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Republic of the Philippines


Professional Regulation Commission
Manila
Professional Regulatory Board of Pharmacy
Resolution No. ___
Series of 2016

IMPLEMENTING RULES AND REGULATIONS (IRR) OF PHILIPPINE PHARMACY


ACT
(REPUBLIC ACT NO. 10918)

Pursuant to Sections 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 promulgates this
Implementing Rules and Regulations to carry out the provisions of Republic Act No. 10918.

RULE I
GENERAL PROVISIONS
Section 1. Title. This resolution shall be known as the IMPLEMENTING RULES AND
REGULATIONS (IRR) OF REPUBLIC ACT (R.A.) NO. 10918, OTHERWISE
KNOWN AS THE PHILIPPINE PHARMACY ACT, hereinafter referred to as
the IRR of R.A. No. 10918.
Section 2. Statement of Policy. The IRR of R.A. No. 10918 is promulgated to recognize the
vital role of pharmacists in the delivery of quality healthcare services through the
provision of safe, effective, and quality pharmaceutical products, pharmaceutical
care, drug information, patient medication counseling, and health promotion. The
pharmacists professional services shall, therefore, be promoted as an indispensable
component of the total healthcare system to 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 and globally competitive through regulatory measures, programs,
and activities that promote and sustain their continuing professional development.
Section 3. Objectives. The IRR of R.A. No. 10918 is likewise promulgated to provide for and
govern the:
a. Standardization and regulation of pharmacy education;
b. Administration of licensure examination, registration, and licensing of
pharmacists;

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c.
d.

e.

Supervision, control, and regulation of the practice of pharmacy in the


Philippines;
Development and enhancement of professional competence of pharmacists,
through continuing professional development, research and other related
activities; and
Integration of the pharmacy profession.

Section 4. Interpretation of the IRR of RA No. 10918. Any doubt in the 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.
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 to Pharmacists
1. Prepare, compound or manufacture, preserve, store, distribute, procure, sell, or
dispense, or both, any pharmaceutical product or its raw materials; or
2. Render services, such as clinical pharmacy services, drug information services,
regulatory services, pharmaceutical marketing, medication management, or
whenever the expertise and technical knowledge of the pharmacist is required; or
3. Engage in teaching scientific, technical, or professional pharmacy courses in a
school or college of pharmacy; or
4. Supervise the practice of sub-professionals in the dispensing of pharmaceutical
products; or
5. Provide other services where pharmaceutical knowledge is required.
B. Activities which are Non-exclusive to Pharmacists
1. Conduct chemical, biological or microbiological analyses and assay of
pharmaceutical products, food/dietary supplements, health supplements,
cosmetics; or
2. Perform physicochemical analyses of medical devices used in aid of
administration of pharmaceutical products; or
3. Administer adult vaccines that are approved by the Food and Drug Administration
(FDA) subject to the training, certification and other requirements as provided in
this IRR of R.A. No. 10918; or
4. Conduct or undertake scientific research in all aspects, involving pharmaceutical
products and health care.
All pharmacists are expected to abide by current standards such as but not limited to
the Philippine Practice Standards for Pharmacists, Good Pharmacy Practice, Good
Regulatory Practice, Good Laboratory Practice, Good Distribution Practice, Good
Storage Practice, Good Warehousing Practice, Good Manufacturing Practice and
Good Clinical Practice, which are deemed vital in the performance of their roles and
functions in different practice areas.

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The Professional Regulatory Board of Pharmacy, hereinafter created, subject to the


approval of the Professional Regulation Commission (PRC), as provided for by
Republic Act 8981, otherwise known as PRC Modernization Act of 2000, and in
consultation with the Accredited Professional Organization (APO), may modify the
above enumerated acts, services, or activities, as the need arises, in order to conform
to the latest trends and developments in the practice of the pharmacy profession:
Provided, that such modifications are consistent with the enumeration above.
Section 6. Definition of Terms. As used in this IRR of R.A. No. 10918:
A. Accredited Professional Organization (APO) refers to the duly accredited
professional organization of pharmacists, of which there shall be only one (1), as
prescribed under Section 41 Article V of the Act.
B. Act refers to Republic Act 10918 known as The Philippine Pharmacy Act
C. Adult Vaccines refer to cervical cancer, flu (influenza), pneumococcal, other preexposure prophylactic vaccines to be administered to patients aged eighteen (18)
years and above, and such other vaccines as may be defined by the Department of
Health (DOH) in an administrative issuance.
D. Adulterated/Deteriorated Pharmaceutical Products refer to pharmaceutical
products, unfit for human consumption, following the standards of quality or purity of
which are, as those stated in the United States Pharmacopeia/National Formulary and
Philippine Pharmacopeia in its latest edition or any standard reference for drugs and
medicines which are given official recognition as well as those provided for in R.A.
No. 3720, otherwise known as the Food, Drug and Cosmetic Act, as amended, and
R.A. No. 9711, known as the Food and Drug Administration Act of 2009.
E. Adverse Drug Reaction refers to a noxious and unintended reaction to a drug which
occurs at doses normally used in human for the prophylaxis, diagnosis or treatment of
disease or for the modification of physiologic function.
F. Biopharmaceuticals refer to pharmaceutical products that are used for therapeutic or
for in vivo diagnostic purposes, such as vaccines, sera, and drugs derived from life
forms using biotechnology. These include proteins, nucleic acids, or living
microorganisms where the virulence is reduced and are used for therapeutic or for in
vivo diagnostic purposes.
G. Brand Name refers to the proprietary name given by the manufacturer to distinguish
its product from those of competitors.
H. Cipher, Code, or Secret Keys refer to a method of secret writing or use of
characteristic style or symbol by substituting other letter/s or character/s for the
letter/s intended, for the purpose of misleading the consumer.

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I. Clinical Pharmacy Services refer to any patient care provided by a pharmacist,


through pharmacologic and non-pharmacologic strategies, that promote the
appropriate selection and utilization of medication to optimize individualized
therapeutic outcomes, achieve wellness or prevent diseases.
J. Compounding refers to the sum of processes performed by a pharmacist in drug
preparation including the calculations, mixing, assembling, packaging, or labeling of
a drug (i) as the result of a prescription or drug order by a physician, dentist or
veterinarian, or (ii) for the purpose of, or in relation to, research, teaching, or
chemical analysis.
K. Continuing Professional Development (CPD) refers to the inculcation of advanced
knowledge, skills, and ethical values in a post-licensure specialized or in an inter- or
multi-disciplinary field of study for assimilation into professional practice, selfdirected research, and/or lifelong learning.
L. Cosmetics refer to a substance or preparation 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 cleaning them,
perfuming them, changing their appearance and/or correcting body odor, and/or
protecting the body or keeping them in good condition, as defined under R.A. No.
9711.
M. Counterfeit Pharmaceutical Products refer to pharmaceutical products which do
not contain the amounts as claimed; with wrong ingredients; without active
ingredients; or, with insufficient quantity of active ingredients, which result in the
reduction of the products safety, efficacy, quality, strength or purity. These also refer
to products that are deliberately and fraudulently mislabeled with respect to identity
and/or source or with fake packaging, and can apply to both branded and generic
products, including the following:
1. the pharmaceutical product itself or the container or labeling thereof or any part of
such product, container, or labeling, bearing without authorization; the trademark,
trade name or other identification marks or imprints 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 pharmaceutical product refilled in containers bearing legitimate labels or marks,
without authority; and
3. a pharmaceutical product 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.
N. Dangerous Drugs refer to those listed in the (1) Schedules annexed to the 1961
Single Convention on Narcotic Drugs, as amended by the 1972 Protocol; (2)
Schedules annexed to the 1971 Single Convention on Psychotropic Substances; (3)

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Annex of R.A. No. 9165, otherwise known as the Comprehensive Dangerous Drugs
Act of 2002, and its amendments.
O. Dispensing refers to the sum of processes performed by a pharmacist from reading,
validating, and interpreting prescriptions; preparing, packaging, labeling, record
keeping, dose calculations, counseling or giving information, in relation to the sale or
transfer of pharmaceutical products, with or without a prescription or medication
order.
P. Drugs refer to pharmaceutical products that pertain 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 the following:
1. any article recognized in the official United States Pharmacopoeia - National
Formulary, Homeopathic Pharmacopoeia of the United States of America,
Philippine Pharmacopoeia, Philippine National Formulary, British
Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, and any
official compendium or any supplement to them;
2. any article intended for use in diagnosis, cure, mitigation, treatment, or prevention
of disease of man or 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 or traditional drugs as defined in R. A. No. 9502 known as Universally
Accessible, Cheaper and Quality Medicines Act.
Q. Drug Distributor/Importer/Exporter/Wholesaler refers to any drug or
pharmaceutical establishment that imports or exports raw materials, active ingredients
and /or finished drug products for its own use or for wholesale distribution to other
drug
or
pharmaceutical
establishments
or
outlets.
If
the
distributor/importer/exporter/wholesaler sells to the general public, it shall be
considered a retailer.
R. Drug Information Services refer to any activity in response to a drug information
request or query from healthcare professionals, organizations, committees, patients
and other individuals with the goal of providing carefully evaluated, evidence-based
drug information and recommendation to support medication use practice, enhance
quality of patient care, improve patient outcomes and ensure prudent use of resources.
S. Drugstore/Pharmacy/Botica and Hospital Pharmacy refer to pharmaceutical
outlets where registered drugs are dispensed directly to the end users or patients.

