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Philippine Pharmacy Act
Republic Act No. 10918
July 21, 2016
Case Overview and Summary
Summary of the Philippine Pharmacy ActTitle and Policy Statement (Sections 1-2)
- This law shall be known as the "Philippine Pharmacy Act".
- It recognizes the vital role of pharmacists in providing quality health care services and aims to promote their professional services as an indispensable component of the total health care system.
- The State shall develop and nurture competent, productive, morally upright, and globally competitive pharmacists through regulatory measures and programs.
Objectives and Scope of Pharmacy Practice (Sections 3-5)
- The law aims to standardize and regulate pharmacy education, administer licensure examinations, supervise and control the practice of pharmacy, enhance professional competence through continuing professional development (CPD), and integrate the pharmacy profession.
- It defines the scope of pharmacy practice, which includes:
• Preparing, compounding, manufacturing, preserving, storing, distributing, procuring, selling, or dispensing pharmaceutical products or raw materials (Section 4a)
• Rendering services like clinical pharmacy, drug information, regulatory services, pharmaceutical marketing, medication management, etc. (Section 4b)
• Teaching pharmacy courses (Section 4c)
• Dispensing pharmaceutical products where supervision is required (Section 4d)
• Analyzing and assaying pharmaceutical products, food/dietary supplements, health supplements, and cosmetics (Section 4e)
• Analyzing medical devices used for administering pharmaceutical products (Section 4f)
• Administering adult vaccines with proper training and certification (Section 4g)
• Conducting scientific research involving pharmaceutical products (Section 4h)
• Providing other services where pharmaceutical knowledge is required (Section 4i)
- The law provides definitions for various terms related to pharmacy practice (Section 5).
Professional Regulatory Board of Pharmacy (Sections 6-12)
- A Professional Regulatory Board of Pharmacy is created under the administrative control and supervision of the Professional Regulation Commission (PRC).
- The Board shall consist of a Chairperson and two members appointed by the President from a list of nominees submitted by the accredited professional organization (APO).
- The Board's powers and functions include administering and implementing the law, promulgating rules and regulations, preparing licensure examination questions, regulating the practice of pharmacy, investigating violations, issuing summons and subpoenas, conducting summary proceedings, issuing guidelines on CPD, accrediting training programs and specialty boards, and performing other implied functions (Section 8).
- The Board members shall hold office for a term of three years, renewable for another term, but not exceeding six years in total (Section 9).
- The Board members shall receive compensation and allowances comparable to other professional regulatory boards (Section 10).
- Grounds for suspension or removal of Board members include gross neglect, involvement in examination irregularities, conviction of a crime involving moral turpitude, and unprofessional conduct (Section 11).
- The PRC shall provide secretariat and support services to the Board (Section 12).
Examination, Registration, and Licensure (Sections 13-24)
- All applicants for registration as pharmacists must pass a licensure examination, unless exempted (Section 13).
- Qualifications for the licensure examination include being a citizen or from a country with reciprocity, having good moral character, holding a Bachelor of Science in Pharmacy or equivalent degree, and completing an approved internship program (Section 14).
- The examination shall cover subjects on pharmacy science and practice, as specified in Section 15.
- The examination shall be held twice a year at designated places (Section 16).
- To pass, a candidate must obtain a general weighted average of 75% with no rating lower than 50% in any subject (Section 17).
- Failing the examination for the third time requires undergoing a refresher program (Section 17).
- The Board shall submit the ratings to the PRC within three working days after the examination (Section 18).
- Successful candidates must take an oath of profession before entering the practice (Section 19).
- A Certificate of Registration (COR) and Professional Identification Card (PIC) shall be issued to registered pharmacists, with the PIC renewed every three years upon proof of CPD completion (Section 20).
- Foreign reciprocity is allowed only if the foreign country permits Filipino pharmacists to practice on the same basis (Section 21).
- Foreign citizens may secure a Special/Temporary Permit (STP) to practice in the Philippines under certain conditions, such as being an expert, working on a project, or being a visiting faculty member (Section 22).
- Grounds for non-registration include conviction of a crime involving moral turpitude, misrepresentation or falsification of documents, immoral conduct, drug addiction, and being declared of unsound mind (Section 23).
- The Board may reinstate or reissue a revoked COR after two years and may require the applicant to retake the licensure examination (Section 24).
Regulation of Pharmacy Practice (Sections 25-40)
- Pharmacists registered before the law's effectivity shall be automatically registered, and their CORs, PICs, or STPs shall remain valid (Section 25).
- Only registered pharmacists can affix the title "Registered Pharmacist" or "RPh" after their names (Section 26).
- Pharmacists must indicate their COR and PIC numbers and APO membership on official documents (Section 27).
- The Board and PRC shall maintain a registry of registered pharmacists, updated annually in coordination with the APO (Section 28).
- Pharmacists must display their original COR prominently in the establishment where they are employed, and a duplicate copy in Category B establishments (Section 29).
- No pharmaceutical product shall be dispensed, sold, or made available except through a licensed retail drug outlet (Section 30).
- Prescription drugs and pharmacist-only OTC medicines shall be dispensed only by registered pharmacists, except in emergencies (Section 30).
- Compounding and dispensing shall be done by registered pharmacists following Good Manufacturing Practice, laboratory practice, and dispensing guidelines (Section 30).
