SIXTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES )
FIRST REGULAR SESSION )

HOUSE OF REPRESENTATIVES.

Introduced by Representative Rufus B. Rodrig
Representative Maximo 8. Rodriguez, Jr.

House Bill No._1622

EXPLANATORY NOTE

This bill was originally introduced as House Bill No. 3389 by the undersigned Rufus
B. Rodriguez during the 15" Congress where it was approved by the Committee on Civil
Service and Professional Regulation and substituted by House Bill No. 6879. It was
subsequently approved on 2™ reading, approved on 3 reading and was transmitted to the
Senate where it was not acted upon.

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,

Its 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.

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


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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.



‘SIXTEENTH CONGRESS
REPUBLIC OF THE PHILIPPINES }
FIRST REGULAR SESSION )

HOUSE OF REPRESENTATIVES

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

622

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
2013”

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 shalll 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, and 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;

(©) The supervision, control and regulation of the practice of pharmacy in the
Philippines;

(a) The enhancement of professional competence through continuing professional
education, research and other related activities; and

(©) The integration of the pharmacy profession.

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

(a) Biopharmaceuticals refer to vaccines, sera and drugs derived from life forms using
biotechnology. They include proteins, nucleic acids and living microorganisms like viruses
and bacteria where the virulence is reduced by attenuation used for therapeutic or in vivo
diagnostic purposes.

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

(©) Cipher refers to 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.

(@) Code refers to a system of words or other symbols arbitrarily used to represent
words.


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(e) Compounding refers to 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 refer to substances or preparations intended to be placed in contact with
the various external parts of the human body or with the teeth and the mucous membranes
of the oral cavity, with a view exclusively or mainly to clean them or perfume them, changing
their appearance and/or correcting body odor, and/or protecting the body or keeping them in
‘good condition

(g) Counterfeit drug/medicine/pharmaceutical refers to medicinal products with either
the correct ingredients but not in the amounts as provided, or wrong ingredient, or without
active ingredients, or with insufficient quantity of active ingredient, which results 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 Intellectual Property Office (IPO) in the name of another
natural or juridical person;

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

3. An 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.

(h) Dangerous drugs refer to those listed in the Schedules annexed to the 1961 Single
Convention on Narcotic Drugs as amended by the 1972 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 this Act.

(i) Dispensing refers to the process of reading, checking and interpretation of
prescription, preparing, packaging, labeling, record keeping and sale or transfer of drugs and
medicines with or without a prescription or medication order which process includes
counseling and information giving by or under supervision of a duly registered pharmacist.

(j) 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 to supplement them:

2. Any article intended for use in diagno:
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
(1), (2) and (3) 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: (i) recognized in the Philippine National Drug
Formulary; (i) intended for use in the treatment or cure or mitigation of
disease symptoms, injury or body defects in humans; (ii) other than food,

, cure, mitigation, treatment or

4


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intended to affect the structure or any function of the human body; (iv) in
finished or ready-to-use dosage form; and (v) intended for use as a
component of any of the articles specified in clauses (a), (b), (c) or (d).

(k) Drug or pharmaceutical laboratory or pharmaceutical manufacturing laboratory
Tefers to an establishment where pharmaceutical products, proprietary medicines or
pharmaceutical specialties are formulated, prepared, compounded and standardized.

( Drug establishments refer to FDA-registered companies involved in the
manufacture, importation, repacking and/or distribution of drugs or medicines.

(m) Drug outlets refer to drugstores, pharmacies and other business establishments
which are registered with the FDA and which legally sell drugs and medicines.

(n) Drugstore or pharmacy refers to a place or establishment licensed by the 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

(0) Emergency cases refer to life-threatening situations where a patient needs
immediate medical attention and treatment or the occurrence of an epidemic or natural
calamities.

(p) Expiration date refers to the date until which the manufacturer can guarantee a
product to possess its claimed potency. efficacy. quality and safety; and after which its sale
or distribution is prohibited.

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

(©) Generic name refers to the scientifically and internationally recognized name of the
active ingredient/s as approved by the FDA.

(8) Household remedies 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 the FDA in the process of registration
as defined in FDA AO No. 115 (s.1991);

() Institutional pharmacies refer to establishments which provide, within their
premises, medicines to their employees andlor relatives either for free or at cost.