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T. Emergency Cases refer to life-threatening situations where a patient needs


immediate medical attention and treatment, including the occurrence of epidemic or
natural calamities.
U. Expiration Date refers to the end date when the manufacturer can guarantee that a
product possesses its claimed potency, efficacy, quality, and safety; after which its
sale or distribution is prohibited.
V. Filling refers to the act of dispensing or providing medicines in accordance with a
prescription or medication order.
W. Food/Dietary Supplements refer to processed food products intended to supplement
the diet that bear or contain one or more of the following dietary ingredients:
vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances to
increase the total daily intake in amounts conforming to the latest Philippinerecommended energy and nutrient intakes or internationally agreed minimum daily
requirements. It usually is in the form of capsules, tablets, liquids, gels, powders, or
pills and not represented for use as a conventional food or as the sole item of a meal
or diet or replacement of drugs and medicines, as defined under R. A. No. 9711.
X. Generic Name refers to the scientifically and internationally recognized name of the
active ingredients, as approved by the FDA pursuant to R. A. No. 6675, otherwise
known as the Generics Act of 1988.
Y. Good Clinical Pharmacy Practice (GCPP) refers to an international ethical and
scientific quality standard for designing, conducting, recording, and reporting trials
that involve the participation of human subjects.
Z. Good Distribution Practice (GDP) refers to that part of quality assurance which
ensures that the quality of a pharmaceutical product is maintained through adequate
control throughout the numerous activities which occur during the distribution
process.
AA. Good Laboratory Practice (GLP) refers to the quality system concerned with the
organizational process and the conditions under which non-clinical health and
environmental safety studies are planned, performed, monitored, recorded, archived
and reported.
BB. Good Manufacturing Practice (GMP) refers to a system of quality assurance aimed
at ensuring that products are consistently manufactured to a quality appropriate for

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their intended use. It is thus concerned with both manufacturing and quality control
processes and procedures.
CC. Good Pharmacy Practice (GPP) refers to the practice of pharmacy that responds to
the needs of the people who use the pharmacists services to provide optimal,
evidence-based care.
DD. Good Regulatory Practice (GRP) refers to the practice of regulation that should be
clear, simple and practical for users through identified policy objectives, consistent
with international standards in a sound legal and empirical basis which produces
benefits that justify and minimize costs and market distortions, in consideration of its
effects across society and taking into account the economic, environmental and social
factors.
EE. Good Storage Practice (GSP) refers to that part of quality assurance which ensures
that the quality of a pharmaceutical product is maintained through adequate control
throughout its storage.
FF. Good Warehousing Practice (GWP) refers to that part of quality assurance which
ensures that the quality of a pharmaceutical product is maintained through adequate
control throughout the warehousing.
GG. Handling of Pharmaceutical Products refers to the activities or range of pharmacy
operations from selecting, ordering, delivery, transport, receipt, inventory of stocks,
to arranging and display, compounding, storage, dispensing, provision of medication
and health information to patients and healthcare providers, selling of pharmaceutical
products including waste disposal.
HH. Health Promotion refers to the process of enabling communities, patients and clients
to increase control over their health and its determinants by engaging in healthy
behaviors to reduce the risk of developing diseases and other comorbidities.
II. Health Supplements refer to any product that is used to maintain, enhance and
improve the healthy function of the human body and contains one (1) or more or a
combination of the following: (1) herbal fatty acids, enzymes, probiotics and other
bioactive substances; (2) substances derived from natural sources, including animal,
plant, mineral and botanical materials in the form of extracts, isolates, concentrates,
metabolites and synthetic sources of substances mentioned in (1) and (2). These are
presented in dosage forms or in small unit doses such as capsules, tablets, powder,
liquids and shall not include any sterile preparations (i.e. injectibles, eye drops).

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JJ. High-alert Medications refers to the drugs that bear a heightened risk of causing
significant patient harm when used in error.
KK. Household Remedies refer to any preparation containing pharmaceutical substances
of common or ordinary use to relieve common physical ailments and which may be
dispensed without a prescription in original packages, bottles or containers, of which
the nomenclature has been duly approved by the FDA.
LL. Immunizing Pharmacist refers to a certified pharmacist who administers selected
vaccines for adult immunization as prescribed under Section 40 Article 4 of the Act.
MM. Institutional Pharmacies refer to pharmacies of institutions, organizations, and/or
corporations that provide a range of pharmaceutical services, given exclusively to the
employees and/or their qualified dependents.
NN. Internship Program refers to a supervised practical experience or supervised
pharmacy practice experience that is required to be completed for licensure as a
Pharmacist.
OO. Label refers to a display of written, printed, or graphic matter on the immediate
container of any article.
PP. Labeling Materials refer 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.
QQ. Marketing Authorization (MA) refers to an official document issued by the FDA
for the purpose of marketing or free distribution of a product after
evaluation
of its safety, efficacy, and quality.
RR. Marketing Authorization Holder (MAH) refers to the company or corporate or
legal entity in the field of pharmaceuticals in whose name the MA for a drug product
has been granted. This party is responsible for all aspects of the product, including
quality and compliance with the conditions of the MA. The MAH may either be a
manufacturer or distributor /exporter/ importer/ wholesaler.
SS. Medical Device refers to any instrument, apparatus, implement, machine, appliance,
implant, in vitro reagent or calibrator, software, material or other similar or related
article intended by the manufacturer to be used alone , or in combination, for human

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beings, for one (1) or more of the specific purpose of: diagnosis, prevention,
monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment or
alleviation of or compensation for an injury; investigation, replacement, modification
or support of the anatomy of a physiological process; supporting or sustaining life;
preventing infection; control of conception; disinfection of medical devices; and
providing information for medical or diagnostic purposes by means of in vitro
examination of specimens derived from the human body. This device 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 its intended
function by such means, as defined under R. A. No. 9711.
TT. Medical Mission refers to an activity conducted in normal circumstances by an
individual or group of health care practitioners to provide health services outside the
hospital, clinic, and health care facility premises as differentiated from humanitarian
missions and relief operations which are conducted during emergency situations such
as calamity, war, or natural and man-made disasters.
UU. Medication Error is any preventable event that may cause or lead to inappropriate
medication use or patient harm while the medication is in the control of the health
care professional, patient, or consumer.
VV. Medication Management involves the patient-centered care provided by the
pharmacist to optimize safe, effective and appropriate drug therapy by ensuring the
proper selection, procurement, storage, order, transcription, preparation, dispensation,
administration of the drug and monitoring of the drug utilization and effect.
WW. Medicines refer to drugs in their appropriate dosage forms, with assured quality,
safety and efficacy for humans or animals, or both.
XX. Medical Representative or Professional Service Representative refers to one who
represents any duly authorized manufacturer, distributor, trader, and wholesaler of
pharmaceutical products and whose primary duty is to promote their products to dulylicensed health professionals.
YY. Non-traditional Outlets refer to entities licensed by appropriate government
agencies to dispense over-the-counter medicines based on an approved list.
ZZ. Online Pharmacy Services refer to pharmaceutical services of a duly licensed
pharmaceutical outlet done over the internet.

