Republic Act 5921

vs
Republic Act 10918
Philippine Pharmacy Act
 Objectives
• Objectives:
• (a) the standardization and regulation of
pharmaceutical education;
• (b) Administration of licensure examination,
registration, and licensing of pharmacists;
– (b) the examination for registration of graduates of school
of pharmacy
• (c) the 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
• (e) Integration of the pharmacy profession.
 Scope of Practice of Pharmacy
• (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 whenever the
expertise and technical knowledge of the
pharmacist is required; or
 Scope of Practice of Pharmacy
• (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
• (e) Chemical, biological or microbiological
analyses and assay of pharmaceutical products,
food/dietary supplements, health
supplements, and cosmetics; or
 Scope of Practice of Pharmacy
• (f) Physico-chemical analyses for medical
devices used in aid of administration of
pharmaceutical products; or
• (g) Administration of adult vaccines as
approved by the Food and Drug
Administration (FDA)
– safe administration of vaccines be part of the
higher education curriculum for pharmacists
 Scope of Practice of Pharmacy
• (h) Conduct or undertake scientific research in all
aspects involving pharmaceutical products and
health care; or
• (i) Provide other services where pharmaceutical
knowledge is required.
 The Professional Regulatory Board of
Pharmacy
• Qualifications:
• (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;
• CHAIRPERSON: ANTHONY ALDRIN C. SANTIAGO
• 2 MEMBERS: MILDRED B. OLIVEROS, ADELINA C. ROYO
 The Professional Regulatory Board of
Pharmacy
• (e) Be a member in good standing of the APO for
atleast 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.
Powers, Functions and Responsibilities
of the Board
• a. Administer and implement the provisions
• b. promulgate rules and regulations,
administrative orders, and issuances necessary to
carry out the provisions.
• c. Prepare licensure examination questions,
score, and rate the examinations and submit the
results to the PRC.
• d. Recommend the issuance, suspension,
revocation, or reinstatement of the COR, PIC or
Special/Temporary Permits (STP) for the practice
of pharmacy:
Powers, Functions and Responsibilities
of the Board
• e. Administer oaths
• f. Regulate and monitor the practice of
pharmacy in the Philippines
– 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
Powers, Functions and Responsibilities
of the Board
• g. Promulgate and prescribe the Pharmacists'
Code of Ethics, Code of Technical Standards
and Guidelines for the Professional Practice of
the Pharmacy Profession.
• h. Represent the pharmacy profession in all
for a involving concerns and issues related to
pharmaceutical products and the practice of
pharmacy.
Powers, Functions and Responsibilities
of the Board
• i. Investigate cases arising from violations of this
Act, the rules and regulations
– Issue summons, subpoena ad testificandum, and
subpoena duces tecum
• 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
Powers, Functions and Responsibilities
of the Board
• k. Conduct, through the Legal Officers of the PRC,
summary proceedings on minor violations of this
Act
• l. Issue and promulgate guidelines on CPD, in
coordination with the APO
• m. Recommend the accreditation of the
standardized training programs for and
certifications
– Promulgate the criteria and guidelines in the
accreditation of training programs and certification
Powers, Functions and Responsibilities
of the Board
• n. Accredit Specialty Boards of Pharmacy based
on the criteria that it shall establish and prescribe
• 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.
 Grounds for suspension or Removal
from Office
• (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.
 Examination, Registration and
Licensure
• Qualifications for the licensure examination:
• (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
• (d) Has completed an internship program approved by
the Board
 Pharmacy Licensure Exam Coverage
• Module 1: Pharmaceutical Chemistry (20%)
• Module 2: Pharmacognosy (15%)
• Module 3: Practice of pharmacy (17.5%)
• Module 4: Pharmacology and
Pharmacokinetics (15%)
• Module 5: Pharmaceutics (17.5%)
• Module 6: Quality assurance and Quality
control (15%)
 Practical Examination
• (1) Identification and Analysis of Drugs
• (2) Preparation of Official Pharmaceuticals
• (3) Compounding and Dispensing of
Prescriptions and fixing of Prices of
Prescriptions, and
• (4) Manufacturing Pharmacy and Quality
Control.
