Philippine Pharmacy Act Modernization

State policy and governing objectives

The State recognizes pharmacists’ vital role in delivering quality health care through safe, effective, and quality pharmaceutical products and professional services including pharmaceutical care, drug information, patient medication counseling, and health promotion (Section 2).
The State develops and nurtures competent, productive, morally upright, well-rounded pharmacists, supported by regulatory measures and programs that promote continuing professional development and global competitiveness (Section 2).
The Act governs: (a) standardization and regulation of pharmacy education; (b) administration of licensure examination, registration, and licensing of pharmacists; (c) supervision, control, and regulation of pharmacy practice; (d) development and enhancement of professional competence through continuing professional development and research; and (e) integration of the pharmacy profession (Section 3).

Core definitions and key concepts

An Accredited professional organization (APO) is the integrated and accredited professional organization of registered and licensed pharmacists, with only one (1) APO, as prescribed under Section 41 and Section 5(a) (Section 5).
Adult vaccines include cervical cancer, flu (influenza), pneumococcal, other pre-exposure prophylactic vaccines for patients aged eighteen (18) years and above, and other vaccines defined by the Department of Health (DOH) in an administrative issuance (Section 5(b)).
Compounding includes processes performed by a pharmacist in drug preparation, including calculations, mixing, assembling, packaging, or labeling, whether resulting from a prescription or for research/teaching/analysis (Section 5(g)).
Continuing professional development (CPD) is post-licensure advanced learning that inculcates knowledge, skills, and ethical values for lifelong learning and assimilation into professional practice (Section 5(h)).
Dispensing covers processes from reading, validating, and interpreting prescriptions; preparing; packaging; labeling; record keeping; dose calculations; and counseling/information for sale or transfer, with or without prescription (Section 5(l)).
Dispensing is exclusive to pharmacists for the Acts under Section 4(a)–(b), (c), (d), and (i) when those activities are performed for pharmacy practice purposes (Section 4).
A Pharmacist is a registered health professional issued a valid Certificate of Registration (COR) and Professional Identification Card (PIC) by the PRC and the Professional Regulatory Board of Pharmacy (Section 5(kk)).
Telepharmacy services are pharmaceutical services of a duly licensed pharmaceutical outlet through telephone, teleconferencing, or facsimile (Section 5(ww)).

Scope of pharmacy practice and exclusivities

A person is practicing pharmacy when they prepare, compound, manufacture, preserve, store, distribute, procure, sell, or dispense pharmaceutical products or raw materials, with or without fee or reward (Section 4(a)).
A person is also practicing pharmacy when they render services such as clinical pharmacy services, drug information services, regulatory services, pharmaceutical marketing, or medication management, or whenever pharmacist expertise is required (Section 4(b)).
Pharmacy practice includes teaching scientific/technical/professional pharmacy courses in a school or college of pharmacy (Section 4(c)).
Pharmacy practice includes dispensing pharmaceutical products in situations where dispensing supervision is required (Section 4(d)).
Pharmacy practice includes chemical, biological, or microbiological analyses and assay of pharmaceutical products, food/dietary supplements, health supplements, and cosmetics (Section 4(e)).
Pharmacy practice includes physico-chemical analyses for medical devices used to aid administration of pharmaceutical products (Section 4(f)).
Pharmacists practice includes administration of adult vaccines as approved by the FDA, but pharmacists must undergo training on safe administration of adult vaccines and management of adverse event following immunization (AEFI) and hold a certificate of training issued by an institution accredited by the PRC (Section 4(g)).
Safe vaccine administration must be part of the higher education curriculum for pharmacists (Section 4(g)).
Pharmacy practice includes conducting or undertaking scientific research in all aspects involving pharmaceutical products and health care (Section 4(h)).
Pharmacy practice includes providing other services where pharmaceutical knowledge is required (Section 4(i)).
Activities under Section 4(a), (b), (c), (d), and (i) are exclusive to licensed pharmacists (Section 4).
Activities limited to e), f), g), and h) may be performed by other persons without requiring them to be licensed pharmacists, subject to qualifications imposed by other laws for those particular activities (Section 4).
Pharmacists must abide by current standards including the Philippine Practice Standards for Pharmacists, Good Laboratory Practice, Good Distribution Practice, Good Manufacturing Practice, and Good Clinical Practice (Section 4).
The Professional Regulatory Board of Pharmacy, subject to PRC approval and in consultation with the integrated and accredited APO, may modify the enumerated acts/services/activities as needed to conform to latest trends and developments, provided modifications remain consistent with the enumeration (Section 4).

