SBN-3140 (Per Ctte. Rpt. No. 129)

8/13/2019 SBN-3140 (Per Ctte. Rpt. No. 129)

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FIFTEENTH CONGRESS OF THE ) -: - i ;:REPUBLIC OF THE PHILIPPINES )

Second Regular Session )SENATE

S.NO. 3140(In substitution of Senate Bill Nos. 746 and 2163)Prepared by the Committees on Civil Service and Government Reorganization; andFinance, with Senators E.jercito-Estrada, Escudero, and Trillanes IV as authors thereof

AN ACTREGULATING THE PRACTICE OF PHARMACY IN THE PHILIPPINES,REPEALING FOR THE PURPOSE REPUBLIC ACT NO. 5921, THE PHARMACYLAW, AS AMENDED, AND FOR OTHER PURPOSESBe it enacted by the Senate and House o Representatives o the Philippines n Congressassembled:

1 ARTICLE I2 GENERAL PROVISIONS3 SECTIOIN 1. Title. - This Act shall be known as the Philippine Pharmacy Act o4 2012 .5

6 SEC. 2. Statement o Policy. The State recognizes the vital role ofphannacists in quality7 healthcare delivery through their services in providing safe, effective, and quality drugs or8 medicines; drug information, patient medication counseling, and health promotion. The9 pharmacists professional service shall, therefore, be promoted as a component of the total

10 health care system, which shall ensure the physical well-being of the Filipinos.11 I-Ience the state shall develop and nnrture competent, productive, morally upright, and12 well-rounded pharmacists whose standards of professional practice and service shall be13 excellent, qualitative, world-class and internationally recognized, globally competitive through14 regnlatory measures, programs, and activities that foster their continuing professional

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SEC. 3. Objectives. - This Act provides for, and shall govem:a) the standardization and regulation ofphannacy education,b) the examination for registration of graduates of schools and colleges of phannacy,c) the supervision, control, and regulation of the practice ofphannacy in the

Philippines,d) the enhancement of professional competence through continuing professional

development, research, and other related activities, ande) the integration of the pharmacy profession.

SEC. 4. Definition o Terms. - For purposes of this Act, the term:Biopharmaceuiicals are vaccines, sera and drugs derived from life forms using

biotechnology. They include proteins nucleic acids and living microorganismslike viruses and bacteria where the virulence is reduced by attenuation used fortherapeutic or in vivo diagnostic purposes.

Brand Name means the proprietary or trade name given by the manufacturer todistinguish its product i'om those of the competitors;

Cipher means a method of secret writing that substitutes other letters or characters forthe letter intend cd or transpose the letter after arranging them in blocks or squares;

Code means a system ofwords or other symbols arbitrarily used to represent words;Compounding is the preparation, mixing, assembling, packaging, or labeling of a drug

i) as the result of a prescription or drug order by a physician, dentist, optometrist, orveterinarian, based on the said practitioner-patient-pharmacist relationship in the courseof professional practice, or ii) for the purpose of, or in relation to, research, teaching, orchemical analysis;Cosmetics are substances or preparations intended to be placed in contact with thevarious external parts of the human body or with the teeth and the mucouS membranes ofthe oral cavity, with a view exclusively or mainly to clean them or perfume themchanging their appearance and/or correcting body odor, andlor protecting the body orkeeping them in good condition. RA 9711);


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1 g) Countelfeit drug/medicine/pharmaceutical refers to medicinal products with the2 correct ingredients but not in the amounts as provided, wrong ingredient, without active3 ingredient/s, with insufficient quantity of active ingredient, which result in the reduction4 of the drug's safety, efficacy, quality, strength or purity. t is a drug that is deliberately5 and fraudulently mislabeled with respect to identity and/or source or with fake packaging,6 and can apply to both branded and generic products. t shall also refer to:7 I the dmg itself or the container or labeling thereof or any parl of such dmg,8 container, or labeling b e t ~ n g without authorization the trademark, trade name9 or other identification mark or imprint or any likeness to that which is owned or

