Republic of the Philippines Professional Requlation Commission Manila PROFESSIONAL REGULATORY BOARD OF PHARMACY Resolution No. _ 52 Series of 2017 IMPLEMENTING RULES AND REGULATIONS (IRR) OF REPUBLIC ACT NO. 10918, OTHERWISE KNOWN AS 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 Pursuant to Sections 8 (b) and 50 of Republic Act (R. A.) No. 10918, also known as the PHILIPPINE PHARMACY ACT, the Professional Regulatory Board of Pharmacy (Board), with the approval of the Professional Regulation Commission (PRC), hereby issues and promulgates this Implementing Rules and Regulations (IRR) to carry out the provisions of R. A. No. 10918. RULE! GENERAL PROVISIONS Section 1. known as the LES PHARMACY ACT” Section 2, Statement of Policy. — The State recognizes the vital role of pharmacists in the delivery of quality healthcare services through the provision of safe, effective, and quality pharmaceutical products, pharmaceutical care, drug information, patient medication counseling, and health promotion. The vices shall, therefore, be promoted as an e total 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 IRR of R. A. No. 10918 is likewise promulgated to provide for and govern the: a. Standardization and regulation of pharmacy education: b. Administration of in and ic of a in the Philippines; 1 £ \ 2 A P. PAREDES ST., CORNER N. REYES ST., SAMPALOC, MANILA, PHILIPPINES. 1008 P.O. BOX. 2038, MANILAIRR OF R.A. NO. to918 (PHILIPPINE PHARMACY ACT) d. Development and erhencement of professional competence of pharmacists, Section 4. Interpretation of the IRR of R. A. No. 10918. — Any doubt in the interpretation of this IRR shall be resolved in a manner that would be consistent to the declared State policy and objectives. Section 5. Scope of the Practice of Pharmacy. - A person is deemed to be practicing pharmacy, within the meaning of R. A. No. 10918, when with or without a fee, salary, percentage or other rewards, paid or given directly or indirectly, shall perform the following activities A. Activities Exclusive to Pharmacists Activities that are identified below shall be practiced only by a pharmacist: a. Preparation, compounding or manufacture, preservation, storing, distribution, procurement, sale, or dispensing, or both. of any pharmaceutical product or its raw materials; b , such as clinical pharmacy services, drug information services, regulatory services, pharmaceutical marketing, medication management, or whenever the expertise and technical kno tis required; °. in teachin , technical, or professional pharmacy courses in a school or college of i Dispensing of prarraeutel mul tut 6 where supenision of di ee pharmaceutical product is required; or e. d. B. Activities which are NotBxelusive to Pharmagiata |. Nothing in R. A. No. 10918 and this IRR shall be construed as requiring other persons carrying out the activities listed below to be pharmacists, subject however to any such qualification that is or may be imposed by other laws with respect to such activity. a. Conduct of chemical, biological or icici SEE age of pharmaceutical products, food/dietary supplements th supplements, and cosmetics; b. Performance of analyses of medi ised in aid of administration of pI CIRR OF R. A.NO. 10978 (PHILIPPINE PHARMACY ACT) ©. peer coral as approved by the Food and Drug Administratio vided, that they shall undergo the training on safe administration of adult vaccines and management of adverse event following immunization (AEF!) for pharmacists and hold a certificate of training issued by an institution duly accredited by the PRC: Provided further, that the safe administration of vaccines be part of the higher ‘education curriculum for pharmacists; and d. Conduct or undertaking of scientific research in all aspects, involving pharmaceutical products and healthcare. “The Professional Regulatory Board of Pharmady hereinatter created may, subject to the approval of the PRC, as provided for by R. A. No. 8981, otherwise known as “PRC Modernization Act of 2000", and in consultation with the Integrated and Accredited Professional Organization (IAPO), modify the above enumerated acts, services, or activities, as the need arises, in order to conform to the latest trends and developments in the practice of the pharmacy profession: Provided, that such modifications are consistent with the enumeration above. All pharmacists are expected to abide by the current standards such as but not limited to the jood Regulatory Pract ution Practice, Good Storage Practice, Good Warel , Good Manufacturing Practice and Good Clinical Practice, which are deemed vital in the performance of their roles and functions in different practice areas. Section 6. Definition of Terms. — As used in this IRR, the following terminologies shall be construed to mean: a. Act refers to R. A. No. 10918, also known as “THe Phlipp he Phaeacy Act, b. Activities Exclusive to Pharmacists refers to a set of functions thal require the unique expertise of the pharmacist, the absence of which would impact on health and safety; ©. Adult Vaccine refors to cervical cancer, flu (influenza), pneumococcal, other pre-exposure prophylactic vaccines to be administered to patients aged eighteen (18) years and above, and such other vaccines, as may be defined by the Department of Health (DOH) in an administrative issuance; G. Adulterated/Deteriorated Pharmaceutical Product refers to a pharmaceutical product unfit for human consumption, following the standards of quality or purity of which are as those stated in the United States Pharmacopeia/National Formulary and Philippine Pharmacopeia in its latest edition or any standard reference for drugs and medicines which are given official recognition, as well as those provided for in R. A. No. 3720, otherwise known as the “Food, Drug and Cosmetic Act’, as amended, and A. A. No. 9711, known as the “Food and Drug Administration Act of 2009": ©. Adverse Drug Reaction refers to a noxious and unintended reaction to a drug which occurs at doses normally used in humans for the prophylaxis, diagnosis or treatment of disease or for the modification of physiologic function;IAROF A.A, NO. 10018 (PHILIPPINE PHARMACY acT) {. Biopharmaceutical refers to a pharmaceutical product used for therapeutic or for in vivo diagnostic purposes, such as vaccines, sera, and drugs derived from life forms by biotechnology. These include proteins, nucleic acids, or living microorganisms where the virulence is reduced and are used for therapeutic or for in vivo diagnostic purposes; 9. Brand Name refers to the proprietary name given by the manufacturer to distinguish its product from those of competitors: h. Cipher, Code, or Secret Key refers to a method of secret writing or use of characteristic style or symbol by substituting other letter/s or character/s for the letter/s intended for the purpose of misleading the consumer. |. Clinical Pharmacy Service refers to any patient care provided by a pharmacist, through pharmacologic and non-pharmacologic strategies, that Promote the appropriate selection and utilization of medication to optimize individualized therapeutic outcomes, prevent diseases or achieve wellness; j. Compounding refers to the sum of processes performed by a pharmacist in Grug preparation including the calculations, mixing, assembling, packaging, or labeling of a drug: (1) as the result of a prescription or drug order by a Physician, dentist or veterinarian, or (2) for the purpose of, or in relation to, research, teaching, or chemical analysis; k. Continuing Professional Development (CPD) refers to the inculcation of advanced knowledge, skills, and ethical values in a post-licensure specialized or in an inter- or multi-disciplinary field of study for assimilation into professional practice, self-directed research, and/or lifelong learning; |. Cosmetics refers to a substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odor, and/or protecting the body or keeping them in good condition, as defined under R. A. No. 9711: ™m. Counterfeit Pharmaceutical Product refers to a pharmaceutical product which does not contain the amounts as claimed; with wrong ingredients; without active ingredients; or with insufficient quantity of active ingredients which result in the reduction of the products’ safety, efficacy, quality, strength or purity. This also refers to a product that is deliberately and fraudulently misiabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products, including the following: 1. the pharmaceutical product itself or the container or labeling thereof or any part of such product, container, or labelling bearing without authorization the trademark, trade name or other identification marks or imprints or any likeness to that which is owned or registered in the Intellectual Property Office (IPO) in the name of another natural or juridical person; 2. a pharmaceutical product refilled in containers bearing legitimate labels or marks, without authority; and 3. a pharmaceutical product which contains no amount of or @ different active ingredient; or less than eighty percent (80%) of the active By ingredient it purports to possess, as distinguished from an adulterated © drug including reduction or loss of efficacy due to expiration; x \\ 4IRR OF R.A. NO. 10918 (PHILIPPINE PHARMACY acT) n, Dangerous Drug refers to those listed in the: (1) Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 Protocol; (2) Schedules annexed to the 1971 Single Convention on Psychotropic Substances; (3) Annex of R. A. No. 9165, otherwise known as the “Comprehensive Dangerous Drugs Act of 2002”, and its amendments; ©. Dispensing refers to the sum of processes performed by a pharmacist from reading, validating, and interpreting prescriptions; preparing; packaging: labelling; record keeping; dose calculations; and counselling or giving information, in relation to the sale, transfer or provision of pharmaceutical products, with or without a prescription