- Licensed manufacturers and wholesalers can sell products only to licensed pharmaceutical outlets (Section 30).
- Establishments requiring a pharmacist's direct control (Category A) and supervision (Category B) are specified, and the FDA may modify the list as needed (Section 31).
- Pharmacists working in Category A establishments may simultaneously work in Category B establishments within specified limits (Section 31).
- Pharmacists in pharmaceutical establishments and outlets are responsible for ensuring the quality of pharmaceutical products (Section 32).
- It is unlawful to manufacture, sell, or dispense adulterated or misbranded pharmaceutical products (Section 32).
- Prescriptions and pharmacist-only OTC medicines shall be filled, compounded, and dispensed only by registered pharmacists following standards and guidelines (Section 33).
- Partial filling of prescriptions is allowed, subject to dispensing guidelines (Section 33).
- Physician's samples shall not be sold, and specific labeling requirements apply (Section 34).
- Antimicrobials and other specified medicines shall not be distributed as physician's samples (Section 34).
- Pharmacists shall not dispense prescriptions written in ciphers, codes, or secret keys, or with unusual names (Section 35).
- Pharmacists shall not substitute medicines without the prescriber's consent, except as allowed under the Generics Act (Section 35).
- Labeling requirements for dispensed medicines are specified (Section 36).
- Patient medication profiles and records of dangerous drugs and referrals shall be maintained (Section 37).
- Requirements for opening and operating a retail pharmaceutical outlet include being applied for by a Filipino registered pharmacist as owner or pharmacist-in-charge (Section 38).
- Persons handling pharmaceutical products other than pharmacists, such as pharmacy owners, medical representatives, and support personnel, must undergo accredited training programs and certification (Section 39).
- Pharmacists administering adult vaccines must follow specific requirements, including obtaining a prescription, submitting reports, and undergoing training (Section 40).
Accredited Professional Organization (Sections 41-43)
- The pharmacy profession shall be integrated into one national accredited professional organization (APO) registered with the Securities and Exchange Commission (SEC) (Section 41).
- All registered pharmacists shall automatically become members of the APO upon payment of fees and dues (Section 41).
- Membership in the APO is mandatory for registered pharmacists and pharmacy support personnel throughout their practice or employment (Section 42).
- Specialty Boards in various areas of pharmacy practice shall be created and accredited by the Board and PRC (Section 43).
Violations, Administrative Sanctions, and Procedures (Section 44)
- The Board has the power to revoke or suspend a pharmacist's COR or cancel an STP on grounds such as violating the law, rules, and codes; conviction of a crime involving moral turpitude; unprofessionalism, malpractice, or negligence; fraud in acquiring the COR or STP; allowing improper display of the COR; addiction; aiding illegal practice; insanity; false advertising; manufacturing, selling, or dispensing counterfeit or illegal drugs; practicing with a suspended COR or expired PIC; unauthorized online dispensing; and immoral or dishonorable conduct.
Penal Provisions (Sections 45-46)
- Violations such as dispensing prescription drugs without a license, allowing unlicensed dispensing, compounding without supervision, selling to unlicensed outlets, substituting drugs without consent, adulterating or misbranding drugs, manufacturing counterfeit drugs, operating unlicensed outlets, practicing with an expired or revoked license, and analogous acts are punishable by a fine of not less than ₱250,000 but not exceeding ₱500,000, or imprisonment of not less than one year and one day but not more than six years, or both (Section 45).
- Other violations such as affixing "RPh" without being a registered pharmacist, practicing without a valid license, non-compliance with display and record-keeping requirements, selling physician's samples, using ciphers or unusual terms in prescriptions, employing untrained personnel, and other violations not mentioned in Section 45 are punishable by a fine of not less than ₱100,000 but not exceeding ₱200,000, or imprisonment of not less than 30 days but not more than one year, or both (Section 46).
- Foreign nationals found guilty shall be subject to deportation after serving the sentence or paying the fine (Section 46).
- Owners/operators and pharmacists/support personnel are jointly liable for willful violations (Section 46).
Final Provisions (Sections 47-53)
- The Board and PRC shall primarily enforce the provisions of this Act, with the assistance of law enforcement agencies (Section 47).
- Funding for the implementation of this Act shall be charged against the current year's appropriations of the PRC and thereafter included in the annual General Appropriations Act (Section 48).
- The incumbent Board members shall continue in an interim capacity until the new Board is appointed and qualified (Section 49).
- The Board shall formulate and issue the implementing rules and regulations within 120 days after the law's approval, in consultation with the APO and subject to PRC approval (Section 50).
- If any part of the law is declared unconstitutional or invalid, the other provisions shall remain valid and effective (Section 51).
- Republic Act No. 5921 (the old Pharmacy Law) is repealed, and all other laws, decrees, orders, and issuances contrary to or inconsistent with this Act are repealed, amended, or modified accordingly (Section 52).
- The law shall take effect 15 days after its publication in the Official Gazette or a newspaper of general circulation (Section 53).
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Law
Philippine Pharmacy Act
Republic Act No. 10918
•July 21, 2016
REPUBLIC ACT NO. 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
ARTICLE I
General Provisions
SECTION 1. Title. — This Act shall be known as the "Philippine Pharmacy Act".
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...
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