Philippine Pharmacy Act: Regulations and Provisions

Philippine Pharmacy Act

The act regulating and modernizing the practice of pharmacy in the Philippines, repealing Republic Act Numbered 5921.

State

Refers to the government of the Philippines.

Pharmacists

Individuals recognized for their role in providing quality health care services through pharmaceutical products, care, information, counseling, and health promotion.

Professional Development

Enhancing the competence of pharmacists through regulatory measures, programs, and activities to ensure excellence and global competitiveness.

Scope of Pharmacy Practice

Includes activities such as preparing, compounding, dispensing pharmaceutical products, providing services, engaging in teaching, conducting research, and more.

Licensed Pharmacists

Individuals authorized to engage in exclusive activities like preparing, compounding, dispensing pharmaceutical products, and providing services.

Accredited Professional Organization (APO)

The integrated and accredited professional organization of registered and licensed pharmacists, of which there is only one as prescribed by the Act.

Adult Vaccines

Vaccines administered to patients aged eighteen years and above, including cervical cancer, flu, pneumococcal vaccines, and others defined by the Department of Health.

Adulterated/Deteriorated Pharmaceutical Products

Pharmaceutical products unfit for human consumption, not meeting quality or purity standards set by recognized pharmacopeias and laws.

Biopharmaceuticals

Pharmaceutical products for therapeutic or diagnostic purposes derived from life forms using biotechnology, such as vaccines and sera.

Brand name

The proprietary name given by the manufacturer to distinguish its product from competitors.

Cipher, Code, or Secret Key

A method of secret writing using symbols to mislead consumers.

Compounding

Processes by a pharmacist in drug preparation, including calculations, mixing, and packaging.

Continuing professional development (CPD)

Advanced knowledge and skills assimilated into professional practice post-licensure.

Cosmetics

Substances intended for external body parts for cleaning, perfuming, or protecting.

Counterfeit pharmaceutical products

Products with wrong ingredients or insufficient active ingredients, reducing safety or efficacy.

Dangerous drugs

Pharmaceuticals listed in international conventions or specific national laws.

Dispensing

Processes by a pharmacist related to preparing and providing pharmaceutical products.

Drugs

Chemical compounds or biological substances for treating diseases in humans or animals.

Emergency cases

Life-threatening situations requiring immediate medical attention.

Expiration date

The end date when a product's claimed potency, efficacy, and safety are guaranteed.

Filling

Providing medicines according to a prescription or medication order.

Food/Dietary supplements

Processed food products with dietary ingredients to supplement the diet.

Generic name

The scientifically recognized name of active ingredients approved by the FDA.

Health supplement

Products used to maintain and enhance healthy body functions containing various substances.

Household remedies

Preparations containing pharmaceutical substances for common ailments, dispensed without a prescription.

Institutional pharmacies

Pharmacies in institutions providing services exclusively to employees and their dependents.

Internship program

Supervised practical experience required for licensure as a registered pharmacist.

Label

Written, printed, or graphic matter on the immediate container of any article.

Labeling materials

All labels and written, printed, or graphic matter on or accompanying an item.

Medical device

Articles intended for various purposes related to human health, excluding primary action by pharmacological means.

Medical mission

Health service activity conducted outside formal healthcare premises under normal circumstances.

Medicines

Drugs in appropriate dosage forms ensuring quality, safety, and efficacy for humans or animals.

Medical representative

Individual promoting pharmaceutical products to licensed health professionals on behalf of manufacturers.

Nontraditional outlets

Entities licensed to dispense over-the-counter medicines based on an approved list.

Online pharmacy services

Pharmaceutical services provided by a licensed outlet over the internet.

Over-the-counter (OTC) medicines

Medicines for minor ailments that can be dispensed without a prescription.

Pharmaceutical establishments

Entities involved in the manufacture, distribution, and sale of pharmaceutical products.

Pharmaceutical manufacturers

Establishments engaged in the production and preparation of pharmaceutical products.

Pharmaceutical marketing

Activities promoting pharmaceutical products undertaken by establishments or outlets.

Pharmaceutical outlets

Entities involved in compounding, dispensing, and selling pharmaceutical products directly to patients.

