispensing is a process whereby a pharmacist receives and checks a valid
prescriber’s medication order or prescription, and makes available drugs and

medicines, with advice on their proper use and other relevant information.

(k) Drugs and Medicines refer to chemical compounds or biological substances,

other than food, intended for use in the treatment, prevention or diagnosis of

disease in humans or animals, including but not limited to:

0)

0)

(0)
(iii)
(iv)

()

any article recognized in the official United States Pharmacopoeia,
National Formulary, official Homeopathic Pharmacopoeia of the United
States, Philippine Pharmacopoeia, Philippine National Drug Formulary,
British Pharmacopoeia, European Pharmacopoeia, Japanese
Pharmacopoeia, and any official compendium or any supplement to
them;

any article intended for use in diagnosis, cure, mitigation, treatment, or
Prevention of disease of man and animals;

any article other than food intended to affect the structure or any
function of the human body or animals;

any article intended for use as a component of articles specified in
clauses (i), (ii), and (iii) not including devices or their components,
parts, accessories; and

herbal and/or traditional drugs which are articles of plant or animal
origin used in folk medicine which are: (a) recognized in the Philippine
National Drug Formulary; (b) intended for use in the treatment, or cure
or mitigation of disease symptoms, injury or body defects in humans;
(c) other than food, intended to affect the structure or any function of
the human body; (d) in finished or ready-to-use dosage form: and (e)
intended for use as a component of any of the articles specified in
clauses (a), (b), (¢) or (d).

Drug or Pharmaceutical Laboratory or Pharmaceutical Manufacturing

Laboratory means an establishment where pharmaceutical products,

Proprietary medicines, or pharmaceutical specialties are formulated,

prepared, compounded, and standardized

(m)Drug Establishments means FDA-registered companies involved in the
manufacture, importation, repacking, and/or distribution of drugs or

medicines.

(n) Orug Outlets refer to drugstores, pharmacies, and other business
establishments which are registered with the FDA and which legally sell drugs

and medicines.


6

(0) Drugstore or Pharmacy means a place or establishment licensed by FDA
where drugs, chemicals, pharmaceutical products, specialties, and devices
are legally sold at retail or wholesale and where medical, dental, and
veterinary prescriptions are compounded and dispensed

(p) Expiration Date means the date after which the product is not expected to
possess its claimed potency, efficacy, quality, and safety, and after which it is
not legal to sell or distribute or use the said product.

(a) Filling of a prescription refers to the act of dispensing or giving out of
medicines in accordance with the doctor's order.

(f) Household Remedies shall refer to any preparation containing pharmaceutical
substances of common or ordinary use to relieve common physical ailments
which may be dispensed without a medical prescription in original packages,
bottles or containers, the nomenclature of which has been duly approved by
FDA in the process of registration as defined in FDA AO No.115 s. 1991)

(s) Generic Name means the scientifically and internationally recognized name of
the active ingredients as approved by the Food and Drug Administration,

() Label means a display of written, printed or graphic information upon the
immediate container, or attached to or accompanying any pharmaceutical
products.

(u) Labeling means all labels and other written, printed, or graphic matter (1)
upon any item or any of its containers or wrappers or (2) accompanying any
such item,

(v) Over-the- counter drugs are drugs used for symptomatic relief of minor
ailments which may be dispensed without a prescription.

(w) Pharmaceutical products or Pharmaceutical specialties are drugs,
preparations, or mixture of drugs under a brand or generic name and
intended for the cure, mitigation, treatment, or prevention of disease in man or
animals.

(x) Pharmacist-only over-the-counter drugs are FDA-classified over-the-counter
drugs and/or substances which should only be obtained from the drugstore or
pharmacy with mandatory pharmacist's advice on their selection and proper
use.

(y) Person includes an individual, partnership, corporation, or any juridical entity.

(2) Pharmaceutical marketing means any activity undertaken, organized or
sponsored by a drug establishment which is directed at promoting the
prescription, recommendation, supply, administration or consumption of its
pharmaceutical product(s) through direct personal contact and all media,
including the internet.

(aa) Pharmacy Assistants are those persons who assist pharmacists in
dispensing medicines in community, hospital, industrial settings and in other
activities, such as, but not limited to medical missions, under the supervision
of the pharmacist and as described in Sections 17 and 42 of this Act.

(bb) _Physician’s samples refer to medicines given to a physician for free for
promotional purposes.
(cc) Prescription drugs are those drugs which can only be dispensed by a

pharmacist to a patient upon the presentation of a valid prescription from a
Physician, dentist, optometrist or veterinarian and for which pharmacist's
advice on their proper use is necessary.

(dd) ___Refilling of a prescription refers to the act of dispensing or giving out
the remaining balance of medicines ordered in the prescription when the
whole quantity ordered is not yet completely filled.


7

(ee) Secret Keys means a characteristic style or symbols kept from the
knowledge of others or disclosed confidentially to a few individuals.

Sec. 5. - Enforcement. - The Professional Regulatory Board of Pharmacy and the
Professional Regulation Commission are the body responsible for the
implementation of the provisions of this Act

ARTICLE Il
THE PROFESSIONAL REGULATORY BOARD OF PHARMACY

Sec. 6. — The Board of Pharmacy and its Composition. - There is hereby created
a Professional Regulatory Board of Pharmacy, hereinafter called the Board, under
the administration, control, and supervision of the Professional Regulation
Commission therein after called the Commission, composed of a Chairman and four
(4) members, each of which represent the areas of practice of community, hospital,
manufacturing, academe, and government service, who shall be appointed by the
President of the Philippines from the recommendees ranked by the Commission
from the list of nominees submitted by the Accredited Integrated National
Organization for Pharmacists.