or medication order; p. Drug refers to a pharmaceutical product that pertains to chemical compound/s or biological substance/s, other than food, intended for use in the treatment, prevention, or diagnosis of disease in humans or animals, including the following: 1. any article recognized in the official United States Pharmacopeia - National Formulary, Homeopathic Pharmacopeia of the United States of America, Philippine Pharmacopeia, Philippine National Drug Formulary, British Pharmacopeia, European Pharmacopeia, Japanese Pharmacopeia, and any official compendium or any supplement to them; 2. any article intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease of man or animals; 3. any article, other than food, intended to affect the structure or any function of the human body or animals; 4. any article intended for use, as a component of articles, specified in clauses (1), (2), and (3), not including devices or their components, parts, accessories; and 5. herbal or traditional drugs as defined in R, A. No. 9502, known as the “Universally Accessible, Cheaper and Quality Medicines Act”: Q, Drug Distributor/Importer/Exporter/Wholesaler refers to any drug or pharmaceutical establishment that imports or exports raw materials, active ingredients and/or finished drug products for its own use or for wholesale distribution to other drug or pharmaceutical establishments or outlets. if the Gistributor/importer/exporter/wholesaler sells to the general public, it shall be considered a retailer, '. Drug Information Service refers to any activity in response to a drug information request or query from healthcare professionals, organizations, Committees, patients and other individuals with the goal of providing carefully evaluated, evidence-based drug information and recommendation to support medication use practice, enhance quality of patient care, improve patient outcomes and ensure prudent use of resources; s. Emergency Case refers to a life-threatening situation where a patient needs immediate medical attention and treatment, including the occurrence of epidemic or natural calamities; Ry 1. Expiration Date refers to the end date when the manufacturer can guarantee that a product possesses its claimed potency, efficacy, quality, and safety, after which its sale or distribution is prohibited:IRR OF R. A.NO. 10918 (PHILIPPINE PHARMACY u. v. cm) Filling refers to the act of dispensing or providing medicines in accordance with a prescription or medication order; Food/Dietary Supplement refers to a processed food product intended to supplement the diet that bears or contains one (1) or more of the following dietary ingredients: vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances to increase the total daily intake in amounts conforming to the latest Philippine-recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It is usually in the form of capsules, tablets, liquids, gels, powders, or pills and not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines, as defined under R. A. No. 9711; w. Generic Name refers to the scientifically and internationally recognized name ae bl of the active ingredients, as approved by the FDA pursuant to R. A. No. 6675, otherwise known as the “Generics Act of 1988"; Good Clinical Practice (GCP) refers to the international ethical and scientific Quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects: Good Distribution Practice (GDP) refers to that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout the numerous activities which occur during the distribution process; Good Laboratory Practice (GLP) refers to the quality system concemed with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported; ‘a.Good Manufacturing Practice (GMP) refers to the system of quality assurance aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use. It is thus concerned with both manufacturing and quality control processes and procedures; b.Good Pharmacy Practice (GPP) refers to the practice of pharmacy that responds to the needs of the people who use the pharmacists’ services to provide optimal evidence-based care; ce. Good Regulatory Practice (GRP) refers to the practice of regulation that d e ff should be clear, simple and practical for users through identified policy objectives, consistent with international standards in a sound legal and empirical basis which produces benefits that justify and minimize costs and market distortions, in consideration of its effects across society and taking into account economic, environmental and social factors; id. Good Storage Practice (GSP) refers to that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout its storage; e. Good Warehousing Practice (GWP) refers to that part of quality assurance which ensures that the quality of a pharmaceutical product is maintained through adequate control throughout the warehousing; Handling of Pharmaceutical Products refers to the activities or range of pharmacy operations from selecting, ordering, delivery, transport, receipt, inventory of stocks, to arranging and display, compounding, storage dispensing, provision of medication and health information to patients and/or healthcare providers and selling of pharmaceutical products, including waste disposal; Qg.Health Promotion refers to the process of enabling communities, patients and clients to increase control over their health and its determinants x by engaging in healthy behaviours to reduce the risk of developing diseases J and other comorbidities; \IRR OF R.A NO. 10918 (PHIUPPINE PHARMACY ACT) hh. Health Supplement refers to any product that is used to maintain, enhance and improve the healthy function of the human body and contains one (1) or more or a combination of the following: (1) herbal fatty acids, enzymes, probiotics and other bioactive substances; (2) substances derived from natural sources, including animal, plant, mineral and botanical materials in the form of extracts, isolates, concentrates, metabolites and synthetic sources of substances mentioned in (1) and (2). These are presented in dosage forms or in small unit doses such as capsules, tablets, powder, liquids and shall not include any sterile preparations (ie. injectibles, eye drops); ii. High-alert Medication refers to a drug that bears a heightened risk of causing significant patient harm when they are used in error; jj. Household Remedy refers to any preparation containing pharmaceutical substances of common or ordinary use to relieve common physical ailments and which may be dispensed without a prescription in original packages, bottles or containers, of which the nomenclature and categorization have been duly approved by the FDA; kk. Immunizing Pharmacist refers to a certified pharmacist who administers selected vaccines for adult immunization as prescribed under Section 40, Article 4 of the Act; ||. Institutional Pharmacy refers to a pharmacy of institutions, organizations, and/or corporations that provide a range of pharmaceutical services exclusively to the employees and/or their qualified dependents; mm. Integrated and Accredited Professional Organization (iAPO) refers to the integrated and accredited professional organization of pharmacists of which there shall be only one (1), as prescribed under Section 41, Article V of the Act; nn.Internship Program refers to a supervised practical experience or supervised pharmacy practice experience that is required to be completed by the pharmacy student prior to licensure as a pharmacist; 00.Label refers to a display of written, printed, or graphic matter on the immediate container of any article; pp.Labelling Material refers to all labels and other written, printed, or graphic matter: (1) upon any item or any of its containers or wrappers; or (2) accompanying any such item; aq. Marketing Authorization (MA) refers to an official document issued by the FDA for the purpose of marketing or free distribution of a product after evaluation of its safety, efficacy, and quality; tr, Marketing Authorization Holder (MAH) refers to the company, corporate or legal entity in the field of pharmaceuticals in whose name the MA for a drug product has been granted. This party is responsible for all aspects of the Product, including quality and compliance with the conditions of the MA. The MAH may either be a manufacturer or distributor/exporter/importer/ wholesaler; ss. Medical Device refers to any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used alone, or in ‘combination, for human beings, for one (1) or more of the specific purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease: diagnosis, monitoring, treatment or alleviation of or compensation _¥ for an injury; investigation, replacement, modification or support of the <~s anatomy of a physiological process; supporting or sustaining life: Preventing infection; control of conception; disinfection of medical devices, and providing information for medical or diagnostic purposes by . | means of in vitro examination of specimens derived from the human body.IRR OF R. A. NO. 10918 (PHILIPPINE PHARMACY ACT) This device does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means, as defined under R. A. No. 9711 {t, Medical Mission refers to an activity conducted in normal circumstances by an individual or group of health care practitioners to provide health services outside the hospital, clinic, and health care facility premises as differentiated from humanitarian missions and relief operations which are conducted during emergency situations such as calamity, war, or natural and man-made disasters; uu.Medication Error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer; w. Medication Management involves the patient-centered care provided by the Pharmacist to optimize safe, effective and appropriate drug therapy by ensuring the proper selection, procurement, storage, order, transcription, Preparation, dispensation, administration of the drug and monitoring