Philippine Pharmacy Act

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R.

A 10918
Philippine Pharmacy Act
ARTICLE I
GENERAL PROVISIONS
OBJECTIVES:
Standardization and regulation of pharmacy education;

Administration of licensure examination, registration, and Licensing of


pharmacists;

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


Philippines;

Development and enhancement of professional competence of pharmacists


through continuing professional development, research, and other related
activities
Integration of the pharmacy profession.
SCOPE OF THE PRACTICE OF PHARMACY
EXCLUSIVE ROLES OF PHARMACIST
(a) Prepare, compound or manufacture, preserve, store, distribute, procure, sell, or dispense, or
both, any pharmaceutical product or its raw materials; or

(b) Render services, such as clinical pharmacy services, drug information services, regulatory
services, pharmaceutical marketing, medication management or wherever, the expertise and
technical knowledge of the pharmacist is required; or

(c) Engage in teaching scientific, technical, or professional pharmacy courses in a school or


college of pharmacy; or

(d) Dispense pharmaceutical products in situations where supervision of dispensing of


pharmaceutical products is required; or

(i) Provide other services where pharmaceutical knowledge is required.


NON - EXCLUSIVE ROLES OF PHARMACIST

(e) Chemical, biological or microbiological analyses and assay of pharmaceutical products,


food/dietary supplements, health supplements, and cosmetics;

(f) Physico-chemical analyses for medical devices used in aid of administration of


pharmaceutical products

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

(h) Conduct or undertake scientific research in all aspects involving pharmaceutical products
and health care;
DEFINITION OF TERMS
◦ Accredited professional organization (ApO) - refers to
the duly integrated and accredited professional
organization of registered and licensed pharmacists

◦ Adult vaccines - refer to cervical cancer, flu


(influenza), pneumococcal, other pre-exposure
prophylactic vaccines to be administered to patients
aged eighteen (18) years and above
◦ Institutional pharmacies - refer to pharmacies of
institutions, organizations, and/or corporations that
provide a range , of pharmaceutical services, given
exclusively to the employees and/or their qualified
dependents

◦ Internship program - refers to a supervised, practical


experience that is required to be completed for
licensure as a registered pharmacist
◦ Nontraditional outlets - refer to entities licensed by
appropriate government agencies to dispense over-
the-counter medicines based on an approved list

◦ Online pharmacy services - refer to pharmaceutical


services of a duly licensed pharmaceutical outlet done
over the internet
◦ Pharmacy aides - refer to 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 - refer to persons who assist the
pharmacists in different aspects of pharmacy
operation based on established standard operating
procedures and processes, with a minimum degree
of independence or decision making and may
have supervised interaction with patient
◦ Pharmacy technicians – refer to persons who assist in
compounding and dispensing of medicines in community,
hospital, institutional and industrial settings or engaged in
other activities under the supervision of the pharmacist

◦ Telepharmacy services - refer to pharmaceutical services of


a duly licensed pharmaceutical outlet done through the use
of telephone, teleconferencing, or facsimile.
ARTICLE II
The Professional Regulatory Board of Pharmacy
Professional Regulatory Board of Pharmacy

Chairperson

Member 1 Member 2
Qualifications of the Chairperson and Members of the Board:
✓ Be a citizen of the Philippines and a resident for at least five (5) years;
✓ Be a duly registered and licensed pharmacist in the Philippines,
preferably a holder of a masteral degree in Pharmacy, or its equivalent
✓ Have been in the active practice of pharmacy for the past ten (10)
years
✓ Have not been convicted of a crime involving moral turpitude
✓ Be a member in good standing of the APO for at least five (5) years,
but not an officer or trustee thereof; and
✓ 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 4 or has any direct or indirect
pecuniary interest or connection in any review center or similar
institution.
Powers, Functions, and, Responsibilities of the Baard:

✓ Administer and implement the provisions of this


Act;
✓ Promulgate rules and regulations, administrative
orders, and issuances necessary to carry out the
provisions of this Act;
✓ Prepare licensure examination questions, score,
and. rate the examinations and submit the results
thereof to the PRC.
Powers, Functions, and, Responsibilities of the Board

