This course is designed to cover the principles of law 1.

4 can be overturned by a later legislative

and ethics in pharmacy. It examines the national and enactment or if found unconstitutional by a court of
local laws that impact the practice of pharmacy, competent jurisdiction
emphasizing legal and ethical principles applied by
pharmacists in decision-making. It also focuses on 2. Regulatory law -laws promulgated by government
theoretical and practical knowledge regarding the agencies at the local & national level.
regulation of food, drugs, medical devices and 2.1 also known as administrative law
cosmetics. The students will learn the national 2.2. all regulatory law run through government
framework within the pharmacy practice, as well as agencies.
acquire an understanding of the laws, regulations 2.3 include everything from rulemaking to
and ethical responsibilities of pharmacists to protect adjudication and enforcement
and ensure the well-being of their patients. 2.4 contain detailed requirements and procedures to
be followed in the implementation of the law
M1 Introduction
Before we go deeper and in details into the different 3. Common law - laws based on stare decisis – the
laws under the jurisdiction of pharmacy practice, this doctrine of precedent.
module will introduce the difference between 3.1 also known as judicial law
jurisprudence and ethics. When face in professional 3.2 precedents are maintained over time through
dilemma, these are both important in setting the records of the courts as well as historically
standard in pharmacy practice which help in documented in collections of case law known as
decision-making of a pharmacist. yearbooks and reports
3.3 decisions adhere to previously decided cases, or
precedents, where the facts are substantially the
same

Ethics is the branch or study dealing with what is the

proper course of action for man. It is a study of
human acts or conduct from a moral perspective as
to whether they are good or bad. It answers the
question, "What do I do?“

 from Greek word “ethos” which means

M1 Lesson 1: Legal and Ethical control of the custom, habit, or character
Pharmacy Practice
 also known as “moral philosophy”
Jurisprudence is a catchall term for entire subject of
 involves moral principles of practice
law, the study of law and legal questions.
 involves systematizing, defending, and
 from the Latin words “iuris” which means
recommending concepts of right and wrong
law and “prudentia” which means wisdom,
behavior
knowledge, philosophy or science
 is the wisdom, the knowledge, the
At a more fundamental level, it is the method by
philosophy or the science of law
which we categorize/ prioritize our values and
 is the study of fundamental legal principles pursue them.
 It refers to the philosophy of law which is
employed in analyzing, explaining, and M1 Lesson 2: Principles of Biomedical Ethics
classifying law; system of laws. Professional ethics
3 basic legal categories in Philippine Pharmacy It is the personal and corporate standards of
practice behavior expected of the members of a particular
profession. Many professions that are trusted by the
1. Statutory law - laws passed by Senate and House public to apply expert knowledge have a Code of
of Representatives and signed and approved by the Ethics which sets out their expectations of a
President of the Philippines. member’s behavior and the boundaries within which
1.1.generally strictly construed by courts members have to operate.
1.2 recorded, or codified, in writing and published
1.3 becomes effective on a set date written into the A MEMBER OF A PROFESSION: well-informed, well-
bill intentioned and unbiased.
Bioethics  term that suggest acts of mercy and charity
It provides a disciplinary framework for the whole expanded to include any action that
array of moral questions and issues surrounding the benefits another
life sciences concerning human beings, animals, and  the obligation to help imposes on
nature. It offers ethical guidance in a particular field healthcare practitioners the duty to
of human conduct. promote the health and welfare of the
patients above other consideration, while
Three Divisions of Bioethics attending and honoring the patient’s
Medical personal autonomy
concerns how to handle moral problems arising out  A practitioner should act in the best interest
of the care of patients of the patient
NON-MALEFICENCE
Animal  "First, do no harm" or “Primum non nocere”
concerns the issues of non-human animals and their is the obligation to avoid or not inflict harm
welfare on others whether intentionally or
unintentionally
Environmental
concerns human beings' ethical relationship with the VERACITY
natural environment "HONESTY WITHOUT DECEPTION”
 binds the health practitioner and the
Patient's Rights patient in an association of truth.
 Patients can expect that clinicians will  When faced with situations in which lying
employ their knowledge and experience in seems a rational solution, other alternatives
caring for them. must be sought.
 Patients can expect that health care  the harm to patient autonomy and the
providers will respond to their wishes about potential loss of practitioner credibility
their treatment. makes lying to patients a practice that in
 Patients generally choose their own almost all cases should be avoided
physician, pharmacy, and hospital. CONFIDENTIALITY
 Patients are allowed to choose from  a patient’s basic right to expect the
multiple options for treatment when they information he gives a health care
exist (such as surgery versus drug therapy). practitioner to be held undisclosed
 Patients must give their approval, through  an important aspect of the trust that
the process of informed consent, prior to patient’s place in health care professionals
the initiation of care. JUSTICE
 Patients have a right to treatment that is  means giving each person what he or she
both safe and effective within given deserves
parameters.  requires that procedures uphold the spirit
of existing laws and are fair to all players
involved
THE UNIVERSAL PRINCIPLES OF BIOMEDICAL ETHICS ROLE OF FIDELITY
The objective of bioethics is to provide awareness to  Self-regulation is one of the key elements of
the health team or workers of the “do’s” and “don’t profession; professional code of ethics are
of medical practice important documents in the process of self-
regulation.
AUTONOMY  Under no circumstances may the
 from Greek word autos (self) and nomos practitioner place his financial interests
(governance) above the welfare of his patients
 self-determination
 Three Elements M1 Lesson 2.1: Framework for Ethical Decision
a. the ability to decide making
b. the power to act on your decisions
c. a respect for the individual autonomy of others

BENEFICENCE
 M1 Lesson 3: Code of Ethics for Pharmacists
Pharmacists are health professionals who help
individuals protect themselves against diseases,
maintain good health and make the best use of their
medications.

The pharmacists promote rational use of drugs and

ensure the provision of safe, effective and quality
drugs for improved patient care and quality of life.

