Course

Title:
Legal Pharmacy and Ethics

Rationale:
This course is designed to cover the principles of law and ethics in pharmacy.

Focus:
It examines the national and local laws that impact the practice of pharmacy, emphasizing legal
and ethical principles applied by pharmacists in decision-making. It also focuses on theoretical
and practical knowledge regarding the regulation of food, drugs, medical devices and cosmetics.

Outcome:
The students will learn the national framework within the pharmacy practice, as well as acquire
an understanding of the laws, regulations and ethical responsibilities of pharmacists to protect
and ensure the well-being of their patients.

CO1 – Discuss the laws governing the practice of pharmacy

CO2 – Recognize the legal and ethical responsibilities of the pharmacist

Unit I. Introduction to Legal Pharmacy and Ethics

1. Introduction to Ethics
● Discuss the concepts and principles of ethics
Ethics
● “the philosophical inquiry of the moral dimensions of human conduct”
● ethical is often used synonymously with the term moral to describe an action or decision as
“good” or “right.”
● Ethics is not the law
● “an ethical, or moral, issue involves judgments between right and wrong human conduct or
praiseworthy and blameworthy human character.”

Those engaged in the practice of pharmacy typically rely on an intuitive sense of ethics: we have the
feeling that the situation we are confronting is a big deal, and somehow anticipate that we should not
address only personal preference in the matter at hand.

2. Distinction between personal and professional role-based ethics
● Distinguish personal and professional role-based ethics
Personal ethics refers to the ethics that a person identifies with in respect to people and situations that
they deal with in everyday life.

Professional ethics refers to the ethics that a person must adhere to in respect of their interactions and
business dealings in their professional life.

3. Principles of Biomedical Ethics
● Apply the principles of biomedical ethics
1. Autonomy
 ● Free will
● Moral right of patients to make their own decisions
● “the ability to think for oneself about the way one wishes to lead one’s life based on
that thinking, and then to enact those decisions.”
2. Beneficence
● To do good and avoid harm, and includes an obligation to help patients.

3. Nonmaleficence
● To do no harm
● Because most medical interventions, including nonprescription and prescription
medications, have the potential for serious harm, the principle of nonmaleficence
typically is interpreted to mean ensuring that potential benefits outweigh the potential
risks.

4. Justice
● Principle that people in similar situations should be treated equitably.

5. Consent
● Right to be informed and to choose a course of action

6. Confidentiality
● right to give or refuse consent relative to release of privileged information

7. Veracity
● obligation to tell the truth, or honesty

4. Relation of law to ethics
● Distinguish law and ethics
What is a law?

● A rule of conduct; Just and obligatory

● Promulgated by competent authority
● For common observance and benefit
● Protect society at large
● Specific rules of conduct which defines which actions are legal and therefore allowed, and which
actions are illegal and therefore not allowed
● Applicable to all members of society
● Enforced by competent authority
● Governs, directs, regulates free acts of men

Professional Ethics Law

Rules of conduct or standards by which a particular Rules of conduct imposed by society on its
group in society regulates its actions and sets members
standards for its members
Involves explicit or implicit rules and standards set Involves written rules set by the whole society
by a professional subgroup of society
Address responsibilities of only those who are Address responsibilities of that society’s members
members of that subgroup
 “do no harm” or “preserve life” – often impossible Criminal law, civil law
to fully regulate by law
May go beyond legal requirements Represents one aspect of the culture within which

ethical decisions are made

5. Legislative and Judicial Process in the Philippines
● Explain the legal system in the Philippines
● Discuss the legislative and judicial processes in the Philippines

Sources of Law
1. Constitution: All laws should not be in conflict with the provisions of the constitution otherwise
they are unconstitutional and therefore invalid

2. Legislation: Undergoes the process of legislation

Process of Legislation: In the congress

● Legislative has two houses: Senate and Lower House.
● All proposed laws (what we call bills) emanates from the two houses
● Once it is filed, it is assigned to a committee who study the bill. If it passes the committee, it
would be taken up by the plenary
● There would be 3 readings afterwards.
● The decision must be the same for both senate and lower house. If not, a bicameral committee
(composed of members from both houses) is formed to reconcile their differences.
● Then it would be submitted to the president for approval.
○ The President will veto the law (Nursing Law)
○ The President will accept & sign the law
○ The President will neither sign nor veto the law. After thirty day, the bill will automatically
turn into a law (New Pharmacy Law)

3. Local Government
● Sangguniang Panlungsod, Pangbayan, Panlalawigan
● Applicable to places in which they have territorial jurisdiction

4. Executive
● Presidential Decree, Executive Order, Martial Law

5. Judiciary
● Force and Effect of Law
● Judiciary interprets the law

6. Other Sources
● Customs and Traditions
● Decisions of Foreign Tribunals
● Principles of Justice and Equity
● Religion

Elements of Law
1. Territorial
2. Jurisdictional
 3. Generality: Applicable to all
4. Prospectivity: Applicable to the future, except if it is favorable to the accused

Classifications of Law
1. Natural Law: Authority from God
a. Physical Law: eg Law of Gravity
b. Moral Law

2. Positive Law
a. Divine Positive Law: e.g. Ten Commandments
b. Human Positive Law: Promulgated by man

Human Positive Law

A. Public Law: Governs relationship between state and citizens
1. Constitutional Law: Defines structure and powers of the government and rights of its citizens
2. Criminal Law: Defines a crime or an offense, and provides punishment
3. Administrative Law: Governs the activities of administrative agencies of the government
4. Law of Public Officers
5. Election Law: Governs exercise of suffrage
6. International Law: Governs relationship between and among nations

B. Private Law: Governs relationship between members of the society and among the citizen of the state

1. Civil Law: Regulates relations among members of the society for the protection of private rights
and interests (e.g. Family Code of the Philippines, Civil Code of the Philippines)
2. Commercial Law: Regulates the commercial or business relations among members of the
society (e.g. Customs and Tariff Code, Banking and Finance Laws)
3. Remedial Law: Describe methods of obtaining rights or obtaining regress for their invasion

State:

● A STATE may be defined as a group of people living together in a definite territory under an
independent government organized for political ends and capable of entering into international
relations.
● The state (or nation) should possess the following elements:
1. People: permanent population
2. Territory: defined territory
3. Government
4. Sovereignty or Independence

Inherent Powers of a State

1. Police Power:
a. To regulate the rights and privileges and property for the promotion of general welfare
2. Eminent Domain:
a. Power to obtain private property for public use with just compensation
3. Power of Taxation:
a. Power to demand contribution in exchange for protection and services the State provides
READ:
 1. The Legislative Process (https://www.officialgazette.gov.ph/about/gov/the-legislative-
branch/)
2. The 1987 Philippine Constitution: Preamble, Article II, Article III and other relevant articles
(https://www.officialgazette.gov.ph/constitutions/1987-constitution/)

Unit II. Standards for the Practice of Pharmacy

1. The Pharmacy Law, RA 10918
● Explain the role of the pharmacist in the delivery of quality health care services through the
provision of safe, effective and quality health care
● Discuss the provision in RA 8981 that govern the practice of pharmacy

History of the Pharmacy Law

REPUBLIC ACT No. 5921: AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING
STANDARDS OF PHARMACEUTICAL EDUCATION IN THE PHILIPPINES AND FOR OTHER
PURPOSES.

A. Introduction

Objectives
● Standardization and regulation of pharmaceutical education
● Examination for registration of pharmacy graduates
● Supervision, control, and regulation of pharmacy practice in the Philippines

Enforcement
1. Council of Pharmaceutical Education Obsolete
2. Board of Pharmacy

B. The Board of Pharmacy (BOP)

● Number of Board Members: 2 members

● Term of Office: 3 years
● Maximum number of years of service: 6 years

Qualifications of Board Members

● Natural-born citizen of the Philippines

● Duly registered pharmacist; at least 10 years of practice in the field of pharmacy
● Good moral character; recognized standing in the pharmaceutical profession
● At the time of appointment, not a member of the faculty of any school, college or university
offering courses in pharmacy or college of pharmacy
● Member of good standing of any bona fide national pharmaceutical association

Removal of Board Members:

● The chairman or member of the Board may be removed by the President if found guilty of neglect
of duty, incompetence, malpractice, or unprofessional, unethical, immoral or dishonorable
 conduct, after having been given the opportunity to defend himself in a proper administrative
investigation. Due process
● The President may in his discretion suspend such member under investigation: Provided,
however, that the period of suspension shall not exceed sixty days after which the latter shall be
automatically reinstated pending the outcome of the investigation. Suspension pending
investigation, preventive
Powers and Duties of the Board suspension, reinstatement

● Examine applicants for the practice of pharmacy

● Issue certificate of registration
● Reprimand pharmacist or suspend or revoke certificate of registration
● Promulgate necessary rules and regulation for effective enforcement of this Act
● Study conditions affecting practice of pharmacy
● Check employment of qualified personnel in drug stores, hospital pharmacies, drug or
pharmaceutical laboratories
● Encourage the development of botanical gardens in cooperation with Department of Agriculture
and Natural Resources

Detailmen “MedRep”

● Any person who shall be employed as detailman by any pharmaceutical or drug laboratory or
other manufacturers of medical, dental pharmaceutical, biological and veterinary products and
by distributors, dealers or wholesalers of said product, doing business directly in the Philippines,
shall be required at the beginning of each year, to register with the Board of Pharmacy that he
is employed as such:
○ Preferably a graduate of a college of pharmacy; initial fee of twenty pesos upon
registration and thereafter fifteen pesos shall be charged annually for renewal
○ Possess necessary credentials issued by the Board of Pharmacy

C. Grounds for Reprimand, Suspension, or Revocation of Registration License

● Conviction by a court of competent jurisdiction of any violation as penalized in sections 40 and
41
● Immoral or dishonorable conduct; criminal offense involving moral turpitude
● Fraud or deceit in the acquisition of the certificate of registration
● Gross negligence, ignorance or incompetence resulting in the injury, damage or death of another
● Malpractice: Criminal abortion or sex crimes
● Acting as a dummy of an alien or a person who is not qualified to establish and operate a retail
drugstore
● Addiction to alcoholic beverage or to any habit-forming drug rendering him incompetent
● Insanity
● False or extravagant or unethical advertisement
● Violations of any provision of the Code of Ethics

Administrative Investigations
● Administrative investigations shall be conducted by all the members of the Board sitting en banc
(refers to the hearing of a case by all the judges of a court).
● The existing rules of evidence shall be observed as far as practicable during administrative
investigations.
 ● If the Board, by majority vote of the members shall find that the charges are sustained by
evidence adduced, it may at its discretion reprimand the respondent or revoke or suspend his
certificate of registration. In case of suspension, it shall be for a period of not more than six
months. Where the certificate of registration has been revoked as herein provided, the Board
may, after the expiration of six months and upon application, issue a new certificate of
registration in place of a revoked certificate without the necessity of undergoing any examination
of the respondent in the meanwhile he has conducted himself in an exemplary manner.

Procedure and Rules:

● The Board of Pharmacy upon receipt of a formal complaint under oath against any pharmacist,
shall furnish the latter a copy of the complaint which he shall answer within ten days from receipt
hereof .
● Then, the Board of Pharmacy, after careful study of the records, find that there is a valid ground
to the charge it shall conduct a formal investigation setting the dates of hearing thereof.
● Then, the Board of Pharmacy, after careful study of the records, find that there is a valid ground
to the charge it shall conduct a formal investigation setting the dates of hearing thereof.
● For this purpose, a subpoena duces tecum may be issued by the Chairman of the Board. The
proceedings shall at all times be recorded. Produce the documents
● The investigation shall be terminated and resolved within ninety days from the time the first date
of hearing has been set and heard.

* Subpoena is a process directed to a person requiring him to attend and to testify at the hearing. May
also require him to bring with him any books, documents, or other things under his control which in this
case, is called subpoena duces tecum

Right of Respondent: The respondent pharmacist shall be entitled to be heard or be represented by

counsel; to have speedy and public hearing to confront and to cross-examine the witness against him;
to summon and present witness in his behalf; or any other process for the protection of his individual or
civil rights. Right to due process “substantial evidence” or such relevant evidence as a reasonable
mind may accept as adequate to support a conclusion
Appeal from Judgement: The decision of the Board of Pharmacy shall automatically become final thirty
days from notice to respondent, unless the latter after receipt of the decision and within the same period
has appealed to the President of the Philippines.
End of Part 1
RA 10918 - AN ACT REGULATING AND MODERNIZING THE PRACTICE OF PHARMACY IN THE
PHILIPPINES, REPEALING FOR THE PURPOSE REPUBLIC ACT NUMBERED FIVE THOUSAND
NINE HUNDRED TWENTY-ONE (R.A. NO. 5921), OTHERWISE KNOWN AS THE PHARMACY LAW

A. Objectives

Section 2. Statement of Policy. — The State recognizes the vital role of pharmacists in the delivery of
quality health care services through the provision of safe, effective, and quality pharmaceutical products,
pharmaceutical care, drug information, patient medication counseling, and health promotion. The
pharmacists’ professional services shall, therefore, be promoted as an indispensable component of the
total health care system to ensure the physical well-being of the Filipinos.

Hence, the State shall develop and nurture competent, productive, morally upright, and well-rounded
pharmacists whose standards of professional practice and service shall be excellent and globally
competitive through regulatory measures, programs, and activities that promote and sustain their
continuing professional development.

Section 3. Objectives. — This Act provides for and shall govern the:

a. Standardization and regulation of pharmacy education;

b. Administration of licensure examination, registration, and licensing of pharmacists;
c. Supervision, control, and regulation of the practice of pharmacy in the Philippines;
d. Development and enhancement of professional competence of pharmacists through continuing
professional development, research, and other related activities; and (h) Continuing professional development (CPD)
refers to the inculcation of advanced knowledge,
e. Integration of the pharmacy profession. skills, and ethical values in a post-licensure
specialized or in an inter- or multidisciplinary field of
study for assimilation into professional practice, self-
B. Scope of the Practice of Pharmacy directed research, and/or lifelong learning

A person is dee\med to be practicing pharmacy, within the meaning of this Act, when with or without a
fee, salary, percentage or other rewards, paid or given directly or indirectly, shall:

Activities EXCLUSIVE to Licensed Pharmacists

1. New - Prepare, Compound, or Manufacture, Preserve, Store, Distribute, Procure, Sell, or

Dispense, or Both, any Pharmaceutical Product or its Raw Materials;

Old - Prepare or manufacture, analyze, assay, preserve, store, distribute or sell any medicine,
drug chemicals, cosmetics, pharmaceuticals, devices of contrivances

2. New - Render Services, Such as Clinical Pharmacy Services, Drug Information Services,
Regulatory Services, Pharmaceutical Marketing, Medication Management

3. New - Engage in Teaching Scientific, Technical, or Professional Pharmacy Courses in a School

or College of Pharmacy

Old - Engage in teaching scientific, technological or professional pharmacy subject in a college

of pharmacy.

4. New - Dispense Pharmaceutical Products in Situations where Supervision of Dispensing of

Pharmaceutical Products is Required Including medical missions

Activities NOT EXCLUSIVE to Licensed Pharmacists

1. New - Chemical, Biological, or Microbiological Analyses and Assay of Pharmaceutical Products,

Food/Dietary Supplements, Health Supplements, and Cosmetics

Old - Conduct or undertake scientific pharmaceutical research for biological and bacteriological
testings and examinations.

2. New - Physico-Chemical Analyses for Medical Devices used in Aid of Administration of

Pharmaceutical Products
 3. New - Administration of Adult Vaccines
a. Must first undergo training and hold a certificate of training issued by an institution
accredited by PRC
b. Safe administration of vaccines must be part of the Pharmacy Curriculum

(g) Administration of adult vaccines as approved by the Food and Drug

Administration (FDA): Provided, That they shall undergo the training on the safe
administration of adult vaccines and management of adverse event following
immunization (AEFI) for pharmacists and hold a certificate of training issued by an
institution duly accredited by the Professional Regulation Commission (PRC);
Provided, Further, That the safe administration of vaccines be part of the higher
education curriculum for pharmacists; or

4. New - Conduct or Undertake Scientific Research in All Aspects Involving Pharmaceutical

Products and Health Care

5. MAY BE MODIFIED TO CONFORM TO THE TRENDS IN THE PRACTICE OF PHARMACY

Activities under paragraphs (a), (b), (c), (d) and (i) are exclusive to licensed pharmacists. However,
nothing herein shall be construed as requiring other persons carrying out only the activities under
paragraphs (e), (f), (g) and (h) to be licensed pharmacists, subject to any qualification that is imposed by
other laws with respect to such particular activity.

All pharmacists are expected to abide by current standards such as the Philippine Practice Standards
for Pharmacists, Good Laboratory Practice, Good Distribution Practice, Good Manufacturing Practice
and Good Clinical Practice, which are deemed vital in the performance of their roles and functions in
different practice areas.

The Professional Regulatory Board of Pharmacy, hereinafter created, subject to the approval of the PRC,
as provided for by Republic Act No. 8981, otherwise known as the "PRC Modernization Act of 2000",
and in consultation with the integrated and accredited professional organization (APO), may modify the
above-enumerated acts, services, or activities, as the need arises, in order to conform to the latest trends
and developments in the practice of the pharmacy profession: Provided, That such modifications are
consistent with the enumeration above.

