Philippine Pharmacy Act PDF
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Our Lady of Fatima University
2015
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Summary
The document is the Philippine Pharmacy Act, also known as Republic Act No. 10918, enacted in 2015. This act regulates and modernizes the practice of pharmacy in the Philippines. It details the scope of pharmacy practice, objectives, and definitions relating to pharmaceutical products and pharmacists.
Full Transcript
1987 CONSTITUTION OF THE REPUBLIC OF THE PHILIPPINES PREAMBLE We, the sovereign Filipino people, imploring the aid of Almighty God, in order to build a just and humane society, and establish a Government that shall embody our ideals and aspirations, promote...
1987 CONSTITUTION OF THE REPUBLIC OF THE PHILIPPINES PREAMBLE We, the sovereign Filipino people, imploring the aid of Almighty God, in order to build a just and humane society, and establish a Government that shall embody our ideals and aspirations, promote the common good, conserve and develop our patrimony, and secure to ourselves and our posterity, the blessings of independence and democracy under the rule of law and a regime of truth, justice, freedom, love, equality, and peace, do ordain and promulgate this Constitution. Philippine Pharmacy Act (c) Supervision, control, and regulation of the practice of pharmacy in the Philippines; Sixteenth Congress Third Regular Session (d) Development and enhancement of professional competence of pharmacists through continuing professional development, research, and other related Begun and held in Metro Manila, on Monday, the activities; and twenty-seventh day of July, two thousand fifteen. (e) Integration of the pharmacy profession. REPUBLIC ACT No. 10918 Section 4. Scope of the Practice of Pharmacy. - A An Act Regulating and Modernizing the Practice person is deemed to be practicing pharmacy, within of Pharmacy in the Philippines, Repealing for the the meaning of this Act, when with or without a fee, Purpose Republic Act Numbered Five Thousand salary, percentage or other rewards, paid or given Nine Hundred Twenty-One (R.A. No. 5921), directly or indirectly, shall: Otherwise Known as the Pharmacy Law (a) Prepare, compound or manufacture, preserve, Be it enacted by the Senate and House of store, distribute, procure, sell, or dispense, or both, Representatives of the Philippine Congress any pharmaceutical product or its raw materials; or Assembled: (b) Render services, such as clinical pharmacy Article I services, drug information services, regulatory General Provisions services, pharmaceutical marketing, medication management, or whenever the expertise and technical Section 1. Title. - This Act shall be known as the knowledge of the pharmacist is required; or "Philippine Pharmacy Act". (c) Engage in teaching scientific, technical, or Section 2. Statement of Policy. - The State recognizes professional pharmacy courses in a school or college the vital role of pharmacists in the delivery of quality of pharmacy; or health care services through the provision of safe, effective, and quality pharmaceutical products, (d) Dispense pharmaceutical products in situations pharmaceutical care, drug information, patient where supervision of dispensing of pharmaceutical medication counseling, and health promotion. The products is required; or pharmacists’ professional services shall, therefore, be promoted as an indispensable component of the total (e) Chemical, biological or microbiological analyses health care system to ensure the physical well-being and assay of pharmaceutical products, food/dietary of the Filipinos. supplements, health supplements, and cosmetics; or Hence, the State shall develop and nurture competent, (f) Physico-chemical analyses for medical devices productive, morally upright, and well-rounded used in aid of administration of pharmaceutical pharmacists whose standards of professional practice products; or and service shall be excellent and globally competitive through regulatory measures, programs, and activities that promote and sustain their (g) Administration of adult vaccines as approved by continuing professional development. the Food and Drug Administration (FDA): Provided, That they shall undergo the training on the safe administration of adult vaccines and management of Section 3. Objectives. - This Act provides for and adverse event following immunization (AEFI) for shall govern the: pharmacists and hold a certificate of training issued by an institution duly accredited by the Professional (a) Standardization and regulation of pharmacy Regulation Commission (PRC); Provided, further, education; That the safe administration of vaccines be part of the higher education curriculum for pharmacists; or (b) Administration of licensure examination, registration, and licensing of pharmacists; (h) Conduct or undertake scientific research in all aspects involving pharmaceutical products and health care; or Republic Act No. 9711, known as the "Food and Drug (i) Provide other services where pharmaceutical Administration Act of 2009"; knowledge is required. (d) Biopharmaceuticals refer to pharmaceutical Activities under paragraphs (a), (b), (c), (d) and (i) are products that are used for therapeutic or for in vivo exclusive to licensed pharmacists. However, nothing diagnostic purposes, such as vaccines, sera, and drugs herein shall be construed as requiring other persons derived from life forms using biotechnology. These carrying out only the activities under paragraphs (e), include proteins, nucleic acids, or living (f), (g) and (h) to be licensed pharmacists, subject to microorganisms where the virulence is reduced and any qualification that is imposed by other laws with are used for therapeutic or for in vivo diagnostic respect to such particular activity. purposes; All pharmacists are expected to abide by current (e) Brand name refers to the proprietary name given standards such as the Philippine Practice Standards for by the manufacturer to distinguish its product from Pharmacists, Good Laboratory Practice, Good those of competitors; Distribution Practice, Good Manufacturing Practice and Good Clinical Practice, which are deemed vital in (f) Cipher, Code, or Secret Key refers to a method of the performance of their roles and functions in secret writing or use of characteristic style or symbol different practice areas. by substituting other letter/s or character/s for the letter/s intended, for the purpose of misleading the The Professional Regulatory Board of Pharmacy, consumer; hereinafter created, subject to the approval of the PRC, as provided for by Republic Act No. 8981, (g) Compounding refers to the sum of processes otherwise known as the "PRC Modernization Act of performed by a pharmacist in drug preparation 2000", and in consultation with the integrated and including the calculations, mixing, assembling, accredited professional organization (APO), may packaging, or labeling of a drug: (i) as the result of a modify the above-enumerated acts, services, or prescription or drug order by a physician, dentist, or activities, as the need arises, in order to conform to the veterinarian; or (ii) for the purpose of, or in relation latest trends and developments in the practice of the to, research, teaching, or chemical analysis; pharmacy profession: Provided, That such modifications are consistent with the enumeration (h) Continuing professional development (CPD) refers above. to the inculcation of advanced knowledge, skills, and ethical values in a post-licensure specialized or in an Section 5. Definition of Terms. - As used in this Act: inter- or multidisciplinary field of study for assimilation into professional practice, self-directed (a) Accredited professional organization (APO) refers research, and/or lifelong learning; to the duly integrated and accredited professional organization of registered and licensed pharmacists, of (i) Cosmetics refer to a substance or preparation which there shall be only one (1), as prescribed under intended to be placed in contact with the various Section 41, Article V of this Act; external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view (b) Adult vaccines refer to cervical cancer, flu exclusively or mainly to cleaning them, perfuming (influenza), pneumococcal, other pre-exposure them, changing their appearance and/or correcting prophylactic vaccines to be administered to patients body odor, and/or protecting the body or keeping them aged eighteen (18) years and above, and such other in good condition, as defined under Republic Act No. vaccines as may be defined by the Department of 9711; Health (DOH) in an administrative issuance; (j) Counterfeit pharmaceutical products refer to (c) Adulterated/Deteriorated pharmaceutical products pharmaceutical products which do not contain the refer to pharmaceutical products unfit for human amounts as claimed; with wrong ingredients; without consumption, following the standards of quality or active ingredients; or with insufficient quantity of purity of which, are as those stated in the United active ingredients, which result in the reduction of the States Pharmacopeia/National Formulary and products’ safety, efficacy, quality, strength, or purity. Philippine Pharmacopeia in its latest edition or any These also refer to products that are deliberately and standard reference for drugs and medicines which are fraudulently mislabeled with respect to identity and/or given official recognition as well as those provided for source or with fake packaging, and can apply to both in Republic Act No. 3720, otherwise known as the branded and generic products, including the "Food, Drug, and Cosmetic Act", as amended, and following: (3) Any article, other than food, intended to affect the (1) The pharmaceutical product itself