10 registered in the Intellectual Property Office IPO) in the name of another11 natural or juridical person;12 2) a drug product refilled in containers by unauthorized persons if the legitimate13 labels or marks are used;14 3) an imported drug product not registered with the Food and Dmg Administration15 (FDA), except dlugs brought in the country for personal use as confinl1ecl and16 justified by accompanying medical records; and17 4) a chug which contains no amount of a different active ingredient or less than18 eighty percent (80 ) of the active ingredient it purports to possess as ,. ,19 distinguished fj-0111 an adulterated dmg including reduction or loss or efficacy20 due to expiration.21 h) Dangerous drugs include those listed in the Schednles annexed to the 1961 Single22 Convention on Narcotic Drugs as amended by the 197 Protocol, and in the Schedules23 aJU1exed to the 1971 Single Convention on Psychotropic Substances as enumerated in the24 attached annex in Republic Act No. 9165, which is an integral pali of the Act;25 (i) Dispensing is a process of reading, checking, and interpretation of prescription,26 preparing, packaging, labeling, record keeping, and sale or transfer of dmgs atld27 medicines with or without a prescdption or medication order which process includes28 counseling and infonnation giving by or nnder supervision of a duly registered and29 licensed pharmacist;

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Drugs and Medicines refer to chemical compounds or biological substances, otherthan food, intended for use in the treatment, prevention or diagnosis of disease in humansor animals, including but not limited to:I any article recognized in the official United States Pharmacopoeia,-National

Formulary, official Homeopathic Pharmacopoeia of the United States, PhilippinePharmacopoeia, Philippine National Dmg Formulary, British Pharmacopoeia,European Pharmacopoeia, Japanese Pharmacopoeia, and any official compendium orany supplement to them;

2) any article intended for use in diagnosis, cure, mitigation, treatment, or prevention ofdisease ofman and animals;

3) any article other than food intended to affect the stmcture or any function of thehuman 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 and/or traditional dmgs which are articles of plant or animal origin used in folkmedicine which are: a) recognized in the Philippine National Dmg Formulary; b)intended for use in the treatment, or cure or mitigation of disease symptoms, injury orbody defects in humans; c) other than food, intended to affect the structure or anyfunction of the human body; d) in finished or ready-to-use dosage form; and e)intended for use as a component of any of the articles specifi.ed in clauses a), b), c)or d);

Drug or Pharmaceutical Laboratory or Pharmaceutical Manufacturing Laboratorymeans an establishment where phannaceutical products, proprietary medicines, orpharmaceutical specialties are formulated, prepared, compounded, and standardized;

Drug Establishments means FDA-registered companies involved in the manufacture,importation, repacking, and/or distribution of dmgs or medicines;

Drug Outlets refer to dmgstores, pharmacies, and other business establislunents whichare registered with the FDA and which legally sell dmgs and medicines;

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Drugstore or Pharmacy means a place or establishment licensed by FDA where fc tugs, chemicals, pharmaceutical products, specialties, and devices are legally sold at ,retail or wholesale and where medical, dental, and veterinary p r ~ s r i p t i o n s arecompounded and dispensed;

Emergency cases refer to life-threatening situations where a patient needsimmediate medical attention and treatment or the occurrence of an epidemic ornatural calamities.

Expiration Date means the date until which the manufacturer can guarantee a productto possess its claimed potency, efficacy, quality, and safety; and after which its sale ordistribution is prohibited;

Filling of a prescription refers to the act of dispensing or giving out of medicines inaccordance with the prescriber's medication order or prescription;

Generic Name means the scientifically and internationally recognized name of theactive ingredienlis as approved by the Food and Drug Administration (FDA);

Household Remedies shall refer to any preparation containing pharmaceuticalsubstances of common or ordinary use to relieve common physical ailments whieh maybe dispensed without a medical prescription in original packages, bottles or containers,the nomenclature of which has been duly approved by FDA in the process ofregistratiol1as defined in FDA AO No.l1S (s. 1991);

Institutional pharmacies are establishments which provide, within their prelTIlSeS,medicines to their employees and/or relatives either for free or at cost;

Label means a display of written, printed or graphic information upon the immediatecontainer, or attached to or accompanying any pharmaceutical products.

