Module 4:
PHARMACY
REGULATIONS
At the end of the module you should be able to:
• Identify the requirements in the processing for the
Pharmacist Licensure Examination and renewal of
license.
• Describe the different laws affecting the practice of
pharmacy.
• Describe the Pharmacist Professional Ethics and the
Philippine Practice Standards for Pharmacists.
• Recognize the different national and international
pharmacy organizations
INTRODUCTION
• The board examination is one of the last hurdles that
a candidate must face before he/she can practice
his/her profession.
• The purpose of a board examination is to identify
persons who possess the minimum knowledge
necessary to perform tasks on the job safely and
competently.
• Also this examination ensures that candidates meet
technical, professional, and legal standards, and
protects the health, safety, and welfare of the public
by assessing the abilities to practice competently.
INTRODUCTION
• In this module, you will learn about
the requirements when applying for
the Pharmacist Licensure
Examination and renewal of license,
the different laws affecting the
pharmacy profession.
• Pharmacist Professional Ethics and
the Philippine Practice Standards for
Pharmacists (PhilPSP), and the
different organizations both in the
national and international level
where a pharmacist could be
affiliated.
Module 4: Pre-Task
A. Search for the title of the following laws pertaining
to Pharmacy. Indicate your sources.
• 1. RA 5921 5. RA 8203
• 2. RA 10918 6. RA 9165
• 3. RA 3720 7. RA 9502
• 4. RA 6675 8. RA 9711
B. Search for the meaning of the following
abbreviations. Indicate your sources.
• 9. AASP 10. FJCPPhA
Module 4: Lesson 1 Check-in
Activity
• After knowing the different requirements needed prior to
the licensure examination, what supporting documents
should be prepare in order to meet the
requirements? Indicate your references.
Requirements Supporting Document/s
1. Filipino Citizenship
2. Graduate of BS Pharmacy
3. Of good moral character
and reputation
4. Completed the Internship
Program
Module 4: Lesson 1
Pharmacist
Licensure
Examination
INTRODUCTION
• A pharmacist before being able to
practice the profession must pass the
licensure examination as required by
the Republic Act 10918 otherwise
known as the “Philippine Pharmacy
Act”.
The following are the requirements for
applicants who will be taking the Pharmacists’
Licensure Examination:
• 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;
The following are the requirements for
applicants who will be taking the Pharmacists’
Licensure Examination:
• Of good moral
character and
reputation;
The following are the requirements for
applicants who will be taking the Pharmacists’
Licensure Examination:
• A degree holder of
Bachelor of Science in
Pharmacy or its
equivalent degree
conferred by an HEI in
the Philippines or an
institution of learning
in a foreign country
duly recognized by the
CHED; For Board Exam Purposes
The following are the requirements for
applicants who will be taking the Pharmacists’
Licensure Examination:
• Has completed an
internship
program approved by the
Board, pursuant to such
guidelines as may
hereinafter be promulgated,
in consultation with the
duly recognized
associations of pharmacy
schools and the CHED.
SCHEDULE OF EXAMINATIONS
• Upon completion of the • APRIL 10-11, 2023
requirements, the • NOVEMBER 2-3, 2023
applicant may take the
licensure examination
usually given two times • Deadline of application
a year in places and 20 working days before
dates designated by the the examination
Professional Regulation
Commission (PRC).
MODULE 1: Pharmaceutical
Chemistry - 20%
•Inorganic Pharmaceutical and
Medicinal Chemistry
•Organic Pharmaceutical and
Medicinal Chemistry
•Qualitative Pharmaceutical
Chemistry
MODULE 2: Pharmacognosy -
15%
•Pharmacognosy
•Plant Chemistry
•Biochemistry
MODULE 3: Practice of
Pharmacy - 17.5%
•Compounding and
Dispensing Pharmacy
•Clinical and Hospital
Pharmacy
•Pharmaceutical
Calculations
MODULE 4: Pharmacology
and Pharmacokinetics - 15%
•Pharmacology
•Pharmacokinetics
•Toxicology
•Incompatibilities and Adverse
Drug Reactions
MODULE 5: Pharmaceutics -
17.5%
•Manufacturing Pharmacy
•Pharmaceutical Dosage
Forms
•Physical Pharmacy
•Jurisprudence and Ethics
MODULE 6: Quality Assurance &
Quality Control - 15%
•Quality Assurance
•Quality Control
•Microbiology and Public Health
•Qualitative Pharmaceutical
Chemistry
•Drug Testing with
Instrumentation
In order to be registered and licensed
as 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.