or the container structure or any function of the human body or or labeling thereof or any part of such product, animals; container, or labeling, bearing without authorization; the trademark, trade name, or other identification (4) Any article intended for use, as a component of marks or imprints or any likeness to that which is articles, specified in clauses (1), (2) and (3), not owned or registered in the Intellectual Property Office including devices or their components, parts and (IPO) in the name of another natural or juridical accessories; and person; (5) Herbal or traditional drugs as defined in Republic (2) A pharmaceutical product refilled in containers Act No. 9502; bearing legitimate labels or marks, without authority; and (n) Emergency cases refer to life-threatening situations where a patient needs immediate medical (3) A pharmaceutical product which contains no attention and treatment, including the occurrence of amount of or a different active ingredient; or less than epidemic or natural calamities; eighty percent (80%) of the active ingredient it purports to possess, as distinguished from an (o) Expiration date refers to the end date when the adulterated drug including reduction or loss of manufacturer can guarantee that a product possesses efficacy due to expiration; its claimed potency, efficacy, quality, and safety; after which its sale or distribution is prohibited; (k) Dangerous drugs refer to those listed in the: (1) Schedules annexed to the 1961 Single Convention on (p) Filling refers to the act of dispensing or providing Narcotic Drugs, as amended by the 1972 Protocol; (2) medicines in accordance with a prescription or Schedules annexed to the 1971 Single Convention on medication order; Psychotropic Substances; and (3) Annex of Republic Act No. 9165, otherwise known as the "Comprehensive Dangerous Drugs Act of 2002", and (q) Food/Dietary supplements refer to processed food its amendments; products intended to supplement the diet that bears or contains one (1) or more of the following dietary ingredients: vitamins, minerals, herbs, or other (l) Dispensing refers to the sum of processes botanicals, amino acids, and dietary substances to performed by a pharmacist from reading, validating, increase the total daily intake in amounts conforming and interpreting prescriptions; preparing; packaging; to the latest Philippine-recommended energy and labeling; record keeping; dose calculations; and nutrient intakes or internationally agreed minimum counseling or giving information, in relation to the daily requirements. It usually is in the form of sale or transfer of pharmaceutical products, with or capsules, tablets, liquids, gels, powders, or pills and without a prescription or medication order; not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs (m) Drugs refer to pharmaceutical products that and medicines, as defined under Republic Act No. pertain to chemical compounds or biological 9711; substances, other than food, intended for use in the treatment, prevention, or diagnosis of disease in (r) Generic name refers to the scientifically and humans or animals, including the following: internationally recognized name of the active ingredients, as approved by the FDA pursuant to (1) Any article recognized in the official United States Republic Act No. 6675, otherwise known as the Pharmacopeia/National Formulary, Homeopathic "Generics Act of 1988"; Pharmacopeia of the United States of America, Philippine Pharmacopeia, Philippine National Drug (s) Health supplement refers to any product that is Formulary, British Pharmacopoeia, European used to maintain, enhance and improve the healthy Pharmacopoeia, Japanese Pharmacopoeia, and any function of the human body and contains one (1) or official compendium or any supplement to them; more or a combination of the following: (1) herbal fatty adds, enzymes, probiotics, and other bioactive (2) Any article intended for use in diagnosis, cure, substances; and (2) substances derived from natural mitigation, treatment, or prevention of disease of man sources, induding animal, plant, mineral, and or animals; botanical materials in the form of extracts, isolates, concentrates, metabolites, synthetic sources of substances mentioned in (1) and (2). It is presented in dosage forms or in small unit doses such as capsules, and relief operations which is conducted during tablets, powder, liquids and it shall not include any emergency situations such as calamity, war, or natural sterile preparations (i.e. injectibles, eyedrops); and man-made disasters; (t) Household remedies refer to any preparation (aa) Medicines refer to drugs in their appropriate containing pharmaceutical substances of common or dosage forms, with assured quality, safety and efficacy ordinary use to relieve common physical ailments and for humans or animals, or both; which may be dispensed without a medical prescription in original packages, bottles or (bb) Medical representative or professional service containers, of which the nomenclature has been duly representative refers to one who represents any duly approved by the FDA; authorized manufacturer, distributor, trader, and wholesaler of pharmaceutical products and whose (u) Institutional pharmacies refer to pharmacies of primary duty is to promote their products to duly institutions, organizations, and/or corporations that licensed health professionals; provide a range of pharmaceutical services, given exclusively to the employees and/or their qualified (cc) Nontraditional outlets refer to entities licensed by dependents; appropriate government agencies to dispense over-the-counter medicines based on an approved list; (v) Internship program refers to a supervised practical experience that is required to be completed for (dd) Online pharmacy services refer to pharmaceutical licensure as a registered pharmacist; services of a duly licensed pharmaceutical outlet done over the internet; (w) Label refers to a display of written, printed, or graphic matter on the immediate container of any (ee) Over-the-counter (OTC) medicines refer to article; medicines used for symptomatic relief of minor ailments and which may be dispensed without a (x) Labeling materials refer to all labels and other prescription; written, printed, or graphic matter: (1) upon any item or any of its containers or wrappers; or (2) (ff) Pharmaceutical establishments refer to entities accompanying any such item; licensed by appropriate government agencies, and which are involved in the manufacture, importation, (y) Medical device refers to any instrument, apparatus, exportation, repacking, and distribution of implement, machine, appliance, implant, in vitro pharmaceutical products to pharmaceutical outlets; reagent or calibrator, software, material or other similar or related article intended by the manufacturer (gg) Pharmaceutical manufacturers refer to to be used alone, or in combination, for human beings, establishments engaged in any or all operations for one (1) or more of the specific purposes of: involved in the production of pharmaceutical products diagnosis, prevention, monitoring, treatment, or including the preparation, processing, compounding, alleviation of disease; diagnosis, monitoring, formulating, filling, packaging, repackaging, altering, treatment, or alleviation of or compensation for an ornamenting, finishing and labeling, preparatory to injury; investigation, replacement, modification or their storage, sale, or distribution, except the support of the anatomy of a physiological process; compounding and filling of prescriptions in supporting or sustaining life; preventing infection; pharmaceutical outlets; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of (hh) Pharmaceutical marketing refers to any activity specimens derived from the human body. This device undertaken, organized, or sponsored by a does not achieve its primary intended action in or on pharmaceutical establishment or outlet which is the human body by pharmacological, immunological, directed at promoting its product; or metabolic means, but which may be assisted in its intended function by such means, as defined under (ii) Pharmaceutical outlets refer to entities licensed by Republic Act No. 9711; appropriate government agencies, and which are involved in compounding and/or dispensing and (z) Medical mission refers to an activity conducted on selling of pharmaceutical products directly to patients normal circumstances of an individual or a group of or end-users; health care practitioners to provide health services outside the hospital, clinic, and health care facility (jj) Pharmaceutical products refer to drugs, medicines, premises as differentiated from humanitarian missions biologicals, pharmaceutical and biopharmaceutical products/specialties, veterinary products, veterinary biologies and veterinary medicinal products; (tt) Referral refers to the process wherein a pharmacist provides consultative services and conducts (kk) Pharmacist refers to a health professional who preliminary assessment of symptoms and refers the has been registered and issued a valid Certificate of patient to a physician or other health care Registration (COR) and Professional Identification professional; Card (PIC) by the PRC and the Professional Regulatory Board of Pharmacy; (uu) Referral registry refers to the record book maintained by pharmacists, listing the patients (ll) Pharmacist-only OTC medicines refer to referred to different health facilities for further over-the-counter medicines classified by appropriate diagnosis; government agencies to be obtained only from a licensed pharmacist, with mandatory pharmacist’s (vv) Refresher program refers to a prescribed study advice on their selection and proper use; program in an accredited school of pharmacy; and (mm) Pharmacy aides refer to