C. Definition of Terms

(refer to Section 5 of RA 10918)

Cipher, Code, or Secret Keys: method of secret writing or use of characteristic style or symbol by
substituting other letter/s or character/s for the letter/s intended, for the purpose of misleading the
consumer

Institutional Pharmacies: Pharmacies of institutions, organizations, and/or corporations that provide a

range of pharmaceutical services, given exclusively to the employees and/or their qualified dependents.
Pharmacy Support Personnel

Pharmacy Aides: Persons who assist the pharmacists in the different aspects of pharmacy operation
based on established standard operating procedures and processes, with very minimal degree of
independence or decision making and without direct interaction with patients

Pharmacy Assistants: Persons who assist the pharmacists in the different aspects of pharmacy operation
based on established standard operating procedures and processes, with minimal degree of
independence or decision making and may have supervised interaction with patients.

Pharmacy Technicians: Persons who assist in compounding and dispensing of medicines in the
community, hospital, institutional and industrial settings or engaged in other activities under supervision
of the pharmacist.

Philippine Practice Standards for Pharmacists refer to the established national framework for quality
standards and guidelines of the practice of pharmacy that respond to the needs of the people who require
the pharmacists’ services to provide optimal, evidence-based care as formulated by the integrated APO
and approved by the Professional Regulatory Board of Pharmacy;

D. Professional Regulatory Board of Pharmacy

Section 6. Creation of the Professional Regulatory Board of Pharmacy. - There is hereby created a
Professional Regulatory Board of Pharmacy, hereinafter called the Board, under the administrative
control and supervision of the PRC, to be composed of a Chairperson and two (2) members, 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 7. Qualifications of the Chairperson and Members of the Board.

The Chairperson and members of the Board, at the time of nomination, must:

(a) Be a citizen of the Philippines and a resident for at least five (5) years;

(b) Be a duly registered and licensed pharmacist in the Philippines, preferably a holder of a masteral
degree in Pharmacy, or its equivalent;

(c) Have been in the active practice of pharmacy for the past ten (10) years;

(d) Have not been convicted of a crime involving moral turpitude;

(e) Be a member in good standing of the APO for at least five (5) years, but not an officer or trustee
thereof; and

(f) At the time of appointment, must neither be a member of the faculty nor an administrative officer of
any school, college or university offering degree programs in pharmacy nor has any direct or indirect
pecuniary interest or connection in any review center or similar institution.
Section 8. Powers, Functions, and Responsibilities of the Board.

The Board shall exercise the following powers, functions, and responsibilities:

(a) Administer and implement the provisions of this Act;

(b) Promulgate rules and regulations, administrative orders, and issuances necessary to carry out the
provisions of this Act;

(c) Prepare licensure examination questions, score, and rate the examinations and submit the results
thereof to the PRC. The Board shall prepare, adopt, issue, or amend the syllabi or tables of specifications
of the subjects in the licensure examination, in consultation with the academe and the Commission on
Higher Education (CHED);

(d) Recommend the issuance, suspension, revocation, or reinstatement of the COR, PIC or
Special/Temporary Permits (STP) for the practice of pharmacy;

(e) Administer oaths in accordance with the provisions of this Act;

(f) Regulate and monitor the practice of pharmacy in the Philippines, including the practice of
subprofessional services such as pharmacy technicians, pharmacy assistants, aides, and other medicine
handlers, as described in this Act; adopt measures that may be deemed proper for the enhancement of
the profession and the maintenance of high professional, academic, ethical, and technical standards;
and conduct ocular inspection of pharmaceutical establishments and higher education institutions (HEIs),
in coordination with concerned government agencies;

(g) Promulgate and prescribe the Pharmacists’ Code of Ethics, Code of Technical Standards and
Guidelines for the Professional Practice of the Pharmacy Profession, in coordination with the APO;

(h) Represent the pharmacy profession in all fora involving concerns and issues related to
pharmaceutical products and the practice of pharmacy;

(i) Investigate cases arising from violations of this Act, the rules and regulations promulgated pursuant
thereto, the Pharmacists’ Code of Ethics, Code of Technical Standards and Guidelines for the
Professional Practice of the Pharmacy Profession, and other Board issuances; issue summons,
subpoena ad testificandum and subpoena duces tecum to secure the attendance of witnesses or
production of documents, or both, and other evidence necessary for such investigation or hearing; and
render decision thereon which shall, unless appealed to the PRC, become final and executory after
fifteen (15) days from receipt of notice of judgment or decision;

(j) Delegate the hearing or investigation of administrative cases filed before the Board, except where the
issue or question involves the practice of the profession, in which case, the hearing shall be presided
over by at least one (1) member of the Board, to be assisted by a Legal or Hearing Officer of the PRC;

(k) Conduct, through the Legal Officers of the PRC, summary proceedings on minor violations of this Act,
the General Instruction to the Examinees, including the implementing rules and regulations issued by the
Board, and to render summary judgment thereon which shall, unless appealed to the PRC, become final
and executory after fifteen (15) days from receipt of notice of judgment or decision;
 (l) Issue and promulgate guidelines on CPD, in coordination with the APO;

(m) Recommend the accreditation of the standardized training programs for and certifications of medical
representatives or professional service representatives, pharmacy technicians, pharmacy assistants,
pharmacy aides and other medicine handlers covered in Section 39, Article IV of this Act. The Board
shall promulgate the criteria and guidelines in the accreditation of training programs and certifications as
described above, in coordination with the APO and with other concerned government agencies;

(n) Accredit Specialty Boards of Pharmacy based on the criteria that it shall establish and prescribe; and

(o) Perform and discharge such other functions and responsibilities, as may be deemed implied,
incidental, and necessary, to preserve the integrity of the pharmacy licensure examination and to
enhance and upgrade the practice of the pharmacy profession in the country.

Section 9. Term of Office of the Members of the Board. - The Chairperson and members of the Board
shall hold office for a term of three (3) years from the date of appointment or until their successors shall
have been qualified and appointed. They may be reappointed in the same office for another term of three
(3) years immediately after the expiry of their term; Provided, That no member of the Board shall hold
office for more than two (2) terms or not more than six (6) years; Provided, further, That the first Board
appointed under this Act shall hold these terms cf office: the Chairperson for three (3) years, the first
member for two (2) years, and the second member for one (1) year; Provided, finally, That an appointee
to a vacancy shall serve only the unexpired portion of the term of office. The Chairperson and members
of the Board shall duly take their oath of office before a duly authorized officer.

Section 11. Grounds for Suspension or Removal from Office of the Chairperson or Member of the Board.

The President of the Philippines may, upon recommendation of the PRC and after due process, suspend
or remove the Chairperson or any member of the Board on any of the following grounds:

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

(b) Involvement in the manipulation, tampering, or rigging of the licensure examination, its questions or
results, or both, and in the disclosure of classified and confidential information pertaining to the licensure
examination;

(c) Conviction of an offense involving moral turpitude by a court of competent jurisdiction; and

(d) Unprofessional, unethical, immoral, or dishonorable conduct.

The PRC, in the conduct of investigation, shall be guided by Sections 7 and 15 of Republic Act No. 8981,
the existing rules on administrative investigation, and the Rules of Court.
End of Part 2
E. Examination, Registration and Licensure

Section 13. Licensure Examination Requirement.

Unless exempted therefrom, all applicants for registration for the practice of pharmacy shall be required
to pass a licensure examination, as provided for in this Act and Section 7(d) of Republic Act No. 8981.
Section 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:

(a) A citizen of the Philippines or of a foreign country which has a law or policy on reciprocity for the
practice of the pharmacy profession;

(b) Of good moral character and reputation;

(c) A degree holder of Bachelor of Science in Pharmacy or its equivalent degree conferred by an HEI in
the Philippines or an institution of learning in a foreign country duly recognized by the CHED; and

(d) Has completed an internship program approved by the Board, pursuant to such guidelines as may
hereinafter be promulgated, in consultation with the duly recognized associations of pharmacy schools
and the CHED.

Requirements

● PSA Birth Certificate (and Marriage certificate)

● Certification of Good Moral Character issued by any of the following: barangay, church, school
or employer
● National Bureau of Investigation Clearance
● Certified true copy of the Transcript of Records in the BS Pharmacy or its equivalent degree
conferred by an HEI in the Philippines or an institution of learning in a foreign country duly
recognized by the CHED;
● Certificate of Completion of the internship program duly signed by the dean / program head

Certificate of Registration

Must Bear:

● Registration Number
● Date of Issuance
● Signatures of PRC Chairperson

PRBOP Professional Identification Card

Must Bear:

● Registration Number and Dates of Issuance and Expiry

● Renewed every 3 years
● Upon Presentation of Certificate of Good Standing from PPhA and Proof of Completion of CPD
Requirements

Foreign Reciprocity
 ● No foreigner shall be allowed to practice Pharmacy unless the requirements imposed under the
laws and regulations in such foreign country are substantially the same as those required
Philippine laws and regulations
● and unless said foreign laws and regulations allow Philippine citizens to practice Pharmacy within
its territorial limits on the same basis, and grant the same privileges as those enjoyed by its own
citizens, subjects or nationals.
● Requirements:
○ Letter / document signed by official of his/her country requesting the Chair of the PRBOP
to allow applicant to take
○ Copy of law or treaty which allows reciprocity
● If approved:
○ BI official document allowing applicant to enter and reside in Phils.
○ Copy of passport
○ TOR from school but certified by CHED that courses are equivalent

Special / Temporary Permit

● Grounds:
1. The person is an internationally renowned pharmacist or expert in a field or specialty of pharmacy
2. The person is engaged in the provision of a professional service which is determined to be
necessary due to lack of Filipino specialist or expert
3. The person is required to work with a Filipino counterpart, a natural person who is a registered
and licensed pharmacist

Ground for Non-registration

1. Convicted of an offense involving moral turpitude by a court of competent jurisdiction

2. Summarily adjudged by the Board as guilty for misrepresentation or falsification of documents in
connection with the application for examination or for violation of the General Instructions to
Examinees;
3. Found guilty of immoral or dishonorable conduct by the Board;
4. Medically proven to be addicted to any drug or alcohol by a medical or drug testing facility
accredited by the government such that it could render him/her incompetent to practice the
profession; and
5. Declared of unsound mind by a court of competent jurisdiction

Reissuance

● PRBOP:
○ can only reinstate a revoked COR after 2 years from date of revocation.
○ may require applicant to take another licensure examination
○ petitioner shall prove reason for reinstatement
F. Practice of Pharmacy

Indication of Information

● A pharmacist shall be required to indicate the

1. Legal documents for government submission in permits, licenses application
a. COR number
b. validity of PIC
c. APO Membership number
2. Documents relative to practice of pharmacy
a. COR number
b. Validity of PIC

Certification
Certificate of Registration
of Registration

● If Category A: Original Copy Must Be Displayed

● If Category B: Duplicate Copy Must Be Displayed
● Displayed in a prominent and conspicuous place can be seen by clients and regulators
● NO PHARMACIST SHALL ALLOW COR TO BE DISPLAYED IN AN ESTABLISHMENT WHERE
HE/SHE IS NOT EMPLOYED
● Original COR of all pharmacists shall be kept securely by the employer for the duration of
employment.
○ If employment ends, the employer must not withhold the return or release of COR.

Section 30. Dispensing/Sale of Pharmaceutical Products. - No pharmaceutical product, of whatever

nature and kind, shall be compounded, dispensed, sold or resold, or otherwise be made available to the
consuming public, except through a retail drug outlet duly licensed by the FDA.

Over-the-counter (OTC) medicines

● medicines used for symptomatic relief of minor ailments and which may be dispensed without a
prescription

Pharmacist-only OTC medicines

● over-the- counter medicines classified by appropriate government agencies to be obtained only

from a licensed pharmacist, with mandatory pharmacist's advice on their selection and proper
use
Prescription drugs and Pharmacist-only OTC medicines

● Dispensed ONLY by the Pharmacist

● In emergency cases, a report shall be made to the supervising Pharmacist within 24 hours after
the emergency

Pharmacist Requirement

CATEGORY A

● Needs direct supervision of a Pharmacist

● Includes:
○ Wholesale and Retail Pharmacy
○ Manufacturing, Importing, Exporting, Distributing Pharmacy
○ Departments of Pharmaceutical Laboratories
○ Government and Non-government Units Distributing and Dispensing Pharmaceutical
Products
○ Local government, City, First to third class MHU

CATEGORY B

● Indirect supervision and OVERSIGHT of a Pharmacist

● Includes:
○ Retail Pharmacy selling OTC drugs and household remedies
○ Satellite institutional pharmacies
○ Fourth, Fifth, Sixth class MHUs
○ Institutions providing tele pharmacy services
● PH must be physically present in the establishment/outlet for a minimum for two (2) hours a week
● The establishment in Cat B of the same pharmacist:
○ same province
○ distance between 2 farthest establishments must not exceed 25km
○ maximum of 15 establishments

A pharmacist working in a Category A establishment may be allowed to simultaneously work or render

pharmacy services in Category B establishments, the maximum number of hours of which shall be
determined, in accordance with such guidelines as may be established therefor by the Board, in
coordination with the FDA, and other agencies, establishments, institutions, and regulatory bodies.

Procurement, storage, distribution, or dispensing of any pharmaceutical product in the national

government and local government units shall be made only under the supervision of a duly registered
and licensed pharmacist.
Filling of Prescription

● If done by PA/PT, pharmacist must have direct supervision

● Ph shall be accountable for the dispensing and counselling
● Clarifications on content should be referred to the PRESCRIBER.

Completely filled:

● surrendered to the pharmacist for recording

Partial filling:

● pharmacist dispensing last quantity completing the prescription shall keep the prescription

Section 34. Physician’s Sample. - Pharmaceutical products given or intended to be given free to any
health professional by a manufacturer or distributor or its professional service representative as part of
its program or promotion shall not be sold to any pharmaceutical outlet or the consuming public.

The statement "Sample, Not for Sale", or its equivalent, shall appear conspicuously on the primary and
secondary packaging of the drug or combination products (medical device and drug) classified as drug
according to the primary intended mode of action to be given. It shall be unlawful to remove, erase,
deface or mark the original labels of samples.

Pharmaceutical products classified as antimicrobials, including anti-TB medicines and other

classifications of medicines, as may be prescribed by the FDA, shall not be given or distributed as
physician’s samples.

Patient Medication Profile

● Recording System in the Pharmacy

● Contents:
○ Name and Address of Patient
○ Name of Prescriber
○ Generic Name and Brand, Dosage Strength, Quantity of Drug, Date dispensed, Batch
no. of drug
○ Initials of Pharmacist

It shall be open for inspection by the representatives of the Board or the FDA, or both, at any time of the
day, when the pharmacy is open, and must be kept for a period of not less than two (2) years after the
last entry.
 Operating Requirements

● All outlets are required to display the following:

○ pharmacy operating hours
○ schedule and name of PHOD
○ name of the drugstore owner

G. Penalties

Section 44. Revocation or Suspension of the Certificate of Registration and Cancellation of

Special/Temporary Permit.— The Board shall have the power, upon notice and hearing, to revoke or
suspend the COR of a registered pharmacist or to cancel an STP of a foreign pharmacist on any of the
following grounds enumerated in Section 44.

Section 45. Penal Provisions. - Any person who shall commit any of the following acts shall, upon
conviction, be sentenced to pay a fine of not less than two hundred fifty thousand pesos (₱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:

Section 46. Other Penalties. - Any person who shall commit any of the following acts shall, upon
conviction, be sentenced to pay a fine of not less than one hundred thousand pesos (₱100,000.00), but
not exceeding two hundred thousand pesos (₱200,000.00) or imprisonment of not less than thirty (30)
days but not more than one (1) year, or both, at the discretion of the court:

2. CPD Law of 2016, RA 10912
● Discuss the mechanism under the law to ensure continuous professional development
Republic Act No. 10912, otherwise known as the “Continuing Professional Development (CPD) Act of
2016”, is an act which requires CPD as the mandatory requirement for the renewal of Professional
Identification Card

CPD Credit Units refer to the value of an amount of learning achieved from formal, informal or non-
formal learning including professional work experience wherein credit units can be accumulated to
predetermined levels for the award of a qualification.

The CPD is hereby made as mandatory requirement in the renewal of the Professional Identification
Cards (PICs) of all registered and licensed professionals under the regulation of the Commission.

Required CPD Credit Units for the renewal of PIC during the transition period:
PHARMACY 15

Who are not covered by the CPD Requirement?
During the transition period, the following are not covered by the CPD requirement:
● Professionals working overseas. However, they need to provide proof such as a valid Certificate
of Employment or Overseas Employment Certificate duly approved by POEA.
● Newly licensed professionals for the first renewal cycle (3 years) after obtaining their license.