Labeling means all labels and other written, printed, or graphic matter I) upon anyitem or any of its containers or wrappers or (2) accompanying any such item;

Medical Devices refer to any instrument, apparatus, implement, machine, implant, invitro reagent or calibrator, software, material or other similar or related article:(a) intended by the manufacturer to be used, along or in combination, for human beings

for one or more of the specific purpose(s) of:5


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I) diagnosis, prevention, monitoring, treatment, alleviation of diseases ofdiseases

2) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;3) investigation, replacement or modification or support of the anatomy of a

physiological process;4) supporting or sustaining life;5) control of conception,6) disinfection ofmedical devices,7) providing information for medical or diagnostic purposes by means of an in

vitro examination of specimen derived from the human body; and,(b) which does not achieve its primary intended action in or on the human body by

phannacological, immunological or metabolic means, but which may be assisted intheir intended fcmction by such means;

Non-traditional outlets other retail outlets licensed by FDA other than drugstoresand pharmacies where drugs are made available in conjunction with the provisions ofR.A.9502.

Online pharmacy refers to any activity of taking orders for medicines online or thruthe inte111et

Over-tlte-counter drugs are drugs used for symptomatic relief ofminor ailments whichmay be dispensed without a prescription;

Pharmaceutical products or Pharmaceutical specialties are drugs, preparations, ormixture of drugs under a brand or generic name and intended for the cure, mitigation,treatment, or prevention of disease in man or animals;

Pharmacist-only over-the-counter drugs are FDA-classified over-the-counter drugsand/or substances which should only be obtained from a legitimate drugstore orpharmacy with mandatory pharmacist s advice on their selection and proper use;

Person includes an individual, partnership, corporation, or any juridical entity;Pharmaceutical marketing means any activity undertaken, organized or sponsored by

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supply, administration or constUnption of its pharmaceutical product(s) through dire(:tpersonal contact and all media, including the internet;Phannacy Assistants are persons who assist pharmacists in compounding

and dispensing of medicines in community, hospital, industrial settings and inother activities, such as, but not limited to medical missions, under thesupervision of the pharmacist and as described in Section 41 of this Act.Pharmacy aides clerks are those who assist in other aspects of pharmacyoperation.

Physician 0 samples refer to medicines given to a physician for fi-ee for promotionalpurposes;

Prescription drugs are those drugs which can only be dispensed by a pharmacist to apatient upon the presentation of a valid prescription from a physician, dentist, optometristor veterinarian and for which phmmacist s advice on their proper use is necessary;

Professional Medical Representative or Company Sales Representative is one whorepresents any duly authorized manufacturer, distributor, trader and wholesaler of dlUgs,pharmaceuticals, biologic products and devices, whose primary duty is to introduce saidproducts to legitimate prescribers and which forms part of their program for promotionby describing its use, composition, action, dosage, administration, contraindication,advantages and other relevant information about the drugs being promoted;

Refilling of a prescription refers to the act of dispensing or giving out the remainingbalance of medicines ordered in the prescription when the whole quantity ordered is notyet completely filled;

Secret Keys means a characteristic style or symbols kept fTOm the knowledge of othersor disclosed confidentially to a few individuals;

Telepharmacy is the provision of pharnlacy services utilizing electronic informationand communication technology under the supervision of a phannacist;

Wholesaler means every person who acts as merchant, broker or agent, who sells ordistributes for resale pharmaceuticals, proprietary medicines 01 pharmaceuticalspeCialties.

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SEC. 5. E l ~ f o l c e m e n t . - The Professional Regulatory Board of Phannacy and the2 Professional Regulation Commission are the bodi0s responsible for the implementation of the3 provisions of this Act.4 ARTICLE II5 THE PROFESSIONAL REGULATORY BOARD OF PHARMACY6

7 SEC. 6. The Board o Pharmacy and its Composition - There is hereby created a8 Professional Regulatory Board of Pharmacy, hereinafter referred to as the Board, under the9 administration, control, and supervision of the Professional Regulation Commission, herein after

10 referred to as the Commission, composed of a Chairman and two 2) members who shall be11 appointed by the President of the Philippines from the recommendees ranked by the Commission12 from the list of nominecs submitted by the Accredited Integrated Professional Organization13 AIPO) for Pharmacists.1415 SEC. 7. Qualifications o Board Members - To be appointed as member ofthe Board of ,16 Pharmacy, a person shall be:17 a) A natural born citizen of the Philippines and a resident for at least five 5) years;18 b) A duly registered pharmacist, preferably a holder of a Master of Science in Pharmacy, or19 its equivalent degree and has been in the practice of pharmacy for at least ten years;20 e) Of good moral character with a valid certificate of registration, valid professional21 identification card and preferably with teaching experience; and preferably representing22 each field of practice;23 d) At the time of appointment, not a member of the faculty or administrative office of any4 school, college or university offering degree programs in pharmacy nor connected in a