✓ Recommend the issuance, suspension, revocation, or


reinstatement of the COR, PIC or Special Temporary Permits
(STP) for the practice of pharmacy;
✓ Administer oaths in accordance with the provisions of this Act;
✓ Regulate and monitor the practice of pharmacy in the
Philippines, including the practice of sub professional services
such as pharmacy technicians, pharmacy assistant, aides, and
other medicine handlers
✓ 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;
✓ Represent the pharmacy profession in all fora involving
concerns and issues related to pharmaceutical products and
the practice of pharmacy;
✓ Investigate cases arising from violations of this Act,
APO;
✓ Delegate the hearing or investigation of
administrative cases filed before the Board
✓ Conduct, through the Legal Officers of the PRC,
summary proceedings on minor violations of this Act
✓ Issue and promulgate guidelines on CPD, in
coordination with the APO
✓ 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
✓ Accredit Specialty Boards of Pharmacy based on the criteria that it
shall establish and prescribe; and
✓ 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.
Article III
Examination, Registration, Licensure
Qualifications for the Licensure Examination

✓ A citizen of the Philippines or of a foreign country which has a law


or policy on reciprocity for the practice of the pharmacy profession;
✓ Of good moral character and reputation;
✓ A degree holder of Bachelor of Science in pharmacy or its
equivalent degree confined by an HEI in the Philippines or an
institution of learning in a foreign country duly recognized by the
CHED; and
✓ Has completed an internship program approved by the Board
◦ Scope of Examination
- Pharmaceutical Administration and Management

◦ Holding of Examination

◦ Ratings in the Licensure Examination


- In order to be registered and licensed as a pharmacist, a
candidate must obtain a general weighted average of
seventy-five percent (75 %), with no rating lower than fifty
percent (50 %) in any of the subjects.
◦ Issuance of Certificate of Registration and
Professional Identification Card
- The PIC shall be renewed every three (3) years, upon
presentation of the Certificate of Good Standing
(COGS) from the APO and proof of completion of the
CPD requirements.
◦ Foreign Reciprocity

◦ Practice Through Special/Temporary Permit (STP)


✓ Being a consultant in foreign-funded or assisted projects of the
government;
✓ Being engaged or employed by a Filipino employer or establishment;
✓ Providing free services in humanitarian missions; and
✓ Being a visiting faculty member in any field or specialty in pharmacy
shall, before assuming such duties, functions and responsibilities,
secure an STP
CONDITIONS IN SECURING STP:

(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; and
(3) The person is required to work with a Filipino counterpart, a natural
person who is a registered and licensed pharmacist
Grounds for Non-registration

✓ Convicted of an offense involving moral turpitude by a court


Guilty for misrepresentation or falsification of documents in
connection with the application for examination
✓ Found guilty of immoral or dishonorable conduct by the Board
✓ Medically proven to be addicted to any drug or alcohol by a
medical or drug testing facility accredited by the government
✓ Declared of unsound mind by a court of competent jurisdiction
ARTICLE IV
Regulation of the Practice of Pharmacy
◦ Section 26: Affixing RPh After a Registered, Pharmacist's Name

◦ Section 27: Indication of Information.


- A pharmacist shall be required to indicate the serial numbers, the date of expiry of
the pharmacist's PIC and APO Certificate of Membership on all pertinent documents
signed by him/her.

◦ SEC.28. Registry of Pharmacist.