Sec. 7. - Qualifications of Board Members. - To be appointed as member of the
Board of Pharmacy, a person shall be

(a) A citizen of the Philippines and a resident for at least five (5) years;

(b) A duly registered pharmacist, preferably a holder of a Master of Science in
Pharmacy, or its equivalent degree and has been in the practice of pharmacy
for at least ten years;

(c) Of good moral character with a valid certificate of registration, valid
professional identification card and preferably with teaching experience; and
preferably representing each field of practice;

(d) At the time of appointment, not a member of the faculty or administrative
office of any school, college or university offering degree programs in
pharmacy nor connected in a review school or center; nor has any direct or
indirect pecuniary interests in any school, college, or any institution offering
pharmacy; and

(e)A member of good standing for at least five (5) years of the accredited
integrated national pharmacy association but, at the time of nomination, not
an officer or trustee thereof.

Sec. 8. - Term of Office of Board Members. - The chairman and the members of
the Board shall hold office for three (3) years after appointment or until their
successors shall have been appointed and duly qualified; Provided, That the
incumbent Board members shall finish their terms to complete the membership of
the Board. Provided, further, that the chairman or any member may be re-appointed
for another term but in no case shall he/she serve for more than six years

Sec. 9. - Compensation of the Board of Pharmacy. - As provided for in R.A. No.
8981, known as the “PRC Modemization Act of 2000", the members of the Board
shall receive allowances and benefits equivalent to at least two salary grades lower
than the salary grade of the Commissioner, while the chairman of the Board shall
receive a monthly compensation equivalent to two steps higher than the members of
the Board. The chairman and members shall be entitled to other allowances and
benefits provided under existing laws.


Sec. 10. - Powers, Functions and Duties of the Board. - The Board shall
exercise these specific powers, functions, and duties:

(a) Conduct licensure examination for pharmacists;

(0) Approve the registration of pharmacists and the certification of drug handlers
as covered by Sec. 42 of this Act,

(c) Prepare, adopt, and issue the Table of Specifications for the subjects in the
board licensure examination for pharmacists in consultation with the
academe; determine and prepare the questions therefor; score and rate the
examination papers with the name and signature of the Board member
concerned appearing thereon and submit the results in all subjects duly
signed by the members of the Board to the Commission no later than three (3)
days from the last day of examination unless extended by the Commission for
justifiable causels;

(d) Review and/or amend the scope of licensure examination;

() Add, delete, modify the scope, definition and standards of practice of
pharmacy;

(f) Reprimand any pharmacist, suspend, or revoke his/her certificate of
registration on the grounds as provided for in Sec. 46 hereof, after a formal
administrative investigation;

(g) Promulgate from time to time the necessary rules and regulations for the
effective enforcement of this Act;

(h) Monitor the conditions affecting the practice of pharmacy in the Philippines
and adopt measures that may be deemed proper for the enhancement of the
profession and/or the maintenance of high professional, academic, ethical and
technical standards;

(i) Verify or confirm the qualifications and conditions of pharmacists employed in
drugstores, hospital pharmacies, drug or pharmaceutical laboratories, drug
traders, importers, cosmetics and medical device establishments for which the
Board may designate inspectors from the Food and Drug Administration and
other related institutions for such purpose;

() Investigate cases arising from violations of this Act, the rules and regulations
promulgated thereunder and the Pharmacist's Code of Ethics, technical
standards, and other Board issuances and for this purpose, may issue
summons, subpoena duces ad testificandum and subpoena duces fecum to
the respondents and/or witnesses to compel their attendance in such
investigations or hearings: Provided that, the decision of the Board shall,
unless appealed to the Commission, becomes final and executory after fifteen
(18) days from receipt of notice of judgment or decision:

(K) Cite a person in contempt for failure or refusal to obey the lawful order of the
Board in accordance with the Revised Rule of Court:

()) Delegate the hearing or investigation of administrative cases filed before them
whereat the hearing shall be presided over by at least one (1) member of the
Board concerned assisted by a Legal or Hearing Officer of the Commission,
provided that if the charge is not related to the technical practice of the
profession, the hearing may be conducted without a member of the Board;

(m)Conduct, through the Legal Officers of the Commission, summary
Proceedings on minor violations of the respective regulatory laws, as
determined by the Board. Violations of the rules and regulations issued by the
Board to implement this Act, including violations of the general instructions to
examinees committed by examinees, and render summary judgment thereon


9

which shall, unless appealed to the Commission, become final and executory
after fifteen (15) days from receipt of notice of judgment or decision;

(n) Subject to the final approval by the Commission, recommend registration
without examination and the issuance of corresponding certificate of
registration and professional identification card to foreign pharmacists duly
licensed in countries with agreement of reciprocity with the Philippine
government:

(0) Prepare an annual report of accomplishments on programs, projects, and
activities of the Board during the year for submission to the Commission after
the close of each calendar year including appropriate recommendations on
issues or problems affecting the practice of pharmacy;

(p) Issue and promulgate guidelines on continuing professional development
education in coordination with the accredited professional organization;

(a) Recommend to the CHED for the closure of the program or course of
pharmacy offered by a school/college pursuant to the latter's policy thereon;
and

(®) Perform any implied, incidental, necessary power for the effective
implementation of this Act.

Sec. 11. - Grounds for Suspension or Termination of Term of Office of the
Chairman or Member of the Board from his/her Office. - The President of the
Philippines, upon the recommendation of the Commission, after giving the Chairman
or the member of the Board an opportunity to defend himself/herself in an
administrative investigation conducted by the Commission, may remove or suspend
hinvher on any of the following grounds:

(a) Gross neglect, incompetence or dishonesty in the discharge of
his/her duty;

() Violation of any of the causes/grounds/ and the prohibited acts
provided in this Act and the offenses in the Revised Penal Code,
the Anti-Graft and Corruption Practices and other laws:

(c) Involvement in the manipulation, tampering or rigging of the
licensure examination, its questions and/or its results and the
disclosure of classified and confidential information pertaining to the
licensure examination.

(4) Conviction of an offense involving moral turpitude by a court of
jurisdiction.

The Commission, in the conduct of investigation shall be guided by Section 7,
and Section 15 of R.A. No. 8981 and the rules on administrative investigation
thereof, and the applicable provisions of the New Rules of Court.