 Issuance of COR and PIC
• Issued to those passed the licensure
examination
• PRC renewal includes presentation of the
Certificate of Good standing for the APO and
proof of completion of the CPD requirements
 Foreign Reciprocity
• The PRC BOP can now work with their
counterparts in other countries for a Mutual
Recognition Agreement allowing them to
practice here and us practicing in their
country.
 Practice through Special/Temporary
Permit
• Any foreigner citizen gained entry in the
Philippines to perform professional services
within the scope of the practice of pharmacy:
• (a) being a consultant in foreign-funded or
assisted projects of the government;
• (b) being engaged or employed by a Filipino
employer or establishment;
• (c) providing free services in humanitarian
missions: and
• (d) being a visiting faculty member in any field or
specialty in pharmacy
 Practice through Special/Temporary
Permit
• Requirements:
• (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
• (a) Convicted of an offense involving moral turpitude by
a court of competent jurisdiction;
• (b) Summarily adjudged by the Board as guilty for
misrepresentation or falsification of documents in
connection with the application for examination or for
violation of the General Instructions to Examinees;
• (c) Found guilty of immoral or dishonorable conduct by
the Board;
• (d) Medically proven to be addicted to any drug or
alcohol by a medical or drug testing facility accredited
by the government; and
• (e) Declared of unsound mind by a court of competent
jurisdiction.
 Reissuance of Revoked COR,
Replacement of Lost or Damaged COR,
PIC or Special/Temporary permit
• Reissue after expiration of 2 years from the
date of is revocation
• Duplicate copy of the COR for display in
category B establishments
Regulation of the Practice of Pharmacy
• Affixing RPh after a Registered Pharmacist’s
Name
• Indication of information
• Registry of Pharmacists
• Display of COR
• Dispensing/Sale of Pharmaceutical Products
 Pharmacist requirement
• Establishments/outlets:
• A. category A
• 1. Pharmaceutical establishments/outlets selling or
otherwise making available to the consuming public
prescription/ethical medicines, combination products
(medical device and drugs) classified as drugs according to
the primary intended mode of action, pharmacist-only OTC
medicine, whether owned by the government or by a
private person or firm, whether sold at wholesale or retail;
• 2. Establishments involved in the manufacture,
importation, exportation, distribution, and sale of
combination products (medical device and drugs) classified
as drugs according to the primary intended mode of action;
 Pharmacist requirement
• 3. Departments/Divisions/Units of pharmaceutical
laboratories, pharmaceutical manufacturing laboratories,
or other establishments with processes involving the
preparation, manufacture, assay, regulation , product
research and development, quality control, repacking,
importation, exportation, distribution, sale or transfer of
pharmaceutical products in quantities greatly in excess of
single therapeutic doses; and
• 4. Government units, including local government, city, first
to third class municipal health units, nongovernment
organizations and/or associations involved in the
procurement, distribution, dispensing and storage of
pharmaceutical products;
 Pharmacist requirement
• 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.
Regulation of the Practice of Pharmacy
• Responsibility for Quality of pharmaceutical products
• Filling and Partial filling of prescription
• Physician‘s sample
• Prohibition against the use of cipher, codes, or unusual
terms in prescriptions and prescription substitution
• Labeled of dispensed drug: the name of patient and
generic name of drug; brandname, if any, strength,
expiry date, directions for use; and name and address
of pharmacy, name of the doctor, the dispensing
pharmacist
– auxilliary labels: dangerous drugs, external-use-only drugs,
drugs with special storage and administration instructions
Regulation of the Practice of Pharmacy
• Recording of patient Medication profile
• Requirements for the opening and operation
of retail pharmaceutical outlet or
establishment
• Handling of pharmaceutical products by
persons other than a pharmacist
• Administration of adult vaccines
 Accredited Professional Organization
• The integrated and Accredited Professional
Organization (APO) of Pharmacists
– Integrated into one national organization
registered with SEC, recognized with board and
PRC
• Specialty Boards in Various areas of Pharmacy
– Accredited by the Board and the PRC
 Penal Provision
• Nlt 250,000 to 500, 000, imprisonment of not
less than 1 year and 1 day, but not more than
6 years

• Nlt 100,000 to 200,000, imprisonment of not