Pharmaceutical products

Includes drugs, medicines, biologicals, and veterinary products.

Pharmacist

Health professional registered and issued a Certificate of Registration by the Professional Regulatory Board of Pharmacy.

Pharmacist-only OTC medicines

Over-the-counter medicines obtained only from a licensed pharmacist with mandatory advice.

Pharmacy aides

Assist pharmacists based on standard procedures with minimal decision-making and no patient interaction.

Pharmacy assistants

Assist pharmacists based on standard procedures with some patient interaction.

Pharmacy technicians

Assist in compounding and dispensing medicines under pharmacist supervision.

Philippine Practice Standards for Pharmacists

National quality standards for pharmacy practice approved by the Professional Regulatory Board of Pharmacy.

Physician's samples

Medicines provided to health professionals for promotional purposes.

Prescription/Ethical medicines

Medicines dispensed by a pharmacist with a valid prescription, requiring pharmacist advice.

Refilling of a prescription

Dispensing the remaining balance of medicines ordered in a prescription.

Referral

Pharmacist consults, assesses symptoms, and refers patients to other healthcare professionals.

Referral registry

Record book listing patients referred to different health facilities for further diagnosis.

Refresher program

Prescribed study program in an accredited school of pharmacy.

Telepharmacy services

Pharmaceutical services provided through telephone, teleconferencing, or facsimile.

Professional Regulatory Board of Pharmacy

Established under PRC, composed of Chairperson and 2 members

Qualifications of Board Chairperson and Members

Includes citizenship, residency, pharmacy license, experience, ethics, and no academic affiliations

Powers of the Board

Includes administering the Act, rule-making, exam preparation, licensing, ethics, and inspections

Code of Ethics

Prescribed by the Board for pharmacy professionals' conduct

CPD Guidelines

Guidelines for Continuing Professional Development coordinated with APO

Term of Office

Members serve 3-year terms, renewable once, with specific provisions for initial appointments

Compensation and Allowances

Board members receive compensation as per General Appropriations Act

Grounds for Suspension or Removal

Includes neglect, dishonesty, exam misconduct, moral turpitude conviction, and unethical conduct

Custodian of Records

PRC holds records related to exams and investigations conducted by the Board

PRC

Professional Regulation Commission responsible for overseeing licensure examinations and professional regulation

Secretary

Designated by the PRC to provide secretariat and support services to the Board

Licensure Examination

Mandatory test for pharmacy practice registration, requiring a passing score

Qualifications

Requirements for Pharmacists' Licensure Examination applicants, including citizenship and degree

Internship Program

Board-approved practical training for licensure exam applicants

Scope of Examination

Subjects covered in the Pharmacists' Licensure Examination, including various aspects of pharmacy

Ratings Requirement

Minimum scores needed for registration as a pharmacist, with specific subject score conditions

Refresher Program

Mandatory program for applicants failing the licensure exam thrice before retaking

Oath of Profession

Required pledge for successful licensure exam candidates before practicing pharmacy

Certificate of Registration (COR)

Issued to passing licensure exam candidates, indicating entitlement to practice pharmacy

Professional Identification Card (PIC)

Identification card issued to registrants, renewable every three years

Foreign Reciprocity

Policy on foreign pharmacists practicing in the Philippines based on reciprocity agreements

Special/Temporary Permit (STP)

Permission for foreign pharmacists to practice in specific circumstances under conditions

Grounds for Non-registration

Reasons for the Board to deny registration, including criminal convictions and misconduct

Reissuance Guidelines

Procedures for reinstating revoked certificates or replacing lost/damaged registration documents

Vested Rights

Automatic registration for pharmacists before the new regulation, subject to future compliance

Affixing RPh

Exclusive right of registered pharmacists to use the title 'Registered Pharmacist'

Registry of Pharmacists

Official list of registered pharmacists' information maintained by the Board and PRC

Display of COR

Requirement for pharmacists to prominently display their Certificate of Registration in their workplace

Dispensing Regulations

Rules governing the sale and dispensing of pharmaceutical products by licensed pharmacists