ARTICLE Ill
EXAMINATION, REGISTRATION, CERTIFICATION, AND LICENSURE

Sec. 12. - Passing of Licensure Examination Requirement. — Except as
otherwise specifically allowed under this Act, applicants for registration for the
practice of pharmacy shall be required to pass a licensure examination as provided
for in this Act and in accordance with Sec. 7 (d) of RA. No. 8981.

Sec. 13. - Qualifications of Applicants. — An applicant for the licensure
examination for pharmacy shall satisfactorily show that he/she possesses the
following qualifications:


10

(a) Citizen of the Philippines or a foreign citizen whose country/state has
reciprocity with the Philippines in the practice of pharmacy;

(b) Of good moral character and reputation;

(c) A holder of a Bachelor's degree in pharmacy duly recognized or accredited by
the Commission on Higher Education (CHED) and conferred by a school/
college/university duly authorized by the government or its equivalent degree
obtained by either a Filipino or foreign citizen from an institution of learning in
a foreign country/state, provided it is duly recognized and/or accredited by
CHED;

(d) Not convicted of an offense involving moral turpitude by a court of competent
jurisdiction; and

(e) He must have completed an Internship Program which shall consist of at least
nine hundred sixty hours (960 hours), six hundred hours (600 hours) of which
shall be spent equally distributed in a community pharmacy, hospital
pharmacy, or pharmaceutical industry — manufacturing, regulatory, marketing,
or research — and other related fields, while three hundred sixty hours (360
hours) of internship shall be spent in any of the accredited pharmacy
establishments or entity chosen by the candidate.

10)

For this purpose, the abovementioned community pharmacy, pharmaceutical
company, and hospital pharmacy shall keep a separate record of pharmacy students
who underwent said internship program directly under their control and as a result
thereof, shall issue the proper certificate of said hours of internship. It shall also be
the duty of said establishments to submit semi-annually a complete report of the
names of those who have undergone training under their supervision and the
corresponding number of hours of internship credit of each of the pharmacy
students to their respective colleges or schools and to the Board.

Sec. 14. - Scope of Examination. - The licensure examination for pharmacists shall
be divided into two major divisions: Pharmacy as Science and Pharmacy as
Practice. Pharmacy as Science shall consist of subjects in Group | (Public Health,
Pharmaceutical Microbiology and Parasitology), Group I! (Drug Delivery Systems,
Physical Pharmacy, Manufacturing Pharmacy, Quality Control |, Quality Control 1),
Group Ill (Pharmaceutical Biochemistry, Pharmacognosy, Plant Chemistry, and
Philippine Medicinal Plants, Pharmacy and Chemistry of Medicinals | and Pharmacy
and Chemistry of Medicinals I

Pharmacy as Practice shall be made up of the following subjects: Group IV
(Pharmaceutical Calculations, Hospital Pharmacy, Clinical Pharmacy, Dispensing
and Medication Counseling), Group V (Biopharmaceutics and Pharmacokinetics,
Pharmacology |, Pharmacology II, Clinical Toxicology), and Group VI
(Pharmaceutical Jurisprudence and Ethics, Pharmaceutical Marketing and
Entrepreneurship and Pharmaceutical Administration and Management).

The subjects shall be weighed as follows: Group |, 10%; Group II, 20%; Group
Ill, 20%; Group IV, 20%; Group V, 20%; and Group VI, 10 %.

The Board subject to the approval by the Commission may introduce relevant
changes, as the need arises, to the content of the examination and the relative
weight attributed to each subject in the examination may be made after consultation

with the duly recognized association of schools or colleges of pharmacy and the
CHED.

Sec. 15. — Holding of Examination. — Examination for registration to practice
pharmacy in the Philippines shall be given twice a year in such places and dates as

10


WW

the Commission may designate in the Resolution thereof on the Master Schedules
for all licensure examinations in accordance with Sec. 7 (d) of R.A. No. 8981. The

said places and dates may be subject to change under valid circumstances and
reasons.

Sec. 16. — Ratings in the Licensure Examination. — \n order to be registered and
licensed as a pharmacist, a candidate must obtain a general weighted average of
seventy-five per cent (75%) or over with no ratings of fifty percent (50%) in more
than two (2) subjects.

Sec. 17. Registration and Licensure of Pharmacy Assistant. - A general
weighted average below 75% but not lower than 70%, with no ratings of fifty percent
(50%) in more than two subjects, shall qualify an examinee to be registered and
licensed by the Professional Regulation Commission to practice as a pharmacy
assistant who shall work under the supervision of a registered pharmacist. To be
licensed as a pharmacist, a pharmacy assistant must pass succeeding board
licensure examination for pharmacists with a general average rating as provided in
Section 16.

Sec. 18. ~ Report of Rating. The Board shall submit to the Commission the ratings
obtained by each candidate within ten (10) calendar days after the examination,
unless extended for just cause. Upon the release of the results of the examination,
the Commission shall send by mail the rating received by each examinee at his/her
given address using the mailing envelope submitted during the examination

Sec. 19. - Oath of Profession. — All successful candidates in the licensure
examination shall take their oath of profession before the Chairman or any member
of the Board or any authorized officer of the Commission to administer oaths, prior to
entering the practice of pharmacy.

Sec. 20. — Issuance of Certificate of Registration and Professional
Identification Card. - A certificate of registration shall be issued to those who are
registered upon payment of fees prescribed by the Commission. It shall bear the
signatures of the Chairperson and the Commissioners of the Commission and the
Chairman and Members of the Board, stamped with the official seal of the
Commission and of the Board, certifying the person named therein is entitled to the
practice of the profession with all the privileges appurtenant thereto. Until revoked or
‘suspended in accordance with this Act, it shall remain in full force and effect.

A professional identification card bearing the registration number and date, its
validity and expiry duly signed by the Chairperson of the Commission shall likewise
be issued to every registrant who has paid the prescribed fee. It shall be reissued
upon compliance with the continuing professional development education
requirement as specified in Article IV, Sec. 27 (d) of this Act and upon payment of
the prescribed three-year registration fees therefor.