of the drug utilization and effect; ww. Medicine refers to a drug in their appropriate dosage forms, with assured quality, safety and efficacy for humans or animals, or both; xx. Medical Representative/Professional Service Representative refers to one who represents any duly authorized manufacturer, distributor, trader, and Wholesaler of pharmaceutical products and whose primary duty is to promote their products to duly-licensed health professionals; yy. Non-traditional Outlet refers to entities licensed by appropriate government agencies to dispense over-the-counter medicines based on an approved list; zz. Online Pharmacy Service refers to the pharmaceutical service of a duly licensed pharmaceutical outlet done over the internet: aaa. Over-the-counter (OTC) Medicine refers to a medicine used for symptomatic relief of minor ailments and which may be dispensed without a prescription; bbb. Patient Medication Counselling refers to a one-on-one interaction between a pharmacist and a patient, client or a caregiver to provide appropriate, understandable and relevant information about the medications prescribed and/or dispensed; ccc. Patient Medication Profile refers to a comprehensive summary of all medications taken by a patient, including prescription, over-the-counter, health supplements and food/dietary supplements; ddd. Pharmaceutical Care refers to any patient-centered, outcomes-oriented activity or intervention that requires the pharmacist to cooperate with other healthcare professionals, patients and their caregivers, and other clients in preventing, identifying and resolving any drug-related problem: ©ee, Pharmaceutical Establishment refers to an entity licensed by appropriate Government agencies, which is involved in the manufacture, importation, exportation, repacking, and distribution of pharmaceutical products to pharmaceutical outlets; ff Pharmaceutical Manufacturer/Drug Manufacturer refers to an establishment engaged in any or all operations involved in the production of pharmaceutical products including the preparation, processing, compounding, formulating, filling, packaging, repackaging, altering. oramenting, finishing and labeling, preparatory to their storage, sale, or distribution, except the compounding and filling of prescriptions’ in pharmaceutical outlets;IRR OF A.A. NO, 10918 (PHILIPPINE PHARMACY ACT) ggg hhh il. kkk, Pharmaceutical Marketing refers to any activity undertaken, organized, or sponsored by a pharmaceutical establishment or outlet which is directed at promoting its product; Pharmaceutical Outlet refers to an entity licensed by appropriate government agencies, which is involved in compounding and/or dispensing and selling of pharmaceutical products directly to patients or end-users. This includes institutional pharmacy, Retail Outlet for Non-Prescription Drugs (RONPD), pharmacy/drugstore/farmaciabotica and hospital pharmacy; Pharmaceutical Product refers to drugs, medicines, biologicals, Pharmaceutical and biopharmaceutical products/specialties, veterinary Products, veterinary biologics and veterinary medicinal products: Pharmacist refers to a health professional who has been registered and issued a valid Certificate of Registration (COR) and Professional 'dentification Card (PIC) by the PRC and Professional Regulatory Board of Pharmacy (Board); Pharmacist-only OTC Medicine refers to over-the-counter medicine Classified by appropriate government agencies that can be obtained only from a pharmacist, with mandatory pharmacist’s advice on its selection and Proper use; Pharmacy Aide refers to a person who assists the pharmacist in the different aspects of pharmacy operation based on established standard Operating procedures and processes, with very minimal degree of independence or decision-making and without direct interaction with patients; mmm. Pharmacy Assistant refers to a person who assists the pharmacist in Ann. 000. Ppp. gaq, rer. sss. ttt different aspects of pharmacy operation based on established standard Operating procedures and processes, with a minimum degree of independence or decision making and may have supervised interaction with patients; Pharmacy Technician refers to a person who assists in compounding and dispensing of medicines in community, hospital, institutional and industrial settings or engaged jin other activities under the supervision of the pharmacist as described in Section 39, Article IV of the Act; Philippine Practice Standards for Pharmacists refers to the established national framework for quality standards and guidelines on the practice of pharmacy that responds to the needs of the people and which requires that the pharmacists’ services provide optimal and evidence-based care. This Standards shall be formulated by the IAPO and approved by the Board: Physician's Sample refers to the medicine given to health professionals for promotional purposes only; Prescription Book refers to the patient medication profile which can be sither electronic or hard copy wherein the dispensed prescription drugs, among others, are recorded; Prescription/Ethical Medicine refers to a medicine which can only be dispensed by a pharmacist to a patient, upon the presentation of a valid Prescription from a physician, dentist, or veterinarian and for which a pharmacist's advice is necessary; Refilling of a Prescription refers to the act of dispensing the remaining balance of medicines ordered in the prescription; Referral refers to the process wherein the pharmacist provides consuttative services, conducts preliminary assessment of symptoms and refers the Patient to a physician or other healthcare professional; \'AR OF FAN. 10918 (PHILIPPINE PHARMACY ACT) uuu. Referral Registry refers to the record book maintained by pharmacists, listing the patients referred to different health facilities for further diagnosis; ww. Refresher Program refers to a prescribed study program of an accredited school of pharmacy or organization of colleges of pharmacy; www. Regulatory Service refers to the service provided by the pharmacist to ensure the compliance of pharmaceutical products to specifications, Policies, standards or laws; xxx, Retail Outlet for Non-prescription Drugs (RONPD) otherwise known as Non-traditional outlet, refers to a pharmaceutical outlet, such as, @ supermarket, convenience store and other similar retail establishment authorized to sell only identified Over-the-Counter (OTC) and household remedy products directly to the general public on a retail basis; Yyy. Sub-professional Service refers to the service provided by a person handling pharmaceutical products other than the pharmacists, such as but Not limited to pharmacy owners, medical representatives, pharmacy technicians, pharmacy assistants and pharmacy aides: and 222. Telepharmacy Service refers to a pharmaceutical service of a duly licensed pharmaceutical outlet done through the use of telephone, teleconferencing or facsimile. RULE II Section 1. There is hereby created a Professional Regulatory Board of Pharmacy, called the Board, under the administrative control and supervision of the PRC, to be composed of a Chairperson and two (2) members, who shall be appointed by the President of the Philippines from a list of three (3) recommendees for each position ranked in the order of preference and submitted by the PRC from a list of five (6) Nominees submitted for each position by the IAPO of pharmacists. Section 2. Qualifications of the Chairperson and Members of the Board, — ‘The Chairperson and Members of the Board, at the time of nomination, must: a. Be citizens of the Philippines and residents thereof for icy oF ©. Have been in the active practice of pharmacy for the Gd. Have not been convicted of a crime e. Be members ing of the IAPO for at least five (5) years, but not) "officers or mstous nereor, and 1 Neither be, at the time of appointment, members of the faculty or administrative officers of any school, college or university offering degree Programs in pharmacy nor have any direct or indirect pecuniary interest or Connection in any review center or similar institution; Assessment and evaluation of nominees for the Board shall be based on the rubric to \ be provided by the Board, in consultation with [APO. 10IRR OF A. A. NO. 10918 (PHILIPPINE PHARMACY ACT) Section 3. ~ The Board shall exercise the following powers, functions, and responsibilities: a. Administer ii : b. , administrative orders and issuances necessary to carry out the provisions of the Act; a ir ic inations d. Prepare, adopt, issue or i is of the jission on Higher Education (CHED); e, Recommend h. Adopt measures that may be deemed proper for the enhancement of the profession and/or the maintenance of high professional, academic, ethical and technical standards in the practice; i. Conduct ocular inspection of pharmaceutical establishments, outlets and higher educational institutions (HEIs), in coordination with concerned jovernment agencies; rescribe the Pharmacists’ C Technical Pharmacy Profession, in coordination with the k. Represent the pharmacy profession in i related to pharmaceutical products and the pri |. Investigate cases arising from violations of the Act, the rules and regulations promulgated pursuant thereto, the Pharmacists’ Code of Ethics, Code of Technical Standards and Guidelines for the Professional Practice of the Pharmacy Profession, and other Board issuances; issue summons, subpoena ad testificandum and subpoena duces tecum to secure the attendance of witnesses or production of documents, or both, and other evidence necessary for such investigation or hearing; and render decision thereon which shall, unless appealed to the PRC, become final and executory after fifteen (15) days from receipt of notice of judgment or decision: m. Delegate the hearing or i i fore the WEEE except where the issue or n involves the practice of the pistes m L hich case, the hearing stall bel presied over by at