 MATRIX OF REQUIRED CPD UNITS PER PROFESSION AFTER 2020: 45 units

3
End of Part
3. Phil PSPs
● Describe the expected competencies of a Filipino Pharmacist
PHILIPPINE PRACTICE STANDARDS FOR PHARMACISTS (PhilPSP)
PhilPSP Technical Working Committee: PPhA Committee on Policies and Standards

The Core Competency Standards
1. Practices in a professional, legal and ethical manner
Each pharmacist must carry out professional duties with utmost competence and in accordance
to legal and ethical standards

2. Places client’s/ patient’s welfare at the center of practice
Each pharmacist must consider at all times the well-being of the client/ patient as the most
important professional concern

3. Demonstrates leadership and management skills
Each pharmacist must exemplify leadership through managing conscientiously one’s work and
improving client/patient outcomes by creating innovative and timely solutions

4. Demonstrates cultural competence and effective communication
Each pharmacist must be able to relate and communicate with people of diverse values, beliefs,
backgrounds and expectations in carrying out his/ her important role as medication expert

5. Engages in interprofessional collaboration
Each pharmacist must be able to actively work in an interprofessional and multidisciplinary
environment

6. Commits oneself to continuing professional development
Each pharmacist must proactively seek opportunities for life-long learning and professional
development.

4. Philippine Pharmacist’s Code of Ethics
● Distinguish the moral obligations of pharmacists in relationships with patients, health
professionals and society
Code of Ethics for Pharmacists

PREAMBLE
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. This Code, prepared and supported by pharmacists, is intended to state publicly the
principles that form the fundamental basis of their roles and responsibilities which are based on moral
obligations and virtues and to guide pharmacists in their relationship with patients, health
professionals, and society.

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 and provides health
for all.
4. A pharmacist respects the rights of patients and upholds the confidentiality of patients’ records.
5. A pharmacist acts with honesty, integrity, and professionalism in relationships with the patients
and other health professionals.
6. A pharmacist respects the abilities, values, and contributions of colleagues and other health
professionals and works with them closely to ensure better patient care.
7. A pharmacist is committed to continuously enhance professional competence.
8. A pharmacist, in coordination with the government and other health professionals helps in the
formulation and implementation of healthcare policies, standards, and programs designed for
the benefit of society.


5. Mexico City Principles, AO 2015-0053 on Marketing of Drugs
● Discuss the ethical standard that govern the marketing, distribution, promotion, and
advertisement of pharmaceuticals

The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector
Ethical interactions help ensure that medical decisions are made in the best interests of patients. For
relationships with healthcare professionals and other stakeholders to meet this standard, companies
in the biopharmaceutical sector (“Companies”) should be guided by these six principles:

1. Healthcare and Patient Focus means everything we do is intended to benefit patients.
2. Integrity means dealing ethically, honestly and respectfully in everything we do.
3. Independence means to respect the need of autonomous decision-making of all parties, free
from improper influence.
4. Legitimate intent means everything we do is for the right reasons, is lawful, and aligns with the
spirit and the values of these Principles.
5. Transparency means a general willingness to be open about our actions while respecting
legitimate commercial sensitivities and intellectual property rights.
6. Accountability means a willingness to be responsible for our actions and interactions.


Preamble
1. Companies engage in the development, manufacturing, research, marketing, distribution,
and/or sale of medicines to benefit patients.
2. Ethical relationships with healthcare professionals, government officials, patients, and other
stakeholders are critical to the mission of Companies to help patients by developing and making
medicines available.
3. In interacting with all stakeholders, Companies are committed to following the highest ethical
standards as well as all applicable laws and regulations. Companies encourage healthcare
professionals, government officials, and others who work with Companies to respect these
Principles and adopt consistent standards if applicable.
4. These Principles are to reinforce our intention that Companies’ interactions are professional
exchanges designed to benefit patients and to enhance the practice of medicine. These
Principles are based on the foundation that a healthcare professional’s care of patients should
 be based solely on each patient’s medical needs and the healthcare professional’s medical
knowledge and experience.
5. Companies have an obligation and responsibility to provide objective, accurate, balanced
information about their medicines to healthcare professionals in order to establish a clear
understanding of the appropriate use of these medicines. Industry relationships with
healthcare professionals must support, and be consistent with, the professional responsibilities
healthcare professionals have towards their patients.
6. Companies should promote, sell and distribute their medicines in a manner that is ethical,
objective, balanced and accountable, and in accordance with all relevant and applicable laws
and regulations. Information in promotional materials must support proper assessment of the
benefits and risks of the product and its proper use.
7. Companies are committed to education and training on the safe, appropriate, and effective use
of their medicines.
8. Companies are accountable for complying with relevant codes of ethical business practices.
They should also ensure that internal structures and procedures (including adequate training
of employees) are created to ensure responsible and ethical activities.
9. Companies will comply with relevant standards regarding the development, production,
processing, distribution, commercialization and safety of medicines.
10. Companies undertake to adhere to relevant local, national, and regional industry ethics codes
in both the spirit and the letter.
11. Companies will respect the independence of patient organizations.
12. Companies should ensure that all relevant personnel and agents acting on their behalf are
appropriately trained in the requirements of local, national, and regional industry ethics codes.
13. Companies will respect patient privacy.
14. Companies will ensure that all personnel and third parties working on their behalf comply with
these Principles and all applicable laws and regulations.

AO 2015-0053 Implementing Guidelines on the Promotion and Marketing of Prescription
Pharmaceutical Products and Medical Devices




1. Interactions with Health Care Professionals (HCP)
2. Promotional Information and Activities
3. Safety of Pharmaceutical and Medical Device Products
4. Symposia and Congresses
5. Informational Presentations by Company Representatives
6. Entertainment and Recreation
7. Educational ltems and Gifts
8. Support for Continuing Professional Development (CPD)
9. Samples
10. Consultant and Speaker Arrangements
11. Compliance Procedures and Responsibilities
12. Conduct of Training of PPPMD Conrpany Representatives
13. Public Sector Relationships and Procurement
14. Clinical Trials
15. PPPMD Company Donations Charitable Purposes
16. Patient Organization
(Read AO 2015 - 0053)


6. Institutional Review Committee
● Discuss the ethical considerations in conducting research
Institutional Review Committee (IRC) or Ethics Committee or Ethical Review Committee (ERC)
A Committee established by an institution in accordance with the regulations of the relevant
governmental agency to review biomedical and behavioral research that involves human subjects and
is conducted at or supported by that institution

ELEMENTS OF RESEARCH ETHICS
Ethical assessment of health and health-related research requires a framework that may consist of
principles, values, and key procedures. The following elements that constitute such a framework are
based on Philippine experience in the conduct of research ethics review.

Social Value
The participation of human beings in research can only be justified if the study has social value. Social
value refers to the relevance of the study to an existing social or health problem such that the results
are expected to bring about a better understanding of related issues, or contribute to the promotion
of well-being of individuals, their families, and communities.

Informed Consent
Informed consent is a decision of a competent potential participant to be involved in research after
receiving and understanding relevant information, without having been subjected to coercion, undue
influence, or inducement.

The researcher shall provide essential information to the potential research participant, whether orally
or in writing, in a language that suits the participant’s level of understanding.

Documentation of consent
As a general rule, documentation of informed consent includes an actual signature or thumb mark of
the prospective participant on the informed consent form.

Vulnerability of Research Participants
Vulnerable participants shall require special protection because of certain characteristics or situations
that render them as such. Vulnerable participants are those who are relatively or absolutely incapable
of deciding for themselves whether or not to participate in a study for reasons such as physical and
mental disabilities, poverty, asymmetric power relations, and marginalization, among others and who
are at greater risk for some harms.

Risks, Benefits, and Safety
Research is justified if there is a reasonable likelihood that the population from which the participants
are derived stand to benefit from the research.

All research involving human participants shall be preceded by a careful assessment of predictable risks,
burdens, and foreseeable benefits to the research participant or to others.

Every precaution shall be taken to minimize the negative impact of the study on the research
participant’s wellbeing.

Research shall be conducted only if there is an acceptable positive benefit-risk ratio.

Privacy and Confidentiality of Information
 Researchers shall adhere to the principles of transparency, legitimate purpose, and proportionality in
the collection, retention, and processing of personal information (Data Privacy Act of 2012).

Justice
In research involving human participants the principle of justice refers primarily to distributive justice,
which requires the equitable distribution of both the burdens and the benefits of participation in
research. That is, it should not be the case that one group in society bears the costs of research while
another group reaps its benefits. Research should not worsen existing health and social inequities.

Transparency
Ethical research shall be characterized by transparency. It is imperative for all parties to be transparent
about matters relating to their involvement. Transparency is not diametrically opposed to privacy. On
the contrary, transparency is an element of ethical research that promotes confidence in the research
enterprise, even when privacy and anonymity need to be preserved about sensitive matters. The need
for transparency also entails disclosure of research results.

Source: National Ethical Guidelines for Health and Health-Related Research (2017) by The Philippine
National Health Research System and Philippine Health Research Ethics Board


Unit III. Standards for Food, Drugs, Devices and Cosmetics

1. Food, Drugs, Cosmetics and Devices Act (RA 3720), Food and Drug Administration Act of 2009,
RA 9711
● Discuss the powers and functions of the FDA
● Discuss the purposes and objectives of RA 3720
● Define food, drugs, devices, and other related terms
● Differentiate adulterated drugs, food and devices and misbranded drugs, food and devices
● Enumerate the objectives of RA 9711
● State the amendments from RA 3720
● Discuss the functions and responsibilities of various FDA Centers and Offices
RA 3720 - An Act to Ensure the Safety and Purity of Foods, Drugs and Cosmetics Being Made Available
to the Public by Creating the Food and Drug Administration which shall Administer and Enforce the
Laws Pertaining Thereto.

EO 175 - Further Amending RA No. 3720

RA 9711 - An Act Strengthening and Rationalizing The Regulatory Capacity of the Bureau of Food and
Drugs (BFAD) by Establishing Adequate Testing Laboratories and Field Offices, Upgrading its Equipment,
Augmenting its Human Resource Complement, Giving Authority to Retain its Income, Renaming it the
Food and Drug Administration (FDA), Amending Certain Sections Of Republic Act No. 3720, as
Amended, and Appropriating Funds Thereof


A. Purposes and Objectives of the Laws

Section 3. It is hereby declared a policy of the State to adopt, support, establish, institutionalize,
improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and
designed to: (a) protect and promote the right to health of the Filipino people; and (b) help establish
and maintain an effective health products regulatory system and undertake appropriate health
manpower development and research, responsive to the country's health needs and problems.
Pursuant to this policy, the State must enhance its regulatory capacity and strengthen its capability with
regard to the inspection, licensing and monitoring of establishments, and the registration and
monitoring of health products.

Section 4. This Act has the following objectives:
(a) To enhance and strengthen the administrative and technical capacity of the FDA in the regulation of
establishments and products under its jurisdiction;
(b) To ensure the FDA's monitoring and regulatory coverage over establishments and products under
its jurisdiction; and
(c) To provide coherence in the FDA's regulatory system for establishments and products under its
jurisdiction.

B. The Food and Drug Administration

Powers and Function of the FDA
a. To administer the effective implementation of this Act and of the rules and regulations issued
pursuant to the same;
b. To assume primary jurisdiction in the collection of samples of health products;
c. To analyze and inspect health products in connection with the implementation of this Act;
d. To establish analytical data to serve as basis for the preparation of health products standards,
and to recommend standards of identity, purity, safety, efficacy, quality and fill of container;
e. To issue certificates of compliance with technical requirements to serve as basis for the issuance
of appropriate authorization and spot-check for compliance with regulations regarding operation
of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other
establishments and facilities of health products, as determined by the FDA;
f. To levy, assess and collect fees for inspection, analysis and testing of products and materials
submitted in compliance with the provisions of this Act.
g. To certify batches of antibiotic and antibiotic preparations in compliance with the provisions of
this Act
h. To conduct appropriate tests on all applicable health products prior to the issuance of appropriate
authorizations to ensure safety, efficacy, purity, and quality;
i. To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers,
consumers, and non-consumer users of health products to report to the FDA any incident that
reasonably indicates that said product has caused or contributed to the death, serious illness or
serious injury to a consumer, a patient, or any person;
j. To issue cease and desist orders motu propio or upon verified complaint for health products,
whether or not registered with the FDA Provided, That for registered health products, the cease
and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after
due process has been observed;
k. After due process, to order the ban, recall, and/or withdrawal of any health product found to have
caused the death, serious illness or serious injury to a consumer or patient, or is found to be
imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to
implement the risk management plan which is a requirement for the issuance of the appropriate
authorization;
 l. To strengthen the post market surveillance system in monitoring health products as defined in
this Act and incidents of adverse events involving such products;
m. To develop and issue standards and appropriate authorizations that would cover establishments,
facilities and health products;
n. To conduct, supervise, monitor and audit research studies on health and safety issues of health
products undertaken by entities duly approved by the FDA;
o. To prescribe standards, guidelines, and regulations with respect to information, advertisements
and other marketing instruments and promotion, sponsorship, and other marketing activities
about the health products as covered in this Act;
p. To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate,
as determined by the director-general for confiscated goods in strategic areas of the country
especially at major ports of entry; and
q. To exercise such other powers and perform such other functions a8 may be necessary to carry
out its duties and responsibilities under this Act."
End of Part 2

Centers:
1. Center for Drug Regulation and Research
2. Center for Food Regulation and Research
3. Center for Cosmetics Regulation and Research
4. Center for Device Regulation, Radiation Health, and Research.
5. Licensing and Registration Division
6. Product Research and Standards Development Division
7. Laboratory Support Division
8. Administration and Finance Office
9. Policy and Planning Office
10. Field Regulatory Operations Office
11. Legal Services Support Center


"SEC. 5. The FDA shall have the following centers and offices:
a. The Centers shall be established per major product category that is regulated, namely:
i. Center for Drug Regulation and Research (to include veterinary medicine, vaccines and
biologicals);
ii. Center for Food Regulation and Research;
iii. Center for Cosmetics Regulation and Research (to include household hazardous/urban
substances); and
iv. Center for Device Regulation, Radiation Health, and Research
These Centers shall regulate the manufacture, importation, exportation, distribution, sale, offer
for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the
use and testing of health products. The Centers shall likewise conduct research on the safety,
efficacy, and quality of health products, and to institute standards for the same.

b. Each Center shall be headed by a director. The Centers shall be so organized such that each will
have, at least, the following divisions:
i. Licensing and Registration Division, which shall be responsible for evaluating health
products and establishments as covered by this Act for the purpose of issuance of
authorizations and conditions to be observed;
 ii. Product Research and Standards Development Division, which shall be responsible for
the conduct of research, development of standards and regulations, compliance
monitoring, and the oversight and audit of related researches that would ensure safety,
quality, purity and efficacy of health products, as covered in this Act; and
iii. Laboratory Support Division, which shall be responsible for the conduct of research and
appropriate tests and calibration, analyses and trials of products including, but not
limited to, assays, and the conduct of oversight and/or audit of centers conducting
bioavailability and bioequivalence tests and other tests as covered by this Act. It shall
likewise provide direct line support to the centers which shall be separate and distinct
per major product category that is regulated.

c. The Administration and Finance Office headed by the deputy director-general for
administration and finance shall have, at least, the following divisions: the Human Resource
Development Division; Property and Logistics Management Division; Human Resource
Management Division; Assets and Financial Management Division; and the Information and
Communication Technology Management Division.

d. The Policy and Planning Office which shall be under the Office of the Director-General shall
have, at least, a training, advocacy and communications division and shall monitor the
performance of the centers for product research and evaluation and standards development.

e. The Field Regulatory Operations Office headed by the deputy director-general for field
regulatory operations shall include, among others, all the field offices, field or satellite
laboratories and the regulatory enforcement units.

f. The Legal Services Support Center shall provide legal services to the entire FDA and shall be
directly under the Office of the Director-General."

Qualifications and Powers of its Officers

The FDA shall be headed by a director-general, with the rank of undersecretary, who shall be tasked,
among others, to determine the needed personnel and to appoint personnel, below the assistant
director level in coordination with the Secretary of Health.

The director-general shall be assisted by two (2) deputy directors-general, one for administration and
finance and another for field regulatory operations.

The director-general and deputy directors-general shall be appointed by the President of the Republic
of the Philippine

Director-General
● May have the following credentials:
○ Doctor of Medicine OR
○ Masters Degree in Pharmaceutical Sciences or Allied Sciences or Equivalent Course in
Regulatory Management OR
○ Management experience in his/her field of discipline or profession and in any
development, manufacturing, regulatory work or quality assurance of products
● Additional Powers:
 ○ To hold in direct or indirect contempt any person who disregards orders or writs he or
she issues and impose the appropriate penalties
○ To issue orders of seizure, to seize and hold in custody any article or articles of food,
device, cosmetics, household hazardous substances and health products that is
adulterated, counterfeited, misbranded or unregistered, or drug, in-vitro diagnostic
reagent, biologicals, and vaccine that is adulterated or misbranded, when introduced
into domestic commerce
○ To call on the assistance of any department, office or agency and deputize members of
the Philippine National Police or any law enforcement agency

Deputy Director-General for FRO
● Masters Degree in Pharmaceutical Sciences or Allied Sciences or Equivalent Course in
Regulatory Management
● Management experience in his/her field of discipline or profession and in any development,
manufacturing, regulatory work or quality assurance of products

Deputy Director-General for AF
● Certified Public Accountant
● Master’s degree in accounting, management, economics or any business course
● Has Management Experience

Regulatory Enforcement Unit
● Qualifications
○ Headed by a Lawyer
○ 5 qualified personnel per region
○ Under the control and supervision of the DG for FRO
● Powers
○ Bear arms, wear official uniforms and insignias and shall be classified as law
enforcement agents
○ Serve and execute rulings, orders, and decisions of the Director-General of the FDA
○ Execute and serve search warrants and arrest warrants issued by the courts in
connection with violations under this Act and related laws concerning the regulation of
End of Part 2 health products
C. Definition of Relevant Terms

Food
● articles used for food or drink for man;
● chewing gum; and
● articles used for components of any such article.