Sec. 21. — Affixing RPh after a Registered Pharmacists Name. - Only
pharmacists who are duly registered and licensed by the Board and the Commission
has the right to affix the title, “Registered Pharmacist’ or “R.Ph.” after his/her name.

Sec. 22, — Grounds for Non-registration. - The Board shall not register any
successful examinee for registration who has been:

iat


12

(a) Convicted of an offense involving moral turpitude by a court of competent
jurisdiction,

(b) Found guilty of immoral or dishonorable conduct by the Board,

(c) Summarily adjudged guilty for violation of the General Instructions to
Examinees by the Board,

(d) Declared of unsound mind by the court of competent jurisdiction, and

(e) Found addicted to dangerous drugs.

In refusing such registration, the Board shall give the applicant a written
statement setting forth the reasons therefor and shall file a copy in its records.

Sec. 23. - Reissuance of Revoked Certificate of Registration, Replacement of
Lost or Damaged Certificate of Registration, Professional Identification Card or
Temporary/Special Permit. - The Board may upon petition, reinstate or reissue a
revoked certificate of registration after two (2) years from the date of the revocation
of the certificate of registration or the surrender of the revoked certificate and/or the
professional identification card if still valid, to the Board and/or the Commission. The
Board may or may not require the pharmacist whose certificate had been revoked to
take another licensure examination. The petitioner shall prove to the Board that
he/she has valid reason/s to be reinstated to the practice of pharmacy. For the grant
of his/her petition, the Board shall issue a Board Resolution subject to the approval
of the Commission.

Duplicate copy of lost or damaged certificate of registration, professional
identification card or temporary/special permit may be reissued in accordance with
rules thereon and upon payment of the prescribed fee therefor

Sec, 24. - Non-payment of the PRC Registration Fees. - The Board shall
suspend a registered pharmacist from the practice of his/her profession for non-
payment of the PRC registration fees for more than three (3) consecutive years from
its last or previous year of payment. The resumption of his/her practice shall take
place only upon payment of delinquency fees plus surcharges and interest and in
accordance with the rules of the Commission. The running of the three-year period
May be interrupted upon written notice about the discontinuance of his/her practice
and surrender of his/her certificate of registration with professional identification card
to the Board and/or the Commission.

Sec. 25. - Vested Rights: Automatic Registration. — All pharmacists registered
before the effectivity of this Act shall automatically be registered hereunder, subject
to the policy as to future requirements.

Certificates of registration and professional identification cards or temporary/special
permits held by such persons in good standing at such effectivity shall have the
same force and effect as though they were issued on or after the said effectivity

ARTICLE IV
REGULATION OF THE PRACTICE OF PHARMACY

Sec. 26. - Scope of the Practice of Pharmacy. - A person deemed to be
practicing pharmacy within the meaning of this Article is one who shall, with or
without a fee, salary, percentage or other rewards, paid or given directly to himself or
indirectly through another —

12


B

(a) Prepare, compound or manufacture, analyze, assay, preserve, store,
distribute, sell and/or dispense any medicine, drug, chemicals, cosmetics,
pharmaceuticals, devices or contrivances used in pursuance thereof, or

(o) render services, such as but not limited to (i) regulatory services, (ii)
pharmaceutical marketing, (iii) drug information service and (iv) medication
management which covers the following: drug selection and procurement,
storage and distribution, dispensing, medication counseling and medication
therapy monitoring, whenever the expertise and the technical knowledge of
the pharmacist is required, in any drug establishment/outlet or healthcare
institution or

(c) provide other services where pharmaceutical knowledge is required; or

(d) engage in teaching scientific, technical or professional pharmacy courses in a
school or college of pharmacy; or

(e) conduct or undertake scientific research in all aspects involving drugs and
healthcare, or

(f) dispense drugs during medical missions and in other situations where
supervision of drugs is required

All government and non-government agencies, establishments, institutions, and
regulatory body with functions that involve the practice of pharmacy shall be headed
and managed only by a qualified, duly registered and licensed pharmacist.

All pharmacists are expected to abide by current standards such as the Good
Pharmacy Practice, Good Laboratory Practice, Good Distribution Practice, Good
Manufacturing Practice, and Good Clinical Practice, which are deemed vital in the
performance of one’s roles and functions in different practice areas.

The Board, subject to the approval by the Commission, may add to, delete, or
modify the above acts, services, or activities as the need arises.

Sec. 27. - Prerequisites for the Practice of Pharmacy. — A person can practice
pharmacy in the Philippines provided he/she:

(a) has satisfactorily passed the licensure examination for pharmacists given by
the Board and the Commission,

(b) is duly registered with and licensed by the Board and the Commission,

(c) is an active member of the accredited integrated national professional
organization,

(d) has submitted continuing professional development education units as
required by the Continuing Professional Education Council for pharmacists or
pertinent laws and regulations for the renewal of his/her professional
identification card, and/or

(e) a holder of a valid temporary/special permit issued by the Board and the
‘Commission to foreign licensed pharmacists pursuant to this Act.

Sec. 28. - Foreign Reciprocity. — No foreigner shall be allowed to take the
licensure examination for pharmacists, register, receive his/her certificate of
registration and professional identification card, and practice pharmacy in the
Philippines unless the requirements for the licensure examination and registration
and practice of pharmacy imposed under the laws and the regulations in his/her
foreign country or state are substantially the same as those required and
contemplated by the Philippine laws and regulations, and unless the said foreign
laws and regulations allow Filipino citizens to practice pharmacy within the territory of
the said foreign country/state on the same basis and grant the same privileges as
those enjoyed by the citizens, subjects or nationals thereof.

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Sec. 29. - Practice through Temporary/Special Permit. — A temporary/ special
permit may be issued by the Board subject to the approval of the Commission and
payment of applicable fees to the following
(a) licensed pharmacists from foreign countries whose services whether for free
ora fee
(1) if they are internationally renowned pharmacists or experts in any field
or specialty of pharmacy,
(2) if their services are deemed necessary for lack of specialists or experts
in a particular field,
(0) licensed pharmacists from foreign countries or states whose services shall be
for free and limited to indigent patients as beneficiaries; or
(c) licensed pharmacists from foreign countries or states employed as visiting
faculty in a field or specialty of pharmacy.
The permit shall, among other things, contain these limitations and conditions for
a period of no more than one year, subject to renewal, the field or specialty of
pharmacy, and the specific place of practice including clinics, hospitals, and schools
of pharmacy. The Board subject to the approval by the Commission shall promulgate
ules and regulations on the implementation of this particular Section.