least one PRC; n, Conduct, through the », Summary proceedings on ‘summary jud become final and exe judgment or decision: ©. Issue and promulgate guidelines on CPD, in coordination with the IAPO and \ Guly recognized association of schools and colleges of pharmacy; © \ uuIRR OF R.A. NO. 10918 (PHILIPPINE PHARMACY ACT) p. Recommend the 's for and istants, pharmacy aides and other rd shai Z 1€ ac ordination with the |APO d government agencies; q Boards of Pharmacy based on the it shall est r. Perform and discharge suct sponsibilities, 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. Section 4. Term of Office of the Members of the Boar: Tt jon and Members of the Board shall hold office for a cities OHR care of appointment or until their successors shall have been qualified and appointed. They may be reappointed he same office for another term of in Provided, that no Member of the Board shall s: Provided further, an appointee to a vacancy shall serve . The Chairperson and Members of the Board shall take their oaths of office before a dul Section 5. Compensation and Allowances of the Board. - The Chairperson and Members of the Board shall receive compensation and allowances comparable to the compensation and allowances received by the members of the other existing Professional regulatory boards under the PRC, as provided for in the General Appropriations Act. nds for Suspension/Removal from Office erson or The President of the Philippines may, upon recommendation of the PRC and after due process, suspend or remove the Chairperson or any Member of the Board, on any of the following grounds: 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 its results, or both, and in the disclosure of classified and confidential information pertaining to the licensure examination; ¢. Conviction of an offense involving moral turpitude by a court of competent jurisdiction; and Gd. Unprofessional, unethical, immoral or dishonorable conduct. 4 The PRC, in the conduct of investigation, shall be guided by Sections 7 and 15 of R. A. No, 8981, the existing rules on administrative investigation, and the Rules of Court. \ 2IRR OF A.A NO. 10918 (PHILIPPINE PHARMACY ACT) Section 7. of its Records, Secretariat anc es. — All records of the Board pertaining to the applications for examinations, administrative and other investigative hearings conducted by the Board shall be under the custody of the PRC. The PRC shall designate a Secretary who shall provide the Board with Secretariat and other support services to implement the provisions of the Act. RULE sh Section 1. Licensure Examination Requirement. — Unless exempted therefrom, all applicants for registration for the practice of pharmacy shall be required to pass a licensure examination, as provided for in the Act and Section 7 (d) of R. A. No. 8981 Section 2. Qualifications for the Licensure Examination. — An applicant for the Pharmacists Licensure Examination shall establish to the satisfaction of the Board that the following qualifications are met: 2. A citizen ofthe Philippines or ofa foreign country which has a law or policy on reciprocity for the practi macy profession; b. Of ©. A graduate of Bachelor of Science in Pharmacy or its equivalent degree that is approved by CHED and cont HEI in the Philippines or an institution of learning in G. Has completed an intemship program approved by the Board, pursuant to such guidelines as may hereinafter be promulgated, in consultation with the Guly recognized association of pharmacy schools and colleges and the CHED; An applicant for the Pharmacists Licensure Examination shall submit the following documentary requirements to support his/her application: Original and ph Philippine Siaiics Autnoriyissued Ceniicate iginal and photocopy of the iage jaracter issu any of the following: e os Bp ea - Certified true copy of the Transcript of Records in B. S. Pharmacy or its equivalent degree conferred by an HE! in the Philippines or an institution of learning in a foreign country duly recognized by the CHED; f i f ly signed by the dean/ pr i 9. Such ot rents as may be reasonably r 13 5 ‘IRAOF A. A.NO. 10918 (PHILIPPINE PHARMACY ACT) Section 3. Scope of Examination. — The Pharmacists’ Licensure Examination shall cover the following subjects on Pharmacy Science and Practice: 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. The subjects listed above shall be categorized into two (2) major areas, namely. Pharmacy Science and Practice. The Board, subject to the approval of the PRC, may introduce relevant changes in the subject areas, format and content of the examination, as well as in the relative weight attributed to each examination subject, as the need arises, and in consultation with the Guly recognized association of pharmacy schools and the CHED. Section 4. Holding of Examination. — The Pharmacists’ Licensure Examination shall be given two times (2x) a year in such places and dates, as the PRC may designate in the Resolution providing for the master schedule of all licensure examinations, pursuant to Section 7 (d) of R. A. No. 8981 Section 5. Ratings in the Licensure Examination. — be a pharmacist, a candidat i ral weighted wih ro arg ower han My parent GOS) Many he supe = An applicant who fails the licensure examination for the allowed to take the ition, without having undertaken a refres program in a duly accredit duly recognized organization of schools and colleges of pharmacy. An applicant who fails three times (83) in the licensure examinations and desires to take the examination again must comply with the following requirements: @. He/she must have satisfactorily completed a refresher program offered by the Pharmacy degree or its equivalent; b. In the event that the school or university from where he/she obtained such degree does not offer a refresher program, the applicant shall be allowed to oR fided; andIRA OF A.A NO. 10018 (PHILIPPINE PHARMACY ACT) The refresher program shall be conducted for a period of not less than one (1) year, with particular focus on the subjects prescribed in Section 15 of the Act The examinee shall be required to comply with the refresher requirement after every three (3) unsuccessful attempts to the Pharmacists Licensure Examination. Section 6. Report of Rating. ~ The Board shall submit to the PRC the ratings obtained by each examinee within three (3) working days after the last day of the examination, unless extended for just cause. Upon the release of the results of the examination, the PRC shall send by mail the rating obtained by each examinee at the Given address using the mailing envelope submitted during the examination, Section7. Oath of Profession. - All successful examinees in the licensure examination shall take their oath of profession before any member of the Board, officer of the PRC or any person authorized by law to administer oaths, prior to entering the practice of the pharmacy profession. Section 8. Issuance of Certificate of Registration (COR) and Professional Identification Card (PIC). - A COR as a pharmacist shall be issued to those who Passed the licensure examination, subject to compliance with the registration requirements and payment of the prescribed fees. The COR shall bear the registration number, date of issuance, with the signatures of the Chairperson of the PRC and the Chairperson and Members of the Board, and stamped with the official seals of the PRC and of the Board, certifying that the person named therein is entitled to practice the Profession, with all the privileges appurtenant thereto. This COR shall remain in full force and effect until suspended or revoked in accordance with the Act. APIC bearing the registration number and dates of its issuance and expiry, duly signed by the Chairperson of the PRC, shall likewise be issued to every registrant, upon Payment of the prescribed fees. The PIC shall be renewed every three (3) years, upon presentation of the Certificate of Good Standing (COGS) from the IAPO and proof of completion of the CPD requirements following existing guidelines. Section 9. Foreign Reciprocity. ~ Unless the country or state of which the foreign Pharmacist is a citizen or subject specifically permits Filipino pharmacists to practice within its territorial limits on the same basis as the subjects or citizens of said foreign country or state under reciprocity and international agreements, no foreigner shall be admitted to the licensure examination, given a COR to practice pharmacy nor be entitled to any of the privileges under the Act. “A foreign citizen, whether he/she studied in the Philippines or not, who desires to take the Pharmacists Licensure Examination through re ity shall establish nce of- letter ite official of his/her cout ir ir 15 ] ee \IRR OF R.A NO. roa1e (PHLIPPINE PHARMACY ACT) his/her country or state of international treaty, agreement or covenant to which his/her country or state is a signato country or state on terms o' including the higher learning duly recognized the Government of the Republic of the Philippines, attaching/appending thereto an authenticated copy of said law, treaty, agreement or covenant officially translated in the English language, if applicable. If the letter/document and the copy of the law or treaty, agreement or covenant submitted by the applicant is satisfactory to the Board, the foreign applicant shall be allowed t ists Licensure Examinati file an application to tab ing the following documents that shall accom, a, if au of lowing the applicant to enter and reside in the Philippines; b. Copy, eee 2"! for photocopying of pertinent informat r cuments must also be certified by CHED to be equivalent to the pharmacy courses accredited/recognized in the Phil a J Section 10. Practice through Special / Temporary Permit (STP). — The practice of pharmacy in the Philippines shall be limited to natural persons only and shall be governed by the provisions of R. A. No. 8981 and other issuances