25 review school or center; nor has any direct or indirect pecuniary interests in any school,6 college, or any institution offering phannacy; and

27 e) A member of good standing for at least five 5) years of the accredited integrated national28 phannacy association but, at the time ofnomination, not an officer or trustee thereof.

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SEC. 8. Terll of Office of Board Members. - The chainnan and the members of theBoard shall hold office for three (3) years after appointment or until their successors shall havebeen appointed and duly qualified; Provided the incumbent Board members shall finish theirterms to complete the membership of the Board. Provided further, that the chainnan or anymembcr may be re-appointed for another tem1 hut in no case shall he/she serve for more than sixyears.

SEC. 9. Compensation of the Board ofPharmacy. - As provided for in R.A. No. 8981,known as the PRC Modernization Act of 2000 , the members of the Board shall receiveallowances and benefits equivalent to at least two salary grades lower than the salary grade of theConnnissioner, while the chairman of the Board shall receive a monthly compensationequivalent to two steps higher than the members of the Board. The chairman and members shallbe entitled to other allowances and benefits provided under existing laws.

5 SEC. 10. Powers Functions and Dllties oftlt Board. - The Board shall exercise these16 specific powers, functions, and duties:17 (a) Conduct licensure examination for pharmacists;18 (b) Prepare, adopt, and issue the Table of Specifications for the subjects in the bom:d19 licensure examination for phannacists in consultation with the academe; determine and20 prepare the questions therefor; score md rate the examination papers with the name and21 signature of the Board member concerned appearing thereon and submit the results in all22 subjects duly signed by the members of the Board to the Commission no later than three23 (3) days from the last day of examination unless extended by the Connnission for24 justifiable causc/s;25 c) Review and/or amend the scope oflicensure examination;26 (d) Approve the registration of phannacists;27 e) Add, delete, modify the scope, definition and standards ofpractice ofphannacy;8 (f) Reprimand any phannacist, suspend, or revoke his/her certificate of registration on the

29 grounds as provided for in Sec. 46 hereof, after a formal administrative investigation;9

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1 (g) Promulgate from time to time the necessary rules and regulations for the effective2 enforcement of this Act;3 11) Monitor the conditions affecting the practice of pharmacy in the Philippines and adopt4 measures that may be deemed proper for the enhancement of the profession and/or the5 maintenance of high professional, academic, ethical and teclmical standards;6 (i) Verify or confirm the qualifications and conditions of pharmacists employed 1117 drugstores, hospital pharmacies, drug or pharmaceutical laboratories, drug traders,8 importers, cosmetics and medical device establislunents for which the Board may9 designate inspectors [rom the Food and Drug Administration and other related

10 institutions for such purpose;11 j) Investigate cases arising from violations of this Act, the rules and regulations12 promulgated thereunder and the Phatmacist s Code of Ethics, technical standards, and13 other Board issuances and for this purpose, may issue summons, subpocna duces ad4 testificandum and subpoena duces tecum to the respondents and/or witnesses to compel

15 their attendance in such investigations or hearings: rovided that, the decision of the16 Board shall, unless appealed to the Commission, becomes final and executory after17 fifteen (15) days from receipt ofnotice of udgment or decision;18 Ie) Cite a person in contempt for failure or refusal to obey the lawful order of the Board in .19 accordance with the Revised Rule ofCourt;20 1) Delegate the hearing or investigation of administrative cases filed before them whereat21 the hearing shall be presided over by at least one (1) member of the Board concemed22 assisted by a Legal or Hearing Officer of the Commission, provided that if the charge is23 not related to the technical practice of the profession, the hearing may be conducted24 without a member ofthe Board;25 (m)Conduct, through the Legal Officers of the Commission, summary proceedings on minor26 violations of the respective regulatory laws, as determined by the Board. Violations of the27 rules and regulations issued by the Board to implement this Act, including violations of28 the general instlUctions to examinees committed by examinees, and render summary