Sec. 30. ~ Indication of Numbers: Certificate of Registration, Professional Tax
Receipt and Accredited Integrated National Organization (AINO) Membership. —
The pharmacist shall be required to indicate on any document he/she signs, uses or
issues in connection with the practice of pharmacy the following information:

(a) his/her registration number and date of issuance,

(b) the expiration date of his/her professional identification card,

(c) the Professional Tax Receipt (PTR) Number and date of issuance, and

(d) the certificate of AINO membership (annuallifetime), number and the official

receipt of payment, number and date.

Sec. 31. — Registry of Pharmacists. - The Board shall prepare and maintain a
registry of the names, residences and/or office addresses of all registered
pharmacists which shall be updated annually in cooperation with the Accredited
Integrated National Organization (AINO), indicating therein the status of the
certificate of registration, professional identification card and Accredited Integrated
National Organization (AINO) membership, whether valid or inactive due to death, or
other reasons, delinquent, suspended or with revoked certificate of registration. The
said registry of pharmacists shall be conspicuously posted within the premises of the
Commission and the information therein made available to the public upon inquiry or
request.

Sec. 32. - Display of Certificate of Registration. — It shall be the duty of every
Pharmacist engaged in the practice of pharmacy either on his/her own account or
under the employ of another to display his/her original certificate of registration in a
Prominent and conspicuous place in a retail drug outlet or drug establishment which
he operates or in which he/she is employed in his/her professional capacity as
pharmacist. No pharmacist shall, with his/her knowledge, allow his/her certificate of
registration to be displayed in such establishment when he/she is not actually
employed or operating therein in his/her professional capacity.

Sec. 33. - Compounding and Dispensing. — No drug or pharmaceutical product of
whatever nature and kind shall be compounded, dispensed, sold or resold, or

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otherwise be made available to the consuming public except through a FDA-licensed
retail drug outlet or other business establishments which are duly established in
accordance with the provisions of applicable laws.

Prescription drugs and pharmacist-only over-the-counter drugs shall be
dispensed only by registered pharmacists

Prescription drugs shall be dispensed only upon presentation of a valid
prescription.

Compounding and dispensing by duly registered and licensed pharmacists
shall be in accordance with current good manufacturing practice, good laboratory
practice, and good pharmacy practice, with the safety and protection of individual
patients as ultimate objective

Licensed pharmaceutical manufacturers, importers and wholesalers are
authorized to sell their products only to duly licensed drug outlets, wholesalers and
other drug establishments,

A registered and licensed pharmacist may refuse to compound, dispense or
sell drugs and pharmaceutical products, if not in accordance with this Act

Sec. 34. — Pharmacist Requirement and Compensation. - Every drug
establishment/outlet selling prescription and pharmacist only over-the-counter drugs
whether owned by the government or a private person or firm shall at all times when
open for business be under the direct control, supervision, and responsibility of a
registered and licensed pharmacist. For retails outlets selling only over-the-counter
drugs, they shall be under the supervision of a registered and licensed pharmacist.

Processes involving the preparation, quality control, or repacking of
pharmaceutical products in quantities greatly in excess of single therapeutic doses
shall for each respective operation be under the direct and immediate supervision of
a registered and licensed pharmacist. In the sale of pharmaceutical products,
medicines and drugs, at wholesale, such business shall be conducted under the
immediate supervision of a registered and licensed pharmacist.

All government and non-government agencies and units which handle the
procurement and distribution of drugs should have a supervising pharmacist. All rural
health units dispensing medicines should be supervised by a pharmacist or a
pharmacy assistant as defined in this Act.

Pharmacists in government service shall receive a starting salary equivalent
to Salary Grade 15 as provided in R.A. 6758 (Compensation and Position
Classification Act of 1989) and its amendments. Those pharmacists in the private
sector shall receive an entry-level salary in peso equivalent of Salary Grade 15 being
received by government pharmacists.

Sec. 35. — Responsibility for Quality of Drugs, Cosmetics and Medical Devices.
~ It shall be the duty of the registered pharmacist of drug outlet/establishment to
ensure that all drug products, cosmetics and medical devices conform to standards
of safety, quality and efficacy and strictly adhere to the guidelines as provided for in
this Act and other pertinent rules and regulations and issuances. Owners, managers,
and/or pharmacists in charge of the operation of drug outlets and drug
establishments shall be held responsible.

It shall be unlawful for any person to manufacture, prepare, sell or dispense
any prescription drug, pharmaceutical, medical devices, or cosmetics under any
fraudulent name, direction or pretense or to adulterate any drug, pharmaceutical,
medical devices, or cosmetics offered for sale. Any drug, pharmaceutical product,
medical devicels or cosmetics shall be held to be adulterated or deteriorated within
the meaning of this section if it differs from the standard or quality or purity given in

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the United States Pharmacopeia/National Formulary and Philippine Pharmacopeia,
in its latest edition, or any standard reference for drugs and medicines given official
recognition, and those which fall within the meaning as provided for in the Food
Drug, Cosmetic and Devices Act, R.A. No. 3720, as amended by pertinent laws and
the Food and Drug Administration Act, R.A.0714

In cases of drug products sold in their original packings, the seal of which has
not been broken or tampered with, the liability that may arise because of their quality
and purity, rests upon the manufacturer or importer, the distributor, representative, or
dealer who is responsible for their distribution or sale.