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

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

(w) Medical devices refer 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 (1) or more of the specific purposes of:
i. Diagnosis, prevention, monitoring, treatment, alleviation of
diseases;
ii. 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 jn 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.

(x) Nontraditional outlets refer to retail outlets licensed by the FDA other than
drugstores and pharmacies where drugs are made available in conjunction with the


6

Provisions of Republic Act No. 9502, otherwise known as the “Universally Accessible
Cheaper and Quality Medicines Act of 2008”.

() Online pharmacy refers to any activity of taking orders for medicines online or
through the internet.

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

(aa) Pharmaceutical products or pharmaceutical specialties refer to 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.

(bb) Pharmacist-only over-the-counter drugs refer to 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.

(cc) Person refers to an individual or a partnership, corporation or any juridical entity.

(dd) Pharmaceutical marketing refers to 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 products
through direct personal contact and all media, including the internet.

(ee) Pharmacy assistants refer to 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
Section 41 of this Act.

(&) Physician's samples refer to medicines given to a physician for free for
promotional purposes.

(gg) Prescription drugs refer to drugs that 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 pharmacists advice on their proper use is necessary.

(hh) Professional Medical Representative or Company Sales Representative refers to a
person 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.

i) 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

(i) Secret keys refer to a characteristic style or symbols kept from the knowledge of
others or disclosed confidentially to a few individuals.

(kk) Telepharmacy refers to the provision of pharmacy services utilizing electronic
information and communication technology under the supervision of a pharmacist.

(ll) Wholesaler refers to a person who acts as merchant, broker or agent, who sells or
distributes for resale pharmaceuticals, proprietary medicines or pharmaceutical specialties.

SEC. 5. Enforcement. - The Professional Regulatory Board of Pharmacy and the
Professional Regulation Commission (PRC) are the agencies 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 PRC, hereinafter called the Commission,
composed of a Chairperson and two (2) members 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 Professional Organization (AIPO) for
Pharmacists.


7

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

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

(b) A duly registered pharmacist preferably 2 holder of a Masteral degree in Pharmacy,
or its equivalent and has been in the practice of pharmacy for at least ten (10) years;

(©) Of good moral character with a valid certificate of registration, valid professional
identification card and preferably with teaching experience 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
professional association of pharmacists but, at the time of nomination, not an officer or
trustee thereof.

SEC.8. Term of Office of Board Members. — The Chairperson 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 reappointed for another term but in no case shall serve for
more than six (6) years.

SEC.9. Compensation of the Board of Pharmacy. — The Chairperson and members of
the Board shall receive compensation, allowances and other benefits comparable to that
being received by the Chairpersons and members of other Professional Regulatory Boards
under the Commission as provided for under Section 10 of Republic Act No. 8981, otherwise
known as the “PRC Modernization Act of 2000" and other 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;

(b) Approve the registration of pharmacists and the certification of drug handlers as
covered by Section 41 of this Act;

(©) 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
cause;

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

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

() Reprimand any pharmacist, suspend or revoke the certificate of registration on the
grounds as provided for in Section 46 hereof after formal administrative investigation;

(g) Promulgate 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,

() 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 FDA and other related institutions for such purpose;

() Investigate cases arising from violations of this Act, the rules and regulations
promulgated hereunder and the Pharmacist's Code of Ethics, technical standards and other
Board issuances and for this purpose, may issue summons, subpoena ad testificandum and

7


8

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
teceipt of notice of judgment or decision:

(k) Cite a person in contempt for failure or refusal to obey the lawful orders of the
Board in accordance with the Revised Rules of Court;

(). Delegate the hearing or investigation of administrative cases filed before them
where the hearing shall be presided over by at least one (1) member of the Board concerned
and 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) Conduet, 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 accredited professional organization;

(a) Recommend to the Commission on Higher Education (CHED) 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 or necessary power for the effective implementation
of this Act.

SEC. 11. Grounds for Suspension or Termination of Term of Office of the Chairperson
or Member of the Board. — The President of the Philippines, upon the recommendation of
the Commission, after giving the Chairperson or the member of the Board an opportunity to
defend oneself in an administrative investigation conducted by the Commission, may remove
or suspend the person on any of the following grounds:

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

(b) Commission of any of 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

(d) Conviction on an offense involving moral turpitude by a court of competent
jurisdiction.