- The Board and the PRC shall prepare and maintain a registry of the names, residences
or office addresses, or both, status of registration and area of practice of all registered
pharmacists, which shall be updated annually, in coordination with the APO
. 29. Display of Certificate of Registration.
◦ SEC. 29. Display of Certificate of Registration
- Display the original copy of one's COR in a prominent and
conspicuous place in the drug establishment in which one is
employed in a professional capacity as pharmacist.
- When employed in establishments under Category B, the duplicate
copy of the pharmacist's COR shall also be displayed.
◦ Sec. 31. Pharmacist Requirement:
(a)Category A
(b)Category B
(1) Retail outlets selling household remedies and OTC drugs as differentiated from the
pharmacist-only OTC medicines;
(2) Satellite institutional pharmacies providing medicines solely to employees of their
respective companies or the employees' qualified dependents, or both; or members of a
duly registered organization or institution;
(3) Fourth, fifth and sixth class municipal health units involved in the procurement,
distribution, dispensing, and storage of pharmaceutical products ;
(4) Institutions providing telepharmacy services; and
(5) Nontraditional outlets of pharmaceutical products: Provided, That no prescription
medicines and pharmacist-only OTC medicines are sold.
◦ SEc. 32. Responsibility for Quality of Pharmaceutical Products.
◦ SEC. 33. Filling and Partial Filling of Prescription
◦ SEc. 34. Physician's Sample.
◦ SEc. 36. Label of Dispensed Medicines
◦ SEC. 37. Recording of Patient Medication Profile.
◦ SEc. 38. Requirements for the Opening and Operation of Retail
Pharmaceutical Outlet or Establishment.
◦ Sec. 40. Administration of Adult Vaccine
ARTICLE V
ACCREDITED PROFESSIONAL ORGANIZATION
◦ SEc. 41. The Integrated, and Accredited professional Organization (APO)
of Pharmacists.
- The pharmacy profession shall be integrated into one (1.) national organization
registered with the Securities and Exchange Commission (SEC) which shall be recognized
by the Board and the PRC as the one and only integrated and accredited professional
organization of pharmacists.

◦ Sec. 42. Membership to the Integrated, and Accredited Professional


Organization
ARTICLE VI
VIOLATIONS, ADMINISTRATIVE SANCTIONS AND
PROCEDURES
SEc. 44. Revocation or Suspension of the Certificate of
Registration and Cancellation of Special/Temporary Permit
(a) Violation of any provision of this Act

(b) Conviction of an offense involving moral turpitude by a court

(c) Unprofessionalism, immorality, malpractice, incompetence,


gross negligence, or imprudence in the practice of the
profession

(d) Fraud or deceit in the acquisition of the COR, PIC or STP, or


renewal
(e) Allowing the COR to be used or displayed in establishments
where the pharmacist is not actually employed and practicing

(f) Addiction to alcoholic beverages or to any habit-forming drug


rendering a pharmacist incompetent to practice the profession

(g) Aiding or abetting the illegal practice of a non-registered and


licensed person.
(h) Insanity or any mental disorder that would render the person
incompetent to practice pharmacy

(i) False, extravagant, or unethical advertisements and


endorsements of pharmaceutical products, pharmaceutical
outlets and establishments where the pharmacist's name or the
pharmacist's professional organization and similar information,
or both, are used
(j) Manufacture, sale, offering for sale of counterfeit, spurious,
substandard and falsified pharmaceutical product

(k) Illegal manufacture, sale, possession, dispensing of dangerous


drugs

(l) Committing acts in violation of Section 6 of Presidential Decree


No. 881, entitled "Empowering the Secretary of Health to
Regulate the Labeling, Sale and Distribution of Hazardous
Substances" and Section 11 of Republic Act No. 3720
(m) Practicing pharmacy with a suspended COR or expired PIC

(n) Unauthorized dispensing of pharmaceutical products through


unregistered online services or direct selling businesses

(o) Being found guilty of immoral, unprofessional, or


dishonorable conduct by the Board
ARTICLE VII
PENAL PROVISION
◦ SEc. 45. Penal provisions.
- Any person who shall commit any of the following acts shall,
upon conviction, be sentenced to pay a fine of thousand
pesos (P250,000.00), but not exceeding five hundred
thousand pesos (P500,000.00) or imprisonment of not less
than one (1) year and one (1) day but not more than six (6)
years, or both, at the discretion of the court
(a) Commission of any act in violation of Sections 30 and 31 of
this Act

(b) Allowing the display of one's COR in a pharmaceutical


establishment where the pharmacist is not employed and
practicing

(c) Displaying of the pharmacist's COR by pharmacy


owners/operators in a pharmaceutical establishment where the
pharmacist is not employed and practicing
(d) Dispensing or allowing the dispensing or offering for sale
of prescription drugs or pharmaceutical products in a place
not licensed by the FDA as a pharmaceutical outlet;

(e) Dispensing of prescription and pharmacist-only OTC


pharmaceutical products by a person other than those under
the direct and immediate supervision of a duly registered and
licensed pharmacist
(f) Allowing the dispensing of prescription and pharmacist
only OTC pharmaceutical products, without the direct and
immediate supervision of a duly registered and licensed
pharmacist