Sec. 36. - Filling and Partial Filling of Prescription.- _All__ prescriptions shall
be filled or compounded only by a registered and licensed pharmacist following the
standards of purity, safety and quality. Completely filled prescriptions should be
surrendered to the pharmacist for recording,

Partial filling of prescription is dispensing units less than the total quantity
indicated in the prescription. The prescription should contain information as to how
many units were served and shall be returned to the buyer after being recorded in
the appropriate book or equivalent system. The drugstore, which completes the filling
of the prescription, shall keep the prescription on file for a prescribed period of time.

Sec. 37. - Physician's sample. — Drugs, biologic products, devices or proprietary
medicines, given or intended to be given free to the physician and other qualified
person by any manufacturer or distributor or its medical representative/detailman as
part of its program or promotion, should not be sold.

The statement “Sample, not for sale” shall appear conspicuously on the
container, package, or carton of the drug or device to be given. It shall be unlawful to
remove, erase, deface already marked original labels of samples.

Sec. 38. — Prohibition against use of cipher or unusual terms in prescriptions
and prescription switching — Pharmacists should not compound or dispense
prescriptions, recipes or formulas which are written in ciphers, codes or secret keys
or prescriptions of drugs using unusual names which differ from those in standard
pharmacopeias or formularies.

The pharmacist dispensing or compounding prescriptions should not
substitute the drug or drugs called for in the prescription with any other drug or
substance or ingredient without prior consultation with, and a written consent of the
person prescribing, except in accordance with RA 6875, known as the Generics Act
of 1988, and other pertinent laws and regulations.

Sec. 39. - Label of Dispensed Medicines. - Upon every box, bottle or package
containing medicine 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, name of patient, generic name of drug; brand name,
if any, strength, expiry date, directions for use, and name and address of drugstore
and other requirements prescribed by the Cheaper Medicines Act (RA 9502) and its
implementing rules and regulations.

Every prescription which in its preparation contains any quantity of a drug,
which is habit-forming, or a derivative of such drug, shall have an auxiliary label or a
notation, "Warning — May be habit forming”. Such prescriptions should comply with
the requirements of the R. A. 9165, the Comprehensive Dangerous Drugs Act of
2002, and any future amendments thereto.

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Filled prescription for external use shall bear the auxiliary label, “For External

Use

Sec. 40. - Record Books for Prescription. — All prescriptions dispensed in the
drugstore shall be recorded in the book or an equivalent recording system approved
by FDA for this purpose indicating therein, among others, the prescription number,
name of prescriber, generic name and brand, dosage strength, quantity of drug,
name of the patient and address, and initials of pharmacist. It shall be open to
inspection by the proper authorities at any time of the day when the pharmacy is
open to the public and must be preserved for a period of not less than two (2) years
after the last entry in it has been made.

All prescriptions shall be attached to the prescription book or compiled (for
equivalent recording system) and numbered consecutively and shall be preserved
for the same period of time as required

Alll 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 R.A. 9165

Sec. 41. - Requirements for the Opening and Operation of Retail Drug Outlet or
Establishment. ~ The minimum requirements necessary for the opening of retail
drug outlet or establishment shall be in accordance with the rules and regulations
prescribed by the Food and Drug Administration in accordance with the provisions of
this Act.

The application for the opening of a retail drug outlet or other business
establishments should not be approved unless applied for by a Filipino registered
pharmacist either as owner or as pharmacist-in-charge pursuant to the provisions of
this Act

Sec. 42. — Handling of Drugs by Persons Other than a Pharmacist. — For the
Purpose of this section, persons handling drugs other than the pharmacist are:
professional medical representatives, pharmacy assistants, pharmacy aides/clerks,
and other persons who assist pharmacists in dispensing medicines or any other
person performing functions involving the handling of drugs and drug products. It is
preferred that these positions are occupied by those who finished pharmacy degree,
Not necessarily licensed as pharmacists and who has undergone the prescribed
training from a Commission-accredited provider.

The professional medical representative or detailman is one who represents
any duly authorized manufacturer, distributor, trader and wholesaler of drugs,
pharmaceuticals, biologic products and devices, whose primary duty is to introduce
said products to legitimate prescribers and which forms part of their program for
promotion by describing its use, composition, action, dosage, administration,
contraindication, advantages and other relevant information about the drugs being
promoted

The pharmacy assistant is one who helps the pharmacist in compounding,
dispensing of medicines and giving of information on proper use of medicines while
the pharmacy aide/clerk is involved in other aspects of operation assigned by the
pharmacist.

Any person who shall be employed or engaged as professional medical
representative or pharmacy aide/clerk shall undergo comprehensive standardized
training programs approved by the Board with providers approved and/or accredited
by the Board in accordance with criteria established therefor

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ARTICLE V
ACCREDITED INTEGRATED NATIONAL ORGANIZATION FOR PHARMACISTS

Sec. 43. - The Accredited Integrated National Professional Organization (AINO)
of Pharmacists — The pharmacists are integrated under one national accredited
professional organization that is duly registered with the Securities and Exchange
Commission (SEC). The Board subject to the approval by the Commission shall
accredit the said organization as the only integrated national organization for
registered pharmacists (and pharmacy assistants). All pharmacists (and pharmacy
assistants) whose names appear in the registry shall ipso facto or automatically
become members thereof and shall receive all the benefits and privileges accorded
to its members upon payment of the required fees and dues. Membership to the
foregoing shall not be a bar to membership in any other association of pharmacists.

Sec. 44. - Membership to the Accredited Integrated National Professional
Organization. ~ All registered pharmacists (and pharmacy assistants) must be
members of the AINO and must maintain membership throughout the duration of the
practice of the profession. Professional identification card shall not be renewed if the
requirements for membership with AINO are not met including credit units for
attendance to duly accredited continuing professional development (CPD) education
activities.

Sec. 45. — Specialty Boards in Various Areas of Pharmacy Practice. — Specialty
Boards created within the affiliate organizations and societies for recognition of the
AINO (1) for the Board, subject to the approval of the Commissioner shall accredit
specialties in various areas of practice, (2) setting standards of practice within
different specialties, and (3) establishing qualifications and requirements for
certification of practitioners under each specialty.