PPhA CODE OF ETHICS FOR PHARMACIST

1. A pharmacist places the well being of the patient

at the center of professional practice.
2. A pharmacist promotes the welfare of each
individual in a caring and compassionate manner.
3. A pharmacist serves the needs of the individual,
community and society.
4. A pharmacist respects the rights of patients and
upholds confidentiality of patient’s record.
Examples of ethical issues 5. A pharmacist acts with honesty, integrity and
In July of 2013, an Indiana pharmacist was sentenced professionalism in relationship with the patients and
to 25 months in prison and Walgreens was fined other health professionals.
$1.44 million for HIPAA violations resulting from 6. A pharmacist respects the abilities, values and
disclosures the pharmacist made to her husband contribution of colleagues and other health
about a customer with whom he was previously professionals and work with them closely to ensure
involved. The husband then used this information to better patient care.
harass the plaintiff in an attempt to avoid paying 7. A pharmacist is committed to continuously
child support payments for a child he had fathered. enhance professional competence.
8. A pharmacist, in coordination with the
In December of 2013, it was reported that over 700 government and other health professionals helps in
illnesses and 64 deaths in 20 states resulted from a the formulation and implementation of health care
fungal meningitis outbreak caused by tainted steroid policies, standards and programs designed for the
injections. The source of the contaminated product, benefit of society.
the New England Compounding Center, agreed to a
preliminary settlement that would create a $100 M2 Introduction
million fund to compensate victims. The pharmacy practice in the Philippines has evolved
On March 10, 2014, the LA Timesreported that CVS many years from product-orientated to patient-
Caremark is facing up to $29 million in fines for oriented pharmacy practice. The foundation of
allegedly losing track of 37,000 hydrocodone pills at pharmacy education should have an extensive
four California stores. They may have been sold on framework of curriculum to develop globally
the black market. competitive pharmacy professionals. The
competency of pharmacy education is the basis for
On March 30, 2014, TheIndianapolis Starreported the legal and ethical pharmacy practice in the
that William J. Cover, former president and current Philippines. In this module, we will tackle these
board member of the Indiana State Board of pharmacy standards which integrate legal and
Pharmacy, used his position to help gain approval for ethical principles, competencies, and lifelong
a controversial Walgreens pharmacy model it calls learning of a pharmacist.
“Well Experience.”
Republic Act 10918: The Philippine Pharmacy Act
These incidents are disturbing, because they cross Article I: General Provisions
the line from human error into negligence, Sec 2. Statement of Policy
intentional deception, and lack of ethics in business The State recognizes the vital role of pharmacists in
and professional practices. In a business where the delivery of quality healthcare services through
patients depend on the integrity of the company and the provision of safe, effective, and quality
its employees to safeguard their health and pharmaceutical products, pharmaceutical care, drug
wellbeing, these acts are particularly heinous. information, patient medication counselling, and
health promotion. The pharmacists’ professional integrated and (influenza), pharmaceutical
services shall, therefore, be promoted as an accredited pneumococc products unfit for
indispensable component of the total health care professional al, other pre- human
system to ensure the physical well-being of the organization exposure consumption,
Filipinos. of registered prophylactic following the
and licensed vaccines to standards of
Sec 3. Objectives pharmacists, be quality or purity of
 standardization and regulation of pharmacy of which there administere which, are as those
education shall be only d to patients stated in the
 administration of licensure examination, one (1), as aged United States
registration, and licensing of pharmacists prescribed eighteen Pharmacopeia/Nati
 supervision, control, and regulation of the under Section (18) years onal Formulary and
practice of pharmacy in the Philippines 41, Article V of and above, Philippine
 development and enhancement of this Act; and such Pharmacopeia in its
professional competence of pharmacists other latest edition or
through continuing professional vaccines as any standard
development, research, and other related may be reference for drugs
activities defined by and medicines
 integration of the pharmacy profession the which are given
 Sec 4. Scope of Pharmacy Practice Department official recognition
of Health as well as those
(DOH) in an provided for in
administrativ Republic Act No.
e issuance; 3720, otherwise
known as the
"Food, Drug, and
Cosmetic Act", as
amended, and
Republic Act No.
9711, known as the
"Food and Drug
Administration Act
of 2009";
(d) (e) Brand (f) Cipher, Code, or
Biopharmaceu name refers Secret Key refers to
ticals refer to to the a method of secret
pharmaceutica proprietary writing or use of
l products that name given characteristic style
are used for by the or symbol by
therapeutic or manufacture substituting other
for in vivo r to letter/s or
diagnostic distinguish character/s for the
purposes, such its product letter/s intended,
as vaccines, from those for the purpose of
sera, and of misleading the
drugs derived competitors; consumer;
from life forms
using
biotechnology.
These include
proteins,
Sec 5. Definition of Terms nucleic acids,
(a) Accredited (b) Adult (c) or living
professional vaccines Adulterated/Deteri microorganis
organization refer to orated ms where the
(APO) refers to cervical pharmaceutical virulence is
the duly cancer, flu products refer to reduced and
are used for authority; and
therapeutic or
for in vivo (3) A pharmaceutical product which contains no
diagnostic amount of or a different active ingredient; or less
purposes; than eighty percent (80%) of the active ingredient it
(g) (h) (i) Cosmetics refer purports to possess, as distinguished from an
Compounding Continuing to a substance or adulterated drug including reduction or loss of
refers to the professional preparation efficacy due to expiration;
sum of developmen intended to be (k) Dangerous (l) (n) Emergency
processes t (CPD) placed in contact drugs refer to Dispensing cases refer to life-
performed by refers to the with the various those listed in refers to the threatening
a pharmacist inculcation external parts of the: (1) sum of situations where a
in drug of advanced the human body or Schedules processes patient needs
preparation knowledge, with the teeth and annexed to performed immediate medical
including the skills, and the mucous the 1961 by a attention and
calculations, ethical membranes of the Single pharmacist treatment,
mixing, values in a oral cavity, with a Convention on from including the
assembling, post- view exclusively or Narcotic reading, occurrence of
packaging, or licensure mainly to cleaning Drugs, as validating, epidemic or natural
labeling of a specialized them, perfuming amended by and calamities;
drug: (i) as the or in an them, changing the 1972 interpreting
result of a inter- or their appearance Protocol; (2) prescriptions
prescription or multidiscipli and/or correcting Schedules ; preparing;
drug order by nary field of body odor, and/or annexed to packaging;
a physician, study for protecting the the 1971 labeling;
dentist, or assimilation body or keeping Single record
veterinarian; into them in good Convention on keeping;
or (ii) for the professional condition, as Psychotropic dose
purpose of, or practice, defined under Substances; calculations;
in relation to, self-directed Republic Act No. and (3) Annex and
research, research, 9711; of Republic counseling
teaching, or and/or Act No. 9165, or giving
chemical lifelong otherwise information,
analysis; learning; known as the in relation to
(j) Counterfeit pharmaceutical products refer to "Comprehensi the sale or
pharmaceutical products which do not contain the ve Dangerous transfer of
amounts as claimed; with wrong ingredients; Drugs Act of pharmaceuti
without active ingredients; or with insufficient 2002", and its cal products,
quantity of active ingredients, which result in the amendments; with or
reduction of the products’ safety, efficacy, quality, without a
strength, or purity. These also refer to products that prescription
are deliberately and fraudulently mislabeled with or
respect to identity and/or source or with fake medication
packaging, and can apply to both branded and order;
generic products, including the following: (m) Drugs refer to pharmaceutical products that
pertain to chemical compounds or biological
(1) The pharmaceutical product itself or the substances, other than food, intended for use in the
container or labeling thereof or any part of such treatment, prevention, or diagnosis of disease in
product, container, or labeling, bearing without humans or animals, including the following:
authorization; the trademark, trade name, or other
identification marks or imprints or any likeness to (1) Any article recognized in the official United States
that which is owned or registered in the Intellectual Pharmacopeia/National Formulary, Homeopathic
Property Office (IPO) in the name of another natural Pharmacopeia of the United States of America,
or juridical person; Philippine Pharmacopeia, Philippine National Drug
Formulary, British Pharmacopoeia, European
(2) A pharmaceutical product refilled in containers Pharmacopoeia, Japanese Pharmacopoeia, and any
bearing legitimate labels or marks, without official compendium or any supplement to them;
 substances mentioned in (1) and (2). It is presented
(2) Any article intended for use in diagnosis, cure, in dosage forms or in small unit doses such as
mitigation, treatment, or prevention of disease of capsules, tablets, powder, liquids and it shall not
man or animals; include any sterile preparations (i.e. injectibles,
eyedrops);
(3) Any article, other than food, intended to affect (t) Household remedies refer to any preparation
the structure or any function of the human body or containing pharmaceutical substances of common or
animals; ordinary use to relieve common physical ailments
and which may be dispensed without a medical
(4) Any article intended for use, as a component of prescription in original packages, bottles or
articles, specified in clauses (1), (2) and (3), not containers, of which the nomenclature has been duly
including devices or their components, parts and approved by the FDA;
accessories; and (u) Institutional pharmacies refer to pharmacies of
institutions, organizations, and/or corporations that
provide a range of pharmaceutical services, given
(5) Herbal or traditional drugs as defined in Republic
exclusively to the employees and/or their qualified
Act No. 9502;
dependents;
(o) Expiration date (p) Filling refers to the act
(v) Internship program refers to a supervised
refers to the end date of dispensing or providing
practical experience that is required to be completed
when the manufacturer medicines in accordance
for licensure as a registered pharmacist;
can guarantee that a with a prescription or
(w) Label refers to a display of written, printed, or
product possesses its medication order;
graphic matter on the immediate container of any
claimed potency,
article;
efficacy, quality, and
(x) Labeling materials refer to all labels and other
safety; after which its
written, printed, or graphic matter: (1) upon any
sale or distribution is
item or any of its containers or wrappers; or (2)
prohibited;
accompanying any such item;
(y) Medical device refers to any instrument,
(q) Food/Dietary supplements refer to processed apparatus, implement, machine, appliance, implant,
food products intended to supplement the diet in vitro reagent or calibrator, software, material or
that bears or contains one (1) or more of the other similar or related article intended by the
following dietary ingredients: vitamins, minerals, manufacturer to be used alone, or in combination,
herbs, or other botanicals, amino acids, and for human beings, for one (1) or more of the specific
dietary substances to increase the total daily purposes of: diagnosis, prevention, monitoring,
intake in amounts conforming to the latest treatment, or alleviation of disease; diagnosis,
Philippine-recommended energy and nutrient monitoring, treatment, or alleviation of or
intakes or internationally agreed minimum daily compensation for an injury; investigation,
requirements. It usually is in the form of capsules, replacement, modification or support of the
tablets, liquids, gels, powders, or pills and not anatomy of a physiological process; supporting or
represented for use as a conventional food or as sustaining life; preventing infection; control of
the sole item of a meal or diet or replacement of conception; disinfection of medical devices; and
drugs and medicines, as defined under Republic providing information for medical or diagnostic
Act No. 9711; purposes by means of in vitro examination of
specimens derived from the human body. This
(r) Generic name refers to the scientifically and device does not achieve its primary intended action
internationally recognized name of the active in or on the human body by pharmacological,
ingredients, as approved by the FDA pursuant to immunological, or metabolic means, but which may
Republic Act No. 6675, otherwise known as the be assisted in its intended function by such means,
"Generics Act of 1988"; as defined under Republic Act No. 9711;
(s) Health supplement refers to any product that is (z) Medical mission refers to an activity conducted
used to maintain, enhance and improve the healthy on normal circumstances of an individual or a group
function of the human body and contains one (1) or of health care practitioners to provide health
more or a combination of the following: (1) herbal services outside the hospital, clinic, and health care
fatty adds, enzymes, probiotics, and other bioactive facility premises as differentiated from humanitarian
substances; and (2) substances derived from natural missions and relief operations which is conducted
sources, induding animal, plant, mineral, and during emergency situations such as calamity, war,
botanical materials in the form of extracts, isolates, or natural and man-made disasters;
concentrates, metabolites, synthetic sources of
(aa) Medicines refer to drugs in their appropriate licensed pharmacist, with mandatory pharmacist’s
dosage forms, with assured quality, safety and advice on their selection and proper use;
efficacy for humans or animals, or both; (mm) Pharmacy aides refer to persons who assist the
(bb) Medical representative or professional service pharmacists in the different aspects of pharmacy
representative refers to one who represents any operation based on established standard operating
duly authorized manufacturer, distributor, trader, procedures and processes, with very minimal degree
and wholesaler of pharmaceutical products and of independence or decision making and without
whose primary duty is to promote their products to direct interaction with patients:
duly licensed health professionals; (nn) Pharmacy assistants refer to persons who assist
(cc) Nontraditional outlets refer to entities licensed the pharmacists in different aspects of pharmacy
by appropriate government agencies to dispense operation based on established standard operating
over-the-counter medicines based on an approved procedures and processes, with a minimum degree
list; of independence or decision making and may have
(dd) Online pharmacy services refer to supervised interaction with patients;
pharmaceutical services of a duly licensed (oo) Pharmacy technicians refer to persons who
pharmaceutical outlet done over the internet; assist in compounding and dispensing of medicines
(ee) Over-the-counter (OTC) medicines refer to in community, hospital, institutional and industrial
medicines used for symptomatic relief of minor settings or engaged in other activities under the
ailments and which may be dispensed without a supervision of the pharmacist as described in Section
prescription; 39, Article IV of this Act;
(ff) Pharmaceutical establishments refer to entities (pp) Philippine Practice Standards for Pharmacists
licensed by appropriate government agencies, and refer to the established national framework for
which are involved in the manufacture, importation, quality standards and guidelines of the practice of
exportation, repacking, and distribution of pharmacy that respond to the needs of the people
pharmaceutical products to pharmaceutical outlets; who require the pharmacists’ services to provide
(gg) Pharmaceutical manufacturers refer to optimal, evidence-based care as formulated by the
establishments engaged in any or all operations integrated APO and approved by the Professional
involved in the production of pharmaceutical Regulatory Board of Pharmacy;
products including the preparation, processing, (qq) Physician’s samples refer to medicines given to
compounding, formulating, filling, packaging, health professionals for promotional purposes only;
repackaging, altering, ornamenting, finishing and (rr) Prescription/Ethical medicines refer to medicines
labeling, preparatory to their storage, sale, or which can only be dispensed by a pharmacist to a
distribution, except the compounding and filling of patient, upon the presentation of a valid prescription
prescriptions in pharmaceutical outlets; from a physician, dentist, or veterinarian and for
(hh) Pharmaceutical marketing refers to any activity which a pharmacist’s advice is necessary;
undertaken, organized, or sponsored by a (ss) Refilling of a prescription refers to the act of
pharmaceutical establishment or outlet which is dispensing the remaining balance of medicines
directed at promoting its product; ordered in the prescription;
(ii) Pharmaceutical outlets refer to entities licensed (tt) Referral refers to the process wherein a
by appropriate government agencies, and which are pharmacist provides consultative services and
involved in compounding and/or dispensing and conducts preliminary assessment of symptoms and
selling of pharmaceutical products directly to refers the patient to a physician or other health care
patients or end-users; professional;
(jj) Pharmaceutical products refer to drugs, (uu) Referral registry refers to the record book
medicines, biologicals, pharmaceutical and maintained by pharmacists, listing the patients
biopharmaceutical products/specialties, veterinary referred to different health facilities for further
products, veterinary biologies and veterinary diagnosis;
medicinal products; (vv) Refresher program refers to a prescribed study
(kk) Pharmacist refers to a health professional who program in an accredited school of pharmacy; and
has been registered and issued a valid Certificate of (ww) Telepharmacy services refer to pharmaceutical
Registration (COR) and Professional Identification services of a duly licensed pharmaceutical outlet
Card (PIC) by the PRC and the Professional done through the use of telephone,
Regulatory Board of Pharmacy; teleconferencing, or facsimile.
(ll) Pharmacist-only OTC medicines refer to over-the-
counter medicines classified by appropriate
government agencies to be obtained only from a
Philippine Practice Standards for Pharmacists
(PhilPSP) Manual is a manual created by the
Philippine Pharmacists Association Inc. to serve as a
guide for Filipino pharmacists in various work
settings. This is a very important document that
reminds us of our responsibility as an indispensable
provider of medication expertise serving our dearest
Filipino patients.