Professional board governance and authority

Section 6 creates a Professional Regulatory Board of Pharmacy under administrative control and supervision of the PRC, composed of a Chairperson and two (2) members appointed by the President from lists of recommendees and nominees submitted through the PRC and the APO (Section 6).
Board Chairperson and members must, at time of nomination: be Philippine citizens and residents for at least five (5) years; be duly registered and licensed pharmacists (preferably with a masteral degree or equivalent); have ten (10) years active practice; not have been convicted of a crime involving moral turpitude; be APO members in good standing for five (5) years but not officers/trustees; and at appointment neither be faculty/administrative officers in pharmacy schools nor have direct/indirect pecuniary interest or connection in any review center (Section 7).
The Board’s functions include administering and implementing the Act; promulgating rules and issuances; preparing and rating licensure exam questions in consultation with academe and CHED; and recommending issuance/suspension/revocation/reinstatement of COR/PIC/STP (Section 8(a)–(d)).
The Board regulates and monitors pharmacy practice, including practice of subprofessional services (pharmacy technicians, assistants, aides, and other medicine handlers) and conducts ocular inspection of pharmaceutical establishments and HEIs in coordination with concerned agencies (Section 8(f)).
The Board promulgates the Pharmacists’ Code of Ethics and the Code of Technical Standards and Guidelines for pharmacy practice in coordination with the APO (Section 8(g)).
The Board investigates violations and conducts proceedings, with authority to issue summons, subpoena ad testificandum, and subpoena duces tecum, and renders decisions that become final and executory unless appealed to the PRC after fifteen (15) days from receipt of notice of judgment/decision (Section 8(i)).
The Board delegates administrative-case hearings except when issues involve practice of the profession; in such cases the hearing is presided over by at least one (1) Board member assisted by a PRC Legal/Hearing Officer (Section 8(j)).
The Board may conduct summary proceedings on minor violations through PRC Legal Officers and issue summary judgments that become final and executory unless appealed after fifteen (15) days from receipt of notice of judgment/decision (Section 8(k)).
The Board issues guidelines on CPD in coordination with the APO and recommends accreditation of standardized training programs and certifications for specified medicine handlers covered by Section 39 (Section 8(l), (m)).
Specialty Boards in pharmacy are accredited by the Board using criteria it establishes and prescribes (Section 8(n)).
The Board’s term is three (3) years, renewable once for another three (3) years immediately after expiry; no Board member may serve more than two (2) terms or not more than six (6) years; first Board terms are staggered: Chairperson three (3) years, first member two (2) years, second member one (1) year; appointees to vacancies serve only the unexpired portion (Section 9).
The Chairperson and members receive compensation comparable to other professional regulatory boards under the PRC as provided in the General Appropriations Act (Section 10).
The President may suspend or remove a Board Chairperson or member upon recommendation of the PRC and after due process for grounds including gross neglect/incompetence/dishonesty; exam rigging/manipulation/tampering/disclosure of confidential licensure information; conviction of an offense involving moral turpitude; or unprofessional/unethical/immoral/dishonorable conduct (Section 11).
Board records related to applications and administrative/investigative hearings are under the custody of the PRC, which designates a Secretary to provide secretariat and support services (Section 12).