ARTICLE VI
VIOLATIONS, ADMINISTRATIVE SANCTIONS, AND PROCEDURES

Sec. 46. — Revocation or Suspension of the Certificate of Registration and
Cancellation of Temporary or Special Permit. - The Board shall have the power,
upon notice and hearing to revoke or suspend the certificate of registration of a
registered pharmacist or to cancel a temporary or special permit granted to a foreign
pharmacist on the basis of the following:

(@) Violation of this Act on unauthorized practice of pharmacy, violation of any
provision of this Act, the Rules and Regulations (RR) thereof, the Code of
Ethics for Pharmacists, Code of Good Governance, Code of Technical
Standards for the practice of pharmacy, policy, and measure of the Board
and/or the Commission;

(©) Malpractice or gross incompetence; negligence, or imprudence resulting to
death or injury of the patient;

(©) Dishonorable conduct and/or conviction by a competent court of any
criminal offense involving moral turpitude:

(4) Fraud or deceit in the acquisition of the certificate of registration,
professional identification card or temporary/special permit or renewal of
license;

(©) Display of certificate of registration of a pharmacist who is not actually
employed in such an establishment as required by law.

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(f) Addiction to alcoholic beverages or to any habit-forming drug rendering
him incompetent to practice his/her profession;

(9) Aiding or abetting the illegal practice of a non-registered and licensed
person by allowing hinvher the use of his/her certificate of registration
and/or professional identification card or his/her special/temporary permit,

(h) Acting as a dummy of an alien or a person who is not qualified to establish
and operate a retail drugstore;

() Insanity or any mental disorder that would render the person incompetent
to practice his/her profession:

() False, extravagant or unethical advertisements and product endorsements
where the pharmacists name, professional organization he/she
represents, and similar information are used;

(k) Manufacture, sale, offering for sale of counterfeit drugs and committing
other acts in violation of Sec. 4 of the Special Law on Counterfeit Drugs,
R.A. No. 8203;

()_ Illegal manufacturing, sale, possession, dispensing of dangerous drugs
and other pertinent acts in violation of Dangerous Drugs Act, RA. No
9165;

(m) Committing acts in violation of Sec. 6 of P.D. No. 881 on Hazardous
Substances; and

(n) Practicing pharmacy while under suspension.

(0) Practicing with an expired professional identification card.

Section 47. - Non-renewal of license. - The following are the grounds for the non-
renewal of professional identification card
(a) Refusal to join or to remain a member of good standing of the AINO;
(b) _Non-payment of annual registration fees for three (3) continuous years;
(©) Non-compliance with the continuing professional development
requirement, for the renewal of his/her professional identification card; and
The Board shall periodically evaluate the aforementioned grounds and revise
as the need arises subject to the approval of the Commission
Any person, entity or organization may file charges according to the provision
of this section against any registrant, or the Board may investigate violation of any of
the abovementioned causes. Affidavit of complaint under oath shall be filed together
with the affidavits of witnesses and other documentary evidence with the Board
through the Legal and Investigation Office. The move to conduct an investigation
shall be embodied in a formal charge to be signed by at least a majority of the
members of the Board. The rules on administrative investigation issued by the
Commission shall govern the hearing or investigation subject to applicable provisions
of this Act, R.A. No. 8981 and its rules and regulations thereof, and Rules of Court

Sec. 48. - Administrative Investigation/Sanctions. — Administrative investigations
shall be conducted by the Board assisted by the Legal or Hearing Officer of the
Commission. The existing rules of evidence shall also be observed and applied
during administrative investigations.

If the Board, by a majority vote of the members, shall find that the charges are
sustained by evidence adduced, it may, at its discretion reprimand the respondent or
revoke or suspend his certificate of registration.

Sec. 49. - Procedure and Rules. - The Board upon receipt of a formal complaint
under oath against any pharmacist shall furnish the latter a copy of the complaint,
which shall be answered in writing within ten (10) days from receipt thereof. If the

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Board, after careful study of the records, finds that there is a valid ground to the
charge, it shall conduct a formal investigation and set the dates of the hearing
thereof. For this purpose, a subpoena and/or subpoena duces tecum may be issued
by the chairman of the Board or by the Chief, Legal and Investigation Division. The
investigation proceedings shall at all times be recorded. The investigation shall have
been terminated and resolved within ninety (90) days from the time the first date of
hearing shall be set and heard

Sec. 50. — Rights of Respondent. - The respondent pharmacist is entitled to be
heard or be represented by counsel; to have speedy public hearing, to confront, and
to cross-examine the witness or witnesses against him; to summon and present
witness or witnesses in his behalf; or to avail himself/herself of any other process for
the protection of his/her constitutional rights,

Sec. 51. - Motion for Reconsideration. — A motion for reconsideration within the
prescribed period may be made based on any of the following grounds:
(a) Grave abuse of discretion by the Board,
(b) Findings not supported by substantial evidence, and irregularity in the conduct
of investigation.

Sec. 52. - Appeal/Finality of Decision. - The decision of the Board shall
automatically become final and executory fifteen (15) days from the appropriate
service of the decision to the respondent, unless the latter within the same period,
has appealed the decision to the Commission; provided that said decision of the
Board and/or the Commission may be appealed to the Court of Appeals

ARTICLE VII
PENAL PROVISIONS

Sec. 53. - Penal Provisions. - Any person who shall violate any of the provisions of
the practice of pharmacy as defined in the following provisions of Article IV:
A. Registration certificate (Section 32)
(a) Allowing the display of his/her registration certificate in an outlet or
establishment by a pharmacist where he/she is not employed
() Display of a pharmacist's registration certificate by an outlet or
establishment when the pharmacist is not employed
Dispensing and compounding (Sections 27, 33, 38, 42)
(©) Dispensing done in, or offering for sale of prescription drugs in a place not
licensed by FDA as drug outlet
(d) Dispensing of prescription of and pharmacist-only over-the-counter drugs
by a person other than a registered pharmacist
(e) Dispensing of prescription drugs without presentation of a valid
prescription
() Compounding of prescription drugs and pharmacist-only over-the-counter
drugs done by a person other than a pharmacist
(g) Selling of prescription and pharmacist-only over-the-counter drugs by
manufacturers, importers, and wholesalers to unlicensed drug outlets and
other drug establishments
(h) Substitution of prescription drugs which are not generically equivalent to
what was on the prescription without the consent of the prescriber
() Compounding not in accordance with the current Good Manufacturing
Practices and Good Pharmacy Practice

