The Philippine Pharmacy Act

RA 10918
The Philippine Pharmacy Act
An act regulating and modernizing the
practice of Pharmacy in the Philippines,
repealing for the purpose republic act
numbered five thousand nine hundred
twenty-one (R.A NO.5921), otherwise
known as the Pharmacy Law.
Implementing Rules and Regulations (IRR) of
Philippine Pharmacy Act ( RA No. 10918)
Pursuant to Section 8 (b) and Section 50 of the Republic
Act No. 10918, known as the
“PHILIPPINE PHARMACY ACT”, the Professional Regulatory
Board of Pharmacy, with the
Approval of the Professional Regulation Commission, hereby
Issues and promulgate this
Implementing Rules and Regulations to carry out the
Provisions of Republic Act No. 10918
ARTICLE 1: GENERAL PROVISIONS
ARTICLE 1: GENERAL PROVISIONS
Section 1. Title. – This act shall be known as the
“Philippine Pharmacy Act”
Section 2. Statement of Policy. – The state
recognizes the vital role of pharmacists in the
delivery of quality health care services through
the provision of safe, effective and quality
pharmaceutical products, pharmaceutical care,
drug information, patient medication counseling
and health promotion.
ARTICLE 1: GENERAL PROVISIONS
Section 3. Objectives.
a. standardization and regulation of pharmacy
education
b. administration of licensure examination,
registration, and licensing of pharmacists;
c. supervision, control, and regulation of the
practice of pharmacy in the Philippines;
ARTICLE 1: GENERAL PROVISIONS
Section 3. Objectives.
d. development and enhancement and
professional competence of pharmacists
through continuing professional development,
research and other related activities; and
e. integration of the pharmacy profession.
ARTICLE 1: GENERAL PROVISIONS
Section 4. Scope of the Practice of
Pharmacy. – Any doubt in interpretation of
the IRR of R.A. No. 10918 shall be resolved
in a manner that would be consistent to the
declared aforementioned policy and
objectives.
ARTICLE 1: GENERAL PROVISIONS
Section 5. Scope of the Practice of Pharmacy. – A
person is deemed to be practicing pharmacy, within
the meaning of the Act, when with or without a fee,
salary, percentage or other rewards, paid or given
directly or indirectly, shall perform the following
activities:
A. Activities Exclusive for Pharmacists
B. Activities which are Non-exclusive to
Pharmacists.
ARTICLE 1: GENERAL PROVISIONS
Section 6. Definition of terms. –
ARTICLE 2: THE PROFESSIONAL
REGULATOR BOARD OF PHARMACY
ARTICLE 2: THE PROFESSIONAL REGULATOR
BOARD OF PHARMACY
Section 1. Creation of the professional Regulatory
Board of Pharmacy. – There is hereby created a
Professional Regulatory Board of Pharmacy,
hereinafter called the Board, under the
administrative control and supervision of the PRC, to
be composed of a Chairperson and two (2) members,
who shall be appointed by the President of the
Philippines
 ARTICLE 2: THE PROFESSIONAL REGULATOR BOARD OF
PHARMACY
Section 2. Qualifications of the Chairperson and Members of the
Board. – The Chairperson and members of the Board, at the time
of nomination, must:
a. Be a citizen of the Philippines and a resident thereof for at least five (5)
years;
b. Be a pharmacist in the Philippines, preferably a holder of a Master’s degree
in Pharmacy or PhD, or their equivalent;
c. Have been in the active practice of pharmacy for the past ten (10) years;
d. Have not been convicted of a crime involving moral turpitude;
ARTICLE 2: THE PROFESSIONAL REGULATOR BOARD OF
PHARMACY
Section 3. Powers, Functions and Responsibilities of the Board. –
The Board shall exercise the following powers, functions, and
responsibilities:
a. Administer and implement the provisions of the Act;
b. Promulgate rules and regulations, administrative orders and
issuances necessary to carry out the provisions of the Act;
c. Prepare licensure examination questions, score and rate the
examinations and submit the results thereof to the PRC
ARTICLE 2: THE PROFESSIONAL REGULATOR BOARD OF
PHARMACY
Section 4. Term of Office of the Members of
the Board. – The Chairperson and
members of the Board shall hold office for
a term of three (3) years from date of
appointment or until their successors shall
have been appointed.