persons who assist the (ww) Telepharmacy services refer to pharmaceutical pharmacists in the different aspects of pharmacy services of a duly licensed pharmaceutical outlet done operation based on established standard operating through the use of telephone, teleconferencing, or procedures and processes, with very minimal degree facsimile. of independence or decision making and without direct interaction with patients: Article II The Professional Regulatory Board of Pharmacy (nn) Pharmacy assistants refer to persons who assist the pharmacists in different aspects of pharmacy operation based on established standard operating Section 6. Creation of the Professional Regulatory procedures and processes, with a minimum degree of Board of Pharmacy. - There is hereby created a independence or decision making and may have Professional Regulatory Board of Pharmacy, supervised interaction with patients; hereinafter called the Board, under the administrative control and supervision of the PRC, to be composed (oo) Pharmacy technicians refer to persons who assist of a Chairperson and two (2) members, to be in compounding and dispensing of medicines in appointed by the President of the Philippines from a community, hospital, institutional and industrial list of three (3) recommendees for each position settings or engaged in other activities under the ranked in the order of preference and submitted by the supervision of the pharmacist as described in Section 39, Article IV of this Act; PRC from a list of five (5) nominees submitted for each position by the duly integrated APO of (pp) Philippine Practice Standards for Pharmacists pharmacists. refer to the established national framework for quality standards and guidelines of the practice of pharmacy Section 7. Qualifications of the Chairperson and that respond to the needs of the people who require Members of the Board. - The Chairperson and the pharmacists’ services to provide optimal, members of the Board, at the time of nomination, evidence-based care as formulated by the integrated must: APO and approved by the Professional Regulatory Board of Pharmacy; (a) Be a citizen of the Philippines and a resident for at least five (5) years; (qq) Physician’s samples refer to medicines given to health professionals for promotional purposes only; (b) Be a duly registered and licensed pharmacist in the Philippines, preferably a holder of a masteral degree (rr) Prescription/Ethical medicines refer to medicines which can only be dispensed by a pharmacist to a in Pharmacy, or its equivalent; patient, upon the presentation of a valid prescription from a physician, dentist, or veterinarian and for (c) Have been in the active practice of pharmacy for which a pharmacist’s advice is necessary; the past ten (10) years; (ss) Refilling of a prescription refers to the act of (d) Have not been convicted of a crime involving dispensing the remaining balance of medicines moral turpitude; ordered in the prescription; (e) Be a member in good standing of the APO for at (g) Promulgate and prescribe the Pharmacists’ Code least five (5) years, but not an officer or trustee of Ethics, Code of Technical Standards and Guidelines thereof; and for the Professional Practice of the Pharmacy Profession, in coordination with the APO; (f) At the time of appointment, must neither be a member of the faculty nor an administrative officer of (h) Represent the pharmacy profession in all fora any school, college or university offering degree involving concerns and issues related to programs in pharmacy nor has any direct or indirect pharmaceutical products and the practice of pecuniary interest or connection in any review center pharmacy; or similar institution. (i) Investigate cases arising from violations of this Section 8. Powers, Functions, and Responsibilities of Act, the rules and regulations promulgated pursuant the Board. - The Board shall exercise the following thereto, the Pharmacists’ Code of Ethics, Code of powers, functions, and responsibilities: Technical Standards and Guidelines for the Professional Practice of the Pharmacy Profession, and (a) Administer and implement the provisions of this other Board issuances; issue summons, subpoena ad Act; testificandum and subpoena duces tecum to secure the attendance of witnesses or production of documents, (b) Promulgate rules and regulations, administrative or both, and other evidence necessary for such orders, and issuances necessary to carry out the investigation or hearing; and render decision thereon provisions of this Act; which shall, unless appealed to the PRC, become final and executory after fifteen (15) days from receipt of (c) Prepare licensure examination questions, score, notice of judgment or decision; and rate the examinations and submit the results thereof to the PRC. The Board shall prepare, adopt, (j) Delegate the he aring or investigation of issue, or amend the syllabi or tables of specifications administrative cases filed before the Board, except of the subjects in the licensure examination, in where the issue or question involves the practice of consultation with the academe and the Commission on the profession, in which case, the hearing shall be Higher Education (CHED); presided over by at least one (1) member of the Board, to be assisted by a Legal or Hearing Officer of the (d) Recommend the issuance, suspension, revocation, PRC; or reinstatement of the COR, PIC or Special/Temporary Permits (STP) for the practice of (k) Conduct, through the Legal Officers of the PRC, pharmacy; summary proceedings on minor violations of this Act, the General Instruction to the Examinees, including (e) Administer oaths in accordance with the the implementing rules and regulations issued by the provisions of this Act; Board, and to render summary judgment thereon which shall, unless appealed to the PRC, become final (f) Regulate and monitor the practice of pharmacy in and executory after fifteen (15) days from receipt of the Philippines, including the practice of notice of judgment or decision; subprofessional services such as pharmacy technicians, pharmacy assistants, aides, and other (l) Issue and promulgate guidelines on CPD, in medicine handlers, as described in this Act; adopt coordination with the APO; measures that may be deemed proper for the enhancement of the profession and the maintenance of (m) Recommend the accreditation of the standardized high professional, academic, ethical, and technical training programs for and certifications of medical standards; and conduct ocular inspection of representatives or professional service representatives, pharmaceutical establishments and higher education pharmacy technicians, pharmacy assistants, pharmacy institutions (HEIs), in coordination with concerned aides and other medicine handlers covered in Section government agencies; 39, Article IV of this Act. The Board shall promulgate the criteria and guidelines in the accreditation of training programs and certifications as described above, in coordination with the APO and with other confidential information pertaining to the licensure concerned government agencies; examination; (n) Accredit Specialty Boards of Pharmacy based on (c) Conviction of an offense involving moral turpitude the criteria that it shall establish and prescribe; and by a court of competent jurisdiction; and (o) Perform and discharge such other functions and (d) Unprofessional, unethical, immoral, or responsibilities, as may be deemed implied, dishonorable conduct. incidental, and necessary, to preserve the integrity of the pharmacy licensure examination and to enhance The PRC, in the conduct of investigation, shall be and upgrade the practice of the pharmacy profession guided by Sections 7 and 15 of Republic Act No. in the country. 8981, the existing rules on administrative Section 9. Term of Office of the Members of the investigation, and the Rules of Court. Board. - The Chairperson and members of the Board shall hold office for a term of three (3) years from the Section 12. Custodian of its Records, Secretariat and date of appointment or until their successors shall Support Services. - All records of the Board, have been qualified and appointed. They may be pertaining to the applications for examinations, reappointed in the same office for another term of administrative and other investigative hearings three (3) years immediately after the expiry of their conducted by the Board, shall be under the custody of term; Provided, That no member of the Board shall the PRC. The PRC shall designate a Secretary who hold office for more than two (2) terms or not more shall provide the Board with secretariat and other than six (6) years; Provided, further, That the first support services to implement the provisions of this Board appointed under this Act shall hold these terms Act. cf office: the Chairperson for three (3) years, the first member for two (2) years, and the second member for Article III one (1) year; Provided, finally, That an appointee to a Examination, Registration, and Licensure vacancy shall serve only the unexpired portion of the term of office. The Chairperson and members of the Section 13. Licensure Examination Requirement. - Board shall duly take their oath of office before a duly Unless exempted therefrom, all applicants for authorized officer. registration for the practice of pharmacy shall be required to pass a licensure examination, as provided Section 10. Compensation and Allowances of the for in this Act and Section 7(d) of Republic Act No. Board. - The Chairperson and members of the Board 8981. shall receive compensation and allowances comparable to the compensation and allowances Section 14. Qualifications for the Licensure received by the members of the other existing Examination. - An applicant for the Pharmacists’ professional regulatory