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() Forcing, coercing or intimidating a registered pharmacist to compound or
dispense drugs not in accordance with this Act
() Preparation and compounding of pharmaceutical products in quantities
greatly in excess of single therapeutic doses without a registered
pharmacist
(1) Non-compliance with the labeling requirement for dispensed medicines by
a drug outlet
(m)Allowing pharmacy assistants to dispense without the supervision of a
pharmacist
Requirement of Pharmacist (Sections 33,34, 36)
(n) Establishmenvioutlet selling prescription and pharmacist-only over-the-
counter drugs which opens for business without a licensed pharmacist
(0) Compounding by a non-registered pharmacist or pharmacist with
expired/revoked/suspended license
(p) Filling of prescription by a non-pharmacist or by a non-registered
pharmacist or pharmacist with expired/revoked/suspended license
(q) Wholesale of pharmaceutical products without the direct and immediate
supervision of a registered pharmacist
(r) Rural Health Units dispensing prescription drugs and pharmacist-only
over-the-counter drugs without the supervision of a registered pharmacist
B. Manufacturing and selling of pharmaceutical products under fraudulent name and
address (Section 35)
C. Adulteration and misbranding of drugs (Section 35)
D. Manufacturing and selling of unsafe and substandard drugs (Section 35)

shall upon conviction thereof, be sentenced to a fine of not less than Two Hundred
Fifty Thousand (Php250,000.00) Pesos but not exceeding Five Hundred Thousand
(Php500,000.00) Pesos and/or to an imprisonment of not less than one year and one

day but not more than six years, or both fine and penalty, at the discretion of the
court.

Sec. 54. - Other Penalties. - Any person who shall violate any of the following
provisions of this Act

(a) Affixing of the title, R.Ph. by a person who is not a pharmacist and a graduate
of pharmacy degree who is not registered with PRC (Section 21)

(b) Practice of pharmacy in the Philippines by a foreigner without special permit
(Section 28)

(c) Non-indication by a pharmacist of his/her registration number and
Professional Tax Receipt number in official documents requiring such
information (Section 30)

(a) Non-display of certificate of registration of a pharmacist in drug establishment
requiring such (Section 32)

(e) Non-display of certificate of registration of a pharmacist by an
establishment/outlet (Section 32)

(f) Non-compliance with this Act's provision on the required salary for a
registered pharmacist (Section 34)

(g) Non-compliance by a pharmacist with the requirement on the filling of
prescription (Section 36)

(h) Non-compliance by a registered pharmacist on the requirement for partially
filled prescription (Section 36)

(i) Selling of physician’s samples (Section 37)

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() The removal, erasure and alteration of mark or label of physician's sample
(Section 37)

(k) Non-compliance with the filling up of Record Books by a drug outlet (Section
40)

()) Employment of persons in a pharmacy without the provision of the required
training (Section 42)

(m)Rendering dispensing-related services by non-pharmacists in a drug outlet
without undergoing the required training (Section 42)

shall upon conviction thereof, be sentenced to a fine of not less than One Hundred
Thousand (Php100,000.00) Pesos but not exceeding Two Hundred Thousand
(Php200,000.00) Pesos or to an imprisonment of not less than Thirty (30) days but
not more than One (1) year, or both fine and penalty at the discretion of the court.

‘Any person other than the citizens of the Philippines having been found guilty
of any violation as provided for in this and the preceding section shall, after having
paid the fine or having served his sentence or both when so adjudged, be also
subject to immediate deportation

For any violation of the provisions of this Act penalized under this and the
preceding section, which also constitutes or considered as punishable offense or
described as a violation of other laws, the applicable penalty shall be that of the law
providing for a higher fine and/or imprisonment.

For any violation of the rules and regulations implementing the provisions of
this Act, appropriate penalty shall be imposed.

ARTICLE VIII
FINAL PROVISIONS

Sec. 55. - Enforcement. - The Commission shall be the enforcement agency of this
Act. As such, the Commission shall implement the appropriate provisions of this Act,
enforce its implementing rules and regulations as adopted by the Board, assist the
Board in the investigation of complaints against violators of this Act, its rules and
regulations, Code of Ethics for pharmacists, professional standards, and other
Policies of the Board and the Commission.

The Commission and/or the Board shall call upon or request any department,
instrumentality, office, bureau, institution or agency of the government, including
local government units to render such assistance as it may require, or to coordinate
or cooperate in order to carry out, enforce or implement the provisions of this Act.

Sec. 56. - Appropriations. - The Chairperson of the PRC shall immediately include
in its programs on 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

Sec. 57. - Implementing Rules and Regulations. - Within one hundred and twenty
(120) days after the approval of this Act, the Board subject to the approval by the
Commission, in consultation with the AINO, shall issue and formulate the rules and
regulations, the Code of Ethics and professional standards for pharmacists, to
effectively implement this Act

Sec. 58. - Separability Clause. — |f any clause, provisions, paragraph or part
hereof shall be dectared unconstitutional or invalid, such judgment shall not affect,
invalidate, impair any other part thereof, but such judgment shall be merely confined

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to the clause, provision, paragraph or part directly involved in the controversy in
which such judgment has been rendered.

Sec. 59. - Repealing clause. — R.A. No. 5921, known as the Pharmacy Law, as
amended by E.0. No. 174, and PD No. 1363, and all other laws are hereby
repealed, Presidential decrees, executive orders, and other administrative issuances
and parts thereof which are inconsistent with the provisions of this Act are hereby
modified, amended, superseded or repealed accordingly

Sec. 60. - Effectivity. - This Act shall take effect after fifteen (15) days following the
full and complete publication thereof in the Official Gazette or in any major daily
newspaper of general circulation in the Philippines.

Approved,

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