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AAA. Over-the-counter (OTC) Medicines refer to medicines used for symptomatic relief
of minor ailments and which may be dispensed without a prescription.
BBB. Patient Medication Counseling refers to a one-on-one interaction between a
pharmacist and a patient, client or a caregiver to provide appropriate, understandable
and relevant information about the medications prescribed and/or dispensed
CCC. Patient Medication Profile is a comprehensive summary of all medications taken by
a patient, including prescription, over-the-counter, health supplements and dietary
supplements.
DDD. Pharmaceutical Care refers to any patient-centered, outcomes-oriented activity or
intervention that requires the pharmacist to cooperate with other healthcare
professionals, patients and their caregivers, and other clients in preventing,
identifying and resolving any drug-related problem.
EEE. Pharmaceutical Establishments refer to entities licensed by appropriate government
agencies, which are involved in the manufacture, importation, exportation, repacking,
and distribution of pharmaceutical products to pharmaceutical outlets.
FFF. Pharmaceutical Manufacturers or Drug Manufacturers refer to establishments
engaged in any or all operations involved in the production of pharmaceutical
products including the preparation, processing, compounding, formulating, filling,
packaging, repackaging, altering, ornamenting, finishing and labeling, preparatory to
their storage, sale, or distribution, except the compounding and filling of prescriptions
in pharmaceutical outlets.
GGG. Pharmaceutical Marketing refers to any activity undertaken, organized, or
sponsored by a pharmaceutical establishment or outlet which is directed at promoting
its product.
HHH. Pharmaceutical Outlets refer to entities licensed by appropriate government
agencies, which are involved in compounding and/or dispensing and selling of
pharmaceutical products directly to patients or end-users.
III. Pharmaceutical Products refer to drugs, medicines, biologicals, pharmaceutical and
biopharmaceutical products/specialties, veterinary products, veterinary biologics and
veterinary medicinal products.

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JJJ. Pharmacist refers to a health professional who has been registered and issued a valid
Certificate of Registration (COR) and Professional Identification Card (PIC) by the
PRC and Professional Regulatory Board of Pharmacy (BOP).
KKK. Pharmacist-only OTC Medicines refer to over-the-counter medicines classified by
appropriate government agencies that can be obtained only from a pharmacist, with
mandatory pharmacists advice on their selection and proper use.
LLL. Pharmacy Aide refers to a persons who assists the pharmacist in the different aspects
of pharmacy operation based on established standard operating procedures and
processes, with very minimal degree of independence or decision making and without
direct interaction with patients.
MMM. Pharmacy Assistant refers to a person who assists the pharmacist in different aspects
of pharmacy operation based on established standard operating procedures and
processes, with a minimum degree of independence or decision making and may have
supervised interaction with patients.
NNN. Pharmacy Technician refers to a person who assists in compounding and dispensing
of medicines in community, hospital, institutional and industrial settings or engaged
in other activities under the supervision of the pharmacist as described in Section 39
Article IV of the Act.
OOO. Philippine Practice Standards for Pharmacists refers to the established national
framework for quality standards and guidelines of the practice of pharmacy that
respond to the needs of the people who require the pharmacists services to provide
optimal, evidence-based care as formulated by the APO and adopted and promulgated
by the Professional Regulatory Board of Pharmacy.
PPP. Physicians Samples refer to medicines given to health professionals for promotional
purposes only.
QQQ. Prescription Book refers to the patient medication profile which can be either
electronic or hard copy wherein the dispensed prescription drugs, among others, are
recorded.
RRR. Prescription / Ethical Medicines refer to medicines which can only be dispensed by
a pharmacist to a patient, upon the presentation of a valid prescription from a
physician, dentist, or veterinarian and for which a pharmacists advice is necessary.

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SSS. Refilling of a Prescription refers to the act of dispensing the remaining balance of
medicines ordered in the prescription.
TTT. Referral refers to the process wherein the pharmacist provides consultative services
and conducts preliminary assessment of symptoms and refers the patient to a
physician or other healthcare professional.
UUU. Referral Registry refers to the record book maintained by pharmacists listing the
patients referred to different health facilities for further diagnosis.
VVV. Refresher Program refers to a prescribed study program of an accredited school of
pharmacy or organization of colleges of pharmacy.
WWW. Regulatory Services refer to services provided by pharmacists to ensure the
compliance of pharmaceutical products to specifications, policies, standards or laws.
XXX. Retail Outlet for Non-prescription Drugs (RONPD) otherwise known as nontraditional outlets, refers to pharmaceutical outlets such as a supermarket,
convenience store and other similar retail establishment authorized to sell only
identified Over-the-Counter (OTC) and household remedy products directly to the
general public on a retail basis.
YYY. Sub-professional Services refer to services provided by persons handling
pharmaceutical products other than the pharmacists, such as but not limited to
pharmacy owners, medical representatives, pharmacy technicians, pharmacy
assistants and pharmacy aides.
ZZZ. Telepharmacy Services refer to pharmaceutical services of a duly licensed
pharmaceutical outlet done through the use of telephone, teleconferencing or
facsimile.

RULE II
THE PROFESSIONAL REGULATORY 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 from a list of three (3) recommendees for each position ranked in the
order of preference and submitted by the PRC from a list of five (5) nominees
submitted for each position by the APO of pharmacists.

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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 Masters 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;
e. Be a member in good standing of the APO for at least five (5) years, but not
an officer or trustee thereof; and
f. At the time of appointment, he/she must neither be a member of the faculty or
an administrative officer of any school, college or university offering degree
programs in pharmacy nor has any direct or indirect pecuniary interest or
connection in any review center or similar institution;
Assessment and evaluation of the nominees for Board of Pharmacy shall be based on
the rubric provided by the BOP in consultation with APO.
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;
d. The Board shall prepare, adopt, issue or amend the syllabi or tables of
specifications of the subjects in the licensure examination, in consultation
with the academe and the Commission on Higher Education (CHED);
e. Recommend the issuance, suspension, revocation or reinstatement of the
COR, PIC or Special/Temporary Permits (STP) for the practice of pharmacy;
f. Administer oaths in accordance with the provisions of the Act;
g. Regulate and monitor the practice of pharmacy in the Philippines, including
the practice of sub-professional services such as pharmacy technicians,

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pharmacy assistants, aides and other medicine handlers, as described in the


Act;
h. Adopt measures that may be deemed proper for the enhancement of the
profession and/or the maintenance of high professional, academic, ethical and
technical standards;
i. Conduct ocular inspection of pharmaceutical establishments and higher
educational institutions (HEIs), in coordination with concerned government
agencies;
j. Promulgate and prescribe the Pharmacists Code of Ethics, code of technical
standards and guidelines for the professional practice of the pharmacy
profession, in coordination with the APO;
k. Represent the pharmacy profession in all fora involving concerns and issues
related to pharmaceutical products and the practice of pharmacy;
l. Investigate cases arising from violations of the Act, the rules and regulations
promulgated pursuant thereto, the Pharmacists Code of Ethics, Code of
technical standards and guidelines for the professional practice of the
pharmacy profession, and other Board issuances; issue summons, subpoena ad
testificandum and subpoena duces tecum to secure the attendance of witnesses
or production of documents, or both, and other evidence necessary for such
investigation or hearing: and render decision thereon which shall, unless
appealed to the PRC, become final and executory after fifteen (15) days from
receipt of notice of judgment or decision;
m. Delegate the hearing or investigation of administrative cases filed before the
Board, except where the issue or question involves the practice of the
profession, in which case, the hearing shall be presided over by at least one (1)
member of the Board, to be assisted by a Legal or Hearing Officer of the PRC;
n. Conduct, through the Legal Officers of the PRC, summary proceedings on
minor violations of the Act, the General Instructions to Examinees, including
the implementing rules and regulations issued by the Board, and to 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;
o. Issue and promulgate guidelines on CPD, in coordination with the APO and
duly recognized association of schools and colleges of pharmacy;
p. Recommend the accreditation of the standardized training programs for the
certification of the registration of medical representatives or professional
service representatives, pharmacy technicians, pharmacy assistants, pharmacy

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aides and other medicine handlers covered in Section 39 Article IV of the Act.
The Board shall promulgate the criteria and guidelines in the accreditation of
training programs and issue certificates of registration as described above, in
coordination with the APO and other concerned government agencies;
q. Accredit Specialty Boards of Pharmacy based on the criteria that it shall
establish and prescribe; and
r. Perform and discharge such other functions and responsibilities, as may be
deemed implied, incidental and necessary, to preserve the integrity of the
pharmacy licensure examination and to enhance and upgrade the practice of
the pharmacy profession in the country.
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. They may be reappointed in the same
office for another term of three (3) years immediately after the expiry of their term;
Provided, that no member of the board shall hold office for more than six (6) years.
Provided further, that the first Board appointed under the Act shall hold these terms
of office: the Chairperson for three (3) years, the first member for two (2) years, and
the second member for one (1) year: Provided, finally, that an appointee to a vacancy
shall serve only the unexpired portion of the term of office. The Chairperson and
members of the Board shall take their oaths of office before a duly authorized officer.
Section 5. Compensation and Allowances of the Board.
the Board shall receive compensation and
compensation and allowances received by the
professional regulatory boards under the PRC,
Appropriations Act.