boards under the PRC, as Licensure Examination shall establish to the provided for in the General Appropriations Act. satisfaction of the Board that the following qualifications are met: Section 11. Grounds for Suspension or Removal from Office of the Chairperson or Member of the Board. - (a) A citizen of the Philippines or of a foreign country The President of the Philippines may, upon which has a law or policy on reciprocity for the recommendation of the PRC and after due process, practice of the pharmacy profession; suspend or remove the Chairperson or any member of the Board on any of the following grounds: (b) Of good moral character and reputation; (a) Gross neglect, incompetence, or dishonesty in the (c) A degree holder of Bachelor of Science in discharge of duty; Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of learning in a (b) Involvement in the manipulation, tampering, or foreign country duly recognized by the CHED; and rigging of the licensure examination, its questions or results, or both, and in the disclosure of classified and (d) Has completed an internship program approved by candidate within three (3) working days after the last the Board, pursuant to such guidelines as may day of the examination, unless extended for just hereinafter be promulgated, in consultation with the cause.Upon the release of the results of the duly recognized associations of pharmacy schools and examination, the PRC shall send by mail the rating the CHED. obtained by each examinee at the given address using the mailing envelope submitted during the Section 15. Scope of Examination. - The Pharmacists’ examination. Licensure Examination shall cover the following subjects on Pharmacy Science and Practice, Inorganic Section 19. Oath of Profession. - All successful Pharmaceutical Chemistry, Organic Pharmaceutical candidates in the licensure examination shall take Chemistry, Qualitative and Quantitative their oath of profession before any member of the Pharmaceutical Chemistry, Pharmacognosy and Plant Board, officer of the PRC, or any person authorized Chemistry, Pharmaceutical Biochemistry, by law to administer oaths, prior to entering the Microbiology and Parasitology, Physical Pharmacy, practice of the pharmacy profession. Biopharmaceutics, Pharmacology and Toxicology, Manufacturing, Quality Assurance and Section 20. Issuance of Certificate of Registration and Instrumentation, Pharmaceutical Calculations, Drug Professional Identification Card. - A COR as a Delivery Systems, Hospital Pharmacy, Clinical pharmacist shall be issued to those who passed the Pharmacy, Dispensing and Medication Counseling, licensure examination, subject to compliance with the Pharmaceutical Administration and Management, registration requirements and payment of the Public Health, Legal Pharmacy, and Ethics. prescribed fees. The COR shall bear the registration number, the date of its issuance, and the signatures of The Board, subject to the approval of the PRC, may the Chairperson of the PRC and the members of the introduce relevant changes on the subject areas, Board, stamped with the official seals of the PRC and format, and content of the examination, as well as on of the Board, certifying that the person named therein the relative weight attributed to each examination is entitled to the practice of the profession, with all the subject, as the need arises, and in consultation with privileges appurtenant thereto. This COR shall remain the duly recognized associations of pharmacy schools in full force and effect until suspended or revoked in and the CHED. accordance with this Act. Section 16. Holding of Examination. - The A PIC bearing the registration number and dates of its Pharmacists’ Licensure Examination shall be given issuance and expiry, duly signed by the Chairperson of two (2) times a year in places and dates as the PRC the PRC, shall likewise be issued to every registrant, may designate in the Resolution providing for the upon payment of the prescribed fees. The PIC shall be master schedule of all licensure examinations pursuant renewed every three (3) years, upon presentation of to Section 7(d) of Republic Act No. 8981. the Certificate of Good Standing (COGS) from the APO and proof of completion of the CPD Section 17. Ratings in the Licensure Examination. - In requirements. order to be registered and licensed as a pharmacist, a candidate must obtain a general weighted average of Section 21. Foreign Reciprocity. - Unless the country seventy-five percent (75%), with no rating lower than or state of which the foreign pharmacist is a subject or fifty percent (50%) in any of the subjects. citizen, specifically permits Filipino pharmacists to practice within its territorial limits on the same basis An applicant who failed in the licensure examination as the subjects or citizens of the said foreign country for the third (3rd) time shall not be allowed to take the or state under reciprocity and under international next succeeding examinations without having agreements, no foreigner shall be admitted to undertaken a refresher program in a duly accredited licensure examinations, given a COR to practice as institution. The Board shall issue guidelines on the pharmacist nor be entitled to any of the privileges refresher program requirement. under this Act. Section 18. Report of Rating. - The Board shall Section 22. Practice Through Special/Temporary submit to the PRC the ratings obtained by each Permit (STP). - The practice of pharmacy in the Philippines shall be limited to natural persons only In refusing the registration, the Board shall give a and shall be governed by the provisions of Republic written statement setting forth the reasons therefor and Act No. 8981 and other issuances pertinent thereto: shall file a copy thereof in its records. Should ground Provided, That any foreign citizen who has gained (d) be proven to be no longer existent, the Board shall entry in the Philippines to perform professional issue a Board Resolution allowing the issuance of services within the scope of the practice of pharmacy, such COR. including the following: (a) being a consultant in foreign-funded or assisted projects of the government; Section 24. Reissuance of Revoked Certificate of (b) being engaged or employed by a Filipino employer Registration, Replacement of Lost or Damaged or establishment; (c) providing free services in Certificate of Registration, Professional Identification humanitarian missions: and (d) being a visiting faculty Card or Special/Temporary Permit. - The Board may, member in any field or specialty in pharmacy shall, upon petition, reinstate or reissue a revoked COR after before assuming such duties, functions and the expiration of two (2) years from the date of its responsibilities, secure an STP from the Board and the revocation. The Board may, in its discretion, require PRC, under the following conditions: the applicant to take another licensure examination. The petitioner shall prove to the Board that there is a (1) The person is an internationally renowned valid reason for such reinstatement. For the grant of pharmacist or expert in a field or specialty of the petition, the Board shall issue a Board Resolution, pharmacy; to be approved by the PRC. (2) The person is engaged in the provision of a A duplicate copy of the COR for display in Category professional service which is determined to be B establishments may be issued. Replacement of lost necessary due to lack of Filipino specialist or expert; or damaged COR, PIC or STP may be issued in and accordance with the pertinent rules that shall be issued thereon. (3) The person is required to work with a Filipino counterpart, a natural person who is a registered and Article IV licensed pharmacist. Regulation of the Practice of Pharmacy Section 23. Grounds for Non-registration. - The Board Section 25. Vested Rights; Automatic Registration. - shall not register any successful examinee who has All pharmacists registered before the effectivity of this been: Act shall automatically be registered hereunder, subject to compliance as to future requirements. (a) Convicted of an offense involving moral turpitude by a court of competent jurisdiction; The CORs, PICs or STPs held by such persons in good standing shall have the same force and effect, as (b) Summarily adjudged by the Board as guilty for though they were issued on or after the effectivity of misrepresentation or falsification of documents in this Act. connection with the application for examination or for violation of the General Instructions to Examinees; Section 26. Affixing RPh After a Registered Pharmacist’s Name. - Only duly registered and (c) Found guilty of immoral or dishonorable conduct licensed pharmacists shall have the right to affix to by the Board; one’s name, the title "Registered Pharmacist" or "RPh". (d) Medically proven to be addicted to any drug or alcohol by a medical or drug testing facility accredited Section 27. Indication of Information. - A pharmacist by the government; and shall be required to indicate the serial numbers, the date of expiry of the pharmacist’s PIC and APO (e) Declared of unsound mind by a court of competent Certificate of Membership on all pertinent documents jurisdiction. signed by him/her. Section 28. Registry of Pharmacists. - The Board and Licensed manufacturers, importers, distributors, and the PRC shall prepare and maintain a registry of the wholesalers of pharmaceutical products are authorized names, residences or office addresses, or both, status to sell their products only to duly licensed of registration and area of practice of all registered pharmaceutical outlets. pharmacists, which shall be updated annually, in coordination with the APO. This registry shall be Section 31. Pharmacist Requirement. - made available to the public upon inquiry or