M2 Lesson 1.2: RA 10918 (Article 2)

Article II
The Professional Regulatory Board of Pharmacy Section 8. Powers, Functions, and Responsibilities of
the Board. - The Board shall exercise the following
Section 6. Creation of the Professional Regulatory powers, functions, and responsibilities:
Board of Pharmacy. - There is hereby created a Section 9. Term of Office of the Members of the
Professional Regulatory Board of Pharmacy, Board.
hereinafter called the Board, under the
administrative control and supervision of the PRC, to
be composed of a Chairperson and two (2) members,
to 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 duly integrated
APO of pharmacists.

Section 11. Grounds for Suspension or Removal from

Office of the Chairperson or Member of the Board.

Section 7. Qualifications of the Chairperson and

Members of the Board. - The Chairperson and
members of the Board, at the time of nomination,
M2 Lesson 1.3: RA 10918 (Article 3)
must:
Article III
Examination, Registration, and Licensure
Sec. 14. 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:
Documentary requirements of the Applicant for
Licensure Examination
a. Original and photocopy of the Philippine Statistics Section 18. Report of Rating. - The Board shall submit
Authority-issued Certificate of Live Birth to the PRC the ratings obtained by each candidate
within three (3) working days after the last day of
b. Original and photocopy of the Philippine Statistics the examination, unless extended for just cause.
Authority-issued Marriage Certificate (for married Upon the release of the results of the examination,
female) the PRC shall send by mail the rating obtained by
c. Certificate of Good Moral Character issued by any each examinee at the given address using the
of the following: barangay, church, school of mailing envelope submitted during the examination.
pharmacy, or employer Section 19. Oath of Profession. - All successful
d. National Bureau of Investigation (NBI) clearance candidates in the licensure examination shall take
e. Certified true copy of the Transcript of Records in their oath of profession before any member of the
BS Pharmacy or its equivalent degree conferred by Board, officer of the PRC, or any person authorized
an HEI in the Philippines or an institution of learning by law to administer oaths, prior to entering the
a foreign country duly recognized by the CHED practice of the pharmacy profession.
f. Certificate of completion of the internship program Section 20. Issuance of Certificate of Registration and
duly signed by the dean/program head, and Professional Identification Card. - A COR as a
g. Such other documents as may be reasonably pharmacist shall be issued to those who passed the
required by the Board. licensure examination, subject to compliance with
Section 15. Scope of Examination. - The Pharmacists’ the registration requirements and payment of the
Licensure Examination shall cover the following prescribed fees. The PIC shall be renewed every
subjects: three (3) years, upon presentation of the Certificate
of Good Standing (COGS) from the APO and proof of
completion of the CPD requirements.
Section 21. Foreign Reciprocity. - Unless the country
or state of which the foreign pharmacist is a subject
or citizen, specifically permits Filipino pharmacists to
practice within its territorial limits on the same basis
as the subjects or citizens of the said foreign country
or state under reciprocity and under international
agreements, no foreigner shall be admitted to
licensure examinations, given a COR to practice as
Sec. 16. Holding of Examination - Licensure pharmacist nor be entitled to any of the privileges
Examination shall be given two (2) times a year under this Act.
Requirements
Section 17. Ratings in the Licensure Examination. - In  Foreign citizen, whether he/she studied in
order to be registered and licensed as a pharmacist, the Philippines or not.
a candidate must obtain a general weighted average  Submit a letter or any document signed by
of seventy-five percent (75%), with no rating lower and under the official seal of the
than fifty percent (50%) in any of the subjects. appropriate official of his country/state
An applicant who failed in the licensure examination requesting the Board to allow the foreign
for the third (3rd) time shall not be allowed to take applicant to take the licensure examination
the next succeeding examinations without having  Authenticated copy of the law, treaty,
undertaken a refresher program in a duly accredited agreement or covenant, regarding foreign
institution. The Board shall issue guidelines on the reciprocity.
refresher program requirement. Section 22. Practice Through Special/Temporary
An applicant who fails 3x in the licensure exam must Permit (STP). - any foreign citizen who has gained
comply with the following requirements entry in the Philippines to perform professional
a. He/she must satisfactorily completed a refresher services within the scope of the practice of
program offered by the school/university where pharmacy, including the following: (a) being a
he/she obtained a BS in Pharmacy consultant in foreign-funded or assisted projects of
b. If the refresher program is not offered by the the government; (b) being engaged or employed by
school /university, an applicant shall allowed to enrol a Filipino employer or establishment; (c) providing
in an institution accredited by the Board based on free services in humanitarian missions: and (d) being
the guidelines a visiting faculty member in any field or specialty in
c. He/she must submit to PRC a certificate of pharmacy shall, before assuming such duties,
completion of refresher program duly signed by the functions and responsibilities, secure an STP from
dean/program head of the school where he/she
completed the refresher program.
the Board and the PRC, under the following accordance with the pertinent rules that shall be
conditions: issued thereon.

(1) The person is an internationally renowned M2 Lesson 1.4: RA 10918 (Article 4)

pharmacist or expert in a field or specialty of Article IV
pharmacy; Regulation of the Practice of Pharmacy
Section 26. Affixing RPh After a Registered
(2) The person is engaged in the provision of a Pharmacist’s Name. - Only duly registered and
professional service which is determined to be licensed pharmacists shall have the right to affix to
necessary due to lack of Filipino specialist or expert; one’s name, the title "Registered Pharmacist" or
and "RPh".

(3) The person is required to work with a Filipino Section 27. Indication of Information. - A pharmacist
counterpart, a natural person who is a registered shall be required to indicate the serial numbers, the
and licensed pharmacist. date of expiry of the pharmacist’s PIC and APO
Certificate of Membership on all pertinent
Section 23. Grounds for Non-registration. - The documents signed by him/her.
Board shall not register any successful examinee
who has been: Section 28. Registry of Pharmacists. - The Board and
the PRC shall prepare and maintain a registry of the
(a) Convicted of an offense involving moral turpitude names, residences or office addresses, or both,
by a court of competent jurisdiction; status of registration and area of practice of all
(b) Summarily adjudged by the Board as guilty for registered pharmacists, which shall be updated
misrepresentation or falsification of documents in annually, in coordination with the APO. This registry
connection with the application for examination or shall be made available to the public upon inquiry or
for violation of the General Instructions to request, subject to such guidelines that shall be
Examinees; established therefor.
(c) Found guilty of immoral or dishonorable conduct
by the Board; Section 29. Display of Certificate of Registration. - It
(d) Medically proven to be addicted to any drug or shall be the duty of every pharmacist engaged in the
alcohol by a medical or drug testing facility practice, whether in private or under the employ of
accredited by the government; and another, to display the original copy of one’s COR in
(e) Declared of unsound mind by a court of a prominent and conspicuous place in the drug
competent jurisdiction. establishment in which one is employed in a
professional capacity as pharmacist. When employed
In refusing the registration, the Board shall give a in establishments under Category B, as defined in
written statement setting forth the reasons therefor Section 31 of this Act, the duplicate copy of the
and shall file a copy thereof in its records. Should pharmacist’s COR shall also be displayed therein. -
ground (d) be proven to be no longer existent, the No pharmacist shall knowingly allow the COR to be
Board shall issue a Board Resolution allowing the displayed in an establishment where one is not
issuance of such COR. actually employed as a professional pharmacist.

Section 24. 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 2 years from the 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 of the COR for display in Category B
establishments may be issued. Replacement of lost
Section 30. Dispensing/Sale of Pharmaceutical
or damaged COR, PIC or STP may be issued in
Products. - No pharmaceutical product, of whatever
nature and kind, shall be compounded, dispensed, pharmaceutical establishment and outlet to ensure
sold or resold, or otherwise be made available to the that all pharmaceutical products conform to
consuming public, except through a retail drug outlet standards of safety, quality and efficacy, as provided
duly licensed by the FDA. for in this Act and other pertinent rules and
regulations and issuances. Owners, managers, or
Prescription drugs and pharmacist-only OTC pharmacists in charge of the operation of
medicines shall be dispensed only by a duly pharmaceutical establishments and outlets shall be
registered and licensed pharmacist, except in held jointly responsible for nonconformance with
emergency cases, where the services of a registered these standards.
and licensed pharmacist are not available: Provided,
That a report shall be made to the supervising Section 33.Filling and Partial Filling of Prescription. -
pharmacist within twenty-four (24) hours after the All prescriptions and pharmacist-only OTC medicines
occurrence of the emergency so that product shall be filled, compounded and dispensed only by a
recording in the prescription books can be done. registered and licensed pharmacist, in accordance
with the Philippine Practice Standards for
Compounding and dispensing shall be done only by Pharmacists, Dispensing Guidelines and other
duly registered and licensed pharmacists, in standards pertaining to purity, safety and quality.
accordance with current Good Manufacturing Completely filled prescriptions should be
Practice, laboratory practice, Philippine Practice surrendered to the pharmacist for recording.
Standards for Pharmacists and dispensing guidelines.
A registered and licensed pharmacist may refuse to Section 34. Physician’s Sample. - Pharmaceutical
compound, dispense or sell drugs and products given or intended to be given free to any
pharmaceutical products, if not in accordance with health professional by a manufacturer or distributor
this Act and the abovementioned standards. or its professional service representative as part of
its program or promotion shall not be sold to any
Licensed manufacturers, importers, distributors, and pharmaceutical outlet or the consuming public.
wholesalers of pharmaceutical products are
authorized to sell their products only to duly licensed The statement "Sample, Not for Sale", or its
pharmaceutical outlets. equivalent, shall appear conspicuously on the
primary and secondary packaging of the drug or
Section 31. Pharmacist Requirement. - combination products (medical device and drug)
Establishments/outlets which are required to employ classified as drug according to the primary intended
and/or retain and maintain the professional services mode of action to be given. It shall be unlawful to
of duly registered and licensed pharmacists shall be remove, erase, deface or mark the original labels of
classified as follows: samples.