The Chairperson and members of


allowances comparable to the
members of the other existing
as provided for in the General

Section 6. Grounds for Suspension or Removal from Office of the Chairperson or Member
of the Board. The President of the Philippines may, upon recommendation of the
PRC and after due process, suspend or remove the Chairperson or any member of the
Board, on any of the following grounds:
a. Gross neglect, incompetence or dishonesty in the discharge of duty;
b. Involvement in the manipulation, tampering or rigging of the licensure
examination, its questions or its results, or both, and in the disclosure of
classified and confidential information pertaining to the licensure
examination;
c. Conviction of an offense involving moral turpitude by a court of competent
jurisdiction; and
d. Unprofessional, unethical, immoral or dishonorable conduct.

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The PRC, in the conduct of investigation, shall be guided by Sections 7 and 15 of


Republic Act No. 8981, the existing rules on administrative investigation, and the
Rules of Court.
Section 7. 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.
The PRC shall designate a Secretary who shall provide the Board with a secretariat
and other support services to implement the provisions of the Act.

RULE III
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.
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:
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 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;
d. Has completed an internship program approved by the Board, pursuant to such
guidelines as may hereinafter be promulgated, in consultation with the duly
recognized association of pharmacy schools and colleges and the CHED;
Documentary requirements include:
a. Original and photocopy of the Philippine Statistics Authority-issued
Certificate of Birth;
b. Original and photocopy of the Philippine Statistics Authority-issued Marriage
Certificate (for married female);
c. Certification of Good Moral Character issued by any of the following:
barangay, church, school or employer;

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d. National Bureau of Investigation Clearance;


e. Certified true copy of the Transcript of Records in the BS Pharmacy or its
equivalent degree coferred by an HEI in the Philippines or an institution of
learning in a foreign country duly recognized by the CHED;
f. Certificate of Completion of the internship program duly signed by the dean /
program head, and
g. Such other documents as may be reasonably required by the Board in
accordance with the provision of the Act.
Section 3. Scope of Examination. The Pharmacists Licensure Examination shall cover the
following subjects on Pharmacy Science and Practice: Inorganic Pharmaceutical
Chemistry, Organic Pharmaceutical Chemistry, Qualitative and Quantitative
Pharmaceutical Chemistry, Pharmacognosy and Plant Chemistry, Pharmaceutical
Biochemistry, Microbiology and Parasitology, Physical Pharmacy, Biopharmaceutics,
Pharmacology and Toxicology, Manufacturing, Quality Assurance and
Instrumentation, Pharmaceutical Calculations, Drug Delivery Systems, Hospital
Pharmacy, Clinical Pharmacy, Dispensing and Medication Counseling,
Pharmaceutical Administration and Management, Public Health, Legal Pharmacy and
Ethics.
The subjects listed above shall be categorized into two major areas namely: Science
and Practice.
The Board, subject to the approval of the PRC, may introduce relevant changes in the
subject areas, format and content of the examination, as well as in the relative weight
attributed to each examination subject, as the need arises, and in consultation with the
duly recognized association of pharmacy schools and the CHED.
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.
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.
An applicant who fails the licensure examination for the third (3rd) time shall not be
allowed to take the succeeding examination, without having undertaken a refresher
program in a duly accredited institution or a duly recognized organization of schools
and colleges of pharmacy.

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An applicant who fails three (3) consecutive licensure examinations and desires to take
the examination again must comply with the following requirements:
a. He/she must have satisfactorily completed a refresher program offered by his/
her school or university, where he/she obtained a Bachelor of Science in
Pharmacy degree or its equivalent;
b. In the event that the school or university from where he/she obtained his/her
degree does not offer a refresher program, the applicant must be allowed to
enrol in an institution or organization duly accredited by the PRC BOP based
on guidelines provided; and
c. He/she must submit to PRC a certificate of completion in a refresher program
duly signed by the dean or program head of the school from where he/she
obtained his/her degree.
The refresher program shall be conducted for a period of not less than one (1) year,
focusing on the subjects prescribed in Sec. 15 of RA 10918. Completion of the
refresher program will allow the applicant three (3) opportunities to take the
examinations.
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. Upon the release of the results of the examination, the PRC
shall send by mail the rating obtained by each examinee at the given address using the
mailing envelope submitted during the examination.
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.
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. The COR shall bear the signatures of the Chairperson
of the PRC and the members of the Board, stamped with the official seals of the PRC
and of the Board, certifying that the person named therein is entitled to the practice of
the profession, with all the privileges appurtenant thereto. This COR shall remain in
full force and effect until suspended or revoked in accordance with the Act.
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 APO and
proof of completion of the CPD requirements following existing guidelines.

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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, and unless said foreign laws and regulations allow
Philippine citizens to practice Pharmacy within its territorial limits on the same basis,
and grant the same privileges as those enjoyed by its own citizens, subjects or
nationals.
A foreign citizen, whether he/she studied in the Philippines or not, who desires to take
the Pharmacists Licensure Examination through reciprocity shall initiate the
establishment of reciprocity between his/her country or state and the Philippines by
submitting a letter or any document signed by and under official seal of the
appropriate official of his/her country or state requesting the Board Chairperson to
allow the foreign applicant to take the licensure examination; and that by express
provision of the law of his/her country or state or international treaty, agreement or
covenant to which his/her country or state is a signatory, Philippine citizens are
allowed to take the Pharmacists Licensure Examination and to register as Pharmacists
in said foreign country or state on terms of strict and absolute equality with its own
citizens or subjects, including the unconditional recognition of prerequisite degrees
issued by institutions of higher learning duly recognized or established by the
Government of the Republic of the Philippines, attaching/appending thereto an
authenticated copy of said law, treaty, agreement or covenant officially translated in
the English language, if applicable.
If the letter/document and the copy of the law or treaty, agreement or covenant
submitted by the applicant is satisfactory to the Board, the foreign applicant shall be
allowed to take the Pharmacists Licensure Examination by requiring him/her to file
an application to take the licensure examination and by submitting the following
documents that shall accompany the application:
a. Original or certified true copy of any official document issued by the Bureau
of Immigration (BI) allowing the applicant to enter and reside in the
Philippines;
b. Copy of passport for examination and for photocopying of pertinent
information about the applicant;
c. Original or certified true copy of the transcript of records or equivalent
document of the course for licensure examination issued by an institution of
higher learning where he/she studied, duly authorized or accredited by his/her
country or state: Provided, that the documents must also be certified by CHED
to be equivalent to the Pharmacy courses accredited/recognized in the
Philippines; and

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d. Other documents which may be required to be submitted by the Board.


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:
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.
before assuming such duties, functions and responsibilities, shall secure an STP from
the Board and the PRC, under the following conditions:
a. The person is an internationally renowned pharmacist or an expert in a field or
specialty of Pharmacy;
b. The person is engaged in the provision of a professional service which is
determined to be necessary due to lack of Filipino specialist or expert; and
c. The person is required to work with a Filipino counterpart, a natural person
who is a pharmacist.
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;
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

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e. Declared of unsound mind by a court of competent jurisdiction.


In refusing such registration, the Board shall give a written statement setting forth the
reasons therefor and shall file a copy thereof in its records. Should the grounds (d) to
be proven to be no longer existent, the Board shall issue a Board Resolution allowing
the issuance of such COR.
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. The
Board may, in its discretion, require the applicant to take another licensure
examination. The petitioner shall prove to the Board that there is a valid reason for
such reinstatement. For the grant of the petition, the Board shall issue a Board
Resolution, to be approved by the PRC.
A duplicate copy, which is a certified true copy obtained from the PRC, of the COR
for display in Category B establishments may be issued. Replacement of lost or
damaged COR, PIC or STP may be issued, in accordance with the pertinent rules that
shall be issued thereon.