• An applicant who failed in the licensure
examination for the third (3rd) time shall not be
allowed to take the next succeeding examinations
without having undertaken a refresher program in
a duly accredited institution.
• The Board shall issue guidelines on the refresher
program requirement.
All successful candidates in the
licensure examination shall:
• Take their oath of
profession prior to
entering the practice of
the pharmacy profession,
in which he or she will be
issued a Certificate of
Registration (COR) and a
• Professional
Identification Card (PIC)
RENEWAL OF LICENSE EVERY 3
YEARS AND THE REQUIREMENTS
• A PIC bearing the registration
number and dates of its issuance
and expiry, duly signed by the
Chairperson of the PRC, shall
likewise be issued to every
registrant, upon payment of the
prescribed fees.
• The PIC shall be renewed every
three (3) years, upon
presentation of the Certificate of
Good Standing (COGS) from the
accredited professional
organization (APO) and proof of
completion of the continuing
professional development (CPD)
requirements.
Module 4: Lesson 2
Part 1 Laws Affecting the
Pharmacy Practice
The practice of pharmacy profession is regulated by
the following laws in the country:
• OLD PHARMACY LAW
The practice of pharmacy profession is regulated by
the following laws in the country:
1. Republic Act 10918 – “Philippine Pharmacy Act”
• It is an act regulating and modernizing the practice of
pharmacy in the Philippines.
It provides for and shall govern the following:
• Standardization and regulation of pharmacy education;
• Administration of licensure examination, registration and
licensing of pharmacists;
• Supervision, control, and regulation of the practice of
pharmacy in the Philippines;
The practice of pharmacy profession is regulated by
the following laws in the country:
1. Republic Act 10918 – “Philippine Pharmacy Act”
• It is an act regulating and modernizing the practice of
pharmacy in the Philippines.
It provides for and shall govern the following:
• Development and enhancement of professional
competence of pharmacists through continuing
professional development, research and other related
activities;
• Integration of the pharmacy profession.
• The Professional Regulatory Board of Pharmacy, under
the administrative control and supervision of the PRC,
shall be responsible for the full implementation of the
law.
2. Republic Act 3720 – “The Foods,
Drugs, Devices and Cosmetics Act”
• It is an act to ensure the safety and purity of
foods, drugs and cosmetics being made
available to the public by creating the Food
and Drug Administration which shall
administer and enforce the laws pertaining
thereto.
• It was made into a law on June 22, 1963 and
was already amended by E.O. No. 175 on May
22, 1987.
2. Republic Act 3720 – “The Foods,
Drugs, Devices and Cosmetics Act”
• In the implementation of this law, it also
stipulated that the government shall
• (a) establish standards and quality
measures for food, drug, devices and
cosmetic; and
• (b) adopt measures to ensure pure and
safe supply of food, drug, devices and
cosmetic in the country.
3. Republic Act 6675 – “The
Generics Law of 1988”
• RA 6675 was made into
law on September 13,
1988.
• It is an act to promote,
require and ensure the
production of an adequate
supply, distribution, use
and acceptance of drugs
and medicines identified
by their generic names.
4. Republic Act 8203 – “Special
Law on Counterfeit Drugs”
• It is an act known as “The Special Law on
Counterfeit Drugs” approved September 4,
1996.
• It is an act prohibiting counterfeit drugs,
providing penalties for violations and
appropriating funds therefor.