‘The Commission, in the conduct of investigation shall be guided by Section 7 and
Section 15 of Republic Act 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 in accordance
with Section 7(d) of Republic Act. No. 8981.


SEC. 13. Qualifications of Applicants. - An applicant for the licensure examination for
pharmacy shall possess 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;

(©) Of good moral character.

(©) Holder of a Bachelor's degree in pharmacy duly recognized or accredited by the
CHED and conferred by a schoolicollege/university duly authorized by the government or its
equivalent degree obtained by either a Filipino or foreign citizen from an institution of
leaming in a foreign country/state, provided it is duly recognized and/or accredited by the
CHED;

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

(e) Must have completed an Internship Program which shall consist of at least nine
hundred sixty (960) hours, six hundred (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 (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 2 separate record of pharmacy students who undenwent
the internship program directly under their control and as a result thereof, shall issue the
proper certificate of the hours of internship. It shall also be the duty of the 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 (2) 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 II (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 1!)

Pharmacy as Practice shall consist 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 I, ten percent (10%); Group Il, twenty
percent (20%); Group Ill, twenty percent (20%); Group IV, twenty percent (20%); Group V,
twenty percent (20%); and Group VI, ten percent (10%).

‘The Board subject to the approval by the Commission may, as the need arises,
introduce relevant changes, 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 the Commission
may designate in the Resolution thereof on the Master Schedules for all licensure
examinations in accordance with Section 7(d) of Republic Act No. 8981. The said places
and dates may be subject to change under valid circumstances and reasons.

SEC.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 percent (75%)


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SEC. 17. Report of Rating. - The Board shall submit to the Commission the fatings
obtained by each candidate within ten (10) calendar days after the examination, unless
extended for a just cause. Upon the release of the results of the examination, the
Commission shall send by mail the rating received by each examinee at the given address
using the mailing envelope submitted during the examination,

SEC. 18. 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. 19. _ 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 practice 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.

SEC. 20. Affixing R.Ph. after a Registered Pharmacist’s Name. - Only a pharmacist
who is duly registered by the Board and the Commission has the right to affix the title
“Registered Pharmacist” or “R.Ph.” after one’s name.

SEC. 21. Grounds for Non-registration. — The Board shall not register any successful
examinee for registration who has been

(@) 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) Declared of unsound mind by a court of competent jurisdiction; and

(e) Found addicted to dangerous drugs by the Department of Health (DOH).

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. 22. __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 its revocation. 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 there is a valid reason for
reinstatement to the practice of pharmacy. For the grant of one’s 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 the rules thereon and
upon payment of the prescribed fee therefor.

SEC. 23. Nonpayment of the PRC Registration Fees. - The Board shall suspend a
registered pharmacist from the practice of the profession for nonpayment of the PRC
registration fees for more than three (3) consecutive years from its last payment. The
resumption of one’s 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 (3)-year period may be interrupted upon written notice about the discontinuance of

10


i

one’s practice and surrender of the certificate of registration with professional identification
card to the Board and/or the Commission.

SEC. 24. 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 or 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. 25. 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:

(@) 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,

(b) Render services not limited to drug information service and medication
management whenever the expertise and the technical knowledge of the pharmacist is
required;

(©) Render services not limited to regulatory services, pharmaceutical marketing and
the conduct or undertaking of scientific research in all aspects involving drugs and
healthcare in collaboration with other qualified practitioners;

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

(e) Conduct or undertake scientific research in all aspects involving drugs and
healthcare;

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

(g) Provide other services where pharmaceutical knowledge is required

All government and nongovernment 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 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. 26. Prerequisites for the Practice of Pharmacy. — A person may practice
pharmacy in the Philippines: Provided, That one:

(@) Has satisfactorily passed the licensure examination for pharmacists given by the
Board and the Commission:

(b) Is duly registered with by the Board and the Commission; and

(c) Is an active member of the accredited integrated professional organization.

SEC. 27. Foreign Reciprocity. — No foreigner shall be allowed to take the licensure
examination for pharmacists, register, receive a pharmacist's 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 one’s foreign country or State are
substantially the same as those required and contemplated by the Philippine laws and
Tegulations, and unless the said foreign laws and regulations allow Filipino citizens to

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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.

SEC. 28. Practice Through Temporary or Special Permit. — A temporary or special
permit may be issued by the Board to the following subject to the approval of the
Commission and payment of applicable fees:

(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; or

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 free
and limited to indigent patients as beneficiaries; or

() Licensed pharmacists from foreign countries or States employed as visiting faculty
ina field or specialty of pharmacy.