request, Establishments/outlets which are required to employ subject to such guidelines that shall be established and/or retain and maintain the professional services of therefor. duly registered and licensed pharmacists shall be classified as follows: Section 29. Display of Certificate of Registration. - It shall be the duty of every pharmacist engaged in the (a) Category A – Pharmaceutical practice, whether in private or under the employ of establishments/outlets where the direct and immediate another, to display the original copy of one’s COR in a control and supervision of a duly registered and prominent and conspicuous place in the drug licensed pharmacist is required, per establishment, establishment in which one is employed in a whether in-store or online, including: professional capacity as pharmacist. When employed in establishments under Category B, as defined in (1) Pharmaceutical establishments/outlets selling or Section 31 of this Act, the duplicate copy of the otherwise making available to the consuming public pharmacist’s COR shall also be displayed therein. - prescription/ethical medicines, combination products No pharmacist shall knowingly allow the COR to be (medical device and drugs) classified as drugs displayed in an establishment where one is not ctually according to the primary intended mode of action, employed as a professional pharmacist. pharmacist-only OTC medicine, whether owned by the government or by a private person or firm, Section 30. Dispensing/Sale of Pharmaceutical whether sold at wholesale or retail; Products. - No pharmaceutical product, of whatever nature and kind, shall be compounded, dispensed, sold (2) Establishments involved in the manufacture, or resold, or otherwise be made available to the importation, exportation, distribution, and sale of consuming public, except through a retail drug outlet combination products (medical device and drugs) duly licensed by the FDA. classified as drugs according to the primary intended mode of action; Prescription drugs and pharmacist-only OTC medicines shall be dispensed only by a duly registered (3) Departments/Divisions/Units of pharmaceutical and licensed pharmacist, except in emergency cases, laboratories, pharmaceutical manufacturing where the services of a registered and licensed laboratories, or other establishments with processes pharmacist are not available: Provided, That a report involving the preparation, manufacture, assay, shall be made to the supervising pharmacist within regulation, product research and development, quality twenty-four (24) hours after the occurrence of the control, repacking, importation, exportation, emergency so that product recording in the distribution, sale or transfer of pharmaceutical prescription books can be done. products in quantities greatly in excess of single therapeutic doses; and Compounding and dispensing shall be done only by duly registered and licensed pharmacists, in (4) Government units, including local government, accordance with current Good Manufacturing city, first to third class municipal health units, Practice, laboratory practice, Philippine Practice nongovernment organizations and/or associations Standards for Pharmacists and dispensing guidelines. involved in the procurement, distribution, dispensing A registered and licensed pharmacist may refuse to and storage of pharmaceutical products; compound, dispense or sell drugs and pharmaceutical products, if not in accordance with this Act and the (b) Category B – Pharmaceutical abovementioned standards. establishments/outlets where the supervision and oversight of a duly registered and licensed pharmacist is required under pertinent provisions of law, shall comply with the provisions of other pertinent including: laws. (1) Retail outlets selling household remedies and OTC Section 32. Responsibility for Quality of drugs as differentiated from the pharmacist-only OTC Pharmaceutical Products. - It shall be the duty of a medicines; duly licensed and registered pharmacist of a pharmaceutical establishment and outlet to ensure that (2) Satellite institutional pharmacies providing all pharmaceutical products conform to standards of medicines solely to employees of their respective safety, quality and efficacy, as provided for in this Act companies or the employees’ qualified dependents, or and other pertinent rules and regulations and both; or members of a duly registered organization or issuances. Owners, managers, or pharmacists in institution; charge of the operation of pharmaceutical establishments and outlets shall be held jointly (3) Fourth, fifth and sixth class municipal health units responsible for nonconformance with these standards. involved in the procurement, distribution, dispensing, and storage of pharmaceutical products; It shall be unlawful for any person to manufacture, prepare, sell, or dispense any pharmaceutical product (4) Institutions providing telepharmacy services; and under a fraudulent name, or pretense or to adulterate any pharmaceutical product offered for sale. (5) Nontraditional outlets of pharmaceutical products: Provided, That no prescription medicines and In cases of pharmaceutical products sold in their pharmacist-only OTC medicines are sold. original package, the seal of which has not been broken or tampered with, the liability that may arise The FDA, in coordination with the Board, and the because of their quality and purity rests upon the approval of the PRC, may add to, delete, reclassify, or manufacturer or importer, the distributor, modify the above list of establishments, as the need representative, or dealer who is responsible for their arises, in order to keep pace with the developments in distribution or sale. the pharmacy practice. Section 33. Filling and Partial Filling of Prescription. - A pharmacist working in a Category A establishment All prescriptions and pharmacist-only OTC medicines may be allowed to simultaneously work or render shall be filled, compounded and dispensed only by a pharmacy services in Category B establishments, the registered and licensed pharmacist, in accordance with maximum number of hours of which shall be the Philippine Practice Standards for Pharmacists, determined, in accordance with such guidelines as Dispensing Guidelines and other standards pertaining may be established therefor by the Board, in to purity, safety and quality. Completely filled coordination with the FDA, and other agencies, prescriptions should be surrendered to the pharmacist establishments, institutions, and regulatory bodies. for recording. Procurement, storage, distribution, or dispensing of Partial filling of prescription less than the total any pharmaceutical product in the national quantity indicated in the prescription shall be allowed, government and local government units shall be made subject to dispensing guidelines as provided in the only under the supervision of a duly registered and immediately preceding paragraph. It is the licensed pharmacist. responsibility of the pharmacist dispensing the last quantity completing the prescription to keep the All units or sub-units of establishments, institutions, prescription according to proper prescription and regulatory bodies whether government or private recording guidelines. with functions and activities that are exclusive for pharmacists, as defined in Section 4, paragraphs (a), Prescription medicines may be dispensed only by a (b), (c), (d) and (i), shall be headed and managed by a duly registered and licensed pharmacist and only with qualified duly registered and licensed pharmacist: a valid prescription of a physician, dentist, or Provided, That an appointment in government service veterinarian. Section 34. Physician’s Sample. - Pharmaceutical regulations and such other guidelines that may be products given or intended to be given free to any promulgated by the Board. Auxiliary labels containing health professional by a manufacturer or distributor or special pharmacists" instructions for the patient shall its professional service representative as part of its be required as prescribed for dangerous drugs, program or promotion shall not be sold to any external-use-only drugs, drugs with special storage pharmaceutical outlet or the consuming public. and administration instructions and such other drugs as may be required by law. The statement "Sample, Not for Sale", or its equivalent, shall appear conspicuously on the primary Section 37. Recording of Patient Medication Profile. - and secondary packaging of the drug or combination All prescriptions dispensed in the pharmacy shall be products (medical device and drug) classified as drug recorded in an appropriate recording system indicating according to the primary intended mode of action to therein, among other things, the name and address of be given. It shall be unlawful to remove, erase, deface the patient, name of prescribes generic name and or mark the original labels of samples. brand, dosage strength, quantity of drug and initials of pharmacist. It shall be open for inspection by the Pharmaceutical products classified as antimicrobials, representatives of the Board or the FDA, or both, at including anti-TB medicines and other classifications any time of the day, when the pharmacy is open, and of medicines, as may be prescribed by the FDA, shall must be kept for a period of not less than two (2) years not be given or distributed as physician’s samples. after the last entry. Section 35. Prohibition Against the Use of Cipher, All required information on dangerous drugs Codes, or Unusual Terms in Prescriptions and dispensed by a pharmacy shall be recorded in the Prescription Substitution. - Pharmacists shall not Dangerous Drugs Book or an equivalent recording compound or dispense prescriptions, recipes, or system as required by Republic Act No. 