Drug
● articles recognized in USP/NF;
● articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
in man or other animals; and
● articles (other than food) intended to affect the structure or any function of the body of man
or animals

Device
 ● instruments, apparatus, or contrivances, including their components, parts, and accessories

Cosmetic
● articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and
● articles intended for use as a component of any such articles

Adulterated
● poisonous or deleterious substance
● filthy, putrid, or decomposed substance
● prepared and packed under unsanitary conditions
● container is composed of poisonous or deleterious substance

Misbranded
● Labeling is false or misleading

D. Adulterated and Misbranded Products

Adulterated Food
A.
• Bears or contains any poisonous or deleterious substance which may render it injurious to
health
• Bears or contains any added poisonous or deleterious substance other than one which as a
pesticide chemical in or on a raw agricultural commodity for which tolerances have been established
• Consists in whole or in part of any filthy, putrid, or decomposed substance
• Prepared, packed, or held under unsanitary conditions whereby it may have been
contaminated by filth
• If, in whole or in part, a product of a diseased animal or an animal which has died otherwise
than slaughter
• Container is composed, in whole or in part, of any poisonous or deleterious substance
B.
• Any valuable constituent has been, in whole or in part, omitted or abstracted therefrom and
the same has not been substituted by any healthful equivalent
• If any substance injurious to health has been added or substituted
• If damage or inferiority is concealed in any manner
• If substance has been added thereto or mixed or packed therewith so as to increase its bulk or
weight, or reduce its quality or strength, or make it appear better or of greater value
C. If it bears or contains a coal-tar color other than on which is permissible
D. If it is confectionary, and bears or contains any alcohol or non-nutritive substance except
harmless coloring, flavoring, resinous glass NMT 0.4 parts per 100 parts, natural gum and pectin
E. Oleomargarine or margarine or butter and any of the raw materials used therein and consists
in whole or in part of any filthy, putrid, decomposed substance

Misbranded Food
• Labeling is false or misleading
• Offered for sale under the name of another food
• Imitation of another food, unless its label bears in uniform size and prominence: “imitation”
and name of food imitated
• If container is made, formed, or filled to be misleading
• If in package form unless it bears a label containing: (1) name and place of business of
manufacturer, packer, distribution; (2) accurate statement of qty of contents in terms of weight,
measure, numerical count
• If any word, statement, or other information required to appear on the label or labeling is not
prominently placed
• (g) If it purports to be or is represented as a food for which a definition and standard of identify
has been prescribed unless (1) it conforms to such definition; (2) its label bears the name of the food
specified in the definition and standard
• If it purports to be or is represented as –
• If it is not subject to provisions of paragraph (g) unless its label bears (1) the common or usual
name of food; (2) if made from 2 or more ingredients, the common and usual name of each ingredient
• If it purports to be or is presented for special dietary uses, unless its label bears such
information concerning its vitamin, mineral, and other dietary properties
• If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative

Adulterated Drugs and Devices
A.
• Consists in whole or in part of any filthy, putrid decomposed substance
• Prepared, packed, or held under unsanitary conditions contaminated with filth
• If it is a drug and its contained is composed, in whole or in part, of any poisonous or deleterious
substance
• If it is a drug, and it bears or contains, for purposes of coloring only, a coal-tar color other than
a permissible one
B. If it purports to be or is represented as a drug a name of which is recognized in an official
compendium, and its strength differs from, or its quality or purity falls below the standards set forth in
such compendium
C. If it is not subject to the provisions of paragraph B and its strength differs from, or its purity or
quality falls below, that which it purports or is represented to possess



Misbranded Drugs and Devices
• Labeling is false or misleading in any particular.
• If in a package form unless it bears a label containing (1) the name and place of business of the
manufacturer, packer or distributor; (2) an accurate statement of the quantity of the contents in terms
of weight, measure, or numerical count.
• If any work, statement, or other information required to appear on the label or labeling is not
prominently placed
• If for use by man and contains any quantity of the narcotic or hypnotic substance or any
chemical derivative of such substance, which, after investigation, has been designated as, habit
forming; unless its label bears the name, and quantity or proportion of such substance or derivative
and in juxtaposition therewith the statement "Warning – May be habit forming."
• If it is a drug and is not designated solely by a name recognized in an official compendium unless
its label bears (1) the common or usual name of the drug, if such there be; and (2) in case it is fabricated
from two or more ingredients, the common or usual name of each active ingredient, including the
 quantity, kind, and proportion of any alcohol, and also including whether active or not, the name and
quality of proportion of any bromides, either, chloroform, acetanilid, acetaphenetidin, amidopyrine,
antipyrine, atropine, hyoscine, hyocyanamine, arsenic, digitalis, digitalis glycosides, mercyry, ouabain,
strophantin, strychnine, thyroid, or any derivative or preparation of any such substances, contained
therein
• Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings
against use in those pathological conditions or by children where its use may be dangerous to health,
or against unsafe dosage or methods or duration of administration or application
• If it purports to be a drug the name of which is recognized in an official compendium, unless it
is packaged and labeled as prescribed therein
• If drug is liable to deterioration, unless it is packaged in such form and manner, and its label
bears a statement of such precautions
• (1) it if is a drug and its container is so made, formed, or filed as to be misleading; or (2) if it is
imitation of another drug; or (3) if it is offered for sale under the name of another drug
• If it is dangerous to health when used in the dosage, or with the frequency of duration
prescribed, recommended or suggested in the labeling thereof
• If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of
antibiotic drug, or any derivative thereof, unless (1) it is from a batch with respect to which a certificate
of release has been issued, and (2) such certificate of release is in effect with respect to such drug

E. Prohibited Acts
● manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-
consumer use, promotion, advertising, or sponsorship of any health product that is
adulterated, unregistered or misbranded.
● the alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the
labeling of, or the doing of any other act with respect to health products if such act is done
while such article is held for sale (whether or not the first sale) and results in such article being
adulterated or misbranded
● the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-
consumer use, promotion, advertisement, or sponsorship of any health product which is not
registered with the FDA
● operating without a Valid License to Operate
● Sale of expired Products

General Conviction:
• Imprisonment - 1 year to 10 years
• Fine: 50,000 - 500,000

Manufacturers, Importer, Distributor
• Imprisonment - 5 years to 10 years
• Fine: 500,000 - 5,000,000
End of Part 4
F. Labelling Requirements
Administrative Order No. 2016-0008 || Revised Rules and Regulations Governing the Generic Labeling
Requirements of Drug Products for Human Use

Article III, Section 7 of the 1987 Philippine Constitution declares that the State recognizes the right of
the people to gain information on matters of public concern, such as those relating to health and health
products.

Labels and labeling materials are the primary sources of information for consumers. They provide useful
information such as those dealing with the safe and effective use of a drug product (e.g. indication(s),
pharmacologic class and dosage), and information dealing with quality (e.g. manufacturing and
expiration dates, registration number, and manufacturer). "

Definition of Terms
1. Active Moiety - the molecule or ion, excluding those appended portions of the molecule that
cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or
other non covalent derivative (such as complex, chelate, or clathrate) of the molecule,
responsible for the physiological or pharmacological action of the drug substance.

2. Active Pharmaceutical Ingredient (API) - a substance or compound that is intended to be used
in the manufacture of a pharmaceutical product as a therapeutically active compound
(ingredient).

3. Adverse Drug Reaction (ADR) - a response to a medicine that is noxious and unintended, and
which occurs at doses normally used in man.

4. Brand Name - the proprietary name assigned to the product by the Marketing Authorization
Holder (MAH)

5. Contraindication - a statement regarding the conditions wherein the use of the drug product
may cause harm to the patient.

6. Generic Class Name - the identification of a drug product containing three or more APIs by its
scientifically and internationally recognized name or by its official generic name as determined
by FDA.

7. Generic Name - the identification of a drug product by its scientifically and internationally
recognized API or by its official generic name as determined by FDA.

8. Indication - the FDA-approved clinical use of a drug product based on substantial, scientifically
supported evidence of its safety and efficacy in the given dosage form.

9. Marketing Authorization (MA) - an official document issued by the competent drug regulatory
authority (DRA) for the purpose of marketing or free distribution of a product after evaluation
for safety, efficacy, and quality, and containing, inter alia: the name of the product; the
pharmaceutical dosage form; the quantitative formula (including excipients) per unit dose; the
shelf-life and storage condition(s); and packaging characteristics, specific information on which
authorization is based (e.g. "The product(s) must conform with all the details provided in the
application and as modified in subsequent correspondence."), the product information
approved for health professionals and the public, the sales category, the name and address of
the holder of the authorization, and the period of validity of the authorization. In the
Philippines, the MA is in the form of a Certificate of Product Registration (CPR).

10. Marketing AuthorizationHolder (MAH) - the company or corporate or legal entity in the field of
pharmaceuticals in whose name the MA for a drug product has been granted. This party is
responsible for all aspects of the product, including quality and compliance with the conditions
of the MA. The authorized holder must be subjected to legislation in the country that issued
the MA, which normally means being physically located in that country. In the Philippines, the
MAH may either be a manufacturer or distributor (exporter, importer or wholesaler).

11. New Chemical Entity NCE) - new chemical or biological API not previously authorized for
marketing for any pharmaceutical use in the country in question

12. Package Insert (PI) - the document defining information that is supplied with prescription drug
products by the MAH. The PI is intended for use by healthcare professionals.

13. Patient Information Leaflet (PIL) - the document defining information that is supplied with non-
prescription drug products by the MAH. The PIL is intended for use by patients and is written
in layman's language.

14. Pharmacologic Category - refers to the classification of the drug product based on its
therapeutic action as specified in the product registration.

15. Precautions - the instruction and the special care required in the use of the drug product to
avoid undesired effects and to ensure its safe and effective use.

16. Primary Label - refers to the label on the primary packaging material of a drug product.

17. Product Name - the name (i.e. generic ruLme and brand name, if any) of the drug product as
registered in FDA.

18. Warnings - statements regarding the occurrence of potential hazards and undesirable effects
associated with the use of the drug product and the limitation of its use.

READ: AO 2016-0008
G. Licensing Requirements
Administrative Order No. 2020-0017 || Revised Guidelines on the Unified Licensing Requirements and
Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003

The objectives for issuing this Administrative Order are as follows:
a. To simplify the requirements and processes for initial, renewal, and variation of License to
Operate (LTO) applications; and
b. To re-engineer and streamline FDA’s processes and automate its system in compliance with the
provisions of RA 11032 in the maximum prescribed processing time depending on the
complexity of the transaction.
READ: AO 2020-00017
TLA: Flowchart, Licensing
End of Part 5

2. Act for Salt Iodization Nationwide (ASIN), RA 8172
 ● Discuss the importance of RA 8172 in the practice of pharmacy and in the public health
The purposes of this Act are to:
a) contribute to the elimination of micronutrient malnutrition in the country, particularly iodine
deficiency disorders, through the cost-effective preventive measure of salt iodization;

b) require all producers manufacturers of food-grade salt to iodize the salt that they produce,
manufacture, import, trade or distribute;

c) require the Department of Health (DOH) to undertake the salt iodization program and for its Bureau
of Food and Drugs (BFAD), to set and enforce standards for food-grade iodized salt and to monitor
compliance thereof by the food-grade salt manufacturers;

xxx.


3. Special Law on Counterfeit Drugs, RA 8203
● Distinguish counterfeit, adulterated or misbranded drugs
Generally prohibits activities related to the importation, manufacture, sale, distribution or mere
possession of “counterfeit drugs”

Counterfeit Drug / Medicine
● Refers to medicinal products
● correct ingredients but not in the amounts as provided
● wrong ingredients
● without active ingredients
● insufficient quantity of active ingredient reduction of the drug’s safety, efficacy, quality,
strength or purity

Counterfeit Drug / Medicine
1. Bearing without authorization the trademark, trade name or other identification mark or
imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark
and Technology Transfer (BPTTT) in the name of another natural or juridical person
2. Refilled in containers by unauthorized persons if the legitimate labels or marks are used;
3. An unregistered imported drug product (with registered counterpart brand in the Philippines)
EXCEPT drugs brought in the country for personal use as confirmed and justified by
accompanying medical records
4. A drug which contains no amount of or a different active ingredient or less than eighty percent
(80%) of the active ingredient it purports to possess, distinguished from an adulterated drug
including reduction or loss or efficacy due to expiration.

Prohibited Acts
● Manufacture, sale, or offering for sale, donation, distribution, trafficking, brokering,
exportation, or importation
● Possession of any such counterfeit drugs
Exemption:
○ presentation of sales invoices, official receipts or other legally acceptable documents
○ presentation of certificates and other documents evidencing the importation or
exportation
 ● Forging, counterfeiting, simulating or falsely representing, or without proper authority, using
any mark, stamp, tag, label or other identification mark or device authorized or required by
Republic Act No. 3720
● Photocopying, duplicating, altering, printing, transferring, obliterating or removing the
approved label or any part therefor, lawfully belonging to another person
● Making, selling, or concealing any punch, dye, plate or any other equipment or instrument
designed to print, imprint or reproduce the trademark, tradename, or any identifying mark of
another registered producer or any likeness

Parties Liable
● Manufacturer, exporter or importer of the counterfeit drugs and their agents
● The seller, distributor, trafficker, broker or donor and their agents
● The possessor of counterfeit drugs
● The manager, operator or lessee of the laboratory or laboratory facilities
● The owner, proprietor, administrator or manager of the drugstore, hospital pharmacy or
dispensary, laboratory or other outlets or premises
● The registered pharmacist of the outlet where the counterfeit drug is sold or found, who sells
or dispenses such drug to a third party and who has actual or constructive knowledge that said
drug is counterfeit

Administrative Sanctions
● Permanent closure and revocation of license to operate of business
● Fine: P100,000-P500,000
● After Court order: Forfeiture, confiscation, and destruction of products
● Filing of proceedings for cancellation of license of RPh
● Filing of criminal charges
● Disqualification to own or operate any business

Penalties
● Possession: 6mo 1d – 6 years
● Prohibited acts: 6mo 1d – 10 years, Fine P100,000-P500,000
● Animals: 6mo 1d – 2y 4 mo
● Sealed: 6y 1 d – 10 y
● Phy injury: 12 -15y, Fine P100,000-P500,000
● Death: Life imprisonment, Fine P500,000 – P5,000,000

4. Tobacco Regulation Act of 2003, RA 9211
● Discuss the policies governing RA 9211
READ: RA 9211

5. Traditional and Alternative Medicine Act (TAMA) of 1997, RA 8423
● Discuss the policies governing RA 9211
READ: RA 8423

6. Household Hazardous Act, PD 881
● Describe the handling and disposal of the different dangerous substances
READ: PD 881


Unit IV. Ensure Affordability and Accessibility of Drugs
● Discuss the policies governing the law
● Discuss the role of the pharmacist in the operationalization of the law

1. Generics Act of 1988, RA 6675
A. Policies

Section 2. Statement of Policy – It is hereby declared the policy of the State:
● To promote, encourage and require the use of generic terminology in the importation,
manufacture, distribution, marketing, advertising and promotion, prescription and dispensing
of drugs;

● To ensure the adequate supply of drugs with generic names at the lowest possible cost and
endeavor to make them available for free to indigent patients;

● To encourage the extensive use of drugs with generic names through a rational system of
procurement and distribution;

● To emphasize the scientific basis for the use of drugs, in order that health professionals may
become more aware and cognizant of their therapeutic effectiveness; and

● To promote drug safety by minimizing duplication in medications and/or use of drugs with
potentially adverse drug interactions.

The Generics Act was declared constitutional in the case of Del Rosario vs. Bengzon (180 SCRA 521,
December 21, 1989).

A case was filed by officers of the Philippine Medical Association, the national organization of medical
doctors in the Philippines asking the Honorable Supreme Court to declare as unconstitutional, hence,
null and void, some provisions of the Generics Act of 1988 (Rep. Act No. 6675), and of the implementing
Administrative Order No. 62 issued.

There is no unequal treatment of government and private prescribers.

PMA argues that paragraphs (a) and (b), Section 6 of the law, is the alleged unequal treatment of
government physicians, dentists, and veterinarians, on one hand, and those in private practice on the
other hand, in the manner of prescribing generic drugs, for, while the former are allegedly required to
use only generic terminology in their prescriptions, the latter may write the brand name of the drug in
parenthesis below the generic name. The favored treatment of private doctors, dentists and
veterinarians under the law is allegedly a species of invalid class legislation.

Section 6. Who Shall Use Generic Terminology -
(a) All government health agencies and their personnel as well as other government agencies shall use
generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing
and administering of drugs and medicines.

(b) All medical, dental and veterinary practitioners, including private practitioners, shall write
prescriptions using the generic name. The brand name may be included if so desired

There is no merit in that argument for it proceeds from a misreading and misinterpretation of the letter
and intent of paragraphs (a) and (b), Section 6 of the Generics Act.

The use of the word ‘all’ in the latter provision emphasizes the absence of any distinction between
government and private physicians. In other words, in prescribing drugs, physicians, whether in
government service or in private practice, are both governed by exactly the same rules, and thus, are
both authorized to include the brand name in their respective prescriptions

The pharmacist merely informs the customer.