RULE IV
REGULATION OF THE PRACTICE OF PHARMACY
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.
The CORs, PICs or STPs held by such persons in good standing shall have the same
force and effect, as though they were issued on or after the effectivity of R.A. No.
10918.
Section 2. Affixing RPh after a Registered Pharmacists Name. Only a pharmacist shall
have the right to affix to his/her name, the title, Registered Pharmacist or RPh.
Any other pharmacy specialty title shall be recognized if granted by an international
certifying body or by the BOP.
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.
Pertinent documents refer to legal documents submitted to government agencies in
the application of permits and licenses relative to the practice of pharmacy.

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For the purpose of traceability and accountability, all other documents relative to the
practice of pharmacy must be signed by the pharmacist-in-charge.
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. This registry shall be made available to the public upon
inquiry or request, subject to such guidelines that shall be established therefor.
It is the responsibility of the pharmacist to update his/her profile, notify and submit
necessary documents to APO within the specified period as determined by the
guidelines that shall be established.
Other than the names and registration status, all information will remain confidential
and shall be made available upon order of competent authorities or with the consent
of the professional.
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 ones COR in a prominent and conspicuous place in the drug/
pharmaceutical establishment and/or outlet in which one is employed in a
professional capacity as pharmacist. When employed in establishments under
Category B, as defined in Section 31 of the Act, the duplicate copy, which is a
certified true copy obtained from the PRC of the pharmacists COR shall also be
displayed therein.
No pharmacist shall knowingly allow the COR to be displayed in a drug/
pharmaceutical establishment and/or outlet where one is not actually employed as a
professional pharmacist.
The original COR of all pharmacists employed in all areas of practice shall be kept
securely by the employer for the duration of her/his employment as pharmacist.
In cases when there are multiple pharmacists employed, the COR of the supervising
pharmacist on duty must be displayed.
Prominent and conspicuous place means an area where the COR of the supervising
pharmacist on duty can be easily seen by clients and/or regulators upon entry to the
establishment.
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.

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a. Prescription medicines shall be dispensed only with a valid prescription of a


physician, dentist, or veterinarian. Dispensing of pharmaceutical or drug
products for veterinary use should be in accordance with the prescribed
guidelines of the FDA.
b. Prescription drugs and pharmacist-only OTC medicines shall be dispensed
only by a pharmacist, except in emergency cases where the services of a
pharmacist are not available, and in situations in accordance with the
provisions in Section 31 (b) (2),(3). In which case, a duly certified pharmacy
assistant or pharmacy technician may dispense the medicine. Provided, That a
report shall be submitted to the supervising pharmacist within twenty-four
(24) hours after the occurrence of the emergency so that product recording in
the prescription books may be done. For the purposes of the Act, prescription
books refer to the patient medication profile record which can be electronic or
manual.
c. Compounding and dispensing shall be done only by a pharmacist, in
accordance with appropriate guidelines such as but not limited to the current
Good Manufacturing Practice, Philippine Practice Standards for Pharmacists,
laboratory practice and dispensing guidelines. A pharmacist may refuse to
compound, dispense or sell drugs and pharmaceutical products, if not in
accordance with the Act and the abovementioned standards.
d. Appropriate medication review and patient medication counselling at the time
of dispensing of medicines should be provided to patients or caregivers, the
content of which should include indication, proper use, precautions, and other
relevant information.
e. Licensed manufacturers, importers, distributors, and wholesalers of
pharmaceutical products are authorized to sell their products only to duly
licensed pharmaceutical establishments and/or outlets.
f. Retail drug outlet duly licensed by the FDA shall compound, dispense, sell or
resell or otherwise make available any pharmaceutical product, of whatever
nature and kind, to the patient and/or caregiver. Retailing by duly licensed
drug retailers to hospital pharmacies or institutional pharmacies may be
allowed in cases of valid emergency purchases following guidelines issued by
the regulatory agencies.
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

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provided. One pharmacist shall supervise each establishment/outlet in order to


dispense prescriptions and pharmacist-only medicines, whether in-store or online.
Virtual pharmacy without a licensed physical outlet is not allowed. Included under
this category are the following:
1. Pharmaceutical establishments/outlets selling or otherwise making available to the
consuming public prescription/ethical medicines, combination products (medical
device and drugs) classified as drugs according to the primary intended mode of
action, pharmacist-only OTC medicines, whether owned by the government or by
a private person or firm, whether sold at wholesale or retail wherein the direct and
immediate supervision of a pharmacist is required whenever the establishment is
dispensing prescription and pharmacist-only OTC drugs;
2. Establishments involved in the manufacture, importation, exportation,
distribution, and sale of prescription/ethical medicines, pharmacist-only OTC
medicines, OTC medicines and combination products (medical device and drugs)
classified as drugs according to the primary intended mode of action;
3. Departments/Divisions/Units of pharmaceutical laboratories such as FDALicensed CROs and Sponsors including bioequivalence and other in vivo testing
centers, pharmaceutical manufacturing laboratories, or other establishments with
processes involving the preparation, manufacture, assay, regulation, product
research and development, quality control, repacking, importation, exportation,
distribution, sale or transfer of pharmaceutical products in quantities greatly in
excess of single therapeutic doses; and
4. Government units, including local government, city, first to third class municipal
health units, nongovernment organizations and/or associations involved in the
procurement, distribution, dispensing and storage of pharmaceutical products.
5. Health facilities that dispense prescription drugs and pharmacist-only OTC drugs;
6. Other establishments/outlets as may be identified by the FDA
Category B. Pharmaceutical establishments/ outlets where the supervision and
oversight of a pharmacist is required.
All of the following oversight requirements and considerations must be satisfied:
1. The supervising pharmacist must be physically present in the establishment/outlet
for a minimum of two (2) hours a week;
2. The location of each establishment/outlet which the pharmacist supervises must
be within the same provincial local government unit (LGU) within each region.
The National Capital Region is considered as a single area due to its
comparatively smaller land mass;

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3. The distance between the two farthest establishments/outlets supervised by a


single pharmacist must not exceed 25 km in distance; All other
establishments/outlets supervised by a single pharmacist must be within a
circumferential area when plotted between the two farthest establishments/outlets;
4. A maximum of fifteen (15) establishments/outlets is allowed to be supervised by a
single pharmacist.
5. Other relevant requirements as may be prescribed and/or modified by the FDA.
Due considerations shall be given for geographically isolated and disadvantaged areas
(GIDA) as identified by the Department of Health (DOH).
Included under this category are the following:
1. Retail outlets selling household remedies and OTC medicines as differentiated
from the pharmacist-only OTC medicines;
2. Satellite institutional pharmacies providing medicines solely to employees of their
respective companies or the employees qualified dependents or both; or members
of a duly registered organization or institution;
3. Fourth, fifth and sixth class municipal health units involved in the procurement,
distribution, dispensing, and storage of pharmaceutical products;
4. Institutions providing telepharmacy services;
5. Non-traditional outlets of pharmaceutical products: Provided, that no prescription
medicines and pharmacist-only OTC medicines are sold;
6. DOH licensed health facilities involved in the handling of medications used in
clinic procedures. Clinic procedures include but not limited to minor surgery,
diagnostic procedures, dialysis, cauterization and vaccination. Provided, that it
shall comply with guidelines issued by the FDA.
7. Other establishments/outlets as may be identified by the FDA.
A pharmacist working in a Category A establishment/outlet may be allowed to
simultaneously work and successively render pharmacy services in Category B
establishments/outlets. Under this provision, simultaneous work means that a
pharmacist can be employed in multiple establishments provided that there is no
overlap of working time. A pharmacist may be allowed to supervise a maximum of 4
establishments classified under Category B.