(a) Category A – Pharmaceutical Pharmaceutical products classified as antimicrobials,

establishments/outlets where the direct and including anti-TB medicines and other classifications
immediate control and supervision of a duly of medicines, as may be prescribed by the FDA, shall
registered and licensed pharmacist is required, per not be given or distributed as physician’s samples.
establishment, whether in-store or online.
Section 35. Prohibition Against the Use of Cipher,
(b) Category B – Pharmaceutical Codes, or Unusual Terms in Prescriptions and
establishments/outlets where the supervision and Prescription Substitution. - Pharmacists shall not
oversight of a duly registered and licensed compound or dispense prescriptions, recipes, or
pharmacist is required under pertinent provisions of formulas which are written in ciphers, codes or
law. secret keys or prescriptions of pharmaceutical
products with unusual names which differ from
those in standard pharmacopeias or formularies.

Section 37. Recording of Patient Medication Profile. -

All prescriptions dispensed in the pharmacy shall be
recorded in an appropriate recording system
indicating therein, among other things, the name
and address of the patient, name of prescribes
Section 32.Responsibility for Quality of generic name and brand, dosage strength, quantity
Pharmaceutical Products. - It shall be the duty of a of drug and initials of pharmacist. It shall be open for
duly licensed and registered pharmacist of a
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 M2 Lesson 1.5: RA 10918 (Article 5)

dispensed by a pharmacy shall be recorded in the Article V
Dangerous Drugs Book or an equivalent recording Accredited Professional Organization
system as required by Republic Act No. 9165 and Section 41. The Integrated and Accredited
other applicable laws and issuances. Professional Organization (APO) of Pharmacists. -
The pharmacy profession shall be integrated into
All referrals such as tuberculosis patients undertaken one (1) national organization registered with the
by the pharmaceutical outlets shall be recorded in Securities and Exchange Commission (SEC) which
the Referral Registry and shall be open for inspection shall be recognized by the Board and the PRC as the
by the Board, or representative of the Department of one and only integrated and accredited professional
Health (DOH) or the FDA, or both, at any time of the organization of pharmacists.
day when the pharmacy is open, and must be kept
for a period of not less than two (2) years after the A pharmacist duly registered with the Board shall
last entry. automatically become a member of the integrated
and accredited professional organization of
Section 38. Requirements for the Opening and pharmacists, and shall receive the benefits and
Operation of Retail Pharmaceutical Outlet or privileges appurtenant thereto upon payment of the
Establishment. - The opening of a retail required fees and dues.
pharmaceutical outlet or establishment shall be
subject to requirements provided for in this Act and Membership in the integrated APO shall not be a bar
the rules and regulations prescribed by the FDA. to membership in other associations of pharmacists.

Section 39. Handling of Pharmaceutical Products by Section 42. Membership to the Integrated and
Persons Other Than a Pharmacist. - For the purpose Accredited Professional Organization. - All registered
of this section, persons handling pharmaceutical pharmacists must be members of the APO and must
products, other than the pharmacist, which shall maintain membership throughout the duration of
include pharmacy owners who are non-pharmacists, the practice of the profession. The PIC shall not be
medical representatives or professional service renewed if the requirements for membership with
representatives, pharmacy support personnel, the APO are not met including credit units for
pharmacy technicians, pharmacy assistants, attendance to duly accredited CPD.
pharmacy aides, persons who assist pharmacists in
any part of a pharmacy operation, or any other All pharmacy support personnel must be registered
person performing functions involved in the handling as affiliate members of the APO and must likewise
of pharmaceutical products, shall be duly certified by maintain membership throughout the duration of
appropriate government agencies after undergoing employment in pharmaceutical establishments and
an accredited training program. outlets.

No person, except pharmacy graduates, shall be

allowed to render such services without undergoing
a comprehensive standardized training program:
Provided, That the job description is defined in the
implementing rules and regulations of this Act.

Section 40.Administration of Adult Vaccines.- In

addition to the requirement provided in Section 4,
paragraph (g) of this Act, licensed and trained
pharmacist who shall administer adult vaccines shall
ensure that the vaccine to be administered shall
have a doctor’s prescription which is not more than Section 43. Specialty Boards in Various Areas of
seven (7) days old and submit a monthly vaccination Pharmacy Practice. - Specialty Boards in various
report and AEFI report to DOH regional offices using areas of pharmacy practice shall be created, subject
the prescribed form. to accreditation by the Board and the PRC. The
Board shall issue guidelines in the accreditation of
specialty boards in various areas of pharmacy approval of this Act, the Board, subject to the
practice, which shall include the standards of approval by the PRC, and in consultation with the
practice within different specialties, qualifications, APO, shall formulate and issue the rules and
and requirements for the certification of regulations to implement the provisions of this Act.
practitioners under each specialty, among others.
Section 51. Separability Clause. - If any clause,
M2 Lesson 1.6: RA 10918 (Article 6 & 7) provision, paragraph or part hereof shall be declared
Article VI unconstitutional or invalid, such declaration shall not
Violations, Administrative Sanctions, and Procedures affect, invalidate, or impair the other provisions
otherwise valid and effective.
Section 44. Revocation or Suspension of the
Certificate of Registration and Cancellation of Section 52.Repealing Clause.- Republic Act No. 5921,
Special/Temporary Permit.— The Board shall have as amended, is hereby repealed. AH other laws,
the power, upon notice and hearing, to revoke or presidential decrees, executive orders and other
suspend the COR of a registered pharmacist or to administrative issuances or parts thereof which are
cancel an STP of a foreign pharmacist. contrary to or inconsistent with the provisions of this
Act are hereby repealed, amended, or modified
Article VII accordingly.
Penal Provisions Section 53.Effectivity.- This Act shall take effect
Section 45. Penal Provisions. - Any person who shall fifteen (15) days after its publication in the Official
commit any of the following acts shall, upon Gazette or in a newspaper of general circulation.
conviction, be sentenced to pay a fine of not less
than two hundred fifty thousand pesos
(₱250.000.00), but not exceeding five hundred
thousand pesos (₱500.000.00) 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.

M2 Lesson 1.7: RA 10918 (Article 8 & 9)

Article VIII
Final Provisions
Section 47.Enforcement.- It shall be the primary duty
of the Board and the PRC to effectively enforce the M2 Lesson 2.1: RA 8981
provisions of this Act. All duly constituted law Professional Regulation Commission (PRC) is a three
enforcement agencies and officers of the national, man commission attached to the office of the
provincial, city or municipal government or of any president for general supervision and coordination.
political subdivision thereof shall ensure the In P.D. No. 223, PRC was first created as a national
effective enforcement and implementation of the government agency which was previously called
provisions of this Act. Office of the Boards of Examiners.

Section 48. Appropriations. - The Chairperson of the

PRC shall immediately include in its programs the
implementation of this Act, the funding of which
shall be charged against their current years’
appropriations and thereafter, in the annual General
Appropriations Act.

Section 49. Transitory Provisions. - The incumbent

Chairperson and members of the Board shall, in an
interim capacity, continue to function as such until
the Chairperson and members of the new Board,
M2 Lesson 2.2: RA 10912
created under this Act, shall have been appointed
and qualified.
RA 10912: CONTINUING PROFESSIONAL
DEVELOPMENT ACT OF 2016 was authored by Sen.
Section 50. Implementing Rules and Regulations. -
Antonio Trillanes IV, Sen. Cynthia Villar, and Sen.
Within one hundred twenty (120) days after the
Francis Escudero. It was lapsed into law July 21,
2016. This law is composed of six Articles that focus according to educational and training
on life long learning of professionals in their arrangements
respective fields. The creation of RA 10912 institutes  Informal learning - refers to learning that
measures that will continuously improve the occurs in daily life assessed, through the
competence of the professionals in accordance with recognition, validation and accreditation
the international standards of practice, thereby, process, and which can contribute to a
ensuring their contribution in uplifting the general qualification.
welfare, economic growth and development of the  Online learning activities -refer to
nation. structured or unstructured learning
initiatives, which make use of the internet
and other web-based Information and
Communications Technology solutions.
 Professional work experience -refers to a
person’s skills, knowledge and
competencies that have been acquired
through work experience, training,
independent study, volunteer activities and
hobbies, that may be applied for academic
credit, as a requirement of a training
program or for occupational certification.
Any excess credit units shall not be carried over
to the next 3-year period, except credit units
earned for doctoral and master's degrees or
specialty trainings which shall only be credited
once during the compliance period.