4. Republic Act 8203 – “Special
Law on Counterfeit Drugs”
Counterfeit drug or medicine refers to
any of the following:
• Medicinal products with the correct
ingredients but not in the amounts as
provided hereunder, wrong ingredients,
without active ingredients, with
sufficient quantity of active ingredient,
which results in the reduction of the
drug’s safety, efficacy, quality, and
strength or purity;
4. Republic Act 8203 – “Special
Law on Counterfeit Drugs”
• Counterfeit drug or medicine refers to any of the
following:
• A drug which 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;
• A drug itself or the container or labeling thereof of
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 which is owned or registered in the
Bureau of Patent, Trademark and Technology Transfer
(BPTTT) in the name of another natural or juridical
person;
4. Republic Act 8203 – “Special
Law on Counterfeit Drugs”
Counterfeit drug or medicine refers to any of the
following:
• A drug refilled in containers by unauthorized
persons if the legitimate labels or marks are used;
• An unregistered imported drug product, except drugs
brought in the country for personal use as confirmed
and justified by accompanying medical records;
• A drug which contains no amount of or 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 of efficacy due to expiration.
Counterfeit drugs
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5. Republic Act 9165 – ‘The
Comprehensive Dangerous Drugs
Act of 2002”
• The Comprehensive Dangerous Drugs Act of 2002 was
made into law on June 7, 2002. It is an act repealing
R.A. 6425, otherwise known as the “Dangerous Drugs
Act of 1972”.
• A Philippine law that was created to safeguard the
integrity of its territory and the well-being of its
citizenry particularly the youth, from the harmful
effects of dangerous drugs on their physical and
mental well-being, and to defend the same against
acts or omissions detrimental to their development and
preservation.
5. Republic Act 9165 – ‘The
Comprehensive Dangerous Drugs
Act of 2002”
• The government shall pursue an intensive and
unrelenting campaign against the trafficking and
use of dangerous drugs and other similar
substances through an integrated system of
planning, implementation and enforcement of
anti-drug abuse policies, programs and
projects.
• The government shall however aim to achieve a
balance in the national drug control program so
that people with legitimate medical needs are not
prevented from being treated with adequate
amounts of appropriate medications, which include
the use of dangerous drugs.
5. Republic Act 9165 – ‘The
Comprehensive Dangerous Drugs
Act of 2002”
• The state shall also
provide effective
mechanisms or
measures to re-
integrate into society,
individuals who have
fallen victims to drug
abuse or dangerous
drug dependence
through sustainable
programs of treatment
and rehabilitation.
6. Republic Act 9502 – “Universally
Accessible Cheaper and Quality
Medicines Act of 2008”
• Republic Act No. 9502 is an act providing for
cheaper and quality medicines that was approved
June 6, 2008.
• The general policy of this act is to protect public
health, and when the public interest or
circumstances of extreme urgency so require, it
shall adopt appropriate measures to promote and
ensure access to affordable quality drugs and
medicines for all.
• In pursuant to the attainment of the general policy,
an effective competition policy in the supply
and demand of quality, affordable drugs and
medicines is recognized by the state as a primary
instrument.
7. Republic Act 9711 - “Food
and Drug Administration Act of
2009”
• It is an act strengthening and rationalizing the
regulatory capacity of the Bureau of Food and
Drugs (BFAD) by establishing adequate
testing laboratories and field offices,
upgrading its equipment, augmenting its
human resource complement, giving
authority to retain its income, renaming it
the Food and Drug Administration (FDA),
amending certain sections of RA No. 3720.
7. Republic Act 9711 - “Food
and Drug Administration Act of
2009”
It was created to have the following objectives of:
• Enhancing and strengthening the administrative
and technical capacity of the FDA in the regulation
of establishments and products under its jurisdiction;
• Ensuring the FDA’s monitoring and regulatory
coverage over establishments and products under its
jurisdiction; and
• Providing coherence in the FDA’s regulatory system
for establishments and products under its
jurisdiction.