9165 and formulas which are written in ciphers, codes or secret other applicable laws and issuances. keys or prescriptions of pharmaceutical products with unusual names which differ from those in standard All referrals such as tuberculosis patients undertaken pharmacopeias or formularies. by the pharmaceutical outlets shall be recorded in the Referral Registry and shall be open for inspection by The pharmacist dispensing or compounding the Board, or representative of the Department of prescriptions shall not substitute the medicine called Health (DOH) or the FDA, or both, at any time of the for in the prescription with any other drug, substance day when the pharmacy is open, and must be kept for or ingredient, without prior consultation with, and a period of not less than two (2) years after the last written consent of the person prescribing, except in entry. accordance with Republic Act No. 6675, as amended, otherwise known as the "Generics Act of 1988", and Section 38. Requirements for the Opening and other pertinent laws and regulations. Operation of Retail Pharmaceutical Outlet or Establishment. - The opening of a retail Section 36. Label of Dispensed Medicines. - Upon pharmaceutical outlet or establishment shall be subject every box, bottle, or package of medicines to requirements provided for in this Act and the rules compounded or dispensed by a registered and licensed and regulations prescribed by the FDA. pharmacist based on prescription, there shall be pasted, affixed, or imprinted a seal or label bearing, The application for the opening and operation of a among others, the name of patient and generic name retail drug outlet or other similar business of drug; brand name, if any, strength, expiry date, establishments shall not be approved, unless applied directions for use; and name and address of pharmacy, for by a Filipino registered and licensed pharmacist, name of the doctor, the dispensing pharmacist and either as owner or as pharmacist-in-charge, pursuant other requirements prescribed in the Philippine to the provisions of this Act. Practice Standards for Pharmacists and Dispensing Guidelines, Republic Act No. 9502, otherwise known Section 39. Handling of Pharmaceutical Products by as the "Universally Accessible Cheaper and Quality Persons Other Than a Pharmacist. - For the purpose of Medicines Act of 2008", its implementing rules and this section, persons handling pharmaceutical products, other than the pharmacist, which shall pharmacists must be members of the APO and must include pharmacy owners who are non-pharmacists, maintain membership throughout the duration of the medical representatives or professional service practice of the profession. The PIC shall not be representatives, pharmacy support personnel, renewed if the requirements for membership with the pharmacy technicians, pharmacy assistants, pharmacy APO are not met including credit units for attendance aides, persons who assist pharmacists in any part of a to duly accredited CPD. pharmacy operation, or any other person performing functions involved in the handling of pharmaceutical All pharmacy support personnel must be registered as products, shall be duly certified by appropriate affiliate members of the APO and must likewise government agencies after undergoing an accredited maintain membership throughout the duration of training program. employment in pharmaceutical establishments and outlets. No person, except pharmacy graduates, shall be allowed to render such services without undergoing a Section 43. Specialty Boards in Various Areas of comprehensive standardized training program: Pharmacy Practice. - Specialty Boards in various areas Provided, That the job description is defined in the of pharmacy practice shall be created, subject to implementing rules and regulations of this Act. accreditation by the Board and the PRC. The Board shall issue guidelines in the accreditation of specialty Section 40. Administration of Adult Vaccines. - In boards in various areas of pharmacy practice, which addition to the requirement provided in Section 4, shall include the standards of practice within different paragraph (g) of this Act, licensed and trained specialties, qualifications, and requirements for the pharmacist who shall administer adult vaccines shall certification of practitioners under each specialty, ensure that the vaccine to be administered shall have a among others. doctor’s prescription which is not more than seven (7) days old and submit a monthly vaccination report and Article VI AEFI report to DOH regional offices using the Violations, Administrative Sanctions, and Procedures prescribed form. Section 44. Revocation or Suspension of the Article V Certificate of Registration and Cancellation of Accredited Professional Organization Special/Temporary Permit.— The Board shall have the power, upon notice and hearing, to revoke or Section 41. The Integrated and Accredited suspend the COR of a registered pharmacist or to Professional Organization (APO) of Pharmacists. - cancel an STP of a foreign pharmacist on any of the The pharmacy profession shall be integrated into one following grounds: (1) national organization registered with the Securities and Exchange Commission (SEC) which shall be (a) Violation of any provision of this Act, its rules and recognized by the Board and the PRC as the one and regulations, the Pharmacists’ Code of Ethics, Code of only integrated and accredited professional Technical Standards for the Professional Practice of organization of pharmacists. the Pharmacy Profession, Code of Good Governance and all other guidelines, policies and regulatory A pharmacist duly registered with the Board shall measures of the Board and/or the PRC relating to the automatically become a member of the integrated and practice of the pharmacy profession; accredited professional organization of pharmacists, and shall receive the benefits and privileges (b) Conviction of an offense involving moral turpitude appurtenant thereto upon payment of the required fees by a court of competent jurisdiction; and dues. (c) Unprofessionalism, immorality, malpractice, Membership in the integrated APO shall not be a bar incompetence, gross negligence, or imprudence in the to membership in other associations of pharmacists. practice of the profession; Section 42. Membership to the Integrated and (d) Fraud or deceit in the acquisition of the COR, PIC Accredited Professional Organization. - All registered or STP, or renewal thereof; Penal Provisions (e) Allowing the COR to be used or displayed in establishments where the pharmacist is not actually Section 45. Penal Provisions. - Any person who shall employed and practicing; commit any of the following acts shall, upon conviction, be sentenced to pay a fine of not less than (f) Addiction to alcoholic beverages or to any two hundred fifty thousand pesos (₱250.000.00), but habit-forming drug rendering a pharmacist not exceeding five hundred thousand pesos incompetent to practice the profession as provided for (₱500.000.00) or imprisonment of not less than one in Section 23 hereof; (1) year and one (1) day but not more than six (6) years, or both, at the discretion of the court: (g) Aiding or abetting the illegal practice of a non-registered and licensed person; (a) Commission of any act in violation of Sections 30 and 31 of this Act; (h) Insanity or any mental disorder that would render the person incompetent to practice pharmacy; (b) Allowing the display of one’s COR in a pharmaceutical establishment where the pharmacist is (i) False, extravagant, or unethical advertisements and not employed and practicing; endorsements of pharmaceutical products, pharmaceutical outlets and establishments where the (c) Displaying of the pharmacist’s COR by pharmacy pharmacist’s name or the pharmacist’s professional owners/operators in a pharmaceutical establishment organization and similar information, or both, are where the pharmacist is not employed and practicing; used; (d) Dispensing or allowing the dispensing or offering (j) Manufacture, sale, offering for sale of counterfeit, for sale of prescription drugs or pharmaceutical spurious, substandard and falsified pharmaceutical products in a place not licensed by the FDA as a products and committing other acts in violation of pharmaceutical outlet; Republic Act No. 9165 and Republic Act No. 8203, otherwise known as the "Special Law on Counterfeit (e) Dispensing of prescription and pharmacist-only Drugs"; OTC pharmaceutical products by a person other than those under the direct and immediate supervision of a (k) Illegal manufacture, sale, possession, dispensing duly registered and licensed pharmacist; of dangerous drugs and other acts in violation of Republic Act No. 9165, and other applicable laws and (f) Allowing the dispensing of prescription and issuances; pharmacist-only OTC pharmaceutical products, without the direct and immediate supervision of a duly (l) Committing acts in violation of Section 6 of registered and licensed pharmacist; Presidential Decree No. 881, entitled "Empowering the Secretary of Health to Regulate the Labeling, Sale (g) Compounding and dispensing not in accordance and Distribution of Hazardous Substances" and with current Good Manufacturing Practice, Good Section 11 of Republic Act No. 3720, as amended; Laboratory Practice and Philippine Practice Standards for Pharmacists, and such other standards and (m) Practicing pharmacy with a suspended COR or guidelines issued by the Board; expired PIC; (h) Selling of prescription and pharmacist-only OTC (n) Unauthorized dispensing of pharmaceutical drugs by manufacturers, importers, and wholesalers to products through unregistered online services or direct unlicensed pharmaceutical outlets and other selling businesses; and establishments; (o) Being found guilty