ARTICLE 2: THE PROFESSIONAL REGULATOR BOARD OF
PHARMACY
Section 5. Compensation and Allowances of the
Board. – The Chairperson and members of the
Board shall receive compensation and
allowances comparable to the compensation
and allowances received by the members of the
other existing professional regulatory boards
under the PRC, as provided for in the General
Appropriations Act.
ARTICLE 2: THE PROFESSIONAL REGULATOR BOARD OF
PHARMACY
Section 6. Custodian of its Records, Secretariat
and Support Services. – All records of the Board
pertaining to the applications for examinations,
administrative and other investigative hearings
conducted by the Board, shall be under the
custody of the PRC.
ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 1. Licensure Examination
Requirement. – Unless exempted
therefrom, all applicants for registration for
the practice of pharmacy shall be required
to pass a licensure examination, as
provided for in the Act and Section 7 (d) of
Republic Act No. 8981.
ARTICLE 3: EXAMINATION,
REGISTRATION, AND LICENSURE
Section 2. Qualifications for the Licensure
Examination. – An applicant for the
Pharmacists Licensure Examination shall
establish to the satisfaction of the Board
that the following qualifications are met:
ARTICLE 3: EXAMINATION,
REGISTRATION, AND LICENSURE
Section 2. Qualifications for the Licensure
Examination. –
a. A citizen of the Philippines or of a foreign country which
has a law or policy on reciprocity for the practice of the
pharmacy profession;
b. Of good moral character and reputation;
c. A graduate of Bachelor of Science in Pharmacy
d. Has completed an internship program approved by the
Board
ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 2. Qualifications for the
Licensure Examination. – An applicant
for the Pharmacists Licensure
Examination shall establish to the
satisfaction of the Board that the
following qualifications are met.
ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 3. Scope of Examination. –
The Pharmacists’ Licensure
Examination shall cover the
following subjects on Pharmacy
Science and Practice.
ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 4. Holding of Examination. – The
Pharmacists’ Licensure Examination shall be
given two (2) times a year in such places and
dates, as the PRC may designate in the
Resolution providing for the master schedule of
all licensure examinations, pursuant to Section
7 (d) of R. A. No. 8981.
ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 5. Ratings in the Licensure Examination. – In
order to be a pharmacist, a candidate must obtain a
general weighted average of seventy-five percent
(75%), with no rating lower than fifty percent (50%)
in any of the subjects.
ARTICLE 3: EXAMINATION,
REGISTRATION, AND LICENSURE
Section 6. Report of Rating. – The Board shall submit
to the PRC the ratings obtained by each candidate
within three (3) working days after the last day of the
examination, unless extended for just cause.
Section 7. Oath of Profession. – All successful
candidates in the licensure examination shall take
their oath of profession before any member of the
Board, officer of the PRC or any person authorized
by law to administer oaths, prior to entering the
practice of the pharmacy profession.
 ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 8. Issuance of Certificate of Registration
(COR) and Professional Identification Card (PIC). – A
COR as a pharmacist shall be issued to those who
passed the licensure examination, subject to
compliance with the registration requirements and
payment of the prescribed fees.
 ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 9. Foreign Reciprocity. – No foreigner shall be
allowed to take the Pharmacists Licensure Examination,
register or receive a COR and PIC, or practice Pharmacy
in the Philippines unless the requirements for the
licensure examination, registration and practice of
Pharmacy imposed under the laws and regulations in
such foreign country or state are substantially the same
as those required and contemplated by the Philippine
laws and regulations.
ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 10. Practice through Special / Temporary
Permit (STP). – The practice of pharmacy in the
Philippines shall be limited to natural persons only
and shall be governed by the provisions of Republic
Act No. 8981 and other issuances pertinent thereto;
Provided, That any foreign citizen who has gained
entry in the Philippines to perform professional
services within the scope of the practice of
pharmacy, including the following:
ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 10. Practice through Special / Temporary Permit
(STP).
a. Consultant in foreign-funded or assisted projects of the
government;
b. Engaged or employed by a Filipino employer or
establishment;
c. Provides free services in humanitarian missions; and
d. Visiting faculty member in any field or specialty in
pharmacy.
 ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 11. Grounds for Non-registration. – The Board shall
not register any successful examinee who has been:
a. Convicted of an offense involving moral turpitude by a
court of competent jurisdiction;
b. Summarily adjudged by the Board as guilty for
misrepresentation or falsification of documents in
connection with the application for examination or for
violation of the General Instructions to Examinees;
c. Found guilty of immoral or dishonorable conduct by the
Board;
 ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 11. Grounds for Non-registration. – The Board
shall not register any successful examinee who has been:
d. Medically proven to be addicted to any drug or
alcohol by a medical or drug testing facility accredited by
the government such that it could render him/her
incompetent to practice the profession; and
e. Declared of unsound mind by a court of competent
jurisdiction.
 ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 12. Reissuance of Revoked Certificate of
Registration, Replacement of Lost or Damaged
Certificate of Registration, Professional Identification
Card or Special/Temporary Permit. – The Board may,
upon petition, reinstate or reissue a revoked COR after
the expiration of two (2) years from date of its
revocation.
 ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 1. Vested Rights and Automatic
Registration. – All pharmacists registered
before the effectivity of the Act shall
automatically be registered hereunder,
subject to compliance as to future
requirements.
 ARTICLE 3: EXAMINATION, REGISTRATION, AND
LICENSURE
Section 2. Affixing RPh after a Registered
Pharmacist’s Name. – Only a pharmacist shall
have the right to affix to his/her name, the
title, “Registered Pharmacist” or “RPh”.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 3. Indication of Information. – A
pharmacist shall be required to indicate
the COR number and validity of his/her PIC
and APO Membership number on all
pertinent documents signed by him/her.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 4. Registry of Pharmacists. – The Board
and the PRC shall prepare and maintain a
registry of the names, residences or office
addresses, or both, status of registration and
area of practice of all registered pharmacists,
which shall be updated annually, in
coordination with the APO.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 5. Display of Certificate of Registration.
– It shall be the duty of every pharmacist
engaged in the practice, whether in private or
under the employ of another, to display the
original copy of one’s COR in a prominent and
conspicuous place in the drug pharmaceutical
establishment.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 6. Dispensing/Sale of Pharmaceutical
Products. – No pharmaceutical product, of
whatever nature and kind, shall be
compounded, dispensed, sold or resold, or
otherwise be made available to the consuming
public, except through a retail drug outlet duly
licensed by the FDA.
ARTICLE 4: REGULATION OF THE
PRACTICE OF PHARMACY
Section 7. Pharmacist Requirement. –
Establishments/outlets which are required to employ
and/or retain and maintain the professional services
of a pharmacists shall be classified as follows:
Category A. Pharmaceutical establishments/Outlets
where the direct and immediate control and
supervision of a pharmacist is required due to the
nature of the pharmaceutical product that will be
dispensed or the kind of service that will be
provided.
 ARTICLE 4: REGULATION OF THE
PRACTICE OF PHARMACY
Section 7. Pharmacist Requirement.
Category A. Pharmaceutical
establishments/Outlets where the direct and
immediate control and supervision of a
pharmacist is required due to the nature of the
pharmaceutical product that will be dispensed or
the kind of service that will be provided.
ARTICLE 4: REGULATION OF THE
PRACTICE OF PHARMACY
Section 7. Pharmacist Requirement.
Category B. Pharmaceutical
establishments/ outlets where the
supervision and oversight of a
pharmacist is required.
 ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 8. Responsibility for Quality of Pharmaceutical Products. – To
ensure the quality of health products, a pharmacist has the following
duties and responsibilities:
a. to ensure that all pharmaceutical products conform to standards of
safety, quality, and efficacy, as provided for in the Act and other
pertinent rules and regulations and issuances.
b. MAHs shall ensure that all drug products comply, and continually
comply with the standards of safety, efficacy, and quality of FDA
from registration up to post-marketing
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 9. Filling and Partial Filling of
Prescription. – All prescriptions and
pharmacist-only OTC medicines shall be
filled, compounded and dispensed only by
a pharmacist, in accordance with the
Philippine Practice Standards for
Pharmacists.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 10. Physician’s Sample. –
Pharmaceutical products intended to be given
free to any health professional by a
manufacturer or distributor or its professional
service representative as part of its program or
promotion shall not be sold to any
pharmaceutical outlet or the consuming public.
 ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 11. Prohibition Against the Use of Cipher,
Codes, or Unusual Terms in Prescriptions and
Prescription Substitution. – Pharmacists shall not
compound or dispense prescriptions, recipes, or
formulas which are written in ciphers, codes, or
secret keys or prescriptions of pharmaceutical
products with unusual names which differ from
those in standard pharmacopeias or formularies.
 ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 12. Label of Dispensed Medicines. – Upon
every bottle, box, or package of medicines
compounded or dispensed by a pharmacist,
based on the prescription, there shall be pasted,
affixed, or imprinted a seal or label bearing,
among others, the name of patient and generic
name of drug, brand name, if any, strength,
expiry date, directions for use
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 13. Recording of Patient
Medication Profile. – All prescriptions
dispensed in the pharmacy shall be
recorded in an appropriate recording
system (i.e., electronic or manual) as may
be required by the Department of Health,
FDA, and/or the Board, the following:
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 13. Recording of Patient Medication Profile.
a. Name of prescriber
b. Name and address of patient
c. Product name (generic and brand name, if any)
d. Dosage strength and form
e. Quantity of drug dispensed
f. Initials of pharmacists
g. Others as may be prescribed
 ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 14. Requirements for the Opening
and Operation of a Retail Pharmaceutical
Outlet or Establishment. – The opening of a
retail pharmaceutical outlet or establishment
shall be subject to requirements provided for
in the Act and the rules and regulations
prescribed by the FDA.
 ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 15. Handling of Pharmaceutical Products by Persons
Other Than a Pharmacist. – persons handling pharmaceutical
products other than the pharmacist, which shall include,
pharmacy owners who are non-pharmacists, pharmacy
technicians, pharmacy assistants or pharmacy aides, or any
other persons performing functions involved in the handling of
pharmaceutical products, shall be duly certified by appropriate
government agencies after undergoing an accredited training
program.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 15. Handling of Pharmaceutical Products by Persons Other
Than a Pharmacist.
These persons include the following with their
corresponding job descriptions relevant to handling of
pharmaceutical products:
a. Pharmacy owners who are non-pharmacists
b. Medical representatives or professional service
representatives
c. Pharmacy Technician
d. Pharmacy Assistant
e. Pharmacy Aide
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 16. Administration of Adult
Vaccines. – trained pharmacist who shall
administer adult vaccines shall ensure that
the vaccine to be administered shall have a
doctor’s prescription.
 ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 16. Administration of Adult Vaccines.
A. Pharmaceutical Outlet
1. It should have a valid License to Operate (LTO) issued
by the FDA.
2. Vaccine products should have duly valid Certificates
of Product Registration (CPR) issued by the FDA.
3. It should maintain patient medication profile/record.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 16. Administration of Adult Vaccines.
A. Pharmaceutical Outlet
4. It should have Standard Operating Procedures
(SOPs) for vaccine storage, handling, preparation,
dispensing, administration, and disposal.
5. It should have a procedure for monitoring,
handling and reporting of AEFI.
6. It should comply with other requirements as may
be prescribed.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 16. Administration of Adult Vaccines.
B. Immunizing Pharmacist
Requirements of an immunizing pharmacist: 1376
1. Certificate of Current Employment in the
Pharmaceutical Outlet;
2. Valid Certificate in Basic Life Support Training; and,
3. Valid Certificate of Training in Vaccination Issued
by PRC-BOP.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 17. Disposal of Medications and
other Pharmacy Documents with
Patient Protected Health Information
(PHI). – It shall be the responsibility of
the pharmacist to oversee disposal of
expired products.
ARTICLE 4: REGULATION OF THE PRACTICE OF
PHARMACY
Section 18. Returns of Medications from
Clients/Patients. – Medication returns shall
be in accordance to the existing laws and
regulations of the Department of Trade
and Industry and other regulatory
agencies, provided that, safety of the
patient will not be compromised.
ARTICLE V. ACCREDITED PROFESSIONAL
ORGANIZATION
ARTICLE V. ACCREDITED PROFESSIONAL
ORGANIZATION
Section 1. The Accredited Professional
Organization (APO) of the Pharmacists.
– The Pharmacy profession shall be
integrated into one national
organization registered with the
Securities and Exchange Commission
(SEC)
ARTICLE V. ACCREDITED PROFESSIONAL
ORGANIZATION
Section 2. Membership to the Accredited
Professional Organization. – All registered
pharmacists must be members of the APO, and
must maintain active membership by paying
their annual member fees, throughout the
duration of the practice of the profession.