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The FDA, in coordination with the Board, and the approval of the PRC, may add to,
delete, reclassify, or modify the above list of establishments as the need arises, in
order to keep pace with developments in the pharmacy practice.
All units or sub-units of establishments, institutions, and regulatory bodies whether
government or private with functions and activities that are exclusive for pharmacists,
as defined in Section 4, paragraphs (a), (b), (c), (d) and (i), shall be headed and
managed by a qualified pharmacist:
Procurement, storage, distribution, or dispensing of any pharmaceutical product in the
national government and local government units shall be made only under the
supervision of a pharmacist. Provided, That an appointment in the government
service shall comply with the provisions of other pertinent laws.
The FDA licensing requirement for LGUs shall be implemented in transitions:
1. By 2018, the FDA licensing shall commence with TESDA-certified Pharmacy
Assistants; and
2. By 2020, LGUs must comply with the Pharmacist requirement.
The concerned government entity/ies shall take the necessary steps or measures to
ensure that the foregoing provisions are implemented and complied with.
Section 8. Responsibility for Quality of Pharmaceutical Products. To ensure the quality of
health products, a pharmacist has the following duties and responsibilities:
a. It shall be the duty of a pharmacist of a pharmaceutical establishment and
outlet, especially the marketing authorization holder (MAH), 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. It shall also be the responsibility of the pharmacist to report any
adverse events associated with medication use such as medication errors,
adverse drug reactions, product defects, counterfeit medications based on
guidelines set by the FDA.
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; likewise, all licensed pharmaceutical establishments and
outlets shall comply with the applicable standards of good practices as
prescribed by FDA. The MAH also has the responsibility to ensure proper
disposition and destruction of pharmaceutical products including physicians
samples.
c. Owners, managers, or pharmacists in charge of the operation of
pharmaceutical establishments and outlets shall be held jointly responsible for
non-conformance with the standards of safety, quality, and efficacy, as

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provided for in the Act and other pertinent rules and regulations and
issuances.
d. In cases of pharmaceutical products sold in their original package, the seal of
which has not been broken or tampered with, the liability that may arise
because of their quality and purity, rests upon the manufacturer or importer,
the distributor, representative, or dealer, who is responsible for their
distribution or sale. Dealer refers to retailer as used in this provision.
It shall be unlawful for any person to manufacture, prepare, sell, or dispense any
pharmaceutical product under a fraudulent name, or pretence or to adulterate any
pharmaceutical product offered for sale.
Efforts should be made by all stakeholders (i.e. manufacturing, regulatory,
distribution, retail) to ensure safety, efficacy and quality of pharmaceuticals.
Strategies aimed at medication safety shall be implemented. These include prevention
of medication errors for high-alert medications and sound-alike, look-alike drugs.
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, Dispensing
Guidelines as adopted and promulgated by the Board, and other standards pertaining
to purity, safety, and quality by the FDA.
Filling of prescription drugs done by the pharmacy assistant or pharmacy technician
shall be under the direct supervision of a pharmacist. The pharmacist shall be
accountable to the dispensing of the prescription and patient medication counseling.
Prescription to be filled should be clear and complete. Clarifications on the content of
the prescription must be referred to the prescriber by the pharmacist on duty to ensure
patient medication safety.
Completely filled prescriptions should be surrendered to the pharmacist for recording
purposes. Retention period for completely filled prescriptions shall be kept for a
period as prescribed by the concerned regulatory agencies.
Disposal of prescriptions and other pharmacy documents that include the patients
name and other identifiers must be discarded under the supervision of a pharmacist
with utmost security to protect the patients privacy and confidentiality.
Partial filling of prescriptions less than the total quantity indicated in the prescription
shall be allowed, subject to dispensing guidelines as provided in the immediately
preceding paragraph. It is the responsibility of the pharmacist dispensing the last
quantity completing the prescription to keep the prescription according to the proper
prescription recording guidelines.

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Drugstores/Pharmacies/Boticas and Hospital Pharmacies engaged in compounding


practices are required to comply with the standards of Good Compounding Practices
and other requirements as prescribed by FDA.
Section 10. Physicians 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.
The statement Sample, Not For Sale, or its equivalent shall appear in red
background or red font on each labeling material of the drug or combination of
products (medical device and drug) classified as drug according to the primary
intended mode of action. In addition, the FDA requirements for labeling materials of
physicians sample shall apply to all drug products. It shall be unlawful to remove,
erase, deface or mark the original labels of samples.
Pharmaceutical products classified as antimicrobials, including anti-TB medicines
and other classifications of medicines, as may be prescribed by the FDA, shall not be
given or distributed as physicians samples. Upon effectivity of this IRR, all MAHs
shall cease distribution of approved samples of antimicrobials including anti-TB
medicines. FDA shall no longer approve applications for physicians samples of these
drugs.
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. These may be reported to
the Board for appropriate action.
The pharmacist dispensing or compounding prescriptions shall not substitute the
medicine called for in the prescription with any other drug, substance, or ingredient as
prescribed by FDA without prior consultation with, and written consent of the person
prescribing. Generic substitution shall be done in accordance with R.A. No. 6675,
R.A. No. 9502, and other pertinent laws and regulations.
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; and name and address of pharmacy, name of the doctor, the dispensing
pharmacist, and other requirements prescribed in the Philippine Pharmacy Act for
Pharmacists and Dispensing Guidelines, RA 9502, its IRR and such other regulations.

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Auxiliary labels containing special pharmacists instructions for the patient shall be
required as prescribed by the FDA. Auxiliary labels should not cover the primary
display panel of the drug product.
Exceptions to labeling prior to dispensing requirement are during cardiopulmonary
resuscitation emergencies and other emergency situations when the medicine
dispensed is to be administered immediately by a licensed professional.
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,
indicating the following:
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
The Patient Medication Profile shall be open for inspection by the representatives of
the Board or the FDA, or both, at any time of the day, when the pharmacy is open,
and must be kept for a period of not less than two (2) years after the last entry.
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 RA 9165 and other applicable laws and issuances.
For any partially filled prescriptions, these shall be appropriately noted in the Patient
Medication Profile or Dangerous Drugs Book or an equivalent recording system.
All referrals such as TB patients undertaken by the pharmaceutical outlets shall be
recorded in the Referral Registry and shall be open for inspection by the
representatives of the Board or the representative of the DOH, or the FDA, or both, at
any time of the day, when the pharmacy is open, and must be kept for a period of not
less than two (2) years after the last entry.
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.
All outlets are required to display in a conspicuous space the following information:
a. office hours;
b. schedule of the supervising pharmacist; and
c. whereabouts or contact information of the supervising pharmacist.

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The applications for the opening and operation of a retail drug outlet or other similar
business establishments shall not be approved, unless applied for by a pharmacist,
either as owner or as pharmacist-in-charge, pursuant to the provisions of the Act.
Telepharmacy and online services of FDA-licensed Drugstores/Pharmacies/Boticas
and Hospital Pharmacies, RONPDs, and Institutional Pharmacies are allowed subject
to the rules and regulations of FDA.
Section 15. Handling of Pharmaceutical Products by Persons Other Than a Pharmacist.
For the purpose of this Section, persons handling pharmaceutical products other than
the pharmacist, which shall include, pharmacy owners who are non-pharmacists,
medical representatives or professional service representatives or pharmacy support
personnel working as pharmacy technicians, pharmacy assistants or pharmacy aides,
persons who assist pharmacists in any part of a pharmacy operation, 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. By 2020, the said provision shall be fully implemented.
For purposes of the Act, handling of pharmaceutical products pertains to activities
or range of pharmacy operations from selecting, ordering, delivery, transport, receipt,
inventory of stocks, to arranging and display, compounding, storage, dispensing, ,
provision of medication and health information to patients and healthcare providers,
selling of pharmaceutical products including waste disposal. Training of other
persons handling pharmaceutical products shall be under the responsibility of the
employer.
No person, except pharmacy graduates, shall be allowed to render such services
without undergoing a comprehensive standardized training program following PRC
and FDA guidelines.
All persons handling pharmaceutical products, other than the pharmacist, shall
undergo an accredited comprehensive training program to be duly certified by
appropriate government agencies. These persons include the following with their
corresponding job descriptions relevant to handling of pharmaceutical products:
a. Pharmacy owners who are non-pharmacists selecting, ordering, delivery,
receipt, arranging, display and storage of pharmaceutical products. Owners are
required to attend FDA licensing seminars
b. Medical representatives or professional service representatives promotion of
pharmaceutical products to professional healthcare providers through
provision of relevant health product information
c. Pharmacy Technician under pharmacist supervision, conducts the following
tasks: monitors the supply/inventory of pharmaceutical products, handles and