PMA also argues that Section 6(d) authorizes the salesgirl at the drugstore counter to “substitute the
prescribed medicine with another medicine belonging to the same generic group.” Since doctors are
not allowed to instruct the druggist not to substitute the prescription, or to “Dispense only as
Prescribed” (per Sec. 4, Adm. Order No. 62).

“(d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional
outlets such as supermarkets and stores, shall inform any buyer about any and all other drug products
having the same generic name, together with their corresponding prices so that the buyer may
adequately exercise his option. Within one (1) year after approval of this Act, the drug outlets referred
to herein, shall post in conspicuous places in their establishments, a list of drug products with the same
generic name and their corresponding prices.”

The PMA argues that “the act of prescribing the correct medicine for the patient becomes the act of
the salesgirl at the drugstore counter, no longer the act of the physician, dentist, or veterinarian.”

The salesgirl and/or druggist does not have discretion to substitute the doctor’s prescription. On the
contrary, Section 4, par. 4.1, of Administrative Order No. 62 directs the pharmacist not to fill “violative
prescriptions” (where the generic name is not written, or illegibly written, and the prescription of a
brand name is accompanied by the doctor’s instruction not to substitute it), as well as “impossible
prescriptions” (par. 4.5). Even a doctor’s “erroneous” prescriptions “shall be filled,” not substituted
(par. 4.3, Adm. Order No. 62). Further, Sections 3 and 5 of Adm. Order No. 63 enjoin the drug outlets
“not (to) favor or suggest” or “impose” a particular brand or product on the customer.
AO 63 provides:
“In order to ensure the informed choice and use of drugs by the patient/buyer, the drug outlet is
required to:

“3.1.1 Inform the patient/buyer of all available drug products generically equivalent to the one
prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest any
particular product so that the patient/ buyer may fully and adequately exercise his option to choose
(Sec. 3, Adm. Order No. 63 s. 1989).

xxx
xxx
xxx
“The following acts or omissions are considered violations of these rules and regulations:
“5.1 Imposing a particular brand or product on the buyer, x x x.”

Contrary the their view, the salesgirl at the drugstore counter merely informs the customer, but does
not determine (for she is incompetent to do so), all the other drug products or brands that have the
same generic name, and their corresponding prices. That information she may obtain from the list of
drug products determined by the Bureau of Food and Drugs to have the same generic name, or which
are the chemical, biological, and therapeutic equivalent of the generic drug. All drugstores or drug
outlets are required by the law to post such a list in a conspicuous place in their premises for the
information of the customers, for the choice of whether to buy the expensive brand-name drug, or the
less expensive generic, should be exercised by the customer alone.

The purpose of the Generics Act is to carry out the policy of the State “to promote and require the use
of generic drug products that are therapeutically equivalent to their brand-name counterparts” for “the
therapeutic effect of a drug does not depend on its ‘brand’ but on the ‘active ingredients’ which it
contains.” The medicine that cures is the “active ingredient” of the drug, and not the brand name by
which it has been baptized by the manufacturer.

The Court has been unable to find any constitutional infirmity in the Generics Act. It, on the contrary,
implements the constitutional mandate for the State “to protect and promote the right to health of the
people” and “to make essential goods, health and other social services available to all the people
at affordable cost” (Section 15, Art. II and Section 11, Art. XIII, 1987 Constitution).

The provision prohibiting the use of “no substitution” in the prescription is valid.

The prohibition against the use by doctors of “no substitution” and/or words of similar import in their
prescription, is a valid regulation to prevent the circumvention of the law. It secures the patient the
right to choose between the brand name and its generic equivalent since his doctor is allowed to write
both the generic and the brand name in his prescription form.

If a doctor is allowed to prescribe a brand-name drug with “no substitution,” the patient’s option to
buy a lower-priced, but equally effective, generic equivalent would thereby be curtailed. The law aims
to benefit the impoverished (and often sickly) majority of the population in a still developing country
like ours, not the affluent and generally healthy minority.

The Honorable Supreme Court held that the Generics Act and the implementing administrative orders
of the Secretary of Health are constitutional. In light of its beneficial provisions, the PMA’s plea cannot
to declare the law unconstitutional cannot be granted before it has had a chance to prove its value to
our people as envisioned by its makers.


B. Operation

Section 6. Who Shall Use Generic Terminology -

(a) All government health agencies and their personnel as well as other government agencies shall use
generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing
and administering of drugs and medicines.

(b) All medical, dental and veterinary practitioners, including private practitioners, shall write
prescriptions using the generic name. The brand name may be included if so desired.

(c) Any organization or company involved in the manufacture, importation, repacking, marketing
and/or distribution of drugs and medicines shall indicate prominently the generic name of the product.
In the case of brand name products, the generic name shall appear prominently and immediately above
the brand name in all product labels as well as in advertising and other promotional materials.

(d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets
such as supermarkets and stores, shall inform any buyer about any and all other drug products having
the same generic name, together with their corresponding prices so that the buyer may adequately
exercise, his option.

Within one (1) year after approval of this Act, the drug outlets referred to herein, shall post in
conspicuous places in their establishments, a list of drug products with the same generic name and
their corresponding prices.

Section 7. Provision on Quality, Manufacturer’s Identity and Responsibility – In order to assure
responsibility for drug quality in all instances, the label of all drugs and medicines shall have the
following: name and country of manufacture, dates of manufacture and expiration. The quality of such
generically labeled drugs and medicines shall be duly certified by the Department of Health.

Section 8. Required Production – Subject to the rules and regulations promulgated by the Secretary of
Health, every drug manufacturing company operating in the Philippines shall be required to produce,
distribute and make available to the general public the medicine it produces, in the form of generic
drugs.

C. Penalty

Violation of 6A, 6B
● 1st Conviction: reprimand which shall be officially recorded in the appropriate books of the
Professional Regulation Commission
● 2nd Conviction: P2000-P5000
● 3rd Conviction: P5000-P10000 with suspension of license to practice for 30 days
● 4th and Subsequent Conviction: NLT P10000 and suspension of license to practice for 1 year or
longer

Violation of 6C, 7, 8
● P5000-P10000
● Establishment: Suspension or revocation of LTO
● Professional: Suspension or revocation of License to practice profession
● Imprisonment of 6mo-1year

READ: AO 62 s. 1968

D. Prescribing Guidelines

Prescribing Requirements
 ● Generic names shall be used in all prescriptions.
● The generic name must be written in full but the salt or chemical form may be abbreviated. The
generic name of the drug must be clearly written on the prescription immediately after the Rx
symbol, or on the order chart
● For branded drugs:
● If written on a prescription pad, the brand name enclosed in parenthesis shall be
written below the generic name.
● If written on a patient’s chart, the brand name enclosed in parenthesis shall be written
after the generic name.

Erroneous Prescriptions
● Where the brand name precedes the generic name
● Where the generic name is the one in parenthesis
● Where the brand name is not in parenthesis
● Where more than one drug product is prescribed on one prescription form.
● BE FILLED. REPORT TO DOH

Violative Prescriptions
● Where the generic name is not written.
● Where the generic name is not legible and a brand name which is legible is written.
● Where the brand name is indicated and instructions added (such as the phrase “no
substitution”) which tend to obstruct, hinder or prevent proper generic dispensing.
● NOT BE FILLED. REPORT TO DOH

Impossible Prescriptions
● When only the generic name is written but it is not legible
● When the generic name does not correspond to the brand name
● When both the generic name and the brand name are no legible
● When the drug product prescribed is not registered with the BFAD
● NOT BE FILLED. REPORT TO DOH

Administrative Order No. 90 s. 1990
● As amended, A.O. 62 thereby permits the writing of the generic names of more than one drug
product in one prescription form.

FDA Circular No. 2020-007 || GUIDELINES IN THE IMPLEMENTATION OF THE USE OF ELECTRONIC
MEANS OF PRESCRIPTION FOR DRUGS FOR THE BENEFIT OF INDIVIDUALS VULNERABLE TO COVID-19

E. Dispensing Guidelines
Administrative Order No. 63 s. 1989

Prescription or Ethical Drugs
● These drugs can only be dispensed upon a written order of a validly- registered physician,
dentist or veterinarian.

Non-Prescription or Over-the-Counter (OTC) Drugs
● These drugs may be dispensed even without a written order of a validly- registered physician,
dentist or veterinarian in duly licensed drug outlets.
 ● When dispensing OTC drugs without a doctor’s prescription, the pharmacist shall give the
necessary information and direction for use of the drug.
● All prescriptions dispensed in the drugstores, botica or hospital pharmacy shall be kept in file
for two years and recorded in a prescription book duly-registered by BFAD which shall be open
for inspection by Food and Drug Inspectors at any time during business hours of the outlet.
● The prescription book shall be kept for two years after the last entry.

Drug Stores, Boticas, and Other Drug Outlets
● Inform the patient/buyer of all available drug products generically equivalent to the one
prescribed with their corresponding prices.
● In so doing, the drug outlet shall not favor or suggest any particular product so that the
patient/buyer may fully and adequately exercise his option to choose.
● For this purpose, all drug outlets shall post in a conspicuous place in their establishment a list
of drug products using generic names with their brand names, if any, and their corresponding
current prices

Dispensing Drugs in List A and List B
● Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription
filled.
● The order and instruction of the doctor as written on the prescription, must be precisely
followed.
● Partial filling of prescription for drugs belonging to List A shall not be allowed/


Violations
● Imposing a particular brand or product on the buyer.
● Inaccurate dispensing i.e. dispensing a drug product which does not meet the prescription as
to any or all of the following: active ingredient, dosage form and strength.
● Failure to post or make accessible the required up-to-date information on drug products.
● Failure to adequately inform the buyer on available products that meet the prescription.
● Failure to indicate the generic name/official name designated by BFAD and other required
information on the drug outlet’s label of the dispensed drug.
● Failure to record and keep prescriptions filled.
● Failure to report to the nearest DOH office cases of violative, erroneous, and/or impossible
prescriptions within three months after receipt of such prescriptions.


2. The Price Act, R.A. 7581, amended by R.A. 10623
A. Introduction
Sec. 2. Declaration of Basic Policy. – It is the policy of the State to ensure the availability of basic
necessities and prime commodities at reasonable prices at all times without denying legitimate
business a fair return on investment. It is also a declared policy of the State to provide effective and
sufficient protection to consumers against hoarding, profiteering and cartels with respect to the supply,
distribution, marketing and pricing of said goods, especially during periods of calamity, emergency,
widespread illegal price manipulation and other similar situations. To these ends, the State shall:

(1) Develop, adopt and promulgate measures to promote productivity in basic necessities and prime
commodities;
(2) Develop an improved and efficient transport and distribution system;
(3) Develop, adopt and promulgate measures to stabilize prices at reasonable levels;
(4) Institute appropriate penalties for illegal price manipulation and other violations of this Act; and
(5) Establish a mechanism that will readily protect consumers from inadequate supply and
unreasonable price increase on occasions of calamities, emergencies and like occurrences.

B. Definition of Terms

“Panic-buying” is the abnormal phenomenon where consumers buy basic necessities and prime
commodities grossly in excess of their normal requirement resulting in undue shortages of such goods
to the prejudice of less privileged consumers;

“Prevailing price” means the average price at which any basic necessity has been sold in a given time
within a month from the occurrence of any of the conditions enumerated under Section 6 of this Act;

“Price ceiling” means the maximum price at which any basic necessity or prime commodity may be sold
to the general public; and

‘Basic necessities’ are goods vital to the needs of consumers for their sustenance and existence in times
of any of the cases provided under Section 6 or 7 of this Act such as, but not limited to, rice, corn, root
crops, bread; fresh, dried or canned fish and other marine products; fresh pork, beef and poultry meat;
fresh eggs; potable water in bottles and containers; fresh and processed milk; fresh vegetables and
fruits; locally manufactured instant noodles; coffee; sugar; cooking oil; salt; laundry soap and
detergents; firewood; charcoal; household liquefied petroleum gas (LPG) and kerosene; candles; drugs
classified as essential by the Department of Health and such other goods as may be included under
Section 4 of this Act;"

‘Prime Commodities’ are goods not considered as basic necessities but are essential to consumers in
times of any of the cases provided under Section 7 of this Act such as, but not limited to, flour; dried,
processed or canned pork, beef and poultry meat; dairy products not falling under basic necessities;
onions, garlic, vinegar, patis, soy sauce; toilet soap; fertilizer, pesticides and herbicides; poultry,
livestock and fishery feeds and veterinary products; paper; school supplies; nipa shingles; sawali;
cement; clinker; GI sheets; hollow blocks; plywood; plyboard; construction nails; batteries; electrical
supplies; light bulbs; steel wire; all drugs not classified as essential drugs by the Department of Health
and such other goods as may be included under Section 4 of this Act."

C. Implementation
"Section 11. Price Coordinating Council. – There is hereby created a Price Coordinating Council,
hereinafter referred to as the Council, to be composed of the following members:
1. The Secretary of Trade and Industry, as chairman;
2. The Secretary of Agriculture;
3. The Secretary of Health;
4. The Secretary of Environment and Natural Resources;
5. The Secretary of Local Government;
6. The Secretary of Transportation and Communications;
7. The Secretary of Justice;
8. The Secretary of Energy;
9. The Director General of the National Economic and Development Authority;
 10. One (1) representative from the consumers’ sector;
11. One (1) representative from the agricultural producers’ sector;
12. One (1) representative from the trading sector; and
13. One (1) representative from the manufacturers’ sector.

Functions of the Implementing Agencies
● May issue Suggested Retail Price (SRP) whenever necessary
○ SRP is set by manufacturers. DTI evaluates the reasonableness of any change/increase
in the SRP based on the changes in the prices of raw materials and other production
costs.
○ SRP also works to ensure free and fair competition among brand owners and of
supermarket and grocery owners
● May determine, recommend and enforce price ceiling/ control whenever necessary

Issuance of Notice of Violation
● Notice of Violation (NOV) is being issued to owners of business establishments selling basic
necessities and prime commodities above the SRPs.
● These establishments are directed to comply and adjust their SRPs and submit a written
explanation within forty-eight (48) hours upon receipt of the NOV

D. Price Control

Sec. 6. Automatic Price Control.
Unless otherwise declared by the President, prices of basic necessities in an area shall automatically be
frozen at their prevailing prices or placed under automatic price control whenever:
(1) That area is proclaimed or declared a disaster area or under a state of calamity;
(2) That area is declared under an emergency;
(3) The privilege of the writ of habeas corpus is suspended in that area;
(4) That area is placed under martial law;
(5) That area is declared to be in a state of rebellion; or
(6) A state of war is declared in that area.

If the prevailing price of any basic necessity is excessive or unreasonable, the implementing agency may
recommend to the President the imposition of a price ceiling for the sale of the basic necessity at a
price other than its prevailing price.

Unless sooner lifted by the President, price control of basic necessities under this section shall remain
effective for the duration of the condition that brought it about, but not for more than sixty (60) days.
The terms “disaster” and “calamity” shall include those brought about by natural or man-made causes,
whether local or foreign.

Sec. 7. Mandated Price Ceiling.
The President, upon the recommendation of the implementing agency, or the Price Coordinating
Council, may impose a price ceiling on any basic necessity or prime commodity if any of the following
conditions so warrants:
(1) The impendency, existence, or effects of a calamity;
(2) The threat, existence, or effect of an emergency;
(3) The prevalence or widespread acts of illegal price manipulation:
(4) The impendency, existence, or effect of any event that causes artificial and unreasonable increase
in the price of the basic necessity or prime-commodity; and
(5) Whenever the prevailing price of any basic necessity or prime commodity has risen to unreasonable
levels.

Sec. 8. Determination of Price Ceilings.
In determining the reasonable price ceiling, the following factors may be taken into consideration:
(1) The average price, in the last three (3) months immediately preceding the proclamation of the price
ceiling, of the basic necessity or prime commodity under consideration;
(2) The supply available in the market;
(3) The cost to the producer, manufacturer, distributor or seller including but not limited to:
a. The exchange rate of the peso to the foreign currency with which a basic necessity or prime
commodity or any component, ingredient or raw material thereof was paid for;
b. Any change in the amortization cost of machinery brought about by any change in the exchange
rate of the peso to the foreign currency with which the machinery was bought through credit
facilities;
c. Any change in the cost of labor brought about by a change in the minimum wage; and
d. Any increase in the cost of transporting or distributing the basic necessity or prime commodity
to the area of destination.
(4) Such other factors or conditions which will aid in arriving at a just and reasonable price ceiling.

E. Illegal Acts of Price Manipulation
1. Hoarding, which is the undue accumulation by a person or combination of persons of any basic
commodity beyond his or their normal inventory levels or the unreasonable limitation or
refusal to dispose of, sell or distribute the stocks of any basic necessity of prime commodity to
the general public or the unjustified taking out of any basic necessity or prime commodity from
the channels of reproduction, trade, commerce and industry.
a. There shall be prima facie evidence of hoarding when a person has stocks of any basic
necessity or prime commodity fifty percent (50%) higher than his usual inventory and
unreasonably limits, refuses or fails to sell the same to the general public at the time
of discovery of the excess.
2. Profiteering, which is the sale or offering for sale of any basic necessity or prime commodity at
a price grossly in excess of its true worth. There shall be prima facie evidence of profiteering
whenever a basic necessity or prime commodity being sold:
a. has no price tag;
b. is misrepresented as to its weight or measurement;
c. is adulterated or diluted; or
d. whenever a person raises the price of any basic necessity or prime commodity he sells
or offers for sale to the general public by more than ten percent (10%) of its price in
the immediately preceding month
3. Cartel, which is any combination of or agreement between two (2) or more persons engaged
in the production, manufacture, processing, storage, supply, distribution, marketing, sale or
disposition of any basic necessity or prime commodity designed to artificially and unreasonably
increase or manipulate its price.