ARTICLE V. ACCREDITED PROFESSIONAL
ORGANIZATION
Section 3. Specialty Boards in Various
Areas of Pharmacy Practice. – Specialty
Boards in various areas of pharmacy
practice shall be created, subject to the
accreditation by the Board of Pharmacy
and the Professional Regulation
Commission
ARTICLE VI. VIOLATIONS, ADMINISTRATIVE
SANCTIONS, AND PROCEDURES
Section1. General Provisions. – These rules shall
apply to all cases concerning violations of the
Act and other relevant laws
Section 2. Commencement of
Action/Procedure. – An action is commenced
when
(a) a complaint or petition has been filed; or
(b) an administrative investigation has been
initiated by the BOP.
ARTICLE VI. VIOLATIONS, ADMINISTRATIVE
SANCTIONS, AND PROCEDURES
Section 3. Violations and Administrative
Sanctions. – The Board shall have the
power, upon notice and hearing, to
revoke or suspend the COR of a
registered pharmacist or to cancel an
STP of a foreign pharmacist on any of
the following grounds
ARTICLE VII. PENAL PROVISIONS
ARTICLE VII. PENAL PROVISIONS
Section 1. Violations and Penalties. – Any person
who shall commit any of the following acts shall,
upon conviction, be sentenced to pay a fine of not
less than two hundred fifty thousand pesos
(Php250,000.00), but not exceeding five hundred
thousand pesos (Php500,000.00) or imprisonment of
not less than one (1) year and one (1) day but not
more than six (6) years or both at the discretion of
the court
ARTICLE VIII. OTHER PENALTIES
ARTICLE VIII. OTHER PENALTIES
Section 1. Other Violations and Penalties. – Any
person who shall commit any of the following acts
shall, upon conviction, be sentenced to pay a fine of
not less than one hundred thousand pesos
(Php100,000.00), but not exceeding two hundred
thousand pesos (Php200,000.00) or imprisonment of
not less than thirty (30) days but not more than one
(1) year, or both at the discretion of the court
ARTICLE VIII. OTHER PENALTIES
Section 2. – 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 imposed
fine or having served the sentence, or
both, when so adjudged, shall also be
subject to immediate deportation.
ARTICLE VIII. OTHER PENALTIES
Section 3. – The penalties and liabilities
herein provided shall be without prejudice
to other sanctions that may be imposed
for violation of other applicable laws,
policies, rules and regulations.
ARTICLE VIII. OTHER PENALTIES
Section 4. – The owner/operator of the
pharmaceutical establishments/outlets, as
well, as the other officers responsible for
the violation , and the pharmacists/
pharmacy support personnel are jointly
liable for the willful violation of any
provision of the Act, as determined by the
court.
ARTICLE IX. FINAL PROVISIONS
Section 1. Enforcement. – It shall be the primary duty
of the Board, PRC, and FDA to 1800 effectively
enforce the provisions of this Implementing Rules
and regulations.
Section 2. Prospectivity. – The administrative
sanctions and penalties imposed herein shall not
1806 apply to acts committed prior to the date the
Act becomes effective.
ARTICLE IX. FINAL PROVISIONS
Section 3. Appropriations. – The Chairperson of the
PRC shall immediately include in its programs the
implementation of the Act, the funding of which
shall be charged against their current years’
appropriations and thereafeter, in the annual
General Approprations Act.
ARTICLE IX. FINAL PROVISIONS
ARTICLE IX. FINAL PROVISIONS
Section 4. Transitory Provisions. – The PRC-
BOP and FDA shall set the period for
compliance to their respective guidelines
that they have to establish for a more
effective enforcement of the requirements
set forth by the Act and this Implementing
Rules and Regulations.
ARTICLE IX. FINAL PROVISIONS
Section 5. Separability Clause. – If for any
reason, any part or provision of these rules and
regulations shall be held or declared to be
unconstitutional or invalid, such declaration
shall not affect, invalidate or impair the other
parts or provisions hereof which are otherwise
valid and effective, and shall continue to be in
full force and effect.
ARTICLE IX. FINAL PROVISIONS
Section 6. Repealing Clause. – All administrative
issuances or parts thereof which are contrary to or
inconsistent with the provisions of this IRR are
hereby repealed.
Section 7. Amendments. – These IRR may be
amended, modified or supplemented when the
effective implementation and enforcement of the
Act would require.
ARTICLE IX. FINAL PROVISIONS
Section 8. Effectivity. – This Implementing Rules and
Regulations shall take effect fifteen (15) days after its
publication in the Official Gazette or in the
newspaper of general circulation.
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