There is hereby created a CPD Council in each of the

regulated professions, which shall be under the
supervision of the concerned PRB. Every CPD Council
shall be composed of a chairperson and two (2)
CONTINUING PROFESSIONAL DEVELOPMENT is
members.
defined as the inculcation of advanced knowledge,
skills and ethical values in a post-licensure
The CPD council is the body created to promote and
specialization or in an inter- or multidisciplinary field
ensure the continuous improvement of
of study, for assimilation into professional practice,
professionals, in accordance with national, regional
self-directed research and/or lifelong learning.
and international standards of practice
CPD is composed of different activities that range
from structured to non-structured activities, which
The chairperson of the CPD Council shall be the
have learning processes and outcomes. The
member of the PRB so chosen by the PRB concerned
following are NATURE OF CPD PROGRAMS:
to sit in the CPD Council.
 Self-directed learning - on-line trainings,
local/international seminars/non-degree
The first member shall be the president or officer of
courses, institution/company-sponsored
the AIPO/APO duly authorized by its Board of
training programs, and the like which did
Governors/Trustees. In the absence of the
not undergo CPD accreditation but may be
AIPO/APO, the PRB concerned shall submit within
applied for and awarded CPD units by the
ten (10) working days from notification of such
respective CPD Councils
absence, a list of three (3) recommendees from the
 Formal learning -educational arrangements
national professional organizations. The PRC shall
such as curricular qualifications and
designate the first member within thirty (30) days
teaching-learning requirements that take
from receipt of the list.
place in education and training institutions
recognized by relevant national authorities,
The second member shall be the president or officer
and which lead to diplomas and
of the national organization of deans or department
qualifications.
chairpersons of schools, colleges or universities
 Nonformal learning - refers to learning that
offering the course requiring the licensure
has been acquired in addition or
examination. In the absence of such organization,
alternatively to formal learning, which may
the PRB concerned shall submit, within ten (10)
be structured and made more flexible
working days from notification of such absence, a list available at Standards and Inspection Division office,
of three (3) recommendees from the academe. The PRC-PICC and PRC Regional Offices
PRC shall designate the second member within
twenty (20) working days from receipt of the list. Under the Self-Directed Learning and/or Lifelong
Learning track, what do you mean when you say that
The term of office of the chairperson of the CPD the prescribed fee is ₱ 1,000.00 per application?
Council shall be coterminous with his/her
incumbency in the PRB unless sooner replaced by A professional shall collate all activities he/she has
the PRB concerned through a resolution, subject to undergone or attended to from a non-CPD Provider 3
the approval of the PRC. The first and second years prior to the renewal of his/her PIC and apply
members shall have a term of office of two (2) years one time to the concerned CPD Council.
unless sooner replaced through a resolution by the
AIPO/APO concerned or the organization of deans or The CPD Council will convert such activities to CPD
heads of departments, respectively. However, Credit Units and the professionals will be entitled to
members of the CPD Council who are appointed by a Certificate of Credit Units Earned.
the PRC may be replaced before the end of the two
(2)-year period, upon the recommendation of the M2 Lesson 3: Institutional Review Board (IRB)
PRB through a resolution. DEFINITION OF TERMS:

Research shall refer to the development of

knowledge with the aim of understanding health
challenges and mounting an improved response to
them. This covers the full spectrum of research in
five (5) generic areas of activity: (1) measuring the
problem; (2) understanding its cause(s); (3)
elaborating solutions; (4) translating the solutions or
evidence into policy, practice and products; and (5)
evaluating the effectiveness of solutions.
Initially, every professional is required to accumulate
45-120 credit units before one can renew the Philippine National Health Research System (PNHRS)
Professional Identification Card. Fortunately, upon shall refer to a framework anchored on the
amending some of the provisions, the required principles of Essential National Health Research on
credit units for professionals were reduced to 15 inclusiveness, participation, quality, equity, efficiency
credit units. and effectiveness, which connect to, and converge
with, the wider health, economic, political,
The following are the series of amendments of RA educational and S&T systems of the country.
10912:
 PRC Resolution 2013-774 Philippine Health Research Ethics Board (PHREB)
 PRC Resolution 2016-990 shall refer to the national policymaking body on
 MC No. 07 s 2017 (CPD Exemption health research ethics, created under DOST Special
Guidelines) Order No. 091, which is mandated to ensure that all
 PRC Resolution No. 2019-1146 phases of health research shall adhere to the
universal ethical principles that value the protection
and promotion of the dignity of health research
Frequently Asked Questions participants.
Are Senior Citizens exempted from CPD
requirement? To read RA 10532 “Philippine National Health
Research System Act of 2013″, download this
No. The law does not provide any exemption from Download this.
CPD compliance for the renewal of Professional
Identification Card. Good Clinical Practices (GCP) – an international
ethical and scientific quality standard for designing,
Where to get the application forms for self-directed? conducting, recording, and reporting trials that
involve the participation of human subjects;
The Continuing Professional Development (CPD) compliance with these standards provides public
forms can be downloaded from PRC website or assurance that the rights, safety, and well-being of
trial subject are protected, consistent with the
principles that have their origin in the International Principle 9: Qualified and duly licensed medical
Declaration of Helsinki, and that the clinical trial data personnel (i.e., physician or, when appropriate,
are credible. dentist) should be responsible for the medical care
of trial subjects, and for any medical decision(s)
WHO Principles of GCP made on their behalf.

Principle 1: Research involving humans should be Principle 10: Each individual involved in conducting a
scientifically sound and conducted in accordance trial should be qualified by education, training, and
with basic ethical principles, which have their origin experience to perform his or her respective task(s)
in the Declaration of Helsinki. Three basic ethical and currently licensed to do so, where required.
principles of equal importance, namely respect for
persons, beneficence, and justice, permeate all other Principle 11: All clinical trial information should be
GCP principles. recorded, handled, and stored in a way that allows
its accurate reporting, interpretation, and
Principle 2: Research involving humans should be verification.
scientifically justified and described in a clear,
detailed protocol. Principle 12: The confidentiality of records that could
identify subjects should be protected, respecting the
Principle 3: Before research involving humans is privacy and confidentiality rules in accordance with
initiated, foreseeable risks and discomforts and any the applicable regulatory requirement(s).
anticipated benefit(s) for the individual trial subject
and society should be identified. Research of Principle 13: Investigational products should be
investigational products or procedures should be manufactured, handled, and stored in accordance
supported by adequate non-clinical and, when with applicable Good Manufacturing Practice (GMP)
applicable, clinical information. and should be used in accordance with the approved
protocol.
Principle 4: Research involving humans should be
initiated only if the anticipated benefit(s) for the Principle 14: Systems with procedures that assure
individual research subject and society clearly the quality of every aspect of the trial should be
outweigh the risks. Although the benefit of the implemented.
results of the trial to science and society should be
taken into account, the most important To read the handbook for Good Clinical Research
considerations are those related to the rights, safety, Practice (GCP) from WHO, download this Download
and well-being of the trial subjects. this.
Ethical Considerations in Research
Principle 5: Research involving humans should  Conflicts of interest
receive independent ethics committee/ institutional  Privacy and confidentiality
review board (IEC/IRB) approval/favorable opinion  Informed consent process
prior to initiation.  Vulnerability
 Recruitment
Principle 6: Research involving humans should be  Justice
conducted in compliance with the approved  Assent
protocol.  Risks and Benefits
 Incentives and compensation
Principle 7: Freely given informed consent should be  Community consideration
obtained from every subject prior to research  Transparency
participation in accordance with national culture(s) 
and requirements. When a subject is not capable of To read the complete content of National Ethical
giving informed consent, the permission of a legally Guidelines 2017, click this Download this.
authorized representative should be obtained in To visit the website of CEU's IERC, click this link.
accordance with applicable law. https://www.ceu.edu.ph/institutional-research-
committees (Links to an external site.)
Principle 8: Research involving humans should be To check for the template used by complying to
continued only if the benefit-risk profile remains university's IERC, download this Download this.
favorable.
Case Study. Research Involving Minors
Comparing Childhood Vaccination Regimens
Source: El Salvador National Ethics Committee, San AO 2015-0053 “Mexico Accord”
Salvador, El Salvador DEC 21, 2015

A study is being planned to compare a new SUBJECT: Implementing Guidelines on the Promotion
childhood vaccine consisting of five components in a and Marketing of
single dose with the existing regimen. At present, Prescription Pharmaceutical Products and Medical
children in this country receive a vaccine with three Devices
components in a single dose, and two additional
components in a separate dose, all given during the Specific Objectives
same visit. To prescribe standards, guidelines, and regulations
with respect to information dissemination,
The study group will be boys and girls, 15 months advertisements, promotion, sponsorship, and other
old, who would go to the country’s Health Units for marketing activities and instruments about
the current vaccination regimen. The plan is to enroll prescription pharmaceutical products and medical
300 children in three months. After parental devices with the end goal of improving and
informed consent, children will be randomized to promoting their rational use, and safeguarding
receive the current vaccination regimen or the new, patient rights and welfare.
one-dose regimen.
This Order shall ensure that ethical interactions
The investigation would be conducted in five Health between industry and other stakeholders shall be
Units of the Ministry of Health, where the guided by the-principles embodied in the Mexico
application of the current vaccination regimen is City and
mandatory and free of charge. The Ministry of Kuala Lumpur Business Codes of Ethics: Healthcare
Health has given approval to conduct the study. and Patient Focus, Integrity, Independence,
Legitimate Intent, Transparency, Accountability,
The main endpoints are: Appropriateness and Advancement.
• Adverse experiences or reactions to the vaccine.
• Antibodies produced in response to the vaccines. DEFINITION OF TERMS
For this purpose, the children will Healthcare Professional (HCP) - means any member
have to provide a blood sample at the time of the of the medical, dental, pharmacy or nursing
injection and one month after. profession or any other person who, in the course of
his/her
Blood samples will be taken at each clinic, be sent to professional activities, may prescribe, recommend,
a central laboratory, and then be sent out of country purchase, supply, administer or dispense a health
for antibody analysis. Private pediatricians will be product accordingly.
contracted as investigators to reinforce the
pediatricians of the Health Units. In case of adverse Promotion - means the practice of giving value to a
events, participants would be referred to the brand, product, service to achieve specific marketing
government’s Children’s Hospital. objectives. It includes the distribution of free/sample
pharmaceutical products. It shall also refer to tall
Observations: informational and persuasive activities by
• The parents of children seeking care in the Health manufacturers and distributors, the effect of which is
Units typically are economically poor. to induce the prescription, supply, purchase and/or
• Most of the parents do not read and write and use of medicinal drugs.
have little formal education.
• Children often come to the Health Units with Salient points
individuals other than parents, who are often Promotional Information and Activities
working.
Information provided by Prescription Pharmaceutical
Thoughts to ponder Products and Medical Devices (PPPMD)
Can researchers assure that the individuals manufacturers and distributors to health
accompanying the children have legal responsibility professionals regarding their products shall be
for the child? What should researchers do in cases restricted to evidence-based scientific data.
where legal responsibility is uncertain? One-sided information and any decisive statement
based on inadequate evidence is prohibited.
M2 Lesson 4 AO 2015-0053 “Mexico Accord” Superlatives, exaggerations and lines with hanging
comparatives, without supporting data. E.g., "This prescription products to anyone other than licensed
product is better (e.g. Safety, efficacy, quality, and physicians and dentist.
price) because...." is also prohibited. Conduct of Training of PPPMD Company
Representatives
Symposia and Congresses
Companies may support party conferences provided: The practice of looking through prescriptions made
The meals provided are modest; by doctors at pharmacy outlets is a violation of
No entertainment that would incur expenses; patient confidentiality. Likewise, the offer and
The venue is appropriate and conducive to the provision of financial rebates to doctors who make a
scientific/educational objectives, no extravagant specified quantity of prescriptions is unethical. Direct
venues are allowed. marketing of medical representatives with patients
are strictly prohibited.

