Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

FIFTEENTH CONGRESS
First Regular Session

Introduced by Representatives
DIOSDADO MACAPAGAL ARROYO and GLORIA MACAPAGAL ARROYO

AN ACT
REGULATING THE PRACTICE OF PHARMACY IN THE PHILIPPINES,
REPEALING FOR THE PURPOSE REPUBLIC ACT NO. 5921 OR THE
PHARMACY LAW OF 1969, AS AMENDED, AND FOR OTHER PURPOSES.

EXPLANATORY NOT!

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 in 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.


Republic Act 5921 or the Pharmacy Law 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 the 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.

Uf

DIOSDADO MACAPAGAL ARROYO GLORIAMACAPAGAL ARROYO.
Second District, Camarines Sur Secdnd District, Pampanga



Republic of the Philippines
HOUSE OF REPRESENTATIVES
Quezon City

FIFTEENTH CONGRESS
First Regular Session

House Bill No. 43.25

Introduced by Representatives
DIOSDADO MACAPAGAL ARROYO and GLORIA MACAPAGAL ARROYO

AN ACT
REGULATING THE PRACTICE OF PHARMACY IN THE PHILIPPINES,
REPEALING FOR THE PURPOSE REPUBLIC ACT NO. 5921 OR THE
PHARMACY LAW OF 1969, 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. Short Title. - This Act shall be known as the “Philippine
Pharmacy Act of 2011”.

SECTION 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.

SECTION 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.
SECTION 4. Definition of Terms. — For purposes of this Act, the term:

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

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

©) 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: (1) 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 (2) for the purpose of, or in
relation to, research, teaching, or chemical analysis and not for sale or dispensing;

f) Cosmetics are: (1) 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 (2)
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 ingredient/s, 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:

1) 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;

2) a drug product refilled in containers by unauthorized persons if the legitimate

2:


h)

k)

labels or marks are used;

3) 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

4) 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

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.

1) diagnosis, prevention, monitoring, treatment, alleviation of diseases;

2) diagnosis, monitoring, treatment, alleviation of or compensation for an
injury;

3) investigation, replacement or modification or support of the anatomy of a
physiological process;

4) supporting or sustaining life;
5) control of conception;
6) disinfection of medical devices,

7) 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;

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:


1) 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:

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

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

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

5) 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), (c) 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) Drug Outlets refer to drugstores, pharmacies, and other business establishments
which are registered with the FDA and which legally sell drugs and medicines;

©) 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;

q) 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 medica! 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)


8) Generic Name means the scientifically and internationally recognized name of the
active ingredient/s as approved by the Food and Drug Administration;

1) 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;

¥) 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 FOA-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; and

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

SECTION 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

SECTION 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.

SECTION 7. Qualifications of Board Members. — To be appointed as member of the
Board of Pharmacy, a person shall be:

(a) Acitizen 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
fepresenting 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) Amember 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

SECTION 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, 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
helshe serve for more than six years.

SECTION 9. Compensation of the Board of Pharmacy. ~ As provided for in R.A. No.
8981, known as the "PRC Modernization 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.

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


(a) Conduct licensure examination for pharmacists;

(b) 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 therefore; 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 cause/s;

(d) Review and/or amend the scope of licensure examination;
(e) 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 tecum 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 (15) 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 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;

(q) 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

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

SECTION 11. Grounds for Suspension or Termination of Term of Office of the
Chairman or Members 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 him/her on any of the following
grounds:

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

(b) 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;

(©) 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; and

(a) 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

SECTION 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 R.A. No. 8981

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

(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;

(0) 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.

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, shalll 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

SECTION 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 Il (Drug Delivery Systems, Physical Pharmacy,
Manufacturing Pharmacy, Quality Control |, Quality Control Il), Group Ill (Pharmaceutical
Biochemistry, Pharmacognosy, Plant Chemistry, and Philippine Medicinal Plants
Pharmacy and Chemistry of Medicinals | and Pharmacy and Chemistry of Medicinals II

Pharmacy as Practice shall be made up of the following subjects: Group IV

9


(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.

SECTION 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 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.

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

SECTION 17. Registration and Licensure of Pharmacy Assistant. ~ A general
weighted average below 75% but not lower than 70%, with no ratings of fifty percent
(60%) 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

SECTION 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.

SECTION 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.

SECTION 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
10


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
therefore.

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

SECTION 22. Grounds for Non-registration. - The Board shail not register any
Successful examinee for registration who has been:

(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;

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

(d) Dectared 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 therefore and shall file a copy in its records.

SECTION 23. Re-issuance of Revoked Certificale 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

Ouplicate 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 therefore.

SECTION 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
ules 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.


SECTION 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

SECTION 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 —

(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

(b)render services, such as but not limited to (1) regulatory services, (2)
pharmaceutical marketing, (3) drug information service and (4) 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/outiet 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.


SECTION 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;

() 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.

SECTION 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
fequirements 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.