F. Penalties
Sec. 15. Penalty for Acts of Illegal Price Manipulation. – Any person who commits any act of illegal price
manipulation of any basic necessity or prime commodity under Section 5 hereof shall suffer the penalty
 of imprisonment for a period of not less than five (5) years nor more than Fifteen (15) years, and shall
be imposed a fine of not less than Five thousand pesos (P5,000) nor more than Two million pesos
(P2,000,000).

Sec. 16. Penalty for Violation of Price Ceiling. – Any person who violates Section 6 or 7 of this Act shall
suffer the penalty of imprisonment for a period of not less than one (1) year nor more than ten (10)
years of a fine of note less than Five thousand pesos (P5,000) nor more than One million pesos
(P1,000,000), or both, at the discretion of the court.


3. Consumer Act of the Philippines
A. Introduction
Article 2. Declaration of Basic Policy. – It is the policy of the State to protect the interests of the
consumer, promote his general welfare and to establish standards of conduct for business and industry.
Towards this end, the State shall implement measures to achieve the following objectives:
a. protection against hazards to health and safety;
b. protection against deceptive, unfair and unconscionable sales acts and practices;
c. provision of information and education to facilitate sound choice and the proper exercise of
rights by the consumer;
d. provision of adequate rights and means of redress; and
e. involvement of consumer representatives in the formulation of social and economic policies.

B. Implementation

Article 6. Implementing Agencies.
The provisions of this Article and its implementing rules and regulations shall be enforced by:
a. the Department of Health with respect to food, drugs, cosmetics, devices and substances;
b. the Department of Agriculture with respect to products related to agriculture, and;
c. the Department of Trade and Industry with respect to other consumer products not specified
above.

Article 10. Injurious, Dangerous and Unsafe Products.
Whenever the departments find, by their own initiative or by petition of a consumer, that a consumer
product is found to be injurious, unsafe or dangerous, it shall, after due notice and hearing, make the
appropriate order for its recall, prohibition or seizure from public sale or distribution: Provided, That,
in the sound discretion of the department it may declare a consumer product to be imminently
injurious, unsafe or dangerous, and order is immediate recall, ban or seizure from public sale or
distribution, in which case, the seller, distributor, manufacturer or producer thereof shall be afforded
a hearing within forty-eight (48) hours from such order.

The ban on the sale and distribution of a consumer product adjudged injurious, unsafe or dangerous,
or imminently injurious, unsafe or dangerous under the preceding paragraph shall stay in force until
such time that its safety can be assured or measures to ensure its safety have been established.

CHAPTER II FOOD, DRUGS, COSMETICS AND DEVICES
Article 20. Declaration of Policy.
The State shall ensure safe and good quality of food, drugs, cosmetics and devices, and regulate their
production, sale, distribution and advertisement to protect the health of the consumer.

Article 21. Implementing Agency.
In the implementation of the foregoing policy, the State, through the Department of Health, hereby
referred as the Department, shall, in accordance with the provisions of this Act:
a. establish standards and quality measures for food, drugs, devices and cosmetics;
b. adopt measures to ensure pure and safe supply of foods and cosmetics, and safe, efficacious
and good quality of drugs and devices in the Country;
c. adopt measures to ensure the rational use of drugs and devices, such as, but not limited to,
banning, recalling or withdrawing from the market drugs and devices which are unregistered,
unsafe, inefficacious or of doubtful therapeutic value, the adoption of an official National Drug
Formulary, and the use of generic names in the labeling of drugs;
d. strengthen the Bureau of Food and Drugs.


C. Consumer Protection
Article 148. National Consumer Affairs Council.
To improve the management, coordination and effectiveness of consumer programs, a National
Consumer Affairs Council is hereby created, hereinafter referred to as the "Council".

Article 159. Consumer Complaints.
The concerned department may commerce an investigation upon petition or upon letter-complaint
from any consumer: Provided, That, upon a finding by the department of prima facie violation of any
provisions of this Act or any rule or regulation promulgated under its authority, it may motu proprio or
upon verified complaint commerce formal administrative action against any person who appears
responsible therefor. The department shall establish procedures for systematically logging in,
investigating and responding to consumer complaints into the development of consumer policies, rules
and regulations, assuring as far as practicable simple and easy access on the part of the consumer to
seek redress for his grievances.

Article 160. Consumer Arbitration Officers.
The concerned Department Secretaries shall appoint as many qualified consumer arbitration officers
as may be necessary for the effective and efficient protection of consumer rights: Provided, however,
That there shall be not more than ten (10) consumer arbitration officers per province, including the
National Capital Region.

Article 163. Investigation Procedure.
a. The consumer arbitration officer shall conduct hearings on any complaint received by him or
referred by the Council.
b. Parties to the case shall be entitled to notice of the hearing, and shall be informed of the date,
time and place of the same. A copy of the complaint shall be attached to the notice.
c. The department shall afford all interested parties the opportunity to submit a statement of
facts, arguments, offers of settlements or proposals of adjustments.
d. The Consumer arbitration officer shall first and foremost ensure that the contending parties
come to a settlement of the case.
e. In the event that a settlement has not been effected, the Mediation officer may now proceed
to formally investigate, hear and decide the case.
f. The Consumer arbitration officer may summon witnesses, administer oaths and affirmations,
issue subpoena and subpoena duces tecum, rule upon offers of proof and receive relevant
 evidence, take or cause deposition to be taken whenever the ends of justice would be served
thereby, regulate the course of the hearing, rule on any procedural request or similar matter
and decide the complaint.
In hearing the complaint, the mediation officer shall use every and all reasonable means to ascertain
the facts in each complaint speedily and objectively without regard to strict rules of evidence prevailing
in suits before courts. The complaints shall be decided within fifteen (15) days from the time the
investigation was terminated.


D. Sanction
Article 164. Sanctions.
After investigation, any of the following administrative penalties may be imposed even if not prayed
for in the complaint:
a. the issuance of a cease and desist order, Provided, however, That such order shall specify the
acts that respondent shall cease and desist from and shall require him to submit a report of
compliance therewith within a reasonable time;
b. the acceptance of a voluntary assurance of compliance or discontinuance from the respondent
which may include any or all of the following terms and conditions:
i. an assurance to comply with the provisions of this Act and its implementing rules and
regulations;
ii. an assurance to refrain from engaging in unlawful acts and practices or unfair or
unethical trade practices subject of the formal investigation;
iii. an assurance to comply with the terms and conditions specified in the consumer
transaction subject of the complaint;
iv. an assurance to recall, replace, repair, or refund the money value of defective products
distributed in commerce;
v. an assurance to reimburse the complaint out of any money or property in connection
with the complaint, including expenses in making or pursuing the complaint, if any, and
to file a bond to guarantee compliance therewith.
c. restitution or rescission of the contract without damages;
d. condemnation and seizure of the consumer product found to be hazardous to health and safety
unless the respondent files a bond to answer for any damage or injury that may arise from the
continued use of the product;
e. the imposition of administrative fines in such amount as deemed reasonable by the Secretary,
which shall in no case be less that Five hundred pesos (P500.00) nor more than Three hundred
thousand pesos (P300,000.00) depending on the gravity of the offense, and an additional fine
of not more than One thousand pesos (P1,000.00) or each day of continuing violation.



4. Universally Accessible Cheaper and Quality Medicines Act of 2008
AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES, AMENDING FOR THE PURPOSE REPUBLIC
ACT NO. 8293 OR THE INTELLECTUAL PROPERTY CODE, REPUBLIC ACT NO. 6675 OR THE GENERICS ACT
OF 1988, AND REPUBLIC ACT NO. 5921 OR THE PHARMACY LAW, AND FOR OTHER PURPOSES
1. R.A. 8293 - IP Code
2. R.A. 6675 - Generics Act
3. R.A. 5921 - Pharmacy Law

A. Introduction

SEC. 2. Declaration of Policy. - It is the policy of the State to protect public health and, when the public
interest or circumstances of extreme urgency so require, it shall adopt appropriate measures to
promote and ensure access to affordable quality drugs and medicines for all.

Pursuant to the attainment of this general policy, an effective competition policy in the supply and
demand of quality affordable drugs and medicines is recognized by the State as a primary instrument.
In the event that full competition is not effective, the State recognizes as a reserve instrument the
regulation of prices of drugs and medicines, with clear accountability by the implementing authority as
mandated in this Act, as one of the means to also promote and ensure access to quality affordable
medicines.

SEC. 3. Construction in Favor of Protection of Public Health. - All doubts in the implementation and
interpretation of the provisions of this Act, including its implementing rules and regulations, shall be
resolved in favor of protecting public health.

B. Definition of Terms
SEC. 4. Definition of Terms
1. "Compulsory License" is a license issued by the Director General of the Intellectual Property
Office to exploit a patented invention without the permission of the patent holder, either by
manufacture or through parallel importation;
2. "Drug outlet" refers to drugstores, pharmacies, and any other business establishments which
sell drugs and medicines;

3. "Essential drugs list or national drug formulary" refers to a list of drugs prepared and
periodically updated by the Department of Health on the basis of health conditions obtaining
in the Philippines as well as on internationally accepted criteria;

4. "Importer" refers to any establishment that imports raw materials, active ingredients and
finished products for its own use or for distribution to other drug establishments or outlets;

5. "Manufacturer" refers to any establishment engaged in the operations involved in the
production of a drug with the end view of storage, distribution, or sale of the product;

6. "Multisource pharmaceutical products" refers to pharmaceutically equivalent or
pharmaceutically alternative products that may or may not be therapeutically equivalent.
Multisource pharmaceutical products that are therapeutically equivalent are interchangeable;

7. "Retailer" refers to a licensed establishment carrying on the retail business of sale of drugs and
medicines to customers;

8. "Trader" refers to any licensed establishment which is a registered owner of a drug product
that procures the materials and packaging components, and provides the production
monographs, quality control standards and procedures, but subcontracts the manufacture of
such products to a licensed manufacturer;

 9. "TRIPS Agreement" or Agreement on Trade-Related Aspects of Intellectual Property Rights
refers to the international agreement administered by the WTO that sets down minimum
standards for many forms of intellectual property regulation; and

10. "Wholesaler" refers to a licensed establishment or drug outlet who acts as merchant, broker or
agent, who sells or distributes for resale or wholesale drugs and medicines.

C. Amendments to the IP Code

a. Patent Rights

SEC. 5.
Section 22 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the
Philippines, is hereby amended to read as follows:

"SEC. 22. Non-Patentable Inventions. - The following shall be excluded from patent protection:

"22.1. Discoveries, scientific theories and mathematical methods, and in the case of drugs and
medicines, the mere discovery of a new form or new property of a known substance which does not
result in the enhancement of the known efficacy of that substance, or the mere discovery of any new
property or new use for a known substance, or the mere use of a known process unless such known
process results in a new product that employs at least one new reactant.

"For the purpose of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size,
isomers, mixtures of isomers, complexes, combinations, and other derivatives of a known substance
shall be considered to be the same substance, unless they differ significantly in properties with regard
to efficacy;

SEC. 6.
Section 26 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the
Philippines, is hereby amended to read as follows:

"SEC. 26. Inventive Step. - 26.1. An invention involves an inventive step if, having regard to prior art, it
is not obvious to a person skilled in the art at the time of the filing date or priority date of the application
claiming the invention. (n)

"26.2. In the case of drugs and medicines, there is no inventive step if the invention results from the
mere discovery of a new form or new property of a known substance which does not result in the
enhancement of the known efficacy of that substance, or the mere discovery of any new property or
new use for a known substance, or the mere use of a known process unless such known process results
in a new product that employs at least one new reactant."

SEC. 7.
Section 72 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the
Philippines, is hereby amended to read as follows:

"SEC. 72. Limitations of Patent Rights. - The owner of a patent has no right to prevent third parties from
performing, without his authorization, the acts referred to in Section 71 hereof in the following
circumstances:

"72.1. Using a patented product which has been put on the market in the Philippines by the owner of
the product, or with his express consent, insofar as such use is performed after that product has been
so put on the said market: Provided, That, with regard to drugs and medicines, the limitation on patent
rights shall apply after a drug or medicine has been introduced in the Philippines or anywhere else in
the world by the patent owner, or by any party authorized to use the invention: Provided, further, That
the right to import the drugs and medicines contemplated in this section shall be available to any
government agency or any private third party;

SECTION 74. Use of Invention by Government.
(not amended, original provision from the IP Code)
74.1. A Government agency or third person authorized by the Government may exploit the invention
even without agreement of the patent owner where(a) The public interest, in particular, national
security, nutrition, health or the development of other sectors, as determined by the appropriate
agency of the government, so requires; or

(b) A judicial or administrative body has determined that the manner of exploitation, by the owner of
the patent or his licensee is anti-competitive; or

(c) In the case of drugs and medicines, there is a national emergency or other circumstance of extreme
urgency requiring the use of the invention; or

(d) In the case of drugs and medicines, there is public non-commercial use of the patent by the
patentee, without satisfactory reason; or

(e) In the case of drugs and medicines, the demand for the patented article in the Philippines is not
being met to an adequate extent and on reasonable terms, as determined by the Secretary of the
Department of Health.

b. Drug and Medicines Price Regulation

SEC. 17. Drugs and Medicines Price Regulation Authority of the President of the Philippines. -
The President of the Philippines, upon recommendation of the Secretary of the Department of Health,
shall have the power to impose maximum retail prices over any or all drugs and medicines as
enumerated in Section 23.

The power to impose maximum retail prices over drugs and medicines shall be exercised within such
period of time as the situation may warrant as determined by the President of the Philippines. No court,
except the Supreme Court of the Philippines, shall issue any temporary restraining order or preliminary
injunction or preliminary mandatory injunction that will prevent the immediate execution of the
exercise of this power of the President of the Philippines.

SEC. 19. Functions and Responsibilities of the Secretary of the Department of Health.
Pursuant to Section 18 of this Act, the Secretary of the Department of Health shall have the following
powers:

(A) Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to Price Regulation
- (1) Upon application or motu proprio when the public interest so requires, the Secretary of the
Department of Health shall have the power to determine the maximum retail prices of drugs and
medicines which shall be recommended to the President of the Philippines for approval. In order that
affordable prices of drugs and medicines from the different manufacturers, importers, traders,
distributors, wholesalers, or retailers shall be made available to the public, the Secretary of the
Department of Health, as he/she may deem fit and after a proper determination, shall have such
approved maximum retail prices of drugs and medicines published;

(2) In recommending the maximum retail price, the Secretary of the Department of Health shall
consider the following factors:

(a) Retail prices of drugs and medicines that are subject to regulation in the Philippines and in other
countries;

(b) The supply available in the market;

(c) The cost to the manufacturer, importer, trader, distributor, wholesaler or retailer of the following,
but not limited to:

(i) The exchange rate of the peso to the foreign currency with which the drug or any of its component,
ingredient or raw material was paid for;

(ii) Any change in the amortization cost of machinery brought about by any change in the exchange rate
of the peso to the foreign currency with which the machinery was bought through credit facilities;

(iii) Any change in the cost of labor brought about by a change in minimum wage; or

(iv) Any change in the cost of transporting or distributing the medicines to the area of destination;

(d) Such other factors or conditions which will aid in arriving at a just and reasonable maximum price;
and

(3) No retailer shall sell drugs and medicines at a retail price exceeding the maximum retail price
approved by the President of the Philippines as provided in Section 17 of this Act: Provided, That, the
Secretary of the Department of Health shall immediately undertake a study on the prevailing prices of
drugs and medicines subject to price regulation and provide an initial list of drugs and medicines, which
maximum retail prices he/she shall recommend to the President of the Philippines.

SEC. 23. List of Drugs and Medicines that are Subject to Price Regulation.
The list of drugs and medicines that are subject to price regulation shall include, inter alia:

(a) All drugs and medicines indicated for treatment of chronic illnesses and life threatening conditions,
such as, but not limited to, endocrine disorders, e.g., diabetes mellitus; gastrointestinal disorders, e.g.,
peptic ulcer; urologic disorders, e.g., benign prostatic hyperplasia (BPH); cardiovascular diseases, e.g.,
hypertension; pulmonary diseases, e.g., pulmonary tuberculosis (PTB), asthma; auto-immune diseases,
e.g., systemic lupus erythematosus (SLE); skin diseases, e.g., psoriasis; neuro-psychiatric disorders;
other infectious diseases, e.g., human immunodeficiency virus-acquired immune deficiency syndrome
(HIV-AIDS); and other conditions such as organ transplants and neoplasm;

(b) Drugs and medicines indicated for prevention of diseases, e.g., vaccines, immunoglobulin, anti-sera;

(c) Drugs and medicines indicated for prevention of pregnancy, e.g., oral contraceptives;

(d) Anesthetic agents;

(e) Intravenous fluids;

(f) Drugs and medicines that are included in the Philippine National Drug Formulary (PNDF) Essential
Drug List; and

(g) All other drugs and medicines which, from time to time, the Secretary of the Department of Health
determines to be in need of price regulation.