Entertainment and Recreation Clinical Trials

To ensure appropriate focus on education and Researchers shall disclose that the activity is funded
informational exchange and to avoid the appearance by a particular PPPMD company in their publication
of impropriety, PPPMD companies shall not provide and any potential or actual conflict of interest in the
any form of entertainment that would incur conduct of the study shall be likewise stated.
expenses. PPPMD Company Donations Charitable Purposes
PPPMD Companies are prohibited from paying any
travel sponsorship, meals, or other expenses of Such donations shall not be made for promotional
accompanying guests or family members of HCPs. reasons, or be an incentive to prescribe, recommend
or purchase any pharmaceutical product or medical
Educational ltems and Gifts device.
Gifts or personal services and benefits unrelated to
the work of the HCP shall not be provided by any Patient Organization
PPPMD company representative to a health care PPPMD companies may give support to patient
professional or members of their families. organizations, provided that it is not intended to
PPPMD companies may provide promotional aids to influence them to favor any particular product.
HCPs, provided these (a) are of modest value; and
(b) are relevant to the practice of the health care Introduction
professions or education of the patients. Drugs must undergo a rigorous evaluation of safety,
PPPMD companies may occasionally provide items of quality, and effectiveness before they can be sold.
medical utility to HCOs and HCPs such as textbooks, The drug review process standard of FDA is set to
subscriptions to medical journals or anatomical follow by drug manufacturers, drug distributors,
models which benefit patients or serve a genuine community/drugstores in regulating the quality of
educational function for the HCO or HCP. Items of medicines for patients. Upon upgrading their
medical utilitv should be modest. organization, the agency ensures the safe and
effective drugs are available to improve the health of
Support for Continuing Professional Development the people of the Philippines.
(CPD)
Industry sponsorship of HCPs to events involving In this module, we will tackle the different laws
foreign/local travel shall be allowed but selection of created to safeguard the health of the people as well
the HCPs should be unrelated to prescribing and sale as the roles of FDA in ensuring the implementation
of the PPPMD company's products. of such laws.
PPPMD company may sponsor a maximum of 20
HCPs to each legitimate overseas scientific M3 Lesson 1: RA 3720
educational event. Family members or guests of the Republic Act No. 3720 “Foods, Drugs, Devices and
HCPs are not allowed to be sponsored. Cosmetics Act” as amended by E.O. 175
Samples Title: AN ACT TO ENSURE THE SAFETY AND PURITY
OF FOODS AND COSMETICS, AND THE PURITY,
Manufacturers and distributors shall not be SAFETY, EFFICACY AND QUALITY OF DRUGS AND
permitted to give directly or indirectly, samples of DEVICES BEING MADE AVAILABLE TO THE PUBLIC,
prescription pharmaceutical products or medical VESTING THE BUREAU OF FOOD AND DRUGS WITH
devices to the general public or gifts of any sort to AUTHORITY TO ADMINISTER AND ENFORCE THE
any member of health care professional's immediate LAWS PERTAINING THRETO, AND FOR OTHER
family. They shall not distribute samples of PURPOSES.
Objectives: manufactured, importer, packer, or
1. Establish standards and quality measures prepared or distributor, and (b) an
for foods, drugs, and devices and cosmetics. held under accurate statement of
2. Adopt measures to ensure pure and safe unsanitary the quantity of
supply of foods and cosmetics, and pure, conditions contents in terms of
safe, efficacious and good quality drugs and 3. It is composed weight, measure or
devices in the country. of any numerical count.
3. Adopt measures to ensure the rational use poisonous or If any word or
of drugs and devices, such as, but not deleterious information required is
limited to, banning, recalling or withdrawing substances not prominently placed
from the market drugs and devices which 4. It contains any with conspicuousness
are not registered, unsafe, inefficacious or color other If it is for use of man
of doubtful therapeutic value, the adoption than a and contains any
of an National Drug Formulary, and the use permissible quantity of narcotic or
of generic names in the labeling of drugs. one hypnotic substances
4. Strengthen the Bureau of Food and Drug 5. It purports to It is not designated
FDA Functions: be an official solely by a name
1. To administer and supervise the drug and its recognized in an official
implementation of this Act and of rules and strength compendium
regulation issued pursuant to the same. differs from,
2. To provide for the collection of samples of or its safely,
food, drug and cosmetic. efficacy,
3. To analyze and inspect food, drug and quality or
cosmetic in connection with the purity falls
implementation of this Act. below the
4. To establish analytical data to serve as basis standards set
for the preparation of food, drug and forth
cosmetic standards, and recommend 6. It has been
standards of identity, purity, quality and fill mixed or
of container. packed or
5. To issue certificate of compliance with substituted so
technical requirements to serve as bases for as to reduce
the issuance of license and spot-check for safety,
compliance with regulations regarding efficacy,
operation of food, drug and cosmetics quality,
manufacturers and establishments. strength or
6. To levy, assess and collect fees for purity
inspection, analysis and testing of products 7. Methods,
and materials submitting in compliance with facilities or
the provisions of this Act. controls used
7. To certify batches of antibiotics and do not
antibiotic preparations conform to
FDA Divisions: current good
 Inspection and Licensing Division manufacturing
 Laboratory Division practices
Adulterated food Misbranded Food
SUMMARY OF ADULTERATED/MISBRANDED
PRODUCTS Contains Misleading label
Adulterated Drugs or Misbranded Drugs and deleterious/poisonous
Devices: Devices: substances Sold under the name of
1. If it consists in another
whole or part Labeling is false or Filthy, putrid,
of any filthy, misleading decomposed subs. Imitation of another
or It did not contain (a) food
decomposed the name and place of Omitted valuable
substances business of the constituents Important information
2. It has been manufacturer, not written on the label
Added substance so as directly to the Secretary of Health (Philippines).
to increase its bulk or - vitamin, mineral, Rolando Enrique Domingo, MD is the incumbent
weight artificial Director General since March 2020.

Contains coal-tar more flavoring The FDA has its central office in Alabang,
than the permissible Muntinlupa. The agency has 4 centers located at its
quantity central office, and 5 clusters of field regulatory
Adulterated Cosmetics Misbranded Cosmetics operations and 4 laboratories located throughout
the archipelago.
Poisonous / deleterious Misleading label
(substances such as
dyes that can cause
blindness or skin
irritation)

Coal-tar (other than

which is permissible)

M3 Lesson 2: RA 9711

REPUBLIC ACT NO. 9 7 11

Approved date: August 18, 2009 M3 Lesson 3.1: RA 8203 Counterfeit drugs

Title: AN ACT STRENGTHENING AND RATIONALIZING R.A. 8203 : "Special Law on Counterfeit Drugs"
THE FOOD AND DRUGS (BFAD) BY ESTABLISHING Approved Date: September 4, 1996
ADEQUATE TESTING LABORATORIES AND FIELD
OFFICES, UPGRADING ITS FQUIPMENT,
AUGMENTING ITS HUMAN RESOURCE
COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS Title: AN ACT OF PROHIBITING COUNTERFEIT DRUGS,
INCOME, RENAMING IT THE FOOD AND DRUG PROVIDING PENALTIES FOR VIOLATIONS AND
ADMINISTRATION (FDA), AMENDING CERTAIN PPROPRIATING
SECTIONS OF REPUBLIC ACT NO. 3720, AS FUNDS THEREFOR
AMENDED, AND APPROPRIATING FUNDS THEREOF
Article II Sec XV of 1987 Philippine Constitution
Background
The Food and Drug Administration (FDA) of the The State shall protect and promote the right to
Philippines, formerly the Bureau of Food and Drugs, health of the people and instill health consciousness
is a health regulatory agency under the Department among them.
of Health (Philippines) created on 1963 by Republic
Act No. 3720, amended on 1987 by Executive Order It is also further declared the policy of the State that
175 otherwise known as the “Food, Drugs and in order to safeguard the health of the people, the
Devices, and Cosmetics Act”, and subsequently State shall provide for their protection against
reorganized by Republic Act No. 9711 otherwise counterfeit drugs.
known as “The Food and Drug Administration Act of
2009”. The agency is responsible for licensing, What is a counterfeit drug/medicine?
monitoring, and regulation of cosmetics, drugs,
foods, household hazardous products, medical a. medicinal products with the correct ingredients
devices[2] and electromagnetic radiation emitting but not in the amounts as provided hereunder,
devices, pesticides, tobacco and related products, wrong ingredients, without active ingredients, with
and vaccines for safety, efficacy, and quality in the insufficient quantity of active ingredient, which
Republic of the Philippines. results in the reduction of the drug’s safety, efficacy,
quality, strength or purity.
The Philippine FDA is led by the Director General
appointed by the President of the Philippines and b. It is a drug which is deliberately and fraudulently
two deputies for Internal Management and Field mislabeled with respect to identity and/or source or
Regulatory Operations. The Director General reports
with fake packaging, and can apply to both branded b.presentation of certificates and other documents
and generic products. evidencing the importation or exportation of the
counterfeit drugs found in his possession as required
c. the drug itself or the container or labeling thereof by existing laws, including those documents required
or any part of such drug, container or labeling in the preceding paragraph covering the commercial
bearing without authorization the trademark, trade transactions involving counterfeit drugs.
name or other identification mark or imprint or any
likeness to that which is owned or registered in the Forging, counterfeiting, simulating or falsely
Bureau of Patent, Trademark and Technology representing, or without proper authority, using any
Transfer (BPTTT) in the name of another natural or mark, stamp, tag, label or other identification mark
juridical person; or device authorized or required by Republic Act No.
3720, as amended, and/or the regulations
d. a drug product refilled in containers by promulgated under this Act;
unauthorized persons if the legitimate labels or Photocopying, duplicating, altering, printing,
marks are used; transferring, obliterating or removing the approved
label or any part thereof, lawfully belonging to
e. an unregistered imported drug product, except another person, for the purpose of using such label
drugs brought in the country for personal use as or a part thereof on any counterfeit drug.
confirmed and justified by accompanying medical Making, selling, or concealing any punch, die, plate
records; or any other equipment or instrument designed to
print, imprint or reproduce the trademark, trade
f. a drug which contains no amount of, or a different name or other identifying mark of another registered
active ingredient, or less than eighty percent (80%) producer without authority from the legitimate
of the active ingredient it purports to possess as owners of the trademark or trade name.
distinguished from an adulterated drug including
reduction or loss or efficacy due to expiration. Parties Liable

a)the manufacturer, exporter or importer of the

counterfeit drugs and their agents: Provided, That
the agents shall be liable only upon proof of actual or
constructive knowledge that the drugs are
counterfeit;

Constructive knowledge – shall mean, that by

exercise of reasonable care, one would have known
the fact or suspect that the drug product he or she
has sold or in possession of is counterfeit, such as
but not limited to the knowledge that the drug was
not covered by any sales invoice or evidence of
delivery of purchase from BFAD license drug
establishment.
Prohibited Acts
The manufacture, sale, or offering for sale, donation, b) the seller, distributor, trafficker, broker or donor
distribution, trafficking, brokering, exportation, or and their agents, upon proof of actual or
importation or possession of counterfeit drugs as constructive knowledge that the drugs sold,
defined in Section 3 hereof not otherwise covered by distributed, offered or donated are counterfeit
Republic Act No. 3720, as amended. drugs;
Possession of any such counterfeit drugs.
HOWEVER, any person found in possession of c) the possessor of counterfeit drugs as provided in
counterfeit drugs, in violation of this subsection, Section 4 (b) hereof;
shall be exempted from liability under the provisions
of this Act after: d) the manager, operator or lessee of the laboratory
or laboratory facilities used in the manufacture of
a.presentation of sales invoices, official receipts or counterfeit drugs;
other legally acceptable documents
e) the owner, proprietor, administrator or manager
of the drugstore, hospital pharmacy or dispensary,
laboratory or other outlets or premises where the –Regulation Division I may require the registered
counterfeit drug is found who induces, causes or brand-owner of the CD certifying the suspected drug
allows the commission of any act herein prohibited; products has been manufactured by them. However,
certification shall be validated by PSD.