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controls pharmaceutical products, arranges the display of pharmaceutical


products, observes good laboratory practices, prepares the product label,
compounds formulations and dispenses both OTC medicines and prescription
pharmaceutical products, demonstrates product knowledge on medicines,
conducts health promotion education, vigilance and observes adherence to
good manufacturing practices; supervises pharmacy assistants and pharmacy
aides.
d. Pharmacy Assistant - under pharmacist supervision, conducts the following
tasks: performs general housekeeping, monitors the supply/inventory of
pharmaceutical products, handles and controls pharmaceutical products,
arranges the display of pharmaceutical products, observes good laboratory
practices, assists in preparing the product label, counts OTC tablets &
capsules, reconstitutes powders for
suspension;
dispenses
OTC
pharmaceutical products, demonstrates product knowledge on medicines,
conducts health promotion education, vigilance and observes adherence to
good manufacturing practices.
e. Pharmacy Aide - under pharmacist supervision, conducts the following tasks:
cleans work areas, answers phone calls and forwards calls or messages to the
pharmacist, assists in placing of prices on products, assists in stocking of
products in the shelves and warehouse, files documents on orders, deliveries,
sales and others assigned by the pharmacist.
Section 16. Administration of Adult Vaccines. In addition to the requirements provided in
Section 4, paragraph (g) of the Act, trained pharmacist who shall administer adult
vaccines shall ensure that the vaccine to be administered shall have a doctors
prescription, which is not more than seven (7) days old and submit a monthly
vaccination report and Adverse Events Following Immunization (AEFI) report to
DOH regional offices using the prescribed form.
The following guidelines are the regulatory and technical requirements for pharmacybased immunization services in the Philippines:
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.
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.
B. Immunizing Pharmacist

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Only PRC-BOP certified immunizing pharmacist shall provide vaccination services in


pharmacies. Below are the requirements of an immunizing pharmacist:
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.
An Immunizing Service Agreement or a notarized declaration of joint undertaking
between the pharmacy owner and the pharmacist, whether employed on a permanent
or contractual basis, shall be made available.
A written and signed service agreement shall be accomplished by both the pharmacy
owner and the health professionals who will be involved in the pharmacy
immunization program. This document shall define and specify the responsibilities
and accountabilities associated with the provision of immunization services in the
pharmacy concerned.
Further, patient informed consent must be secured by the immunizing pharmacist
prior to any vaccination to be administered.
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 The pharmacist shall be
responsible in coordinating with the supplier or manufacturer the return as per
company policy and the timely retrieval, and/or proper disposal of pharmaceutical
wastes, unused and expired pharmaceutical products in accordance to the provisions
set by the Department of Health and the Department of Environment and Natural
Resources.
Pharmacy documents with patient protected health information (PHI) that includes
the patient name and other identifiers must be discarded under the supervision of a
pharmacist with utmost security to protect the patients privacy and confidentiality.
Disposal of expired physicians samples shall be the responsibility of the
supplier/distributor who provided the sample.
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.
To ensure quality and integrity of medications for all patients, drugs with special
storage requirements and compounded products shall not be accepted for return.

RULE V

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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) which shall be recognized by the
Board of Pharmacy and the Professional Regulation Commission (PRC) as the one
and only integrated and accredited professional organization of pharmacists.
A pharmacist duly registered by the Board shall automatically become a member of
the accredited professional organization of pharmacists and shall receive the benefits
appurtenant thereto upon payment of the required fees and dues.
Membership in the APO shall not prevent membership in other associations of
pharmacists.
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. The PIC shall not be renewed if the requirements for membership with the
APO, are not met including the requirements pursuant to the guidelines set by PRC.
Pharmacy support personnel working as Pharmacy Technicians, Pharmacy Assistants,
and Pharmacy Aides must be registered as affiliate members of APO. They must
maintain membership throughout the duration of their employment.
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 as recommended or
concurred by the Accredited Professional Organization. The Board shall issue
guidelines in the accreditation of specialty boards in various areas of pharmacy
practice, which shall include the standards of practice within different specialties,
qualifications, and requirements for the certification of practitioners under each
specialty. The guidelines shall be developed by a Committee headed by the PRC and
composed of the APO and other concerned affiliate organizations. The Committee
may invite an expert to serve as an adviser or as a consultant in the development of
the guidelines.

RULE VI
VIOLATIONS, ADMINISTRATIVE SANCTIONS, AND PROCEDURES
Section 1. General Provisions. These rules shall apply to all cases concerning violations of
the Act and other relevant laws.

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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.
A. Based on a Complaint
1. A written complaint under oath shall be filed by any person against a pharmacist
with the BOP. The complaint shall be in four (4) copies complaint with
supporting documentary evidences and/or affidavits of witnesses. The respondent
shall be furnished with a copy of the complaint and its attachments.
2. Respondent shall submit a reply with supporting documentary evidences and/or
affidavits including its witness/es within ten (10) calendar days from receipt of the
complaint.
3. The BOP hears and investigates cases arising from the violation of the Pharmacy
Act, its implementing rules and regulations, Code of Ethics, and other laws
relevant to the practice of pharmacy. It may issue summons, subpoena and
subpoena duces tecum to compel attendance of respondent(s) and/or witnesses.
4. The BOP may delegate the hearing or investigation of administrative cases filed
before it, except when the issue or question strictly involves or concerns the
practice of pharmacy profession or occupation, in which case, the hearing shall be
presided over by at least one (1) member of the BOP assisted by a legal or hearing
officer of the PRC, subject to applicable provisions of the Pharmacy Act and/or
its implementing rules and regulations.
5. The BOP shall conduct or delegate the conduct of summary proceedings on minor
violations of the Pharmacy Act and its implementing rules and regulations, as
well as, violations of the general instructions to examinees committed by
examinees.
6. The BOP renders judgements or decisions in all administrative investigations, as a
collegial body, by a majority vote of all its members, subject to applicable
provisions of the Pharmacy Act.
7. A motion for reconsideration may be filed from an adverse judgement or decision
within 10 calendar days from the receipt thereof.
8. All judgements or decisions become final and executory, fifteen (15) days from
the receipt thereof ,or from the receipt of the resolution of the motion for
reconsideration, unless appealed to the PRC.
B. Based on Information or as a Result of BOPs Inspection
The BOP prepares the charge sheet, containing the particulars of the violation, committed
and the affidavit(s) of witness(es) and documentary evidence(s) attached thereto. Then
the procedure in a., above is followed.
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:

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a. Violation of any provision of this Act, its Rules and Regulations, the
Pharmacists Code of Ethics, Code of Technical Standards for the
Professional Practice of the Pharmacy Profession (PhilPSP), Code of Good
Governance, and all other guidelines, policies and regulatory measures of the
Board and/or the Commission relating to the practice of the pharmacy
profession;
b. Conviction of an offense involving moral turpitude by a court of competent
jurisdiction;
c. Unprofessionalism, immorality, malpractice, incompetence, gross negligence,
or imprudence in the practice of the profession;
d. Fraud or deceit in the acquisition of the COR, PIC or STP or renewal thereof;
e. Allowing the certificate of registration to be used or displayed in
establishments where the pharmacist is not actually employed and practicing,
whether on part-time or full time basis;
f. Addiction to alcoholic beverages or to any habit-forming drug, as provided for
in Section 23 d), rendering a pharmacist incompetent to practice the
profession;
g. Aiding or abetting the illegal practice of pharmacy;
h. Insanity or any mental disorder, as provided for in Sec. 23 (e), that would
render the person incompetent to practice pharmacy, as determined by a
competent medical professional;
i. False, extravagant, or unethical advertisements, endorsement, and promotion
of pharmaceutical products, pharmaceutical outlets and establishments where
the pharmacists name or the pharmacists professional organization and
similar information, or both, are used;
j. Manufacture, sale, offering for sale of counterfeit, spurious, substandard,
falsified pharmaceutical products and committing other acts in violation of
R.A. No. 8203, otherwise known as the Special Law on Counterfeit Drugs
The administrative sanctions under Section 7. of R.A. No. 8203, and Rule VII,
Sections 1. to Section 9., Rules and Regulations Implementing Republic Act
No. 8203, shall apply.
k. Illegal manufacture, sale, possession, dispensing of dangerous drugs and other
acts in violation of Republic Act No. 9165, and other applicable laws and
issuances. The administrative sanctions in the pertinent provisions of R.A. No.
9165, The Comprehensive Dangerous drugs Act of 2002and its
implementing rules and regulations, shall apply;

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l. Committing acts in violation of Section 6 of Presidential Decree No 881,


entitled, Empowering the Secretary of Health to Regulate the Labeling, Sale
and Distribution of Hazardous Substances and Section 11 and Section 29-A
of Republic Act No. 3720, as amended R.A. No. 9711, The Food and Drug
Administration act of 2009;
m. Practicing pharmacy with a suspended or revoked COR, or with expired
PIC;
n. Unauthorized dispensing of pharmaceutical products through unregistered
online services or direct selling businesses, in accordance with the guidelines
issued by FDA and BOD-PRC; and,
o. Being found guilty of immoral, unprofessional or dishonorable conduct by the
Board.