of immoral, unprofessional, or (i) Substituting prescription drugs which are not dishonorable conduct by the Board. generically equivalent to what was on the prescription, without the consent of the prescriber or not in Article VII accordance with Republic Act No. 6675; (j) Forcing, coercing, or intimidating a duly registered Section 46. Other Penalties. - Any person who shall and licensed pharmacist to compound or dispense commit any of the following acts shall, upon medical and pharmaceutical products in violation of conviction, be sentenced to pay a fine of not less than the provisions of this Act; one hundred thousand pesos (₱100,000.00), but not exceeding two hundred thousand pesos (₱200,000.00) (k) Preparing and compounding of pharmaceutical or imprisonment of not less than thirty (30) days but products in quantities greatly in excess of single not more than one (1) year, or both, at the discretion therapeutic doses, without the presence and of the court: supervision of a duly registered and licensed pharmacist; (a) Affixing of the title "RPh" by a person who is not a duly registered and licensed pharmacist; (l) Noncompliance with the labeling requirements for dispensed medicines by a pharmaceutical outlet; (b) Practicing the pharmacy profession in the Philippines without a valid COR, PIC or STP; (m) Manufacturing and selling of pharmaceutical products under fraudulent name or address, or both; (c) Non-indication of a pharmacist of his/her COR and professional tax receipt numbers in official documents (n) Adulterating and misbranding of pharmaceutical requiring such information; products; (d) Refusal to display the COR of the pharmacist in a (o) Manufacturing and selling of unsafe, substandard prominent and conspicuous place in the establishment and counterfeit pharmaceutical products; and outlet where the pharmacist is employed and practicing; (p) Operating an unlicensed pharmaceutical outlet such as online pharmacy service or direct selling not (e) Noncompliance by a duly registered and licensed authorized by the FDA; pharmacist with the requirements on the filling of prescription; (q) Operating a Category A establishment which opens for business without a duly registered and (f) Noncompliance by a duly registered and licensed licensed pharmacist; pharmacist on the requirements for partially-filled prescription; (r) Operating a Category B establishment without the supervision and oversight of a duly registered and (g) Selling of physician’s samples; licensed pharmacist; (h) Distribution of antimicrobials, including anti-TB (s) Practicing pharmacy with an expired, suspended or drugs and other product classification as may be revoked license; prohibited by law as physician’s samples; (t) Filling and refilling of prescription and (i) Removal, erasure and alteration of mark or label of pharmacist-only OTC pharmaceutical products by a physician’s sample; person other than a duly registered and licensed pharmacist without the direct and immediate (j) Use of cipher, codes, or secret keys or unusual supervision; names or terms in prescriptions; (u) Dispensing prescription drugs and pharmacist-only (k) Filling of prescriptions where cipher, codes, or OTC drugs by rural health units without the secret keys or unusual names or terms are used; supervision of a duly registered and licensed pharmacist; and (l) Noncompliance with labeling requirements for dispensed medicines; (v) All other acts or omissions analogous to the foregoing. (m) Noncompliance with the requirements on the licensed pharmacists/pharmacy support personnel are keeping of record books by a pharmaceutical outlet; jointly liable for the willful violation of any provision of this Act. (n) Employment of personnel in a pharmacy or pharmaceutical operation without the required training Article VIII and certification; Final Provisions (o) Refusal of a non-pharmacist owner/operator of a Section 47. Enforcement. - It shall be the primary duty pharmaceutical outlet to undergo training and of the Board and the PRC to effectively enforce the certification; provisions of this Act. All duly constituted law enforcement agencies and officers of the national, (p) Refusal by the owner/operator to allow and require provincial, city or municipal government or of any duly registered and licensed pharmacists and political subdivision thereof shall ensure the effective pharmacy support personnel to undergo CPD, training enforcement and implementation of the provisions of and certification; this Act. (q) Rendering dispensing-related services by Section 48. Appropriations. - The Chairperson of the non-pharmacists in a pharmaceutical outlet without PRC shall immediately include in its programs the undergoing the required training and certification; implementation of this Act, the funding of which shall be charged against their current years’ appropriations (r) Dispensing pharmaceutical products in medical and thereafter, in the annual General Appropriations missions without the supervision of a duly registered Act.1âwphi1 and licensed pharmacist; Section 49. Transitory Provisions. - The incumbent (s) Noncompliance with the required training and Chairperson and members of the Board shall, in an certification of professional service or medical interim capacity, continue to function as such until the representatives or professional service representatives, Chairperson and members of the new Board, created pharmacy technicians, pharmacy assistants, pharmacy under this Act, shall have been appointed and aides, pharmacy clerks, and other medicine handlers qualified. of pharmaceutical products. Both the medical representatives or professional service representatives, Section 50. Implementing Rules and Regulations. - pharmacy technicians, pharmacy assistants, pharmacy Within one hundred twenty (120) days after the aides, pharmacy clerks, or medicine handlers and the approval of this Act, the Board, subject to the pharmaceutical establishment and outlet emploving approval by the PRC, and in consultation with the any such individual shall be held jointly liable; and APO, shall formulate and issue the rules and regulations to implement the provisions of this Act. (t) Violation of any provision of this Act and its rules and regulations not aforementioned above. Any Section 51. Separability Clause. - If any clause, person, other than the citizens of the Philippines, provision, paragraph or part hereof shall be declared having been found guilty of any violation as provided unconstitutional or invalid, such declaration shall not for in this section and the preceding section shall, after affect, invalidate, or impair the other provisions having paid the fine or having served the sentence, or otherwise valid and effective. both, when so adjudged, shall also be subject to immediate deportation. Section 52. Repealing Clause. - Republic Act No. 5921, as amended, is hereby repealed. AH other laws, The penalties and liabilities herein provided shall be presidential decrees, executive orders and other without prejudice to other sanction/s that may be administrative issuances or parts thereof which are imposed for violation of other applicable laws, contrary to or inconsistent with the provisions of this policies, rules and regulations. Act are hereby repealed, amended, or modified accordingly. The owner/operator of the pharmaceutical establishments/outlets and the duly registered and Section 53. Effectivity. - This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in a newspaper of general circulation. Approved, FRANKLIN M. DRILON President of the Senate FELICIANO BELMONTE, JR. Speaker of the House of Representatives This Act was passed by the House of Representatives as House Bill No. 5616 on May 23, 2016 and adopted by the Senate as an amendment to Senate Bill No. 2436 on May 30, 2016. OSCAR G. YABES Secretary of the Senate MARILYN B. BARUA-YAP Secretary General House of Representatives Approved: July 21, 2016 (Sgd.) BENIGNO S. AQUINO, III President of the Philippines ARTICLE VI of at least two hundred fifty thousand, or each province, shall have at least one representative. THE LEGISLATIVE DEPARTMENT 4. Within three years following the return of every census, the Congress shall make a Section 1. The legislative power shall be vested in the reapportionment of legislative districts based Congress of the Philippines which shall consist of a on the standards provided in this section. Senate and a House of Representatives, except to the extent reserved to the people by the provision on Section 6. No person shall be a Member of the House initiative and referendum. of Representatives unless he is a natural-born citizen of the Philippines and, on the day of the election, is at Section 2. The Senate shall be composed of least twenty-five years of age, able to read and write, twenty-four Senators who shall be elected at large by and, except the party-list representatives, a registered the qualified voters of the Philippines, as may be voter in the district in which he shall be elected, and a provided by law. resident thereof for a period of not less than one year immediately preceding the day of the election. Section 3. No person shall be a Senator unless he is a natural-born citizen of the Philippines and, on the day Section 7. The Members of the House of of the election, is at least thirty-five years of age, able Representatives shall be elected for a term of three to read and write, a registered voter, and a resident of years which shall begin, unless otherwise provided by the Philippines for not less than two years law, at noon on the thirtieth day of June next immediately preceding the day of the election. following their election. No Member of the House of Representatives shall serve for more than three Section 4. The term of office of the Senators shall be consecutive