pertinent thereto: Provided, that any foreign citizen who has gained entry in the Philippines to perform Professional services within the scope of the practice of pharmacy, including. the following: (a) as projects (b) bei cy, before assuming such duties, d from the Board and the PRC, under the following secure an STP responsibilities, conditions: a. The is is expert in a field vision of Tvice which is pert; and Section 11. Grounds for Non-registration. - The Board shall not register any ‘successful examinee who has been: 16 3 \ { fe \JAR OF R.A, NO. 10918 (PHILIPPINE PHARMACY acT) @. Convicted of an offense involving moral turpitude by a court of competent jurisdiction; b. Summarily adjudged by the Board as guilty of misrepresentation or falsification of documents in connection with the application for examination or for violation of the General Instructions to Examinees; ¢. Found guilty of immoral or dishonorable conduct by the Board: 4. Medically proven by a medical or drug testing facility accredited by the government to be addicted to any drug or alcohol such that it could render him/her incompetent to practice the profession; and ©. Declared of unsound mind by a court of competent jurisdiction In refusing such registration, the Board shall give a written statement setting forth the reasons therefor and shall file a copy thereof in its records. Should ground (d) be proven to be no longer existent, the Board shall issue a Board Resolution allowing the issuance of such COR Section 12. Reissuance of Revoked Certificate of Registration, Replacement of Lost or Damaged Certificate of Registration, Professional Identification Card or Special/Temporary Permit. — The Board may, upon petition, reinstate or reissue a revoked COR after the expiration of two (2) years from date of its revocation. The Board may, in its discretion, require the applicant to take another licensure examination, The petitioner shall prove to the Board that there is a valid reason for such reinstatement. For the grant of the petition, the Board shall issue a Board Resolution, to be approved by the PRC. A duplicate copy, which is a certified true copy of the COR, may also be secured from the PRC for display in Category B establishments/outlets where the pharmacist is employed or hired. Replacement of lost or damaged COR, PIC or STP may be issued, in accordance with the pertinent rules that shall be issued thereon. SSUURTION RULE IV Section 1. Vested Rights and Automatic Registration. ~ All pharmacists registered before the effectivity of the Act shall automatically be registered hereunder, subject to compliance as to future requirements. gt The CORS, PICs or STPs held by such persons in good standing shall have the same \ force and effect, as though they were issued on or afer the effectivity of the Act. Section 2. Affixing RPh after a Registered Pharm: e. — Only a registered and licensed pharmacist shall have the GHEE cae, the title _ “Registered Pharmacist’ or “RPh”. Any other pharmacy specialty title shall be > recognized if granted by an international certifying body or by the Board. X v\IRR OF R.A. NO. 10918 (PHILIPPINE PHARMACY AcT) Section 3. ‘ation of Informatis harmacist shall be indicate the DEIR anc VERE IGREERMES ons sree Raa Pertinent documents refer to legal documents submitted to nt agencies in the application of permits and licenses relative tothe practice of armacy All other documents relative to the practice of pharmacy must be signed by the pharmacist-in-charge to include the pharmacist's name, registration number and its validity for purposes of accountability and traceability, For this purpose, the pharmacist-in-charge is the pharmacist whose name appears in t Section 4. Registry of Pharmacists. — The Board and the PRC shall prepare and maintain a registry of the names, residences or office addresses, or both, status of registration and area of practice of all pharmacists. This registry shall be updated annually, in coordination with the |APO. It is the necessary be prescribe Other than the registry of egistration status which shall be made available to the public upon hall of the professional, subject to the pro thereon. Section 5. Display of Certificate of Registration. - It shall be the duty of every pharmacist engaged in th in private or under the employ of another, to i drug/pharmaceutical establishment and/or outlet in aaa as pce employed in a professional capacity as pharmacist. For this purpose, prominent and conspicuous place means an area within the office premi employed can be easily seen by upon entry to ti establishment. g laws and policies of the When employed in establishments under Category B, as defined in Section 31 of the Act, the dupli ich is a certified true copy obtained from the: x No pharmacist shall knowingly allow his/her COR to i in a drug/pharmaceutical establishment and/or outlet where qaeralanen eae 3 18IRR OF A.A. NO. 10918 (PHILIPPINE PHARMACY acT) The original COR of all pharmacists employ) securely by the employer for the In no case shall the em pharmacist upon Section 6. Dispensing/Sale of Pharmaceutical Products. No pharmaceutical Product, of whatever nature and kind, shall be compounded, dispensed, sold or resold, eaten se be made available tothe consuming public, except through a rotall drug a. IRE eeeREs shat be dispensed only with a valid prescription of a Physician, dentist, or veterinarian, Dispensing of pharmaceutical or drug Products for veterinary use should be in accordance with the prescribed guidelines of the FDA. b. Prescription drugs and pharmacist-only OTC medicines shall be dispensed only by a pharmacist, except in where the services of a pharmacist are not available. In which case, a may dispense the medicine: Provided, that a report shall be to the supervisi i at produ Shall be done, in accordance with appropriate guidelines, such as but not limited to the Philippine Practice Standards for Pharmacists ani pharmacist shall refuse to compound, dispense or sell drugs and pharmaceutical products, if not in eas of practice shall be ki . Appropriate medication review and patient medication selling at the time of dispensing of medicines should be provided to patients or caregivers, which should include information on indication, proper use, precautions, amo e. importers, distributors, and wholesalers of Pharmaceutical products are authorized to sell their products only to duly the FDA shall compound, available any Prescription medicines or pharmacist-only OTC medicines, of whatever nature and kind, to the patient and/or caregiver. Retailing by duly licensed drug retailers to hospital pharmacies or institutional pharmacies may be allowed in cases of valid emergency purchases following such guidelines as may be issued by the regulatory agencies. Section 7. Pharmacist Requirement. - Establishments/outlets which are required to employ and/or retain and maintain the professional services of a pharmacist shall be classified as follows: 19JAR OF A.A.NO. 10918 (PHILIPPINE PHARMACY ACT) A. B. harmaceutical establishments/outlets where the of a pharmacist is required due to the nature of the pharmaceutical product that will be dispensed or the kind of service that will be provided. hall have direct and immediate control and supervisi blishmenvoutlet in order to dispense whether in- store or online.’ allowed. Included under this Category are the following: sellin available to the consuming public d as drugs according to primary intended mode of action, pharmacist-only OTC medicines, 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 prescription/ethical medicines, pharmacist-only OTC medicines, OTC medicines and combination products (medical device and drugs) classified as drugs according to the primary intended mode of action; 3 ti S, pharmaceutical manufacturing laboratories, ts 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 theray _ government, city, associations involved in the procurement ution, dispensing and storage of pharmaceutical products; that dispense prescription drugs and pharmacist-only 3 and 'er_establishments/outlets as may be identified by the FDA, in coordination with the Board and the PRC. Categor utical establishments/outlets where the supervision and t is required under pertinent provisions of the law. Included under this Category are the following: 1 selling household remedies and OTC medicines as di tiated from the pharmacist-only OTC medicines; 2, roviding medicines solely to employees of their respective companies or the employees’ qualified Gependents or both; or members of a duly registered organization or institution; 3. fifth (5") i its invol distribution, dispensing, and storage of ical products; 4. instutons proving slephamacy secs; 20IRR OF A. A. NO. 10918 (PHILIPPINE PHARMACY ACT) pharmaceutical products: Provided, th ’andling of medications used in clinic procedures. shall include but not be limited to ry, n and n. Such health facilities shall comply 8 issued by the FDA; and 7. Other establishments/outlets as may be identified by the FDA, in coordination with the Board and the PRC. The following rules on the oversight role and functions of pharmacists must be strictly complied with: 1. The st ist_must be physicall in the estabishmentutlet fora minimum of wo (@) hours gece 2. The location of each let which the pharmacist supervises must be (LGU) within each region. However, in the case of the National Capital single unit; Region (NCR), it shall be considered as a 3. The distance between the two farthest establishments/outlets supervised by a single pharmacist must ; All other establishments/outlets supervised 4. A pharmacist shall be allowed to supervise & maximum of fifteen (15) ESahnen waa: and 5. The supervising pharmacist shall likewise comply with the other relevant requirements as may be prescribed by the Board, in coordination with the FDA. Due considerations shall however be given to geographically