SEC. 26. Display of Maximum Retail Price Fixed and Approved by Order of the President of the
Philippines for Drugs and Medicines Subject to Price Regulation.
The maximum retail price shall be printed on the label of the immediate container of the drug and
medicine and the minimum pack thereof offered for retail sale with the words "RETAIL PRICE NOT TO
EXCEED" preceding it, and "UNDER DRUG PRICE REGULATION" on a red strip.

The Secretary of the Department of Health from time to time, every manufacturer, importer, or trader
shall issue a price list to wholesalers, distributors, retailers and to the Secretary of the Department of
Health, indicating the retail price, the maximum retail price, and such other information as may be
required by the Secretary of the Department of Health.

d. Illegal Acts

Illegal Acts of Price Manipulation
● it shall be unlawful to engage in acts of price manipulation such as hoarding, profiteering, or
illegal combination or forming cartel of drugs.

Penalty:
● Imp: 5-15 years
● Fine: PhP 100,000-10,000,000
● Suspension or revocation of its license to operate (LTO), professional or business license.

D. Amendments to the Generics Act
“SEC. 5. Posting and Publication. – The Department of Health shall publish annually in acceptable means
of public dissemination in at least two (2) newspapers of general circulation in the Philippines the
generic names, and the corresponding brand names under which they are marketed, of all drugs and
medicines available in the Philippines.”

Section 6: Who Shall Use Generic Terminology

e. There shall appear prominently on the label of a generic drug the following statement:

“THIS PRODUCT HAS THE SAME THERAPEUTIC EFFICACY AS ANY OTHER GENERIC PRODUCT OF THE
SAME NAME. SIGNED: BFAD.”

E. Amendment to the Pharmacy Law

Section 25 of RA 5921
“Pharmaceutical, drug or biological manufacturing establishments, importers and wholesalers of drugs,
medicines, or biologic products, shall not sell their products for re-sale except only to retail drug outlets,
hospital pharmacies or to other drug wholesalers under the supervision of a registered pharmacist, and
supermarkets, convenience stores, other retail establishments for over-the-counter drugs, duly
licensed by the Bureau of Food and Drugs.”


5. Expanded Senior Citizens Act of 2010
Republic Act No. 9994 (Expanded Senior Citizen Act of 2010)
Amends:
● RA 7432 - Senior Citizen Act of 1992
● RA 9257 - Expanded Senior Citizens Act of 2003

A. Introduction
Senior citizen or elderly refers to any Filipino citizen who is a resident of the Philippines, and who is at
least sixty (60) years old and above;

Three Elements
1. Citizenship- you need to be a Filipino in order to avail the privileges afforded of this act
2. A resident of the country
3. The age element- you must be at least 60 years old

B. Privileges

To avail privileges SC or duly authorized representative may show any of the ff:
1. OSCA ID (Honored Nationwide)
2. SC Passport
3. other documents that establish that the senior citizen is a citizen of the Republic and is at least
sixty (60) years of age

4. 20% discount and VAT free
a. purchase of medicines, including the purchase of influenza and pnuemococcal
vaccines, and such other essential medical supplies, accessories and equipment
b. on the professional fees of attending physician/s in all private hospitals, medical
facilities, outpatient clinics and home health care services;
c. on the professional fees of licensed professional health providing home health care
services as endorsed by private hospitals or employed through home health care
employment agencies;
d. on medical and dental services, diagnostic and laboratory fees in all private hospitals,
medical facilities, outpatient clinics, and home health care services
5. free
 a. medical and dental services, diagnostic and laboratory fees such as, but not limited to,
x-rays, computerized tomography scans and blood tests, in all government facilities,
b. vaccination against the influenza virus and pneumococcal disease for indigent senior
citizen patients;
6. provision of express lanes for senior citizens in all commercial and government establishments;
in the absence thereof, priority shall be given to them
7. death benefit assistance of a minimum of Two thousand pesos (Php2,000.00) shall be given to
the nearest surviving relative of a deceased senior citizen, subject to adjustments due to
inflation
8. the grant of a minimum of five percent (5%) discount relative to the monthly utilization of water
and electricity supplied by the public utilities, Provided
a. Meter is registered in the name of the senior citizen
b. That the monthly consumption does not exceed one hundred kilowatt hours (100 kWh)
of electricity and thirty cubic meters (30 m3) of water:
c. That the privilege is granted per household regardless of the number of senior citizens
residing therein;
9. “In the purchase of goods and services which are on promotional discount, the senior citizen
can avail of the promotional discount or the discount provided herein, whichever is higher”
10. “Throughout the country, there shall be established a “senior citizens’ ward” in every
government hospital.”
11. Additional Government Assistance
a. Indigent senior citizens shall be entitled to a monthly stipend amounting to Five
hundred pesos (Php500.00) to augment the daily subsistence and other medical needs
of senior citizens,
b. All indigent senior citizens shall be covered by the national health insurance program
of PhilHealth

Tax Provision
“The establishment may claim the discounts granted under subsections (a) and (c) of this section as tax
deduction based on the cost of the goods sold or services rendered: Provided, That the cost of the
discount shall be allowed as deduction from gross income for the same taxable year that the discount
is granted: Provided, further, That the total amount of the claimed tax deduction net of VAT, if
applicable, shall be included in their gross sales receipts for tax purposes and shall be subject to proper
documentation and to the provisions of the National Internal Revenue Code (NICR), as amended.”

C. Penalties
First Violation
● 2 - 6 years imprisonment
● PhP 50,000-100,000 fine
Subsequent Violation
● 2 - 6 years imprisonment
● PhP 100,000-200,000 fine
Abuse privileges:
● PhP 50,000 – 100,000 Fine
● NLT 6 months imprisonment

D. AO No. 32 s. 2010
 ● Guidelines and Mechanisms to Implement the Provisions of Republic Act No. 9994. otherwise
known as “The Expanded Senior Citizens Act of 2010”, on the Sale of Medicines and the Sharing
of the 20% Senior Citizens' Discount
● The 20% discount is non-transferable. It shall be applied exclusively to drugs and medicines for
the use of Senior Citizens. Drugs in formulation, such as pediatric formulations medically
prescribed for use of Senior Citizens shall also be granted a 20% discount

Documentary Requirements
● Purchase slip booklets shall be used to record the kind of OTC medicine purchased, how many,
when and where it was purchased. Likewise, this will help the drugstores to monitor the last
purchase made for a certain medicine.

Dispensing
● Prescription drugs
○ Single dispensing: should not cover more than one (1) month supply of medicines for
the Senior Citizens.
● OTC drugs
○ limit the dispensing of OTCs for a supply of one (1) day but not to exceed to a maximum
of seven (7) days supply.

Unit V. Control of the Use of Dangerous Drugs

1. The Dangerous Drugs Act and the Comprehensive Dangerous Drugs Act of 2002
● Applying the skills of pharmacist in ordering, dispensing, refilling and transferring prescriptions of
controlled substances
● Analyzing the different issues in the implementation of the law
AN ACT INSTITUTING THE COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002, REPEALING REPUBLIC
ACT NO. 6425, OTHERWISE KNOWN AS THE DANGEROUS DRUGS ACT OF 1972, AS AMENDED,
PROVIDING FUNDS THEREFOR, AND FOR OTHER PURPOSES

A. Introduction
SEC. 2. Declaration of Policy. — It is the policy of the State to safeguard the integrity of its territory and
the well-being of its citizenry particularly the youth, from the harmful effects of dangerous drugs on
their physical and mental well-being, and to defend the same against acts or omissions detrimental to
their development and preservation. In view of the foregoing, the State needs to enhance further the
efficacy of the law against dangerous drugs, it being one of today’s more serious social ills.

Toward this end, the government shall pursue an intensive and unrelenting campaign against the
trafficking and use of dangerous drugs and other similar substances through an integrated system of
planning, implementation and enforcement of anti-drug abuse policies, programs, and projects. The
government shall however aim to achieve a balance in the national drug control program so that people
with legitimate medical needs are not prevented from being treated with adequate amounts of
appropriate medications, which include the use of dangerous drugs.

It is further declared the policy of the State to provide effective mechanisms or measures to re-integrate
into society individuals who have fallen victims to drug abuse or dangerous drug dependence through
sustainable programs of treatment and rehabilitation.

B. Definitions
SEC. 3. Definitions. — As used in this Act, the following terms shall mean:

Acts
Cultivate or Culture. — Any act of knowingly planting, growing, raising, or permitting the planting,
growing or raising of any plant which is the source of a dangerous drug.

Manufacture. — The production, preparation, compounding or processing of any dangerous drug
and/or controlled precursor and essential chemical, either directly or indirectly or by extraction from
substances of natural origin, or independently by means of chemical synthesis or by a combination of
extraction and chemical synthesis, and shall include any packaging or repackaging of such substances,
design or configuration of its form, or labeling or relabeling of its container; except that such terms do
not include the preparation, compounding, packaging or labeling of a drug or other substances by a
duly authorized practitioner as an incident to his/her administration or dispensation of such drug or
substance in the course of his/her professional practice including research, teaching and chemical
analysis of dangerous drugs or such substances that are not intended for sale or for any other purpose.

Chemical Diversion. — The sale, distribution, supply or transport of legitimately imported, in-transit,
manufactured or procured controlled precursors and essential chemicals, in diluted, mixtures or in
concentrated form, to any person or entity engaged in the manufacture of any dangerous drug, and
shall include packaging, repackaging, labeling, relabeling or concealment of such transaction through
fraud, destruction of documents, fraudulent use of permits, misdeclaration, use of front companies or
mail fraud.

Protector/Coddler. — Any person who knowingly and willfully consents to the unlawful acts provided
for in this Act and uses his/her influence, power or position in shielding, harboring, screening or
facilitating the escape of any person he/she knows, or has reasonable grounds to believe on or suspects,
has violated the provisions of this Act in order to prevent the arrest, prosecution and conviction of the
violator.

Pusher. — Any person who sells, trades, administers, dispenses, delivers or gives away to another, on
any terms whatsoever, or distributes, dispatches in transit or transports dangerous drugs or who acts
as a broker in any of such transactions, in violation of this Act.

Sell. — Any act of giving away any dangerous drug and/or controlled precursor and essential chemical
whether for money or any other consideration.

Trading. — Transactions involving the illegal trafficking of dangerous drugs and/or controlled
precursors and essential chemicals using electronic devices such as, but not limited to, text messages,
e-mail, mobile or landlines, two-way radios, internet, instant messengers and chat rooms or acting as
a broker in any of such transactions whether for money or any other consideration in violation of this
Act.

Use. — Any act of injecting, intravenously or intramuscularly, of consuming, either by chewing,
smoking, sniffing, eating, swallowing, drinking or otherwise introducing into the physiological system
of the body, any of the dangerous drugs.

Clandestine Laboratory. — Any facility used for the illegal manufacture of any dangerous drug and/or
controlled precursor and essential chemical.

Den, Dive or Resort. — A place where any dangerous drug and/or controlled precursor and essential
chemical is administered, delivered, stored for illegal purposes, distributed, sold or used in any form.

Employee of Den, Dive or Resort. — The caretaker, helper, watchman, lookout, and other persons
working in the den, dive or resort, employed by the maintainer, owner and/or operator where any
dangerous drug and/or controlled precursor and essential chemical is administered, delivered,
distributed, sold or used, with or without compensation, in connection with the operation thereof.

Financier. — Any person who pays for, raises or supplies money for, or underwrites any of the illegal
activities prescribed under this Act.

Illegal Trafficking. — The illegal cultivation, culture, delivery, administration, dispensation,
manufacture, sale, trading, transportation, distribution, importation, exportation and possession of any
dangerous drug and/or controlled precursor and essential chemical.

Planting of Evidence. — The willful act by any person of maliciously and surreptitiously inserting,
placing, adding or attaching directly or indirectly, through any overt or covert act, whatever quantity of
any dangerous drug and/or controlled precursor and essential chemical in the person, house, effects
or in the immediate vicinity of an innocent individual for the purpose of implicating, incriminating or
imputing the commission of any violation of this Act.

Practitioner. — Any person who is a licensed physician, dentist, chemist, medical technologist, nurse,
midwife, veterinarian or pharmacist in the Philippines.


Testing
Screening Test. — A rapid test performed to establish potential/presumptive positive result.

Confirmatory Test. — An analytical test using a device, tool or equipment with a different chemical or
physical principle that is more specific which will validate and confirm the result of the screening test.


Substances
Dangerous Drugs. — Include those listed in the Schedules annexed to the 1961 Single Convention on
Narcotic Drugs, as amended by the 1972 Protocol, and in the Schedules annexed to the 1971 Single
Convention on Psychotropic Substances as enumerated in the attached annex which is an integral part
of this Act.
Controlled Precursors and Essential Chemicals. — Include those listed in Tables I and II of the 1988 UN
Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances as enumerated in the
attached annex, which is an integral part of this Act.

Cannabis or commonly known as “Marijuana” or “Indian Hemp” or by its any other name. — Embraces
every kind, class, genus, or specie of the plant Cannabis sativa L. including, but not limited to, Cannabis
americana, hashish, bhang, guaza, churrus and ganjab, and embraces every kind, class and character of
marijuana, whether dried or fresh and flowering, flowering or fruiting tops, or any part or portion of
the plant and seeds thereof, and all its geographic varieties, whether as a reefer, resin, extract, tincture
or in any form whatsoever.

1. Cannabis Sources (SIR)
a. Cannabis sativa
b. Cannabis indica
c. Cannabis ruderalis
2. Cannabis americana
a. Cannabis sativa fluid extracts
3. Hashish
a. extracted product composed of compressed or purified preparations of stalked resin
glands, called trichomes, from the cannabis plant
4. Bhang
a. a mild preparation of marijuana made from young leaves and stems of the Indian hemp
plant, Cannabis sativa, drunk with milk or water as a fermented brew or smoked for its
hallucinogenic effects
5. Churrus
a. A narcotic gum resin which exudes from the flower heads, seeds, etc., of Indian hemp.
6. Other
a. Guaza
b. Ganjab


Methylenedioxymethamphetamine (MDMA) or commonly known as “Ecstasy”, or by its any other
name. — Refers to the drug having such chemical composition, including any of its isomers or
derivatives in any form.

Methamphetamine Hydrochloride or commonly known as “Shabu”, “Ice”, “Meth”, or by its any other
name. — Refers to the drug having such chemical composition, including any of its isomers or
derivatives in any form.

Opium. — Refers to the coagulated juice of the opium poppy (Papaver somniferum L.) and embraces
every kind, class and character of opium, whether crude or prepared; the ashes or refuse of the same;
narcotic preparations thereof or therefrom; morphine or any alkaloid of opium; preparations in which
opium, morphine or any alkaloid of opium enters as an ingredient; opium poppy; opium poppy straw;
and leaves or wrappings of opium leaves, whether prepared for use or not.

Opium Poppy. — Refers to any part of the plant of the species Papaver somniferum L., Papaver
setigerum DC, Papaver orientale, Papaver bracteatum and Papaver rhoeas, which includes the seeds,
straws, branches, leaves or any part thereof, or substances derived therefrom, even for floral,
decorative and culinary purposes.


C. Violations relevant to the Practice of Pharmacy

SECTION 17. Maintenance and Keeping of Original Records of Transactions on Dangerous Drugs and/or
Controlled Precursors and Essential Chemicals. — The penalty of imprisonment ranging from one (1)
year and one (1) day to six (6) years and a fine ranging from Ten thousand pesos (P10,000.00) to Fifty
thousand pesos (P50,000.00) shall be imposed upon any practitioner, manufacturer, wholesaler,
importer, distributor, dealer or retailer who violates or fails to comply with the maintenance and
keeping of the original records of transactions on any dangerous drug and/or controlled precursor and
essential chemical in accordance with Section 40 of this Act.

An additional penalty shall be imposed through the revocation of the license to practice his/her
profession, in case of a practitioner, or of the business, in case of a manufacturer, seller, importer,
distributor, dealer or retailer.

SEC. 18. Unnecessary Prescription of Dangerous Drugs. — The penalty of imprisonment ranging from
twelve (12) years and one (1) day to twenty (20) years and a fine ranging from One hundred thousand
pesos (P100,000.00) to Five hundred thousand pesos (P500,000.00) and the additional penalty of the
revocation of his/her license to practice shall be imposed upon the practitioner, who shall prescribe
any dangerous drug to any person whose physical or physiological condition does not require the use
or in the dosage prescribed therein, as determined by the Board in consultation with recognized
competent experts who are authorized representatives of professional organizations of practitioners,
particularly those who are involved in the care of persons with severe pain.

SEC. 19. Unlawful Prescription of Dangerous Drugs. — The penalty of life imprisonment to death and a
fine ranging from Five hundred thousand pesos (P500,000.00) to Ten million pesos (P10,000,000.00)
shall be imposed upon any person, who, unless authorized by law, shall make or issue a prescription or
any other writing purporting to be a prescription for any dangerous drug.