The permit shall be valid for a period of not more than one (1) year_and shall among
other things, contain these limitations and conditions, the field or specialty of pharmacy, and
the specific place of practice including clinics, hospitals and schools of pharmacy and shall
be subject to renewal. The Board subject to the approval by the Commission shall
promulgate rules and regulations on the implementation of this particular section.

SEC. 29. Indication of Numbers: Certificate of Registration, Professional Tax Receipt
and Accredited Integrated Professional Organization (AIPO) Membership. - The pharmacist
shall be required to indicate on any document one signs, uses or issues in connection with
the practice of pharmacy the following information

(a) One's registration number and date of issuance;

(b) The expiration date of one’s professional identification card;

(©) The Professional Tax Receipt (PTR) Number and date of issuance; and

(d) The certificate of AIPO membership (annuallifetime), number and the official
receipt of payment, number and date

SEC. 30. Registry of Pharmacists. - The Board shall prepare and maintain a registry of
the names, residences andlor office addresses of all registered pharmacists which shall be
updated annually in cooperation with the AIPO, indicating therein the status of the certificate
of registration, professional identification card and AIPO membership, whether valid or
inactive due to death, or other reasons, delinquent, suspended or with revoked certificate of
registration, The 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. 31. Display of Certificate of Registration. - It shall be the duty of every
pharmacist engaged in the practice of pharmacy, either on one’s own account or under the
employ of another, to display the original certificate of registration in a prominent and
conspicuous place in a retail drug outlet or drug establishment which one operates or is
employed in a professional capacity as pharmacist. No pharmacist shall knowingly allow
one's certificate of registration to be displayed in such establishment when one is not
actually employed or operating therein in a professional capacity

SEC.32. Sale of Drugs, Medicines, Pharmaceuticals, Medicated Cosmetics and Medical
Devices. — No drug, medicines, pharmaceuticals, biopharmaceuticals, medicated cosmetics
and medical devices 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, medicines or
pharmaceutical products shall be dispensed only by a registered pharmacist except only in

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an emergency case where the services of a registered pharmacist are not available:
Provided, That prescription drugs and pharmacist-only over-the-counter drugs, medicines or
Pharmaceutical products are sourced only in pharmacies under the direct control,
Supervision and responsibility of a registered pharmacist.

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

Licensed manufacturers, importers and wholesalers of drugs, medicines, medicated
cosmetics, pharmaceutical and biopharmaceuticals are authorized to sell their products only
to duly licensed drug outlets, wholesalers and other drug establishments.

SEC.33. Pharmacist Requirement and Compensation. - Every drug
establishmenoutlet 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 nongovernment agencies and units which handle the procurement
and distribution of drugs shall 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 Republic Act No. 6758 (Compensation and Position Classification
Act of 1989) and its amendments. The pharmacists in the private sector shall receive an
entry-level salary in peso equivalent of Salary Grade 15 being received by government
pharmacists.

SEC. 34. Responsibility for Quality of Drugs, Cosmetics and Medical Devices. - It shall
be the duty of the registered pharmacist of drug outleVestablishment 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 PharmacopeiaiNational
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, known as Republic Act No. 3720,
as amended, and the Food and Drug Administration Act, also known as Republic Act No.
9711

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 responsible for
their distribution or sale

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SEC. 35. 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 filing 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
a record of the prescription on file for a prescribed period of time.

SEC. 36. 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 as part of its program or
promotion may 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 or
deface already marked original labels of samples.

SEC.37. Prohibition Against Use of Cipher or Unusual Terms in Prescriptions and
Prescription Switching. — Pharmacists shall 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 callled 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 Republic Act No. 6675, known as the Generics Act of 1988, and other
pertinent laws and regulations

SEC. 38. 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 Republic Act No. 9502, otherwise known as the “Universally Accessible
Cheaper and Quality Medicines Act of 2008", and its implementing rules and regulations.

Every prescription which in its preparation contains any quantity of a drug, which is
habit-forming, or @ 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 Republic Act No. 9165, otherwise known as 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
Only’.

SEC. 39. Record Books for Prescription. — All prescriptions dispensed in the drugstore
shall be recorded in the book or an equivalent recording system approved by the 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.