isolated and disadvantaged areas (GIDA) as may be determined by the DOH. A pharmacist working in a be allowed to essively rende rec estabiist wultaneous work mi a pharmacist can be employed in multiple establishments/outlets: Provided, that there is A pharmacist supervise a maximum of The FDA, in coordination with the Board, and the approval of the PRC, may add to, delete, reclassify, or modify the above list of establishments/outlets, as the need arises, in order to keep pace with developments in the pharmacy practice. All units or sub-units of establishments/outlets, institutions, and regulatory bodies, whether government or private, with functions and activities that are exclusive for pharmacists, as defined in Section 4 (a), (b), (c), (d) and (i) of the Act, shall be headed and managed by a qualified pharmacist: Provided, that an appointment in. the government service shall comply with the provisions of other pertinent laws. 2 3 4IRROF A. A, NO. 10918 (PHILIPPINE PHARMACY ACT) Procurement, storage, distribution, or dispensing of any pharmaceutical product in the national government and local government units shall be made only under the supervision of a pharmacist. The licensing of LGUs involved in the manufacture, importation, exportation, procurement, storage, distribution or dispensing or otherwise making available any pharmaceutical product to the consuming public shall be implemented through such guidelines as may be prescribed by FDA. Section 8. . — To ensure the quality of pharmaceutical products, the following standards or requirements shall be observed: a. It shall be the duty of a pharmacist of a pharmaceutical establishment/outlet, especi: to ensure that all pharmaceutical products conform to the Act and other pertinent rules and regulations and issuances. it shal the responsibility of the pharmacist to po ay aero event ase ih ‘medication use such as medication errors, a rug reactions, product d iefects, counterfeit medications based on guidelines set by the FDA. b. MAHs shall ensure that all drug products comply, and continually comply with the standards of safety, efficacy, and quality prescribed by the FDA from "elstaten up to postmarting Likewise, all licensed pharmaceutical establishments and outlets shall comply with the applicable standards of good practices as he Iso have the responsibility to including s. ¢. In cases of pharmaceutical products sold in their original package, the seal of which has the liability that may arise because of their quality and purity rests upon the manufacturer or importer, the distributor, representative, or dealer, who is responsible for their distribution or sale. d pharmaceu outlets st responsible for non-conformance with the standards of safety, quality, and efficacy, as. provided for in the Act and other pertinent rules and regulations and issuances. It shall be Stakeholders (i.e. manufacturing, regulatory, distribution, retail) shall exert all efforts to ensure the safety, efficacy and quality of pharmaceuticals. Strategies aimed at medication safety shall be implemented. These include prevention of medication errors = for high-alert medications and sound-alike, look-alike drugs. 2IRR OF A. A.NO. 10918 (PHILIPPINE PHARMACY ACT) Section 9. 5 All Preseripions and pharmacist-only OTC medicines shall be mpounded and dispensed only by a Pharmacist, in accordance with the Philippine Practice Standards for Pharmacists, Good Dispensing Guidelines as adopted and promulgated by the Board, and other standards Pertaining to purity, safety, and quality prescribed by the FDA. Filling of prescription dr assistant or pharmacy technician shall be | The pharmacist shall be @ccountable for the dispensing of the prescription and patient medication counseling, to be filled shoul . Clarificatio tent of rescription must be duty to ensure patient medication safety. Completely filled prescriptions should be st purpura, Batention Period for completely filled prescriptions shal riod Partial filling of prescriptions less than the indicated in the prescription shall be allowed. subject to dispensing nee Provided above. It is the responsiblity of the pharmacist dispensing the last quantity completing the prescription to keep the prescription according to the proper prescription recording guidelines. Prugstores/pharmacies/boticas and hospital pharmacies engaged in compounding Practices are required to comply with the standards of Good Compounding Practices and other requirements of the FDA. Prescription medicines it be dispensed only by a pharmacist and only upon a valid Section 10. Physician's Sample. ~ Pharmaceutical products intended to be to any manufa 'aceutical outlet or the consumin, The statement or its equivalent shall appear conspicuously in or in the on each labelling material of the drug or combination of products (medical device and drug) classified ag dug according to the primary intended mode of action. in addition, the FDA ‘eavlrements for labeling materials of physician's sample shall apply to all drug Produets. It shall be unlawful to remove, erase, deface or mark the original labels of X samples. \ 23IRA OF A. A, NO. 10918 (PHILIPPINE PHARMACY ACT) Pharmaceutical products classified as s and other classifications of medi may be prescribed by ei shal en ordeteted a ican aries Upon effectivity of this IRR, all MAHs shall cease production of aie les of antimicrobials, including anti-TB medicines, and for this purpose, the f these drugs. Appropriate exhaustion period for remaining stocks of samples shall be granted following the guidelines of FDA. Section 11. i fl |. — Pharmacists shall not compound or disper lions, recipes, or formulas which are written in ciphers, codes, or secret keys or prescriptions of pharmaceutical products with unusual names which differ from those in standard pharmacopeias or formularies. These cases shall be The pharmacist ensing or compounding prescriptions shall Mase medicine called for in the prescription with any other drug, substance, or ingredient as preserved by FDA wih t prior consultation with and the written consent pune”: scribing. , and other pertinent laws and regulations. Section 12. ESRI Epapsee es ona Upon every bottle, box, or package of medicines compounded or dispensed by a pharmacist, based on the prescription, there shall be pasted, affixed, or imprinted a seal or label bearing, among others, the name of patient and generic name of drug, brand name, if any, strength, expiry date, directions for use; and name and address of pharmacy, name of the doctor, the dispensing pharmacist, and other requirements prescribed in the Philippine Practice Standards for Pharmacists and Good Dispensing Guidelines, R. A. No. 9502, its IRR and such other guidelines and regulations that may be promulgated by the Board, Auxiliary labels containing special pharmacists’ instructions for the patient shall be required for drugs with labels shou! Exceptions to the requirement on | made during include those which are and other Section 13. Recording of Patient Medeaton Profi = All prescriptions dispensed in the pharmacy shall be fan appropriate recording system (ic., electronic or ‘ manual); indicating the following: a. Name of prescriber; b. Name and address of patient; 3 c. Product name (generic and brand name, if any); S\IRA OF A.A.NO. 10918 (PHILIPPINE PHARMACY ACT) Dosage strength and form; Quantity of drug dispensed; Date dispensed; Batch no. of the drug dispensed; Initials of pharmacist; and Other information as may be required rzeso@e The Patient Medication Profile and the fullysilied prescriptions shall be open for inspection by the representative/s of the Board or the FDA, or both, ecak ean amanis 0. and must be kept for a period All required informat drugs dispensed by a pharmacy sh recorded in the by nces. For any partially-filled prescriptions, these shall be appropriately noted in the Patient ran equivalent recording system. \dertaken by the pharmaceutical outlets shall be for i by the recorded in the when the is open, and must be kept for a aso eae Section 14. R The opening of a retail pharmaceutical o shall be subject to requirements provided for in the Act and the rules and regulations prescribed by the FDA. All outlets are required to display in a conspicuous space within their premises the following information: a. pharmacy operating hours; b. schedule and name of the pharmacist on duty; and ©. name of the drugstore owner (natural or juridical person). ‘The applications for the opening and operation of a retail drug outlet or other similar business establishments shall not be approved, unless applied for by a Filipino pharmacist, either as owner or as pharmacist-in-charge, pursuant to the provisions of the Act. Offering of — telepharmacy and ~~ online services._—of_~—«FDAvlicensed drugstores/pharmacies/boticas and hospital pharmacies, RONPDs, and institutional pharmacies are allowed, subject to the rules and regulations of FDA. 25IRR OF R.A, NO. 10916 (PHILIPPINE PHARMACY ACT) Section 15. Handling of Pharmaceutical Products by Persons Other Than a Pharmacist. — For the purpose of this Section, persons handling pharmaceutical products other than the pharmacist, w rs who are non- sonnel working as p , persons who assist phat other person p shall be d 9 idelines issued by the Board. No person all be allowed to render such services without undergoing a comprehensive standardized training program pursuant to PRC guidelines. except graduates of a pharmacy degree program: Provided, that the latter shall still undergo assessment and certification. The following are deemed to be handling pharmaceutical products, and who, as such, are required to undergo training program as provided for under this Section: a. = They are responsible for selecting, ordering, delivery, receipt, arranging, display and storage of Pharmaceutical products. Owners are required to attend FDA licensing seminars; b — They are responsible