(g) Compounding Lnd dispensing not in accordance with


current Good Manufacturing Practice, Good Laboratory
Practice and Philippine Practice Standards for Pharmacists,
and such other standards and guidelines issued by the Board
(h) Selling of prescription and pharmacist-only OTC drugs by
manufacturers, importers, and wholesalers to unlicensed
pharmaceutical outlets. and other establishments

(i) Substituting prescription drugs which are not generically


equivalent to what was on the prescription, without the
consent of the prescriber or not in accordance with Republic
Act No. 6675;
(j) Forcing, coercing, or intimidating a duly registered and
licensed pharmacist to compound or dispense medical and
pharmaceutical products in violation of the provisions of this
Act

(k) Preparing and compounding of pharmaceutical products


in quantities greatly in excess of single therapeutic doses,
without the presence and supervision of a duly registered and
licensed pharmacist;
(l) Noncompliance with the labeling requirements for
dispensed medicines by a pharmaceutical outlet

(m) Manufacturing and selling of pharmaceutical


products under fraudulent name or address, or both

(n) Adulterating and misbranding of pharmaceutical


products
(o) Manufacturing and selling of unsafe, substandard
and counterfeit pharmaceutical products

(p) Operating an unlicensed pharmaceutical outlet


such as online pharmacy service or direct selling not
authorized by the FDA;
(q) Operating a Category A establishment which
opens for business without a duly registered and
licensed pharmacist

(r) Operating a Category B establishment and without


the supervision and oversight of a duly registered and
licensed pharmacist;
(s) Practicing pharmacy with an expired, suspended or
revoked license

(t) Filing and refilling of prescription and pharmacist-


only OTC pharmaceutical products by a person other
than a duly registered and licensed pharmacist
without the direct and immediate supervision;
(u) Dispensing prescription drugs and pharmacist-only
OTC drugs by rural health units without the supervision
of a duly registered and licensed pharmacist

(v) All other acts or omissions analogous to the


foregoing.
SEC 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 (P200,000.00) or imprisonment of
not less than thirty (30) days but not more than
one (1) year, or both, at the discretion of the court
(a) Affixing of the title “RPh" by a person who is not a duly
registered and Iicensed pharmacist

(b) Practicing the pharmacy profession in the Philippines without


a valid COR, PIC or STP

(c) Non-indication of a pharmacist of his/her COR and


professional tax receipt numbers in official documents requiring
such information
(d) Refusal to display the COR of the pharmacist in a prominent
and conspicuous place in the establishment and outlet where
the pharmacist is employed and practicing

(e) Noncompliance by a duly registered and licensed pharmacist


with the requirements on the filling of prescription

(f) Noncompliance by a duly registered and licensed pharmacist


on the requirements for p partially-filled prescription
(g) Selling of physician's samples

(h) Distribution of antimicrobials, including anti-TB drugs and


other product classification as may be prohibited by law as
physician's samples

(i) Removal, erasure and alteration of mark or label of


physician's sample;
(j) Use of cipher, codes, or secret keys or unusual names or terms
in prescriptions

(k) Filling of prescriptions where cipher, codes, or secret keys or


unusual names or terms are used

0) Noncompliance with labeling requirements for dispensed


medicines

(m) Noncompliance with the requirements on the keeping of


record books by a pharmaceutical outlet;
(n) Employment of personnel in a pharmacy or pharmaceutical
operation without the required training and certification

(o) Refusal of a non pharmacist owner/operator of a


pharmaceutical outlet to undergo training and certification

(p) Refusal by the owner/operator to allow and require duly


registered and licensed pharmacists and pharmacy support
personnel to undergo CPD
(q) Rendering dispensing-related services by non pharmacists
in a pharmaceutical outlet without undergoing the required
training and certification

(r) Dispensing pharmaceutical products in medical missions


without the supervision of a duly registered and licensed
pharmacist;
(s) Noncompliance with the required training and certification of
professional service or medical representatives or professional
service representatives, pharmacy technicians, pharmacy
assistants, pharmacy aides, pharmacy clerks, and other medicine
handlers of pharmaceutical products

(t) Violation of any provision of this Act and its rules and
regulations not aforementioned above.
Angelica R.
Balais, RPh

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