When to refer to LICD for Investigation

–If the product’s result is counterfeit, LSD or PSD
shall forward the result to LICD. Otherwise, the
result of the examination shall be released by the
Regulation Division concerned.

When the product is found not counterfeit

–PSD of LSD shall forward the report of
exam/evaluation to the FDRO through his division
chief.

–If the sealed products are within Metro Manila, the

reg div concerned shall, within 16 working hours
M3 Lesson 3.2: RA 8203 Monitoring of CDs
from the receipt of the report shall notify the outlet/
establishment through the fastest communication.
Only FDRO can unseal suspected products before it
can be released for distribution to legitimate
commerce.

–If the sealed products are outside Metro Manila,

the reg div concerned shall send a notice to release
the products through the FDA Regional Director
Monitoring of Counterfeit Drugs within 16 working hours from receipt of the notice.

Procedure for monitoring counterfeit drugs –The FDRO assigned in the said province shall within
–The FDROs, during inspection of the establishment, 16 hours from the receipt of the notice unseal the
shall determine whether the drug product is suspected drugs for distribution to legitimate
counterfeit or not. commerce.

– If suspect certain stocks are CD, they shall conduct Possession of CD by Owners of Trademarks, Trade
an inventory, segregate and seal it. Collect samples Names or Other Identifying Marks; when to report
for examination of its genuineness and authenticity –It shall be reported to FDA within 10 days from the
time of purchase or acquisition of such drugs as
–The FDRO shall require the owner/ representative indicated in the sales invoices or receipt or other
of the establishment/ outlet to produce the sales similar documents.
invoice, delivery receipt, or documents covering the
suspected CDs. –The sales invoices or receipt or other similar
documents shall be attached to the said report on
FDRO will only acknowledge invoices or documents CDs.
issued by a FDA-licensed establishment (lot # and
expiry date) –Failure to comply is a violation under Sec 4(a) of RA
–FDRO shall submit the samples to LSD or PSD for 8203.
examination and evaluation.

Duration in the conduct of Examination

–FDA shall have 20 working days to determine the
genuineness and authenticity of the product.

When there is no need for laboratory testing

–Physical examination shall be done and PSD shall
conduct the examination of the same.
 determined or found to be counterfeit, the Bureau
shall, within (15) days from their seizure, issue an
order directing the preventive closure of the
business establishment for a period not exceeding
thirty (30) days.

Thereafter, administrative proceedings shall be

initiated by the Bureau against the parties concerned
where they shall have the opportunity to be heard
and present evidence on their behalf;

–In the hearing, upon the motion of the Respondent,

the witness upon which the memorandum of
Procedure in the Filing of Administrative Complaint evidence had been issued shall be called to affirm
the documentary evidence.
Where to file the complaint
–File an affidavit or letter form with the FDA LICD or –The party-respondent shall be given the
any FDA accredited Complaint Desk opportunity to confront or cross-examine the said
witnesses.
Contents of the Complaint Affidavit
–Name of the product, lot number, expiry –After cross-examination, the party respondent shall
–Name and address of the person or establishment be given another 10 days to supplement his position
or company (respondent) paper.
–Specific acts that shall allege as having been
committed c) to ensure the effective enforcement of the
-Remedy or relief or action he shall intend FDA to foregoing, the Bureau may enlist the assistance of
take the national or local law enforcement agencies.

Complaint filed by a Consumer, a Physician The administrative proceedings shall be completed

Prescriber and Other Interested Party and terminated within 30 days period; otherwise, an
–May file a letter of complaint or information about order lifting the preventive closure shall be issued
suspected CD. The letter shall state: without prejudice to the resolution of the
administrative case.
Name of suspected product
 The source – name and address whom Decision
he/she acquire the said product –It shall be decided by the Director General of FDA
 Mode of acquisition within 30 days from the date it shall be deemed
 Reason or fact giving rise to the suspicion submitted for decision.
that the drug product is counterfeit.
–Final and executory after the lapse of 15 days from
Administrative Proceedings the receipt of parties or from notice.
a) the duly authorized / deputized officers by the
Bureau for the purpose shall segregate, seal and Finality of Decision /Resolution
after having obtained a valid search warrant from a
competent court, seize such counterfeit drugs and –Final and executory after the lapse of 15 days from
take them into custody: the receipt of parties or from notice.

Provided, That in case the suspected counterfeit Appeal

drugs are found in a private residence, or in other
premises not covered by a valid license to operate Motion for Reconsideration
issued by the Bureau, the duly authorized officer of –No motion for reconsideration from an
the Bureau shall secure a search warrant for the interlocutory order shall be allowed.
purpose of seizing and taking into custody such
suspected counterfeit drugs; –Only one motion for reconsideration shall be
allowed and only upon the grounds that:
b) if, after the appropriate examination of the
samples by the Bureau, the seized drugs are Resolution is not supported by substantial evidence
Conduct of the administrative investigation is than 6 months and 1 day, but not more than 6 years
attended with irregularity imprisonment; or

When to appeal? e) if, as a result of the use of the drug found to be

–The aggrieved party may appeal the decision of the counterfeit, the illness sought to be cured is
Director General of the FDA within 15 days from the aggravated or physical injury or suffering results
receipt thereof to the Secretary of Health. therefrom, a punishment of imprisonment from 12
years to 15 years and a fine ranging from P100,000
–Abuse of discretion to P500,000 or
–Decision is not supported by substantial evidence f) should a counterfeit drug be the proximate cause
–Irregularity in the conduct of investigation of death of a victim, who unknowingly purchased
and took a counterfeit drug, the penalty of life
Ground for appeal imprisonment and a fine of P500,000 to P5,000,000
–Abuse of discretion shall be imposed. In case any act prohibited in
–Decision is not supported by substantial evidence Section 4 hereof is also punishable under other laws,
–Irregularity in the conduct of investigation the offender shall, if warranted by the evidence, be
prosecuted under the law prescribing the highest
How appeal is made? penalty.
–File a Notice of appeal with the FDA
–FDA shall forward the records of the case to the M3 Lesson 4.1: AO 2016-0034 General Provisions
Office of the Secretary within 15 days from receipt of
the notice of appeal. Administrative Order No. 2014-0034
Execution Pending Appeal October 13, 2014
–The appeal when filed by respondent shall not stop
the execution of the decision, unless the bond in the RULES AND REGULATIONS ON THE LICENSING OF
amount of P100,000.00, the minimum administrative ESTABLISHMENTS ENGAGED IN THE MANUFACTURE,
fine imposable. CONDUCT ON CLINICAL TRIAL, DISTRIBUTION,
IMPORTATION, EXPORTATION AND RETAILING OF
M3 Lesson 3.3: RA 8203 Sanctions and penalties DRUG PRODUCTS, AND ISSUANCE OF OTHER
Administrative Sanctions RELATED AUTHORIZATIONS

