Objectives
- Standardize and regulate pharmacy education.
- Administer licensure exams and licensing of pharmacists.
- Supervise and regulate pharmacy practice.
- Enhance pharmacists’ professional competence via continuing development and research.
- Integrate the pharmacy profession.
Scope of Pharmacy Practice
- Covers preparation, compounding, manufacturing, distribution, dispensing, and sale of pharmaceuticals.
- Includes clinical pharmacy services, drug information, pharmaceutical marketing, teaching, and research.
- Administration of adult vaccines by trained, certified pharmacists.
- Certain activities exclusively for licensed pharmacists; others may be performed by non-pharmacists if allowed by other laws.
- Compliance with standards like Good Manufacturing Practice and Philippine Practice Standards is mandatory.
Definitions
- Defines key terms including APO, adult vaccines, adulterated products, biopharmaceuticals, compounding, continuing professional development, counterfeit products, dangerous drugs, dispensing, generic and brand names, pharmaceutical establishments, pharmacist, pharmacy assistants/technicians, prescription drugs, and many more.
Creation and Composition of the Professional Regulatory Board of Pharmacy
- Board consists of a Chairperson and two members appointed by the President from PRC-submitted nominees.
- Members must be Filipino registered pharmacists with 10 years of practice and good moral character.
- Cannot be faculty or have pecuniary interest in pharmacy education institutions.
Powers and Functions of the Board
- Implement the Act and promulgate necessary rules and regulations.
- Prepare and oversee licensure exams, including syllabi.
- Recommend issuance, suspension, or revocation of registrations and permits.
- Regulate pharmacy practice including subprofessionals.
- Investigate violations and conduct hearings.
- Coordinate continuing professional development and accredit training programs.
- Accredit Specialty Boards in pharmacy practice.
Term, Compensation, and Removal of Board Members
- Members serve 3-year terms with maximum two terms.
- Receive compensation comparable to other PRC boards.
- Removal grounds include gross neglect, exam tampering, conviction for moral turpitude, and unethical conduct.
Examination, Registration, and Licensure
- Licensure exam requires qualifications: citizenship (or reciprocity), good moral character, pharmacy degree, completed internship.
- Exam covers comprehensive pharmacy subjects.
- Examination held twice yearly; passing requires 75% general average with no score below 50%.
- Successful candidates take an oath and receive Certificate of Registration (COR) and Professional Identification Card (PIC).
- Foreign reciprocity rules apply; special/temporary permits for qualified foreigners under strict conditions.
Practice Regulation
- Licensure prior to Act’s effectivity automatically recognized.
- Only registered pharmacists can use the title "RPh."
- Pharmacists must indicate registration info on official documents.
- Registry of pharmacists maintained by Board and PRC.
- COR must be displayed prominently at place of employment.
- Pharmaceutical products dispensed only through licensed outlets.
- Compounding and dispensing are exclusive functions of licensed pharmacists, except in emergencies.
- Classification of establishments into Category A (direct pharmacist control required) and Category B (supervision required).
- Duty to ensure pharmaceutical product quality and safety; joint liability for owners and pharmacists in charge.
- Prescription filling and partial filling rules.
- Prohibitions on selling physician’s samples.
- Prohibitions against use of ciphers/codes in prescriptions and unauthorized substitution.
- Labeling, patient medication profiles, and record keeping requirements.
- Requirements for opening and operation of retail pharmaceutical outlets.
- Pharmacy support personnel must be properly trained and certified.
- Pharmacists authorized to administer adult vaccines under specified conditions.
Accredited Professional Organization (APO)
- Single integrated national organization for pharmacists recognized by Board and PRC.
- Registered pharmacists automatically members; membership required for practice and PIC renewal.
- Specialty Boards can be accredited for various pharmacy practice areas.
Violations and Administrative Sanctions
- Grounds for revocation or suspension of COR include violations of laws, immoral conduct, malpractice, fraud, addiction, aiding illegal practice, advertising violations, manufacturing and selling counterfeit or illegal drugs, and unauthorized online pharmacy operations.
Penal Provisions
- Serious violations punishable by fines between P250,000 to P500,000 and/or imprisonment from 1 year and 1 day to 6 years.
- Includes illegal dispensing, display of COR in unauthorized places, unauthorized compounding, selling to unlicensed outlets, substitution without consent, and related acts.
- Other violations punishable by fines of P100,000 to P200,000 and/or imprisonment 30 days to 1 year, including misuse of title, practice without license, non-compliance with record keeping and labeling, selling physician’s samples, unauthorized personnel employment, and failure to undergo required training.
- Foreign violators subject to deportation after penalties.
- Joint liability of owners and pharmacists for violations.
Enforcement, Appropriations, and Implementation
- Board and PRC primarily responsible for enforcement.
- Law enforcement agencies mandated to support enforcement.
- PRC to include implementation funding in its programs and budget.
- Interim Board continues until new members appointed.
- Rules and regulations to be issued within 120 days of the Act’s approval.
Miscellaneous Provisions
- Separability clause ensures unaffected provisions remain valid if any part declared invalid.
- Repeals Republic Act No. 5921 and inconsistent laws.
- Effectivity 15 days after publication.