Licensure, registration, examinations

Registration for pharmacy practice requires passing the licensure examination unless exempted (Section 13).
Applicants must establish qualifications including: citizenship of the Philippines or a foreign country with reciprocity policy; good moral character and reputation; a BS Pharmacy degree or equivalent recognized degree; and completion of an internship program approved by the Board (Section 14).
The licensure examination covers subjects including Inorganic Pharmaceutical Chemistry, Organic Pharmaceutical Chemistry, Qualitative and Quantitative Pharmaceutical Chemistry, Pharmacognosy and Plant Chemistry, Pharmaceutical Biochemistry, Microbiology and Parasitology, Physical Pharmacy, Biopharmaceutics, Pharmacology and Toxicology, Manufacturing, Quality Assurance and Instrumentation, Pharmaceutical Calculations, Drug Delivery Systems, Hospital Pharmacy, Clinical Pharmacy, Dispensing and Medication Counseling, Pharmaceutical Administration and Management, Public Health, Legal Pharmacy, and Ethics (Section 15).
The Board, subject to PRC approval, may introduce relevant changes on subject areas, exam format/content, and relative weight in consultation with recognized pharmacy school associations and CHED (Section 15).
The licensure examination is held two (2) times a year at places and dates designated by the PRC master schedule resolution (Section 16).
A candidate must obtain a general weighted average of seventy-five percent (75%) with no subject rating lower than fifty percent (50%) to be registered and licensed as a pharmacist (Section 17).
A candidate failing the licensure examination for the third (3rd) time may not take the next succeeding examinations without completing a refresher program in a duly accredited institution, and the Board shall issue guidelines on this refresher requirement (Section 17).
The Board submits each candidate’s ratings to the PRC within three (3) working days after the last day of the examination unless extended for just cause (Section 18).
After results release, the PRC sends by mail each examinee’s rating using the mailing envelope submitted during the examination (Section 18).
Successful candidates must take an oath of profession before entering practice, prior to practicing (Section 19).
The Board issues a COR to those who passed the exam subject to compliance with registration requirements and payment of prescribed fees; the COR includes registration number, issuance date, signatures of PRC Chairperson and Board members, and official seals certifying eligibility, and remains effective until suspended or revoked under the Act (Section 20).
A PIC is issued upon payment of prescribed fees; it bears registration number and issuance/expiry dates, is signed by the PRC Chairperson, and must be renewed every three (3) years upon presentation of a Certificate of Good Standing (COGS) from the APO and proof of completion of CPD requirements (Section 20).
Foreign reciprocity: no foreigner may be admitted to licensure examination, be given a COR to practice, or be entitled to privileges under the Act unless the foreign country/state specifically permits Filipino pharmacists to practice under reciprocity and international agreements (Section 21).

Special/temporary permits for foreigners

Pharmacy practice in the Philippines is limited to natural persons only, governed by Republic Act No. 8981 and related issuances (Section 22).
A foreign citizen entering the Philippines to perform professional services within the scope of pharmacy practice must secure a Special/Temporary Permit (STP) from the Board and the PRC before assuming duties if the foreigner serves as: a consultant in foreign-funded/assisted government projects; an employee/engaged by a Filipino employer/establishment; provides free services in humanitarian missions; or is a visiting faculty member in a pharmacy field/specialty (Section 22).
The STP is issued only if: (1) the foreign citizen is an internationally renowned pharmacist or expert in a pharmacy field/specialty; (2) the professional service is determined necessary due to lack of Filipino specialist/expert; and (3) the foreign citizen is required to work with a Filipino counterpart who is a registered and licensed pharmacist (Section 22).

Non-registration and reissuance rules

The Board must not register successful examinees who: were convicted of an offense involving moral turpitude; were summarily adjudged guilty for misrepresentation/falsification of documents connected with the application or violation of the General Instructions to Examinees; were found guilty by the Board of immoral or dishonorable conduct; are medically proven addicted to any drug or alcohol by a government-accredited medical/drug testing facility; or were declared of unsound mind by a court of competent jurisdiction (Section 23).
On refusal to register, the Board must give a written statement of reasons, file a copy in its records, and—if addiction under Section 23(d) is later proven nonexistent—must issue a Board Resolution allowing issuance of the COR (Section 23).
The Board may, upon petition, reinstate or reissue a revoked COR after two (2) years from the revocation date; the Board may require another licensure examination; the petitioner must prove a valid reason; and grant requires a Board Resolution to be approved by the PRC (Section 24).
Duplicate COR for display in Category B establishments may be issued, and replacement of lost/damaged COR, PIC, or STP is governed by pertinent rules to be issued (Section 24).