OBJECTIVES:
To establish rules and regulations in the licensing of
Penalties drug establishments to align with the recently
a)Possession of counterfeit drugs - imprisonment of promulgated laws and regulations;
not less than 6 months and 1 day; but not more than To ensure compliance of establishments to FDA and
6 years international regulatory standards and requirements
b) Manufacturer, seller, etc. (under Sec. 4) - of the following, but not limited to, Good
imprisonment of 6 years and 1 day, but not more Manufacturing Practice (GMP), Good Distribution
than 10 years or a fine of not less than P100,000 but Practice (GDP), Good Storage Practice (GSP), and
not more than P500,000 or Good Clinical Practice (GCP); and
c) counterfeit drug is intended for animals To prescribe the use and implementation of
imprisonment of not less than 6 months and 1 day, innovations, such as but not limited to, electronic
but not more than 2years and 4 months data messages, electronic submission of documents
d) imprisonment of not less than 6 years and 1 day and electronic signatures in the Food and Drug
but not more than 10 years for any manufacturer, Administration pursuant to Republic Act No. 8792 or
seller or distributor who shall conceal, substitute, the “Electronic Commerce Act of 2000”
dispose or destroy any drug as may have been
segregated and sealed by the Bureau or who shall SCOPE AND COVERAGE
break, alter or tamper any mark or seal used by the  Shall apply to establishments in the country,
Bureau to identify those segregated drugs as including local government units,
provided for under Section 6(a) of this Act. government owned and controlled
corporations, non-government
Any other person who breaks, alters or tampers organizations, other government offices and
any mark or seal used by the Bureau to identify the instrumentalities engaged in the
segregated drugs shall suffer the penalty of not less manufacture, distribution, importation,
exportation, sale, offer for sale and transfer
 of drug product. This shall also apply to
Contract Research Organizations (CROs) and
/ or Sponsors engaged in the conduct of
clinical trials.
 Entities engaged in the activities such as
donation, promotion, advertising, or
sponsorship of drug product shall secure
appropriate authorizations in accordance
with existing rules and regulations.
GENERAL PROVISIONS / GUIDELINES
 No drug establishment shall manufacture,
import, export, sell, offer for sale,
distribute, transfer, promote, advertise
and/or sponsor any activity that involves
drug product without first securing a
License to Operate or an appropriate
authorization from FDA pursuant to this
Administrative Order.
 The responsibility of ensuring the safety,
efficacy, quality and/or purity of any drug
product sold in its original packaging
(container) of which the seal has not been
broken or tampered with shall rest upon
the drug establishments involved in the
supply chain of sale, handling, transport,
distribution, trading and storage, among
others.  Any information, education and
 All establishments are required to communication campaign material
implement a risk management plan (RMP) promoting the safe and rational use of
which is a requirement for the issuance of drugs sha ll be displayed in a conspicuous
an LTO or other authorization. area of the drugstore.
o RMP- shall contain details on how  The FDA shall have the authority to enter
to identify, characterize, prevent, any establishment for (1) inspection of
and minimize risk relating to compliance and/or (2) verification of
products. This shall include submitted documents in relation to any
pharmacovigilance activities and application for issuance of appropriate
interventions authorization
 All drug distributors shall not sell directly to  All establishments shall abide with the
the general public or consumer, unless they guidelines of the FDA on electronic
have a License to Operate as a retailer. submissions and processes of LTO
 All institutional pharmacies procuring drugs applications into electronic format pursuant
to be dispensed whether at a cost or as part to Republic Act No. 8792 or the “Electronic
of employee’s benefits and/or its Commerce Act of 2000”
dependents must secure a LTO.
 All establishments engaged in retail, CLASSIFICATION OF DRUG ESTABLISHMENTS
whether privately owned or government-  Drug Manufacturer - Establishment
owned, shall be under the supervision of a engaged in all operations involved in the
registered pharmacist when operating or production of the drug product.
open for business, except otherwise  Drug manufacturer-Repacker -
allowed by other pertinent laws. Establishment that repacks a finished
 All licensed establishments engaged in the product into smaller quantities in a separate
manufacture, distribution, exportation, container.
importation, selling, transportation/  Drug manufacturer-Packer - Establishment
shipment of vaccines, biologics and other that packages a bulk drug product into its
temperature-sensitive drug products are immediate container.
hereby directed to comply with the Cold  Drug manufacturer-Trader - Establishment
Chain Management requirement. which is a registered owner of the drug
 product and the formulation and procures continuing non-submission of renewal
the RM and packaging components. application up to a maximum of 120 days.
 Renewal filed there after shall be
Drug Distributor considered expired and the application shall
 Drug Distributor-Exporter - Establishment be subject to a fee equivalent to the total
that exports RM, API, FP for distribution to surcharge plus the initial filing fee; the
other establishment outside the country application shall undergo the initial filing
o Drug Distributor-Importer - and evaluation procedure (FDA Circular #
Establishment that imports RM, 2011-004 dated 02 Nov 2011 for
API, FP for wholesale distribution computation of surcharge or penalty)
to other local FDA-licensed  For applications that undergo the initial
establishment. filing and evaluation:
o Drug Distributor-Wholesaler - o Submission of documentary
Establishment that procures RM, requirement is hereby waived
API, FP from local FDA-licensed except when there is a change or
establishment for local distribution variation effected on the drug
on wholesale basis. establishment.
AUTOMATIC RENEWAL (in IRR of RA 9711)
 Drugstore - Drugstore/Pharmacy/Botika,
including hospital pharmacy and Maybe granted under the following conditions:
institutional pharmacy shall refer to drug –Application is filed before the expiration date
establishment where registered drugs, –Prescribed renewal fee is paid upon filing
chemical products, dental, medicinal and –A sworn statement indicating no change or
household remedies are dispensed directly variation whatsoever in the establishment is
to the general public on a retail basis. attached to the application.

 Retail Outlet For Non-prescription Drug VARIATIONS IN LTO

(RONPD) -Drug establishment such as a MAJOR VARIATIONS
supermarket, convenient store and other  Refers to changes in the drug establishment
similar retail establishment authorized to operations that may affect significantly
sell only identified Over-The-Counter (OTC) and/or directly the aspects of safety,
and household remedy products directly to efficacy and quality of drug products they
the general public on a retail basis. are engaged in, and those changes affecting
significant particulars of the issued LTO.
 Sponsor - is an individual, company, MAJOR VARIATIONS
institution, organization or an entity which  Refers to changes in administrative
takes the responsibility for the initiation, documents and/or changes in the drug
management, and/or financing of a clinical establishment operations with minimal
trial. impact on the aspects of safety, efficacy and
quality of drug products they are engaged
 Contract Research Organization (CRO) - CRO in.
refers to a person or an organization
(commercial, academic, or other) M3 Lesson 4.3: FDA CIRCULAR NO. 2014-025
contracted by the sponsor to perform one (Drugstore)
or more of the sponsor’s trial-related duties FDA CIRCULAR NO. 2014-025
and functions. November 21, 2014

M3 Lesson 4.2: AO 2016-0034 Renewal and Variation GUIDELINES ON THE IMPLEMENTATION OF NEW
Renewal of LTO RULES AND REGULATIONS ON THE LICENSING OF
 Application for regular renewal shall be filed DRUGSTORE/ PHARMACY/ BOTICA AND SIMILAR
within six (6) months from the date of OUTLETS FOLLOWING ADMINISTRATIVE ORDER
expiration of LTO. NUMBER 2014-0034, DATED 13 OCTOBER 2014
 Renewal of LTO received after its expiration
date shall pay a surcharge equivalent to Evaluation
twice the renewal fee and additional 10% Application are initially reviewed by the respective
per month or a fraction thereof of FDA Regional Field Offices to determine the
compliance with the administrative and technical
requirements.

Post-Licensing Inspection
-Waived pre-opening inspection
-All drugstore/pharmacy/botica shall be subjected to
routine inspection for their compliance to GDP and
GSP.

DOCUMENTARY REQUIREMENTS
A. Initial LTO Application
1.Application Form
2.Proof of Business Name Registration
 Single proprietorship (DTI)
 Corporation/Partnership (SEC)
 Cooperative (CDA)
 Government-owned or controlled corp.
3. Credentials of Pharmacist
 Valid PRC ID
 Certificate of Attendance to appropriate
FDA Licensing Seminar
 Resignation of the Pharmacist from the
previous employer (if previously employed).
 Credentials of Responsible Pharmacy
Assistant (Certificate of Training for PA)
4.Risk Management Plan
 How to identify, characterize, prevent or
minimize risk relating to product and
patient safety
5. Location Plan (GPS coordinates)
6. Picture of establishment with display of signage
7. Proof of payment
e.g official receipt or authorized bank payment slip
8. Self-Assessment Toolkit (SATK)
 Shall be provided to serve as a guide to
clients in assuring the completeness and
correctness of the documentary
requirements to be submitted.
Additional Requirements

M3 Lesson 4.4: FDA CIRCULAR NO. 2014-026 (Drug

Distributor)

FDA CIRCULAR NO. 2014-026

November 21, 2014

GUIDELINES ON THE IMPLEMENTATION OF NEW

RULES AND REGULATIONS ON THE LICENSING OF
DRUG DISTRIBUTOR FOLLOWING ADMINISTRATIVE
ORDER NUMBER 2014-0034, DATED 13 OCTOBER o A plotted geolocation of all the
2014 other RONPDs supervised must
TO: DOCUMENTARY REQUIREMENTS also be submitted.
 Almost similar requirements with the
drugstore/ pharmacy/ botica outlet Evaluation of application
 Credentials of the Pharmacist and other  Application shall be initially reviewed by the
Qualified Personnel respective FDA Regional Field Offices
 The other qualified personnel shall be
listed, which includes pharmacovigilance Post-licensing inspection
officer. The credential will not be submitted  Must comply with GDP and GSP
during application but may be verified  Additional requirements:
during inspection.  Records/E-file (eg. Distribution records, SC
 Evaluation of the application and PWD record books, schedule of visit of
Desktop evaluation supervising pharmacist, location plan of
 Reviewed by FDA Regional Field Offices other RONPDs supervised)
 May require additional documents that will
show proof of compliance EXEMPTION IN PROVIDING ANOTHER PHARMACIST
Pre-Opening Inspection FOR ADDITIONAL LICENSED ACTIVITY
 Quality Management System
 Quality Manual and SOP MULTIPLE RONPD SUPERVISION
 Distributorship Agreement with foreign A single pharmacist is allowed to supervise multiple
source/supplier RONPDs provided the following rules are met:
 GMP Certificates or equivalent document of  The pharmacist is required to dedicate a
contracted foreign manufacturer minimum of two (2) hours a week of
 Credentials of other qualified personnel physical presence in the RONPD;
 Proof of Ownership/Lease of Agreement  The location of each RONPD must be within
 Reference Materials the same provincial local government unit
Post-Licensing Inspection (LGU) within each region, with the National
Capital Region considered as a single area
M3 Lesson 4.6: FDA CIRCULAR NO. 2014-028 due to its comparatively smaller land mass;
(RONPDS)  The distance between the two farthest
RONPDs must not exceed 25 km in distance;
FDA CIRCULAR NO. 2014-028  All other RONPDs supervised by a single
November 21, 2014 pharmacist must be within a circumferential
area when plotted between the two
GUIDELINES ON THE IMPLEMENTATION OF NEW farthest RONPDs; and
RULES AND REGULATIONS ON THE LICENSING OF  A maximum of fifteen (15) RONPDs is
RETAIL OUTLET FOR NON-PRESCRIPTION DRUGS allowed to be supervised by a single
(RONPDS) FOLLOWING ADMINISTRATIVE ORDER pharmacist.
NUMBER 2014-0034, DATED 13 OCTOBER 2014  Considerations may be given to
geographically disadvantaged areas.
LTO: DOCUMENTARY REQUIREMENTS  This exemption shall be duly noted in the
application indicating the pharmacist’s
 Almost the same with the drugstore/ duties and responsibilities, schedule and
pharmacy/ botica outlet, Drug Distributors, hours of supervision to each establishment
and Manufacturer signed both by the pharmacist and
 Credentials of the Pharmacist and other owner/authorized representative, LTO
Qualified Personnel number, validity and name of
 In the credentials of the supervising establishment.
pharmacist, a list of the other RONPDs
supervised must be submitted with the List of non-prescription drugs
respective addresses and LTO numbers, as  Not all non-prescription drugs may be made
well as the supervising hours available to the public without the
 Location Plan immediate supervision of a pharmacist or
o A sketch of the location pharmacy assistant.
o GPS Coordinates  FDA prescribes only selected non-
prescription drugs (eg. Household remedies,
selected traditional medicines, herbal, and
other OTC drugs) to be offered for sale in a
RONDP.