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1 judgment thereon which shall, unless appealed to the Commission, become final and2 executory after fifteen 15) days from receipt ofnotice of udgment or decision;3 (n) Subject to the final approval by the Commission, recommend registration without4 examination and the issuance of corresponding certificate of registration and professional5 identification card to foreign pharmacists duly licensed in countries with agreement of6 reciprocity with the Philippine government;7 (0) Prepare an annual repOli of accomplislunents on programs, projects, and activities of the8 Board during the year for submission to the Commission after the close of each calendar9 year including appropriate recommendations on issues or problems affecting the practice

10 ofphannacy;(p) Issue and promulgate guidelines on continuing professional development education in

12 coordination with the accredited professional organization;13 (q) Recommend to the CHED for the closure of the program or course ofphannacy offered14 by a school/college pursnant to the latter S policy thereon;15 (r) Approve the certification of drug handlers covered by Sec. 4 of this Act;16 (s) Approve the standardized training programs for pharmacy assistants, clerks, and medical17 representatives; and,18 (t) Perform any implied, incidental, necessary power for the effective implementation ofthis19 Act.221 SEC. 11 Grounds for Suspension or Termination of Term of Office of tfte Chairman22 or Member of the oard fi olll his/her Office. - The President of the Philippines, upon the23 recommendation of the Commission, after giving the Chailman or the member of the Board an24 opportunity to defend himself/herself in an administrative investigation conducted by the25 Commission, may remove or suspend himlher on any ofthe following grounds:26 (a) Gross neglect, incompetence or dishonesty in the discharge of his/her duty;27 (b) Violation of any ofthe canses/grounds/ and the prohibited acts provided in this Act and28

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(c) Involvement in the manipulation, tampering or rigging of the licensure examination, itsquestions and/or its results and the disclosure of classified and confidential infOlmationpertaining to the licensure exmnination.

4 (d) Conviction of an offense involving moral turpitude by a court of competent jurisdiction.S The Commission, in the conduct of investigation shall be guided by Section 7, mJd6 Section 15 of R.A. No. 8981 and the rules on administrative investigation thereof, and the7 applicable provisions of the New Rules of Court.89

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ARTICLE IIIEXAMINATION, REGISTRATION, CERTIFICATION, AND LICENSURE

2 SEC. 12. - Passing o Licensure Examination Requirement - Except as otherwise13 specifically allowed under this Act, applicants for registration for the practice of pham1aey shall14 be required to pass a licensure examination as provided for in this Act and in aceordance with5 Sec. 7 (d) of R.A. No. 8981.

1617 SEC. 13. - Qualifications o Applicants - An applicant for the licensure examination8 for pharmacy shall satisfactorily show that he/she possesses the following qualifications:

19 (a) Citizen of the Philippines or a foreign citizen whose country/state has reciprocity with the2 Philippines in the practice of pharmacy;21 (b) Of good moral character and reputation;22 (c) A holder of a Bachelor s dcgree in phannacy duly recognized or accredited by the23 Commission on Higher Education (CHED) and confen ed by a school/ college/university24 duly authorized by the government or its equivalent degree obtained by either a Filipino25 or foreign citizen from an institution oflearning in a foreign country/state, provided it is26 duly recognized and/or accredited by CHED;27 (d) Not convicted of an offense involving moral turpitUde by a court of competent28 jurisdiction; ancl

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(e) I-Ie must have completed an Internship Program which shall consist of at least ninehundred sixty hams (960 hams), six hundred hours (600 hours) of which shall be spentequally distributed in a community pharmacy, hospital pharmacy, or pharmaceuticalindustry - manufacturing, regulatory, marketing, or research - and other related fields,while three hundred sixty hours (360 hours) of internship shall be spent in any of theaccredited pharmacy establishments or entity chosen by the candidate.For this purpose, the abovementioned community pharmacy, pharmaceutical company,

and hospital pharmacy shall keep a separate record of pharmacy students who underwent saidinternship program directly under their control and as a result thereof, shall issue the properceriificate of said homs of internship. t shall also be the duty of said establishments to submit

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semi-annually a complete report of the names of those who have undergone training under theirsupervision and the corresponding number of hours of internship credit of each of the pharmacy tstudents to their respective colleges or schools and to the Board.