Pharmacy practice requirements and outlets

All pharmacists registered before the effectivity of the Act automatically remain registered, subject to compliance with future requirements; their COR/PIC/STP in good standing have the same force and effect as though issued on or after effectivity (Section 25).
Only duly registered and licensed pharmacists may use the title “Registered Pharmacist” or “RPh” after their name (Section 26).
Pharmacists must indicate serial numbers and the date of expiry of the pharmacist’s PIC and APO certificate of membership on all pertinent documents they sign (Section 27).
The Board and PRC prepare and maintain a registry of names, residences/office addresses, registration status, and area of practice, updated annually with the APO, and made available to the public upon inquiry/request under guidelines established (Section 28).
Every pharmacist must display the original COR in a prominent and conspicuous place in the drug establishment where employed as a pharmacist; pharmacists in Category B establishments must also display the duplicate COR (Section 29).
A pharmacist may not knowingly allow COR display in an establishment where the pharmacist is not actually employed as a professional pharmacist (Section 29).
No pharmaceutical product may be compounded, dispensed, sold, or otherwise made available to the consuming public except through a retail drug outlet duly licensed by the FDA (Section 30).
Prescription drugs and pharmacist-only OTC medicines may be dispensed only by a duly registered and licensed pharmacist except in emergency cases where a registered and licensed pharmacist’s services are not available; in emergencies, a report must be made to the supervising pharmacist within twenty-four (24) hours for product recording in prescription books (Section 30).
Compounding and dispensing must be done only by duly registered and licensed pharmacists in accordance with current GMP, Good Laboratory Practice, Philippine Practice Standards for Pharmacists, and dispensing guidelines; a registered and licensed pharmacist may refuse to compound/dispense/sell if not in accordance with the Act and standards (Section 30).
Licensed manufacturers, importers, distributors, and wholesalers may sell only to duly licensed pharmaceutical outlets (Section 30).

Pharmacist staffing categories

Establishments/outlets requiring employment/retention/maintenance of professional services of duly registered and licensed pharmacists are classified into Category A and Category B (Section 31).
Category A requires direct and immediate control and supervision of a duly registered and licensed pharmacist per establishment, whether in-store or online, including outlets for prescription/ethical medicines, combination products classified as drugs by primary intended mode of action, pharmacist-only OTC medicines, and processes involving preparation/manufacture/assay/quality control/repacking/importation/exportation/distribution/sale or transfer of pharmaceutical products in quantities greatly in excess of single therapeutic doses (Section 31(a)(1), (3)).
Category A includes government units and specified organizations involved in procurement, distribution, dispensing, and storage of pharmaceutical products (Section 31(a)(4)).
Category B requires supervision and oversight of a duly registered and licensed pharmacist and includes retail outlets selling household remedies and OTC drugs differentiated from pharmacist-only OTC medicines; satellite institutional pharmacies providing medicines solely to employees and/or their qualified dependents; certain class municipal health units involved in procurement/distribution/dispensing/storage; institutions providing telepharmacy services; and nontraditional outlets, with the condition that no prescription medicines and pharmacist-only OTC medicines are sold (Section 31(b)(1), (2), (3), (4), (5)).
The FDA, in coordination with the Board and with PRC approval, may add to, delete, reclassify, or modify the listed establishments in Categories as needed (Section 31).
A pharmacist working in Category A may simultaneously work/render services in Category B up to a maximum number of hours determined by guidelines established by the Board in coordination with the FDA and other bodies (Section 31).
Procurement, storage, distribution, or dispensing in national government and local government units must be made only under supervision of a duly registered and licensed pharmacist (Section 31).
Units/sub-units of establishments/institutions/regulatory bodies—whether government or private—with functions exclusive for pharmacists must be headed and managed by a qualified duly registered and licensed pharmacist, subject to other appointment requirements in government service (Section 31).