D. Drug Testing
SEC. 36. Authorized Drug Testing. — Authorized drug testing shall be done by any government forensic
laboratories or by any of the drug testing laboratories accredited and monitored by the DOH to
safeguard the quality of test results. The DOH shall take steps in setting the price of the drug test with
DOH accredited drug testing centers to further reduce the cost of such drug test. The drug testing shall
employ, among others, two (2) testing methods, the screening test which will determine the positive
result as well as the type of the drug used and the confirmatory test which will confirm a positive
screening test. Drug test certificates issued by accredited drug testing centers shall be valid for a one-
year period from the date of issue which may be used for other purposes. The following shall be
subjected to undergo drug testing:

(a) Applicants for driver’s license. — mandatory

(b) Applicants for firearm’s license and for permit to carry firearms outside of residence. — mandatory

(c) Students of secondary and tertiary schools. — random, pursuant to the related rules and regulations
as contained in the school’s student handbook and with notice to the parents, Provided, That all drug
testing expenses whether in public or private schools under this Section will be borne by the
government;

(d) Officers and employees of public and private offices. — random, as contained in the company’s work
rules and regulations, which shall be borne by the employer

(e) Officers and members of the military, police and other law enforcement agencies. —annual
mandatory

(f) All persons charged before the prosecutor’s office with a criminal offense having an imposable
penalty of imprisonment of not less than six (6) years and one (1) day shall have to undergo a mandatory
drug test;

(g) All candidates for public office whether appointed or elected both in the national or local government
shall undergo a mandatory drug test.

HOWEVER, the case of Social Justice Society (SJS) vs. Dangerous Drugs Board, 570 SCRA 410,
November 03, 2008 declared unconstitutional Section 36(f) and (g).

(c) Students of secondary and tertiary schools. — random, pursuant to the related rules and regulations
as contained in the school’s student handbook and with notice to the parents, Provided, That all drug
testing expenses whether in public or private schools under this Section will be borne by the
government;

The Court is of the view and so holds that the provisions of RA 9165 requiring mandatory, random, and
suspicionless drug testing of students are constitutional. Indeed, it is within the prerogative of
educational institutions to require, as a condition for admission, compliance with reasonable school
rules and regulations and policies. To be sure, the right to enroll is not absolute; it is subject to fair,
reasonable, and equitable requirements.

Accordingly, and until a more effective method is conceptualized and put in motion, a random drug
testing of students in secondary and tertiary schools is not only acceptable but may even be necessary
if the safety and interest of the student population, doubtless a legitimate concern of the government,
are to be promoted and protected.

(d) Officers and employees of public and private offices. — random, as contained in the company’s work
rules and regulations, which shall be borne by the employer

The mandatory but random drug test prescribed by Sec. 36 of RA 9165 for officers and employees of
public and private offices is justifiable. Taking into account the foregoing factors, i.e., the reduced
expectation of privacy on the part of the employees, the compelling state concern likely to be met by
the search, and the well-defined limits set forth in the law to properly guide authorities in the conduct
of the random testing, the Supreme Court held that the challenged drug test requirement is, under the
limited context of the case, reasonable and, ergo, constitutional.

The mandatory, random, and suspicionless drug testing under Sec. 36(c) and (d) of RA 9165 was not
proven to violate the right to privacy and does not constitutes unlawful and/or unconsented search
under Art. III, Secs. 1 and 2 of the Constitution.

(f) All persons charged before the prosecutor’s office with a criminal offense having an imposable
penalty of imprisonment of not less than six (6) years and one (1) day shall have to undergo a mandatory
drug test;

In the case of persons charged with a crime before the prosecutor’s office, a mandatory drug testing
can never be random or suspicionless; To impose mandatory drug testing on the accused is a blatant
attempt to harness a medical test as a tool for criminal prosecution, contrary to the stated objectives
of RA 9165.

The operative concepts in the mandatory drug testing are “randomness” and “suspicionless. The ideas
of randomness and being suspicionless are antithetical to their being made defendants in a criminal
complaint. They are not randomly picked; neither are they beyond suspicion. When persons suspected
of committing a crime are charged, they are singled out and are impleaded against their will. The
persons thus charged, by the bare fact of being haled before the prosecutor’s office and peaceably
submitting themselves to drug testing, if that be the case, do not necessarily consent to the procedure,
let alone waive their right to privacy.

Drug testing in this case would violate a persons’ right to privacy guaranteed under Sec. 2, Art. III of the
Constitution. Worse still, the accused persons are veritably forced to incriminate themselves.

(g) All candidates for public office whether appointed or elected both in the national or local
government shall undergo a mandatory drug test.

The right of a citizen in the democratic process of election should not be defeated by unwarranted
impositions of requirements not otherwise specified in the Constitution. The COMELEC cannot, in the
guise of enforcing and administering election laws or promulgating rules and regulations to implement
Sec. 36(g), validly impose qualifications on candidates for senator in addition to what the Constitution
prescribes.

Therefore, 36(f) and (g) are unconstitutional and the implementing agencies are permanently
enjoined from implementing Sec. 36(f) and (g) of RA 9165.

E. Records Required
SEC. 40. Records Required for Transactions on Dangerous Drugs and Precursors and Essential
Chemicals.
a. Every pharmacist dealing in dangerous drugs and/or controlled precursors and essential
chemicals shall maintain and keep an original record of sales, purchases, acquisitions and
deliveries of dangerous drugs, indicating therein the following information:
i. License number and address of the pharmacist;
ii. Name, address and license of the manufacturer, importer or wholesaler from whom
the dangerous drugs have been purchased;

(3) Quantity and name of the dangerous drugs purchased or acquired;

(4) Date of acquisition or purchase;

(5) Name, address and community tax certificate number of the buyer;

(6) Serial number of the prescription and the name of the physician, dentist, veterinarian or practitioner
issuing the same;

(7) Quantity and name of the dangerous drugs sold or delivered; and

(8) Date of sale or delivery.

A certified true copy of such record covering a period of six (6) months, duly signed by the pharmacist
or the owner of the drugstore, pharmacy or chemical establishment, shall be forwarded to the Board
within fifteen (15) days following the last day of June and December of each year, with a copy thereof
furnished the city or municipal health officer concerned.

(b) A physician, dentist, veterinarian or practitioner authorized to prescribe any dangerous drug shall
issue the prescription therefor in one (1) original and two (2) duplicate copies. The original, after the
prescription has been filled, shall be retained by the pharmacist for a period of one (1) year from the
date of sale or delivery of such drug. One (1) copy shall be retained by the buyer or by the person to
whom the drug is delivered until such drug is consumed, while the second copy shall be retained by the
person issuing the prescription.

For purposes of this Act, all prescriptions issued by physicians, dentists, veterinarians or practitioners
shall be written on forms exclusively issued by and obtainable from the DOH. Such forms shall be made
of a special kind of paper and shall be distributed in such quantities and contain such information and
other data as the DOH may, by rules and regulations, require. Such forms shall only be issued by the
DOH through its authorized employees to licensed physicians, dentists, veterinarians and practitioners
in such quantities as the Board may authorize. In emergency cases, however, as the Board may specify
in the public interest, a prescription need not be accomplished on such forms. The prescribing
physician, dentist, veterinarian or practitioner shall, within three (3) days after issuing such
prescription, inform the DOH of the same in writing. No prescription once served by the drugstore or
pharmacy be reused nor any prescription once issued be refilled.

(c) All manufacturers, wholesalers, distributors, importers, dealers and retailers of dangerous drugs
and/or controlled precursors and essential chemicals shall keep a record of all inventories, sales,
purchases, acquisitions and deliveries of the same as well as the names, addresses and licenses of the
persons from whom such items were purchased or acquired or to whom such items were sold or
delivered, the name and quantity of the same and the date of the transactions. Such records may be
subjected anytime for review by the Board.

F. Dangerous Drugs Board

SEC. 77. The Dangerous Drugs Board. — The Board shall be the policy-making and strategy-formulating
body in the planning and formulation of policies and programs on drug prevention and control. It shall
develop and adopt a comprehensive, integrated, unified and balanced national drug abuse prevention
and control strategy. It shall be under the Office of the President.

SEC. 78. Composition of the Board. — The Board shall be composed of seventeen (17) members
wherein three (3) of which are permanent members, the other twelve (12) members shall be in an ex
officio capacity and the two (2) shall be regular members.

The three (3) permanent members, who shall possess at least seven-year training and experience in the
field of dangerous drugs and in any of the following fields: in law, medicine, criminology, psychology or
social work, shall be appointed by the President of the Philippines. The President shall designate a
Chairman, who shall have the rank of a secretary from among the three (3) permanent members who
shall serve for six (6) years. Of the two (2) other members, who shall both have the rank of
undersecretary, one (1) shall serve for four (4) years and the other for two (2) years. Thereafter, the
persons appointed to succeed such members shall hold office for a term of six (6) years and until their
successors shall have been duly appointed and qualified.

The other twelve (12) members who shall be ex officio members of the Board are the following:
(1) Secretary of the Department of Justice or his/her representative;
(2) Secretary of the Department of Health or his/her representative;
(3) Secretary of the Department of National Defense or his/her representative;
(4) Secretary of the Department of Finance or his/her representative;
(5) Secretary of the Department of Labor and Employment or his/her representative;
(6) Secretary of the Department of the Interior and Local Government or his/her representative;
(7) Secretary of the Department of Social Welfare and Development or his/her representative;
(8) Secretary of the Department of Foreign Affairs or his/her representative;
(9) Secretary of the Department of Education or his/her representative;
(10) Chairman of the Commission on Higher Education or his/her representative;
(11) Chairman of the National Youth Commission; and
(12) Director General of the Philippine Drug Enforcement Agency.

Cabinet secretaries who are members of the Board may designate their duly authorized and permanent
representatives whose ranks shall in no case be lower than undersecretary.

The two (2) regular members shall be as follows:

(a) The president of the Integrated Bar of the Philippines; and

(b) The chairman or president of a non-government organization involved in dangerous drug campaign
to be appointed by the President of the Philippines.

The Director of the NBI and the Chief of the PNP shall be the permanent consultants of the Board, and
shall attend all the meetings of the Board.

All members of the Board as well as its permanent consultants shall receive a per diem for every
meeting actually attended subject to the pertinent budgetary laws, rules and regulations on
compensation, honoraria and allowances: Provided, That where the representative of an ex officio
member or of the permanent consultant of the Board attends a meeting in behalf of the latter, such
representative shall be entitled to receive the per diem.

SECTION 82. Creation of the Philippine Drug Enforcement Agency (PDEA). — To carry out the provisions
of this Act, the PDEA, which serves as the implementing arm of the Board, and shall be responsible for
the efficient and effective law enforcement of all the provisions on any dangerous drug and/or
controlled precursor and essential chemical as provided in this Act.

The PDEA shall be headed by a Director General with the rank of Undersecretary, who shall be
responsible for the general administration and management of the Agency. The Director General of the
PDEA shall be appointed by the President of the Philippines and shall perform such other duties that
may be assigned to him/her. He/she must possess adequate knowledge, training and experience in the
field of dangerous drugs, and in any of the following fields: law enforcement, law, medicine,
criminology, psychology or social work.

The Director General of the PDEA shall be assisted in the performance of his/her duties and
responsibilities by two (2) deputies director general with the rank of Assistant Secretary; one for
Operations and the other one for Administration. The two (2) deputies director general shall likewise
be appointed by the President of the Philippines upon recommendation of the Board. The two (2)
deputies director general shall possess the same qualifications as those of the Director General of the
PDEA. The Director General and the two (2) deputies director general shall receive the compensation
and salaries as prescribed by law.


G. Issued Licenses

WHAT ARE DANGEROUS DRUGS ?
Dangerous drugs include those listed in the Schedules annexed to the 1961 Single Convention on
Narcotic Drugs, as amended by the 1972 Protocol, and in the Schedules annexed to the 1971 Single
Convention on Psychotropic Substances as enumerated in the attached annex of RA9165.

WHAT ARE THE CHEMICALS CONTROLLED UNDER RA 9165?
The controlled chemicals are the following:

TABLE I+ Table II+

ACETIC ANHYDRIDE ACETONE

N-ACETYLANTHRANILIC ACID ANTHRANILIC ACID

ERGOMETRINE ETHYL ETHER

ERGOTAMINE HYDROCHLORIC ACID

ISOSAFROLE METHYL ETHYL KETONE

 LYSERGIC ACID PHENYL ACETIC ACID

3,4-METHYLENEDIOXYPHENYL-2 PROPANONE PIPERIDINE

NOREPHEDRINE SULFURIC ACID

1-PHENYL-2-PROPANONE TOLUENE

PIPERONAL ** THIONYL CHLORIDE

POTASSIUM PERMANGANATE

SAFROLE

* PSEUDOEPHERDINE

* EPHEDRINE

* RECLASSIFIED AS DANGEROUS DRUGS PURSUANT TO B.R. NO. 4, S. 2005

** CLASSIFIED UNDER TABLE II PURSUANT TO B.R. NO. 5,S. 2005

+ THE SALTS OF THE SUBSTANCES LISTED IN THIS TABLE WHENEVER THE EXISTENCE OF SUCH SALTS IS
POSSIBLE.

++ THE SALTS OF THE SUBSTANCES LISTED IN THIS TABLE WHENEVER THE EXISTENCE OF SUCH SALTS IS
POSSIBLE.THE SALTS OF HYDROCHLORIC ACID AND SULFURIC ACID ARE SPECIFICALLY EXCLUDED.





WHAT ARE THE LICENSES ISSUED AT THE COMPLIANCE SERVICE, PDEA, AND THE SCOPE OF COVERAGE
OF EACH LICENSE WITH THE CORRESPONDING FEES?
The following are the dangerous drugs, dangerous drugs preparation/s, Table I controlled chemical/s
used in the manufacture of drug preparation/s &/or their preparation/s categorized as S-LICENSE/S and
the precursors and essential chemical/s or controlled chemical/s &/or mixture/s categorized as P-
LICENSE/S that are issued at said Service:
1. For handlers of dangerous drug/s(DD) , dangerous drugs preparation/s(DDP/s), Table I
Controlled Chemical/s used in the manufacture of drug preparation/s &/or their
preparation/s (DP/s):

Annual Fee
Category
(PhP)

S-1 Retail of DP/s containing Table I Controlled Chemical/s 500.00

S-3 Retail of DD/DDP/s & /or DP/s containing Table I Controlled 1,000.00
Chemical/s

S-4 Wholesale/Distribution of DD/DDP/s/Table 1 Controlled 3,000.00

Chemical/s used in the manufacture of drug preparation/s/
&/or their preparation/s

S-5 C Compounding/Manufacture of DD/ DDPs &/or D P/s 5,000.00

containing Table I Controlled Chemical/s
S-5I Importation of DD/DDP/s /Table I Controlled Chemical/s 5,000.00
used in the manufacture of drug preparation/s &/or their
preparation/s

S-5E Exportation of DDP/s &/or D P/s containing Table I 5,000.00

Controlled Chemical/s

S-5D Depot/Storage for S-4 & S-5 license holder (When such 5,000.00
address is separate and distinct from the office address of the
license holder)

S-6 License to conduct laboratory analysis or technical research 500.00

using DD/DDPs &/or DP/s

2.For handlers of Precursors and Essential Chemical/s or Controlled Chemical/s &/ or

mixture/s (PECS)

Annual Fee
Category
(PhP)

P-1 Retail of Precursor & Essential Chemicals ( PECS) &/or 500.00

mixture/s

P-3 End-Use of PECS &/or mixture/s 2,500.00

P-4 Wholesale/Distribution/Trading of PECS&/or mixture/s 3,000.00

 P-5-C Compounding/Manufacture/Repack/Recycling of PECS &/or 5,000.00
mixture/s

P-5-D Bulk Depot/Storage for P4 & P5-Holders ( Such location is 3,000.00

deemed separate& distinct from the office address of the
license holder)

P-5-E Exportation of PECS &/or mixture/s 5,000.00

P-5-I Importation of PECS &/or mixture/s 5,000.00

P-5-IM Importation of PECS to End-Use 5,000.00

P-6 License to conduct laboratory analysis or technical research 500.00

using PECS

3. For Practitioners (Physician, Dentist, Veterinarian)

Annual Fee
(PhP)
Category

S-2 License to prescribe DD/DDPs, &/or DP/s containing Table I

Controlled Chemical/s

DDB Forms
1. DDB Form No. 1-72 - official prescription
 2. DDB Form No. 8-72 - local purchase form


Only drugs in Philippine Schedules 4 and 5 are allowed to be written in an ordinary prescription form.
● Codeine derivatives (Sched 3 1961)
● Most benzodiazepines (Sched 4 1971)
● Ephedrine, Pseudoephedrine
● Nalbuphine, Ketamine


What are the guidelines pharmacists must remember when dispensing dangerous?
The Board set forth several regulations and resolutions and other issuances to guide medical
practitioners in the handling and dispensing of dangerous drugs. Among others, pharmacists should
ensure that the following requirements are met before dispensing dangerous drugs: personalized
prescription which shall contain the date of prescription, name of patient, name of prescribing
physician, PTR , S2 License Number, address, telephone number, brand name or generic name of the
drug, total number of units to be supplied in words, followed by its equivalent in Roman numerals
enclosed in parenthesis; specified direction for use, words “non-repetition”; and signature of the
prescriber. In addition, a valid ID should be presented by the buyer. The type of ID used and its number
should be written at the back of the prescription along with the full name and address of the buyer.