All required information on dangerous drugs dispensed by a pharmacy shall be
recorded in the Dangerous Drugs book or an equivalent recording system as required by
Republic Act No. 9165

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SEC. 40. 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
FDA in accordance with the provisions of this Act.

The application for the opening of a retail drug outlet or other business establishments
shall 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. 41. 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
have undergone the prescribed training from a ‘Commission-accredited provider.

The professional medical representative or detail man 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.

ARTICLE V
ACCREDITED INTEGRATED PROFESSIONAL ORGANIZATION

SEC. 42. The Accredited Integrated Professional Organization (AIPO) 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.

SEC. 43. Membership to the Accredited Integrated Professional Organization (AIPO). —
All registered pharmacists (and pharmacy assistants) must be members of the AIPO and
must maintain membership throughout the duration of the practice of the profession. The
professional identification card shall not be renewed if the requirements for membership with
the AIPO are not met including credit units for attendance to duly accredited continuing
professional education (CPE) activities.

ARTICLE VI
VIOLATIONS, ADMINISTRATIVE SANCTIONS AND PROCEDURES

SEC. 44. 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:

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(@) Violation of this Act on unauthorized practice of pharmacy, violation of any
Provision of this Act, the implementing rules and regulations (IRR) thereof, the Code of
Ethics for Pharmacists, the Code of Good Governance, the 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 in death or
injury of the patient,

(©) Dishonorable conduct and/or conviction by @ 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 or special permit or renewal of license

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

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

(g) Aiding or abetting the illegal practice of a nonregistered and licensed person by
allowing him/her the use of his/her certificate of registration and/or professional identification
card or his/her specialtemporary 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 pharmacist’ 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 Section 4 of Republic Act No. 8203, the Special Law on Counterfeit Drugs;

()) legal manufacturing, sale, possession, dispensing of dangerous drugs and other
pertinent acts in violation of Republic Act No. 9165, the Dangerous Drugs Act:

(m) Committing acts in violation of Section 6 of Presidential Decree No. 881 on
Hazardous Substances;

(n) Practicing pharmacy while under suspension; and

(0) Practicing with an expired professional identification card,

SEC. 45. Grounds for Nonrenewal of License. — The following are the grounds for the
nonrenewal of professional certificate of registration:

(@) Refusal to join or to remain a member of good standing of the AIPO:

(b) Nonpayment of annual registration fees for three (3) continuous years; and

() Noncompliance with the continuing professional development requirement, for the
renewal of one's 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. An 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 govem the hearing or
investigation subject to applicable provisions of this Act, Republic Act No. 8981 and its rules
and regulations thereof, and the Rules of Court

SEC. 46. 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.

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

SEC. 47. Procedure and Rules. - The Board upon receipt of a formal complaint under
ath 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 fecum may be issued by the Chairperson of the Board or by the Chief of
the Legal and Investigation Division. The investigation proceedings shall at all times be
recorded. The investigation shall be resolved and terminated within ninety (90) days from
the time the first date of hearing shall be set and heard.

SEC. 48. 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; to summon and present witness or witnesses in one’s behalf; or to
avail of any other process for the protection of one’s constitutional rights.

SEC. 49. 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; and

(b) Findings not supported by substantial evidence and irregularity in the conduct of
investigation.

SEC. 50. — 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 the decision of the Board and/or the Commission may be
appealed to the Court of Appeals.

ARTICLE VII
PENAL PROVISIONS

SEC. 51. 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 shall, upon
conviction thereof, be sentenced to a fine of not less than Two hundred fifty thousand pesos
(Php250,0000.00) but not exceeding Five hundred thousand pesos (Php500,000.00) or to
imprisonment of not less than one (1) year and one (1) day but not more than six (6) years,
or both, at the discretion of the court:

Registration Certificate (Sections 30 and 31):

(a) Allowing the display of the certificate of registration in an outlet or establishment by
a pharmacist where one is not employed; and

(b) Display of a pharmacist's certificate of registration by an outlet or establishment
when the pharmacist is not employed.