Quality assurance and unlawful practices

A duly licensed and registered pharmacist of a pharmaceutical establishment/outlet must ensure pharmaceutical products conform to standards of safety, quality, and efficacy under the Act and other rules (Section 32).
Owners, managers, or pharmacists in charge of the operation are jointly responsible for nonconformance with these standards (Section 32).
It is unlawful to manufacture, prepare, sell, or dispense any pharmaceutical product under a fraudulent name or pretense or to adulterate any pharmaceutical product offered for sale (Section 32).
For products sold in original packages with seals unbroken or untampered with, liability for quality and purity rests on the manufacturer or importer and the distributor/representative/dealer responsible for distribution/sale (Section 32).

Prescription filling, partial filling, and substitution

All prescriptions and pharmacist-only OTC medicines must be filled, compounded, and dispensed only by a registered and licensed pharmacist in accordance with Philippine Practice Standards, Dispensing Guidelines, and standards on purity, safety, and quality (Section 33).
Completely filled prescriptions must be surrendered to the pharmacist for recording (Section 33).
Partial filling of prescriptions is allowed for less than the total quantity indicated, subject to dispensing guidelines; the pharmacist dispensing the last quantity must keep the prescription according to proper prescription recording guidelines (Section 33).
Prescription medicines may be dispensed only by a duly registered and licensed pharmacist and only with a valid prescription from a physician, dentist, or veterinarian (Section 33).

Physician samples and labeling controls

Physician samples intended for free distribution to health professionals by a manufacturer/distributor/professional service representative as promotion must not be sold to pharmaceutical outlets or the consuming public (Section 34).
The marking “Sample, Not for Sale” or equivalent must appear conspicuously on primary and secondary packaging of the specified drug/combination product classified as drugs by primary intended mode of action; removing/erasing/defacing/marking original labels is unlawful (Section 34).
Pharmaceutical products classified as antimicrobials, including anti-TB medicines and other FDA-prescribed classifications, must not be given or distributed as physician samples (Section 34).

Cipher/secret prescription and substitution bans

Pharmacists may not compound or dispense prescriptions written in ciphers, codes, or secret keys, or prescriptions using unusual names that differ from those in standard pharmacopeias or formularies (Section 35).
Pharmacists may not substitute the medicine called for in the prescription with another drug/substance/ingredient without prior consultation with and written consent of the prescriber, except as allowed under the Generics Act of 1988 (Republic Act No. 6675, as amended) and other pertinent laws and regulations (Section 35).

Dispensed medicine labeling and patient instructions

Every box/bottle/package of medicines compounded or dispensed by a registered and licensed pharmacist based on a prescription must bear a seal/label that includes patient name and generic name of drug; brand name if any; strength; expiry date; directions for use; and name/address of pharmacy; name of the doctor; dispensing pharmacist and other requirements under Philippine Practice Standards/Dispensing Guidelines, Republic Act No. 9502 (Universally Accessible Cheaper and Quality Medicines Act of 2008), its IRR, and other Board guidelines (Section 36).
Auxiliary labels containing special pharmacist instructions are required for dangerous drugs, external-use-only drugs, drugs with special storage and administration instructions, and other drugs required by law (Section 36).

Patient medication profile and recordkeeping

Prescriptions dispensed in the pharmacy must be recorded in an appropriate recording system showing at least patient name/address, prescriber name, generic and brand, dosage strength, quantity, and pharmacist initials (Section 37).
These records must be open for inspection by Board and/or FDA representatives at any time the pharmacy is open and must be kept for not less than two (2) years after the last entry (Section 37).
Dangerous drugs dispensed must be recorded in the Dangerous Drugs Book or equivalent system required under Republic Act No. 9165 and applicable laws/issuances (Section 37).
Referrals such as tuberculosis patients must be recorded in the Referral Registry, open for inspection by the Board or DOH or FDA representatives at any time the pharmacy is open, and kept for not less than two (2) years after last entry (Section 37).