for the to professional healthcare providers of relevant health product information; Pharmacy Technicians who work under pharmacist supervision — They are responsible for the following tasks: monitoring of the supply/inventory of pharmaceutical products; handling and control of pharmaceutical products; arrangements of the display of pharmaceutical products; observance of Good Laboratory Practices; preparation of the product label; compounding of formulations and dispensing of both OTC medicines and prescription pharmaceutical products; demonstration of product knowledge on medicines; ‘conduct of health promotion education; vigilance, observance and adherence to Good Manufacturing Practices; and exercise of supervision over pharmacy assistants and pharmacy aides; d. who works under the supervision of the pharmacist — They are responsible for the following tasks: performing general InUSEHEEpIDD: monitoring of the supply/inventory of phan ical products; handling and control of pharmaceutical products: CEDURE STSSTS of pharmaceutical products; observance of Good Laboratory Practices; assisting in the p and capsules, pharmaceutical products this IRR; demonstration of fices; e. SAEIMERMALER no works under the supervision of the p shelves and warehouse; filing of documents on orders, deliveries, sales; and other tasks as may be assigned by the pharmacist; and - SsIRR OF A. A. NO. 10918 (PHILIPPINE PHARMACY ACT) f. All other persons handling pharmaceutical products as may be determined by the Board, in coordination with other government agencies. Section 16. Administration of Adult Vaccines. - A pharmacist shall be allowed to administer adult vaccine: Provided, that the following conditions have been met: a. He/she is a pharmacist, with valid COR and current PIC; b. The vaccine to be administered is an adult vaccine which is covered by a valid registration issued by the FDA; ¢. He/she has undergone the prior training on the safe administration of adult vaccines and management of AEFI for pharmacists and hold a certificate of training issued by an institution duly accredited by the PRC; d. He/she shall ensure that the vaccine to be administered shall have a doctor's prescription, which is not more than seven (7) days old; e. He/she shall submit a monthly vaccination report and AEFI report to DOH regional offices using the prescribed form; and f. If vaccination is conducted in a pharmaceutical outlet: 1. It should have a valid LTO issued by the FDA; 2. Its vaccine products should have valid Certificates of Product Registration (CPR) issued by the FDA; 3. It should maintain Patient Medication Profile/Record; 4. It should have Standard Operating Procedures (SOPs) for vaccine storage, handling, preparation, dispensing, administration, and disposal; 5. It should have a procedure for monitoring, handling and reporting of AEFI; and 6. It should comply with other requirements as may be prescribed by the FDA or DOH Section 17. Disposal of Medications and other Pharmacy Documents with Patient Protected Health Information (PHI). ~ The pharmacist shall have the responsibility to oversee disposal of expired or damaged pharmaceutical products. It is likewise the pharmacist’s responsibility to coordinate with the supplier or manufacturer for the return of expired or damaged pharmaceutical products per company policy as well as the timely retrieval, and/or proper disposal of pharmaceutical wastes, unused and expired pharmaceutical products in accordance with the provisions set by the DOH and the Department of Environment and Natural Resources (DENR). Disposal of prescriptions and other pharmacy documents with patient protected health information (PHI) that includes the patient name and other identifiers must be done under the supervision of a pharmacist with utmost security to protect the patient's privacy and confidentiality. Disposal under this Section shall include the implementation of data privacy measures on digital prescription and pharmacy data. Disposal of expired physician's samples shall be the responsibility of the supplier/distributor who provided the sample. a \ y \ x . QIRROF A.A, NO. 10918 (PHILIPPINE PHARMACY ACT) Section 18. Returns of Medications from Clients/Patients. — Medication returns shall be in accordance with the existing laws and regulations of the Department of Trade and Industry (DT!) and other regulatory agencies: Provided, that patient safety shall at all times be of paramount consideration. To ensure quality and integrity of medications for all patients, drugs with special storage requirements, those not in their original packaging, or with tampered seal and ‘compounded products shall not be accepted for return: RULE V INTEGRATED AND ACCREDITED PROFESSIONAL ORGANIZATION Section 1. The Integrated and Accredited Professional Organization (IAPO) of the Pharmacists. - The Pharmacy profession shall be integrated into one (1) national organization that is registered with the Securities and Exchange Commission (SEC), and which shall be recognized by the Board and the PRC as the one and only integrated and acoredited professional organization of pharmacists. A pharmacist duly registered with the Board shall automatically become a member of the IAPO of pharmacists and shall receive the benefits appurtenant thereto upon payment of the required fees and dues. Membership in the IAPO shall not prevent membership in other associations of pharmacists. Section 2. Membership to the Integrated and Accredited Professional Organization. - All pharmacists must be members of the IAPO and must maintain active membership by paying their annual member fees throughout the duration of the practice of the profession. The PIC shall not be renewed if the requirements for membership with the IAPO, including credit units for attendance to duly accredited Continuing Professional Development (CPD) programs, pursuant to the CPD guidelines, are not met. Pharmacy support personnel working as pharmacy technicians, pharmacy assistants, and pharmacy aides must be registered as affiliate members of IAPO. They must maintain membership throughout the duration of their employment. No membership fees shall be collected by the IAPO for pharmacy support personnel. Section 3. Specialty Boards in Various Areas of Pharmacy Practice. ~ Specialty Boards in various areas of pharmacy practice shall be created, subject to the accreditation by the Board and the PRC The Board shall issue guidelines on the accreditation of specialty boards in various areas of pharmacy practice, which shall include the standards of practice within different specialties, qualifications, and requirements for the certification of practitioners under each specialty, 28IRR OF R.A. NO. 10918 (PHILIPPINE PHARMACY ACT) RULE VI VIOLATIONS, ADMINISTRATIVE SANCTIONS, AND PROCEDURES Section 1. Violations and Administrative Sanctions. The Board shall have the power, upon notice and hearing, to revoke or suspend the COR of a pharmacist or the STP of a foreign pharmacist on any of the following grounds: @. Violation of any provision of the Act, its IRR, the Pharmacists’ Code of Ethics, Code of Technical Standards for the Pharmacists, Philippine Practice Standards for Pharmacists (PhilPSP), Code of Good Governance, and all other guidelines, policies and regulatory measures of the Board and/or the PRC relating to the practice of the pharmacy profession; b. Conviction of an offense involving moral turpitude by a court of competent jurisdiction; c. Unprofessionalism, immorality, malpractice, incompetence, gross negligence, or imprudence in the practice of the profession; G. Fraud or deceit in the acquisition of the COR, PIC or STP or renewal thereof; €. Allowing the COR to be used or displayed in establishments where the pharmacist is not actually employed and practicing, whether on a part-time or full time basis; 1. Addiction to alcoholic beverages or to any habit-forming drug rendering a pharmacist incompetent to practice the profession; 9. Aiding or abetting the illegal practice of pharmacy; h. Insanity or any mental disorder that would render the person incompetent to practice pharmacy, as determined by a competent medical professional; i. False, extravagant, or unethical advertisements, endorsement, and promotion of pharmaceutical products, pharmaceutical outlets and establishments where the pharmacists name or the pharmacist’s professional organization and similar information, or both, are used; Manufacture, sale, offering for sale of counterfeit, spurious, substandard, falsified pharmaceutical products and committing other acts in violation of R.A. No, 8203, otherwise known as the “Special Law on Counterfeit Drugs”; k. Illegal manufacture, sale, possession, dispensing of dangerous drugs and other acts in violation of R. A. No. 9165, and other applicable laws and issuances; |. Committing acts in violation of Section 6 of Presidential Decree (P. D.) No. 881, entitled, "Empowering the Secretary of Health to Regulate the Labeling, Sale and Distribution of Hazardous Substances” and Sections 11 and 29-A of R.A. No, 3720, as amended R. A. No. 9711; m. Practicing pharmacy with a suspended or revoked COR, or with an expired PIC; n, Unauthorized dispensing of pharmaceutical products through unregistered online services or direct selling businesses, in accordance with the guidelines issued by FDA and Board; and ©. Being found guilty of immoral, unprofessional or dishonorable conduct by the Board. The existing PRC Rules on Administrative Investigation shall govern the hearing or investigation of cases, subject to the applicable provisions of R. A. No. 8981, the Act, and the Rules of Court. 