terms. Voluntary renunciation of the six years and shall commence, unless otherwise office for any length of time shall not be considered as provided by law, at noon on the thirtieth day of June an interruption in the continuity of his service for the next following their election. No Senator shall serve full term for which he was elected. for more than two consecutive terms. Voluntary renunciation of the office for any length of time shall Section 8. Unless otherwise provided by law, the not be considered as an interruption in the continuity regular election of the Senators and the Members of of his service for the full term of which he was the House of Representatives shall be held on the elected. second Monday of May. Section 5. Section 9. In case of vacancy in the Senate or in the 1. The House of Representatives shall be House of Representatives, a special election may be composed of not more than two hundred and called to fill such vacancy in the manner prescribed by fifty members, unless otherwise fixed by law, law, but the Senator or Member of the House of who shall be elected from legislative districts Representatives thus elected shall serve only for the apportioned among the provinces, cities, and unexpired term. the Metropolitan Manila area in accordance with the number of their respective Section 10. The salaries of Senators and Members of inhabitants, and on the basis of a uniform and the House of Representatives shall be determined by progressive ratio, and those who, as provided law. No increase in said compensation shall take effect by law, shall be elected through a party-list until after the expiration of the full term of all the system of registered national, regional, and Members of the Senate and the House of sectoral parties or organizations. Representatives approving such increase. 2. The party-list representatives shall constitute twenty per centum of the total number of Section 11. A Senator or Member of the House of representatives including those under the Representatives shall, in all offenses punishable by party list. For three consecutive terms after not more than six years imprisonment, be privileged the ratification of this Constitution, one-half from arrest while the Congress is in session. No of the seats allocated to party-list Member shall be questioned nor be held liable in any representatives shall be filled, as provided by other place for any speech or debate in the Congress law, by selection or election from the labor, or in any committee thereof. peasant, urban poor, indigenous cultural Section 12. All Members of the Senate and the House communities, women, youth, and such other of Representatives shall, upon assumption of office, sectors as may be provided by law, except the make a full disclosure of their financial and business religious sector. interests. They shall notify the House concerned of a 3. Each legislative district shall comprise, as far potential conflict of interest that may arise from the as practicable, contiguous, compact, and adjacent territory. Each city with a population filing of a proposed legislation of which they are yeas and nays on any question shall, at the authors. request of one-fifth of the Members present, be entered in the Journal. Each House shall Section 13. No Senator or Member of the House of also keep a Record of its proceedings. Representatives may hold any other office or 5. Neither House during the sessions of the employment in the Government, or any subdivision, Congress shall, without the consent of the agency, or instrumentality thereof, including other, adjourn for more than three days, nor government-owned or controlled corporations or their to any other place than that in which the two subsidiaries, during his term without forfeiting his Houses shall be sitting. seat. Neither shall he be appointed to any office which may have been created or the emoluments thereof Section 17. The Senate and the House of increased during the term for which he was elected. Representatives shall each have an Electoral Tribunal which shall be the sole judge of all contests relating to Section 14. No Senator or Member of the House of the election, returns, and qualifications of their Representatives may personally appear as counsel respective Members. Each Electoral Tribunal shall be before any court of justice or before the Electoral composed of nine Members, three of whom shall be Tribunals, or quasi-judicial and other administrative Justices of the Supreme Court to be designated by the bodies. Neither shall he, directly or indirectly, be Chief Justice, and the remaining six shall be Members interested financially in any contract with, or in any of the Senate or the House of Representatives, as the franchise or special privilege granted by the case may be, who shall be chosen on the basis of Government, or any subdivision, agency, or proportional representation from the political parties instrumentality thereof, including any and the parties or organizations registered under the government-owned or controlled corporation, or its party-list system represented therein. The senior subsidiary, during his term of office. He shall not Justice in the Electoral Tribunal shall be its Chairman. intervene in any matter before any office of the Government for his pecuniary benefit or where he Section 18. There shall be a Commission on may be called upon to act on account of his office. Appointments consisting of the President of the Senate, as ex officio Chairman, twelve Senators, and Section 15. The Congress shall convene once every twelve Members of the House of Representatives, year on the fourth Monday of July for its regular elected by each House on the basis of proportional session, unless a different date is fixed by law, and representation from the political parties and parties or shall continue to be in session for such number of organizations registered under the party-list system days as it may determine until thirty days before the represented therein. The chairman of the Commission opening of its next regular session, exclusive of shall not vote, except in case of a tie. The Commission Saturdays, Sundays, and legal holidays. The President shall act on all appointments submitted to it within may call a special session at any time. thirty session days of the Congress from their submission. The Commission shall rule by a majority Section 16. vote of all the Members. 1. The Senate shall elect its President and the House of Representatives, its Speaker, by a Section 19. The Electoral Tribunals and the majority vote of all its respective Members. Commission on Appointments shall be constituted Each House shall choose such other officers within thirty days after the Senate and the House of as it may deem necessary. Representatives shall have been organized with the 2. A majority of each House shall constitute a election of the President and the Speaker. The quorum to do business, but a smaller number Commission on Appointments shall meet only while may adjourn from day to day and may the Congress is in session, at the call of its Chairman compel the attendance of absent Members in or a majority of all its Members, to discharge such such manner, and under such penalties, as powers and functions as are herein conferred upon it. such House may provide. 3. Each House may determine the rules of its Section 20. The records and books of accounts of the proceedings, punish its Members for Congress shall be preserved and be open to the public disorderly behavior, and, with the in accordance with law, and such books shall be concurrence of two-thirds of all its Members, audited by the Commission on Audit which shall suspend or expel a Member. A penalty of publish annually an itemized list of amounts paid to suspension, when imposed, shall not exceed and expenses for each Member. sixty days. 4. Each House shall keep a Journal of its Section 21. The Senate or the House of proceedings, and from time to time publish Representatives or any of its respective committees the same, excepting such parts as may, in its may conduct inquiries in aid of legislation in judgment, affect national security; and the accordance with its duly published rules of procedure. The rights of persons appearing in, or affected by, the general appropriations law for their such inquiries shall be respected. respective offices from savings in other items of their respective appropriations. Section 22. The heads of departments may, upon their 6. Discretionary funds appropriated for own initiative, with the consent of the President, or particular officials shall be disbursed only for upon the request of either House, as the rules of each public purposes to be supported by House shall provide, appear before and be heard by appropriate vouchers and subject to such such House on any matter pertaining to their guidelines as may be prescribed by law. departments. Written questions shall be submitted to the President of the Senate or the Speaker of the Section 26. House of Representatives at least three days before 1. Every bill passed by the Congress shall their scheduled appearance. Interpellations shall not embrace only one subject which shall be be limited to written questions, but may cover matters expressed in the title thereof. related thereto. When the security of the State or the 2. No bill passed by either House shall become public interest so requires and the President so states a law unless it has passed three readings on in writing, the appearance shall be conducted in separate days, and printed copies thereof in executive session. its final form have been distributed to its Members three days before its passage, Section 23. except when the President certifies to the 1. The Congress, by a vote of two-thirds of both necessity of its immediate enactment