Administrative Sanctions shall also be imposed for violations under Section 45. and
Section 46. of the Act.
a. Under Section 45. b); d); g); i); l); n); q); s); v); and z)
b. Under Section 46 c); e); f); g); h); i); k); and l)

RULE 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:
a. Commission of any act in violation of Sections 30 and 31 of this Act;
b. Allowing the display of ones COR in a pharmaceutical establishment where
the pharmacist is not employed and practicing;
c. Displaying of the pharmacists COR by pharmacy owners/operators in a
pharmaceutical establishment where the pharmacist is not employed and
practicing;

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d. Dispensing or allowing the dispensing or offering for sale of prescription


drugs or pharmaceutical products in a place not licensed by FDA as a
pharmaceutical outlet;
e. Dispensing of prescription and pharmacist-only OTC pharmaceutical products
by a person other than those under the direct and immediate supervision of a
pharmacist;
f. Allowing the dispensing of prescription and pharmacist-only OTC
pharmaceutical products, without the direct and immediate supervision of a
pharmacist;
g. Compounding and dispensing not in accordance with current Good
Manufacturing Practice, Good Laboratory Practice and Philippine Practice
Standards for pharmacists (PhilPSP), and such other standards and guidelines
issued by the Board;
h. Selling of prescription and pharmacist-only OTC drugs by manufacturers,
importers, and wholesalers to unlicensed pharmaceutical outlets and other
establishments;
i. Substituting prescription drugs which are not generically equivalent to what
was on the prescription, without the consent of the prescriber or not in
accordance with R. A. No. 6675, any amendment thereto, and relevant
issuances;
j. Forcing, coercing or intimidating a pharmacist to compound or dispense
medical and pharmaceutical products in violation of the provisions of the Act,
its IRR, and other relevant laws, rules and regulations;
k. Preparing and compounding of pharmaceutical products in quantities greatly
in excess of single therapeutic doses, without the presence and supervision of
a pharmacist, or in a place not duly registered with the FDA;
l. Noncompliance with the labeling requirements for dispensed medicines by a
pharmaceutical outlet as provided for by law and current guidelines;
m. Manufacturing, selling, importing, and exporting of pharmaceutical products
under fraudulent name or address, or both;
n. Adulterating and misbranding of pharmaceutical products, and/or causing the
commission of the said acts;
o. Manufacturing, selling, importing, exporting, or making available in
commerce unsafe, substandard and counterfeit pharmaceutical products;

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p. Operating an unlicensed pharmaceutical outlet such as online pharmacy


service or direct selling not authorized by the FDA;
q. Operating a Category A establishment which opens for business without a
pharmacist;
r. Operating a Category B establishment, without the required supervision and
oversight of a pharmacist;
s. Practicing pharmacy without a valid license or with an expired, suspended or
revoked license;
t. Filling and refilling of prescription and pharmacist-only OTC pharmaceutical
products by person other than a pharmacist or without his/her the direct and
immediate supervision;
u. Dispensing prescription drugs and pharmacists-only OTC drugs by rural
health units, and other national and local government units, agencies, and
facilities, as well as, by other private institutions and establishments, without
the required supervision of a pharmacist;
v. Manufacture, sale, offering for sale of counterfeit, spurious, substandard,
falsified pharmaceutical products and committing other acts in violation of
R.A. No. 8203, otherwise known as the Special Law on Counterfeit Drugs;
w. Illegal manufacture, sale, possession, dispensing of dangerous drugs and other
acts in violation of Republic Act No. 9165, and other applicable laws and
issuances. The penalties in the pertinent provisions of R.A. No. 9165, The
Comprehensive Dangerous drugs Act of 2002and its implementing rules and
regulations, shall apply;
x. Committing acts in violation of Section 6 of Presidential Decree No 881,
entitled, Empowering the Secretary of Health to Regulate the Labeling, Sale
and Distribution of Hazardous Substances and Section 11 and Section 29-A
of Republic Act No. 3720, as amended by R.A. No. 9711, The Food and
Drug Act of 2009;
y. Use and abuse of authority as pharmacist, to gain access to prohibited drugs
for illicit use or purpose;
z. Engaging in immunization as provided for in the Act without the required
training and license/certification from the appropriate agency;
aa. Compounding, dispensing, selling, reselling or otherwise making available to
the consuming public, pharmaceutical products, not through a retail outlet
duly licensed by FDA;

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bb. Manufacturing, compounding, distribution, selling, offering for sale of


medicines and other pharmaceutical products without license from FDA, and
without the supervision of a pharmacist, when so required; and,
cc. Other acts/omissions analogous to the foregoing.

RULE 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:
a. Affixing of the title RPh by a person who is not a pharmacist;
b. Practicing the pharmacy profession in the Philippines without a valid COR,
PIC or STP;
c. Non-indication of a pharmacist of his/her COR and professional tax receipt
numbers in official documents requiring such information, as prescribed by
the Board in particular, in an issuance;
d. Refusal to display the COR of the pharmacist in a prominent and conspicuous
place in the establishment and outlet where the pharmacist is employed and
practicing;
e. Non-compliance by a pharmacist with the requirements on the filling of
prescription, as provided for in the appropriate guidelines issued by BOPPRC;
f. Non-compliance by a pharmacist on the requirements for partially-filled
prescription as provided for in the appropriate guidelines issued by BOP-PRC
;
g. Selling of physicians samples;
h. Distribution of antimicrobials, including anti-TB drugs and other product
classification, as may be prohibited by law and pertinent regulations as
physicians samples;
i. Removal, erasure, and alteration of mark or label of physicians sample, and
non-labeling or marking of physicians sample as such;

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j. Use of cipher, codes or secret keys or unusual names or terms in prescriptions;


k. Filling or partial filling of prescriptions where cipher, codes, secret keys or
unusual names and terms are used;
l. Non-compliance with labeling requirements for dispensed medicines;
m. Non-compliance with the requirements on the keeping of records or record
books by a pharmaceutical outlet
n. Employment of personnel in a pharmacy or pharmaceutical operation without
the required relevant training and certification;
o. Refusal of a non-pharmacist owner/operator of a pharmaceutical outlet to
undergo the required and relevant training and certification;
p. Refusal by the owner/operator, general manager, supervisor, and other heads
of units of government and of private establishments, to allow and require
pharmacists and pharmacy support personnel to undergo CPD, training and
certification;
q. Rendering dispensing-related services by non-pharmacists in a pharmaceutical
outlet without undergoing the required training and certification;
r. Dispensing pharmaceutical products in medical missions without the direct
and immediate supervision of a pharmacist;
s. Non-compliance with the required training and certification of by professional
service or medical representatives or professional service representatives,
pharmacy technicians, pharmacy assistants, pharmacy aides, pharmacy clerks,
and other medicine handlers of pharmaceutical products. Both the medical
representatives or professional service representatives, pharmacy technicians,
pharmacy assistants, pharmacy aides, pharmacy clerks, or medicine handlers
and the owners/proprietors, and responsible officers and employees of
pharmaceutical establishment/outlet employing any such individual shall be
held jointly liable; and,
t. Violation of any provision of this Act and its Rules and Regulations not
aforementioned above.
u. Non-compliance with the requirements of the Act in dispensing prescription
and pharmacist-only OTC medicines during emergency cases, where the
services of a pharmacist are not available.

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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.
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.
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.

RULE IX
FINAL PROVISIONS
Section 1. Enforcement. It shall be the primary duty of the Board, PRC, and FDA to
effectively enforce the provisions of this Implementing Rules and regulations. All
duly constituted law enforcement agencies and officers of the national, provincial,
city or municipal government or of any political subdivision thereof shall ensure the
effective enforcement of this Implementing Rules and regulations.
Section 2. Prospectivity. The administrative sanctions and penalties imposed herein shall not
apply to acts committed prior to the date the Act becomes effective.
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.
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.
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.
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.

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Section 7. Amendments. These IRR may be amended, modified or supplemented when the
effective implementation and enforcement of the Act would require.
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.