29 aN 2IRROF A. A. NO. 10918 (PHILIPPINE PHARMACY ACT) RULE VII PENAL PROVISIONS Section 1. Violations and Penalties. - Any person who shall commit any of the following acts shall, upon conviction, be sentenced to pay a fine of not less than Two Hundred Fifty Thousand Pesos (Php250,000.00), but not exceeding Five Hundred Thousand Pesos (Php500,000.00) or imprisonment of not less than one (1) year and one (1) day but not more than six (6) years, or both, at the discretion of the court: @. Commission of any act in violation of Sections 30 and 31 of the Act; b. Allowing the display of one's COR in a pharmaceutical establishment where the pharmacist is not employed and practicing; c. Displaying of the pharmacist's COR by pharmacy owners/operators in a pharmaceutical establishment where the pharmacist is not employed and/or practicing; 4. Dispensing or allowing the dispensing or offering for sale of prescription drugs or pharmaceutical products in a place not licensed by FDA as a pharmaceutical outlet; e. Dispensing of prescription and pharmacist-only OTC pharmaceutical products by a person other than those under the direct and immediate supervision of a pharmacist; f. Allowing the dispensing of prescription and pharmacist-only OTC Pharmaceutical products, without the direct and immediate supervision of a pharmacist; g. Compounding and dispensing not in accordance with current Good Manufacturing Practice, Good Laboratory Practice and Philippine Practice Standards for pharmacists (PhiIPSP), and such other standards and guidelines issued by the Board; h. Selling of prescription and pharmacist-only OTC drugs by manufacturers, importers, and wholesalers to unlicensed pharmaceutical outlets and other establishments; i. Substituting prescription drugs which are not generically equivalent to what was on the prescription, without the consent of the prescriber or not in accordance with R. A. No. 6675, any amendment thereto, and other relevant L issuances; j. Forcing, coercing or intimidating a pharmacist to compound or dispense medical and pharmaceutical products in violation of the provisions of the Act, an this IRR, and other relevant laws, rules and regulations: k. Preparing and compounding of pharmaceutical products in quantities greatly in excess of single therapeutic doses, without the presence and supervision of a pharmacist; |. Noncompliance with the labelling requirements for dispensed medicines by a pharmaceutical outlet as provided for by law and current guidelines: m. Manufacturing, selling, importing, and exporting of pharmaceutical products under fraudulent name or address, or both; n. Adulterating and misbranding of pharmaceutical products, and/or causing the commission of the said acts; ©. Manufacturing, selling, importing, exporting, or making available in commerce unsafe, substandard and counterfeit pharmaceutical products; p. Operating an unlicensed pharmaceutical outlet such as online pharmacy \ an service or direct selling not authorized by the FDA; 30IRR OF A.A. NO. 10918 (PHILIPPINE PHARMACY ACT) g. Operating a Category A establishmentioutlet which opens for business without a pharmacist; r. Operating a Category B establishment/outlet, without the required supervision and oversight of a pharmacist; 8. Practicing pharmacy without a valid license or with an expired, suspended or revoked license; t. Filling and refilling of prescription and pharmacist-only OTC pharmaceutical products by person other than a pharmacist or without his/her direct and immediate supervision; u. Dispensing prescription drugs and pharmacists-only OTC drugs by rural health units, and other national and local government units, agencies, and facilities, as well as by other private institutions and establishments, without the required supervision of a pharmacist; and v. Other acts/omissions analogous to the foregoing RULE VIII OTHER PENALTIES Section 1. Other Violations and Penalties. — Any person who shall commit any of the following acts shall, upon conviction, be sentenced to pay a fine of not less than One Hundred Thousand Pesos (Php100,000.00), but not exceeding Two Hundred Thousand Pesos (Php200,000.00) or imprisonment of not less than thirty (30) days but not more than one (1) year, or both, at the discretion of the court: a. Affixing of the title “RPh” by a person who is not a pharmacist; b. Practicing the pharmacy profession in the Philippines without a valid COR, PIC or STP; c. Non-indication by a pharmacist of his/her COR and professional tax receipt (PTR) numbers in official documents requiring such information; Gd. Refusal to display the COR of the pharmacist in a prominent and conspicuous place in tne establishment and outlet where the pharmacist is employed and practicing; ©. Non-compliance by a pharmacist with the requirements on the filling of prescription; f, Non-compliance by a pharmacist on the requirements for partially-filled prescription; g. Selling of physicians’ samples; h. Distribution as physicians’ samples of antimicrobials, including anti-TB drugs and other product classification; i. Removal, erasure, non-labelling or marking and alteration of mark or label of physician's sample; j. Use of cipher, codes or secret keys or unusual names or terms in prescriptions; k. Filling or partial filling of prescriptions where cipher, codes, secret keys or unusual names and terms are used; |. Non-compliance with labelling requirements for dispensed medicines; m. Non-compliance with the requirements on the keeping of records or record books by a pharmaceutical outlet; 1. Employment of personnel in a pharmacy or pharmaceutical operation without the required relevant training and certification; 31 Ve \ > x XIRR OF A.A.NO. 10918 (PHILIPPINE PHARMACY ACT) ©. Refusal of a non-pharmacist owner/operator of a pharmaceutical outlet to undergo the required and relevant training and certification; p. Refusal by the owner/operator, general manager, supervisor, and other heads of units of government and of private establishments, to allow and require pharmacists and pharmacy support personnel to undergo training and certification; g. Rendering dispensing-related services by non-pharmacists in a pharmaceutical outlet without undergoing the required training and certification; . Dispensing pharmaceutical products in medical missions without the direct and immediate supervision of a pharmacist; s. Non-compliance with the required training and certification of medical tepreseniatives/professional service representatives, pharmacy technicians, pharmacy assistants, pharmacy aides, pharmacy clerks, and other medicine handlers of pharmaceutical products. Both the —_- medical representatives/professional service representatives, pharmacy technicians, pharmacy assistants, pharmacy aides, pharmacy clerks, or medicine handlers and the owners/proprietors, and responsible officers and employees of pharmaceutical establishment/outlet employing any such individual shall be held jointly liable; and t. Violation of any provision of the Act and this IRR other than those aforementioned. Any person, other than the citizens of the Philippines, having been found guilty of any violation as provided for in this Section and the preceding Section shall, after having paid the imposed fine or having served the sentence, or both, when so adjudged, shall also be subject to immediate deportation The penalties and liabilities herein provided shall be without prejudice to other sanctions that may be imposed for violation of other applicable laws, policies, rules and regulations. The owner/operator of the pharmaceutical establishments/outlets, as well as the other officers responsible for the violation, and the pharmacists/pharmacy support personnel are jointly liable for the wilful violation of any provision of the Act. RULE IX FINAL PROVISIONS Section 1. Enforcement. ~ It shall be the primary duty of the Board and the PRC to effectively enforce the provisions of the Act and this IRR. All duly constituted law enforcement agencies and officers of the national, provincial, city or municipal government or of any political subdivision thereof shall comply and ensure the effective enforcement thereof Section 2. Appropriations. — The Chairperson of the PRC shall immediately include in its programs the implementation of the Act, the funding of which shall be charged against their current year’s appropriations and thereafter, in the annual General Appropriations Act 32 ve \IRR OF R.A NO. toate (PHIUPPINE PHARMACY ACT] Section 3. Transitory Provisions. — The incumbent Chairperson and Members of the Board shall, in an interim capacity, continue to function as such, until the Chairperson and Members of the new Board created under the Act shall have been appointed and qualified Section 4, Separability Clause. — If for any reason, any part or provision of this IRR shall be held or declared to be unconstitutional or invalid, such declaration shall not affect, invalidate or impair the other parts or provisions hereof which are otherwise valid and effective Section 5. Repealing Clause. — All administrative issuances or parts thereof which are contrary to or inconsistent with the provisions of this IRR are hereby repealed, amended or modified accordingly. Section 6, Amendments. - This IRR may be amended, modified or supplemented when necessary for the effective implementation or enforcement of the Act. Section 7. Effectivity. - This IRR shall take effect fifteen (15) days after its publication in the Official Gazette or in the newspaper of general circulation. Let a copy hereof be further furnished the U. P. Law Center, DOH, FDA, Philippine Pharmacists Association (PPhA), and other relevant associations/organizations for information. Done this _21st__day of Feb. 2017 in the City of Manila. | a, MILDRED B. OLIVEROS Member Attested by: ep, ho bet. LOVELIKA T. BAUTISTA OIC, Office of the Secretary of the Professional Regulatory Boards 33IRROF A.A. NO. 10918 (PHILIPPINE PRARMACY ACT) Approved by: LC Lo TEOFILO S. PILANDO, JR. Chairman ANGELINE T. CHUA CHIACO Commissioner ‘Commissioher ©-C}'0-ComMCOMMI/PRB-PHAD-LQL/O-SPRE TSPIATCCYDRIACRIERIILTE, VATE OF PUBLIGATIUN IN. HE OFICIAL GazeTTE ; S-1S-{7 NATE OF EFeectivity: £-3d-\] 34