SECTION 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 or a
fee:
(1) if they are internationally renowned pharmacists or experts in any field or
specialty of pharmacy; and

(2) if their services are deemed necessary for lack of specialists or experts in
a particular field.

(b) 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
ina 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, hospitais, and schools of pharmacy

13


The Board subject to the approval by the Commission shall promulgate rules and
regulations on the implementation of this particular Section.

SECTION 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/ner professional identification card;
(c) the Professional Tax Receipt (PTR) Number and date of issuance; and

(q) the certificate of AINO membership (annualllifetime), number and the official
receipt of payment, number and date.

SECTION 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.

SECTION 32. Display of Certificate of Registration. — |t 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

SECTION 33. Compounding and Dispensing. - No drug or 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 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.

SECTION 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.

SECTION 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 device/s 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 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.
o711

15


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.

SECTION 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.

SECTION 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.

SECTION 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 6675, known as the Generics Act of 1988, and other pertinent laws
and regulations,

SECTION 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 shail 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, “Waring —
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,

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

16


SECTION 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
tecording system) and numbered consecutively and shall be preserved for the same
period of time as required.

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 R.A. 9165

SECTION 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 shail 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.

SECTION 42. Handling of Drugs by Persons Other than a Pharmacist. - For the
Purpose of this section, persons handling drugs other than the pharmacist are: 1)
professional medical representatives; 2) pharmacy assistants; 3) pharmacy aides/clerks:
and 4) other persons who assist pharmacists in dispensing medicines or any other person
performing functions involving the handling of drugs and arug products. It is preferred that
these positions are occupied by those who finished a pharmacy degree, not necessarily
licensed as pharmacists and who has undergone the prescribed training from a
Commission-accredited provider.

The professional medical representative or detaiiman 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 andjor accredited by the Board in
accordance with criteria established therefore.


ARTICLE V
ACCREDITED INTEGRATED NATIONAL ORGANIZATION FOR PHARMACISTS

SECTION 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 jpso 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.

SECTION 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,

SECTION 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

SECTION 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:

(a) 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 Govemance, Code of Technical
Standards for the practice of pharmacy, policy, and measure of the Board
and/or the Commission;

(b) 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;

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

18


)

1)

(9)

(h)

0)

0)

(k)

wo

(m)

(n)
(0)

Display of certificate of registration of a pharmacist who is not actually
employed in such an establishment as required by law;

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

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

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 pharmacist's name, professional organization he/she represents,
and similar information are used;

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, R.A. No. 9165;

Committing acts in violation of Sec. 6 of P.D. No. 881 on Hazardous
‘Substances;

Practicing pharmacy while under suspension; and

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)
(b)
(co)

Refusal to join or to remain a member of good standing of the AINO;
Non-payment of annual registration fees for three (3) continuous years; and

Non-compliance with the continuing professional development requirement,
for the renewal of his/her professional identification card

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

19


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.

SECTION 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 shail 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.

SECTION 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 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.

SECTION 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.

SECTION 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

SECTION 52. AppealFinality of Decision, - The decision of the Board shail
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 VI
PENAL PROVISIONS

SECTION 53. Penal Provisions. - Any person who shall violate any of the

20


provisions of the practice of pharmacy as defined in the following provisions of Article IV:
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

(b) 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)

(c) 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

(f) 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

(i) Compounding not in accordance with the current Good Manufacturing Practices
and Good Pharmacy Practice

() Forcing, coercing or intimidating a registered pharmacist to compound or dispense
drugs not in accordance with this Act

(k) Preparation and compounding of pharmaceutical products in quantities greatly in
excess of single therapeutic doses without a registered pharmacist

() 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) Establishment/outlet 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

21


(p) Filling of prescription by a non-pharmacist or by a non-registered pharmacist or
pharmacist with expired/revoked/suspended license

(@) Wholesale of pharmaceutical products without the direct and immediate
supervision of a registered pharmacist

(1) Rural Health Units dispensing prescription drugs and pharmacist-only over-the-
counter drugs without the supervision of a registered pharmacist

Manufacturing and selling of pharmaceutical products under fraudulent name and
address (Section 35)

Adulteration and misbranding of drugs (Section 35)

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.

SECTION 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)

(d) 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 establishmentoutlet
(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)

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

22


(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 penaity at the discretion of the court

Any person other than the citizens of the Philippines naving 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 Vili
FINAL PROVISIONS

SECTION 55. Enforcement. - The Commission shall be the enforcement agency of
this Act. As such, the Commission shail 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.

SECTION 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.

SECTION 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.

23


SECTION 58. Separability Clause. — If any clause, provisions, paragraph or part
hereof shall be declared unconstitutional or invalid, such judgment shall not affect,
invalidate, impair any other part thereof, but such judgment shall be merely confined to the
clause, provision, paragraph or part directly involved in the controversy in which such
judgment has been rendered.

SECTION 59. Repealing Clause. - R.A. No. 5921, known as the Pharmacy Law, as
amended by E.O. 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.

SECTION 60. Effectivity Clause. - 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,

24