Dispensing and compounding (Sections 25, 26, 32, 33, 34, 35, 38 and 41):

(2) Dispensing or offering for sale of prescription drugs in a place not licensed by the
FDA as drug outlet;

(b) Dispensing of prescription drugs and pharmacist-only over-the-counter drugs by a
person other than those under the direct and immediate supervision of a registered
pharmacist;

(c) Compounding and dispensing not in accordance with current good manufacturing
practice, good laboratory practice and good pharmacy practice;

(d) Selling of prescription drugs and pharmacist-only over-the-counter drugs by
manufacturers, importers and wholesalers to unlicensed drug outlets and other drug
establishments;

(€) Substitution of prescription drugs which are not generically equivalent to what was

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‘on the prescription without the consent of the prescriber;

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

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

(h) Noncompliance with the labeling requirement for dispensed medicines by a drug
outlet;

(i) Allowing pharmacy assistants to dispense without the supervision of a pharmacist;

(). Manufacturing and selling of pharmaceutical products under fraudulent name and
address;

(K)_Adulteration and misbranding of drugs;

(1). Manufacturing and selling of unsafe, substandard and counterfeit drugs; and

(m) Operating an online pharmacy service or selling of drugs online (Section 32)

SEC. 52. Other Penalties — Any person who shall violate any of the following provisions
of this Act shall, upon conviction, be sentenced to a fine of not less than One hundred
thousand pesos (Php100,000.00) but not exceeding Two hundred thousand pesos
(Php200,000.00) or to an imprisonment of not less than thirty (30) days but not more than
one (1) year, or both, at the discretion of the court, thus:

(2) Affixing of the title, R.Ph. by a person who is not a pharmacist and a graduate of
pharmacy degree and who is not registered with the PRC (Section 20);

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

(©) Non-indication by a pharmacist of one’s registration number and Professional Tax
Receipt number in official documents requiring such information (Section 29);

(d) Failure to display the original certificate of registration of a pharmacist in drug
establishment requiring such (Section 31);

(e) Refusal to display the certificate of registration of a pharmacist in a prominent and
conspicuous place by an establishmentioutlet (Section 31);

(f) Refusal by an establishment to comply with compensation requirement as provided
in Section 33 of this Act;

(g) Noncompliance by a pharmacist with the requirement on the filing of prescription
(Section 35);

(h) Noncompliance by a registered pharmacist on the requirement for partially filled
prescription (Section 35);

(i). Selling of physician's samples (Section 36);

() Distribution of physician's samples of drugs classified as antibiotics, anti-infectives
or anti-TB (Section 36);

(k) The removal, erasure and alteration of mark or label of physician's sample (Section
36),

() The use of cipher, codes or secret keys or unusual names and terms in
prescriptions (Section 37);

(m) Filling of prescriptions where ciphers, codes, secret keys or unusual names and
terms are used (Section 37);

(n) Noncompliance with the Provisions on Record Books for Prescription by a drug
outlet (Section 39);

(0) Employment of persons in a pharmacy or pharmaceutical operation without the
\N of the required training and certification (Section 41); and

(p) Rendering dispensing-related services by non-pharmacists in a drug establishment
without undergoing the required training (Section 41).

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

For any violation of the provisions of this Act penalized under this section and the
preceding section which also constitutes or considered as punishable offense or described

provi

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as a violation of other laws, the applicable penalty shall be that of the law providing for a
higher penalty.

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

ARTICLE VIII
MISCELLANEOUS PROVISIONS

SEC. 53. 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. 54. Appropriations. ~ The Chairperson of the PRC shall immediately include in the
Commission's programs the implementation of this Act, the funding of which shall be
included in the annual General Appropriations Act.

SEC.55. Transitory Provisions. - The incumbent Chairperson and members of the
Board shall, in an interim capacity, continue to function as such until the Chairperson and
members of the new Board created under this Act shall have been appointed, constituted
and/or organized pursuant thereto.

SEC.56. — Implementing Rules and Regulations. - Within one hundred twenty (120)
days after the approval of this Act, the Board, subject to the approval by the Commission, in
consultation with the AIPO, shall issue and formulate the rules and regulations, the Code of
Ethics and professional standards for pharmacists, to effectively implement this Act.

SEC. 67. Separabilty Clause. - If any clause, provision, 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,

SEC. 58. Repealing Clause. ~ Republic Act No. 5921, known as the Pharmacy Law, as
amended by Executive Order No. 174 and Presidential Decree 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.59. _Effectivity Clause. - This Act shall take effect fifteen (15) days after its
complete publication in the Official Gazette or in any major daily newspaper of general
circulation

Approved,

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