Opening and operating retail pharmaceutical outlets

Opening of a retail pharmaceutical outlet/establishment must comply with requirements in the Act and FDA rules and regulations (Section 38).
No application to open and operate a retail drug outlet or similar business is approved unless filed by a Filipino registered and licensed pharmacist as owner or pharmacist-in-charge under the Act (Section 38).

Handling by non-pharmacists and training certification

Persons handling pharmaceutical products other than the pharmacist—including non-pharmacist pharmacy owners, medical/professional service representatives, pharmacy support personnel, pharmacy technicians, pharmacy assistants, pharmacy aides, persons assisting pharmacists in pharmacy operations, and other persons performing functions involved in handling pharmaceutical products—must be duly certified by appropriate government agencies after undergoing an accredited training program (Section 39).
No person may render these services without undergoing a comprehensive standardized training program, except pharmacy graduates; the implementing rules define job descriptions (Section 39).

Adult vaccine administration reporting

Licensed and trained pharmacists administering adult vaccines must ensure the vaccine has a doctor’s prescription not more than seven (7) days old and must submit monthly vaccination reports and AEFI reports to DOH regional offices using prescribed forms (Section 40).

Integrated and Accredited Professional Organization (APO)

The pharmacy profession is integrated into one (1) national organization registered with the Securities and Exchange Commission (SEC) and recognized by the Board and PRC as the one and only integrated and accredited professional organization of pharmacists (Section 41).
A pharmacist registered with the Board automatically becomes a member of the APO upon payment of required fees and dues, and receives benefits and privileges appurtenant thereto (Section 41).
Membership in the integrated APO does not bar membership in other pharmacists’ associations (Section 41).
All registered pharmacists must be APO members and must maintain membership throughout practice; PIC renewal is not granted if APO membership requirements are not met, including credit units for attendance to duly accredited CPD (Section 42).
Pharmacy support personnel must register as affiliate members of the APO and must maintain membership throughout employment in pharmaceutical establishments and outlets (Section 42).

Administrative sanctions for COR and STP

The Board may, upon notice and hearing, revoke/suspend a pharmacist’s COR or cancel a foreign pharmacist’s STP on grounds including violations of the Act/rules, Code of Ethics, Code of Technical Standards, Code of Good Governance, Board/PRC measures; conviction for moral turpitude; unprofessionalism/immorality/malpractice/incompetence/gross negligence/imprudence; fraud/deceit in acquisition/renewal; allowing COR to be displayed where not actually employed; addiction to alcohol or habit-forming drugs rendering the pharmacist incompetent; aiding illegal practice by unregistered/unlicensed persons; insanity/mental disorder rendering incompetence; false/extraordinary/unethical advertisements/endorsements; manufacture/sale of counterfeit/spurious/substandard/falsified pharmaceutical products and related acts in violation of Republic Act No. 9165 and Republic Act No. 8203; illegal manufacture/sale/possession/dispensing of dangerous drugs and related acts in violation of Republic Act No. 9165 and other laws; acts in violation of Section 6 of Presidential Decree No. 881 and Section 11 of Republic Act No. 3720; practicing with suspended COR or expired PIC; unauthorized dispensing through unregistered online services/direct selling; and immoral/unprofessional/dishonorable conduct by Board finding (Section 44).

Criminal penalties for violations

Upon conviction, violations enumerated under Section 45 carry a penalty of a fine of not less than PHP 250,000 but not exceeding PHP 500,000, or imprisonment of not less than one (1) year and one (1) day but not more than six (6) years, or both, at the court’s discretion (Section 45).
Section 45 penalizes, among others, acts in violation of Sections 30 and 31, including unlawful dispensing/sale and pharmacist staffing/requirements violations (Section 45(a)).
Section 45 penalizes allowing display of one’s COR where the pharmacist is not employed and practicing, and also penalizes display of the COR by owners/operators in such circumstances (Section 45(b), (c)).
Section 45 penalizes dispensing or offering for sale prescription drugs/pharmaceutical products in places not licensed by the FDA as pharmaceutical outlets (**Section