1415 SEC. 14. Scope o E Camiltatiolt. - The licensure examination for phannacists shall be16 divided into two major divisions: Pharmacy as Science and Pharmacy as Practice. Pharmacy as17 Science shall consist of subjects in Group I (Manufactllling, Quality Control I and II, and Legal18 Pharmacy and Ethics), Group II (Chemistry and Phannacy of Medicinals I, and Chemistry and19 Pharmacy of Medicinals II, Pharmacognosy and Plant Chemistry, and Pharmaceutical20 Biochemistry), Group III (Physical Pharmacy, Biophannaccutics and Pharmacokinetics,21 Pharmacology I and II).22 Pharmacy as Practice shall be made up of the following subjects: Group IV23 (Pharmaceutical Calculations, Drug Delivery Systems, and Phannaceutical Administration and24 Management), Group V (Microbiology and Parasitology, Public Health, and Clinical25 Toxicology), and Group VI (Hospital Pharmacy, Clinical Phannacy, and Dispensing and26 Medication Counseling).27 The subjects shall be weighted as follows: Group I, 15 ; Group II, 15 ; Group Ill , 20 ;28 Group IV, 15 ; Group V, 15 ; and Group VI, 20 .

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1 The Board subject to the approval by the Commission may introduce relevant changes, as2 the need arises, to the content of the examination and the relative weight attributed to each3 subject in the examination may be made after consultation with the duly recognized association45

of schools or colleges ofpharmacy and the CHED.

6 SEC. 15. Holdi1lg of Examination. - Examination for registration to practice phannacy7 in the Philippines shall be given twice a year in such places and dates as the Commission may8 designate in the Resolution thereof all the Master Schedules for all licensure examinations in9 accordance with Sec. 7 d) ofR.A. No. 8981. The said places and dates may be subject to change

10 under valid circumstances and reasons.1112 SEC. 16. Ratings ill t e Licensul e Examination. - In order to be registered and licensed13 as a pharmacist, a candidate must obtain a general weighted average of seventy-five per cent14 (75 ).1516 SEC. 17. Report of Rating. -The Board shall submit to the Commission the ratings17 obtained by each candidate within three 3) calendar days after the examination, unless extended18 for just cause. Upon the release of the results of the examination, the COlmnission shall send by19 mail the rating received by each examinee at his/her given address using the mailing envelope20 submitted during the examination.2

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SEC. 18. Oath of Profession. - All successful candidates in the licensure examinationshall take their oath of profession before the Chairman or allY member of the Board or anyauthorized officer of the Commission to administer oaths, prior to entering the practice ofpharmacy.

27 SEC. 19. Issuance of CeI tificate of Registration and Professional Identification Card.28 - A certificate of registration shall be issued to those who are registered upon payment of fees

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1 prescribed by the Commission. It shall bear the signatures of the Chairperson and the2 Commissioners of the Commission and the Chairman and Members of the Board, stamped with3 the official seal of the Commission and of the Board, certifying the person named therein is4 entitled to the practice of the profession with all the plivileges appurtenant thereto. Until revoked5 or suspended in accordance with this Act, it shall remain in full force and effect.6 A professional identification card bearing the registration number and date, its validity7 and expiry duly signed by the Chairperson of the Commission shall likewise be issued to every8 registrant who has paid the presclibed fee.9

10 SEC. 20. ffixing R.Ph. after a Registered Pharmacist's Name. - Only pharmacists11 who are duly registered and licensed by the Board and the Commission has the light to affix the12 tille, Registered Pharmacist or R.Ph. after his/her name.1314 SEC. 21. Grounds for Non-registration. - The Board shall not register any successful15 examinee for registration who has been:6 (a) Convicted of an offense involving moral turpitude by a cOllli of competent jurisdiction,7 (b) Found guilty ofimtnoral or dishonorable conduct by the Board,8 (c) Adjudged guilty for violation of the General Instructions to Examinees by the Board,

19 (d) Declared ofunsound mind by the court of competent jurisdictiou, and20 (e) Found addicted to dangerous drugs.21 In refusing such registration, the Board shaH give the applicant a written statement setting22 forth the reasons therefor and shaH file a copy in its records.2324 SEC. 22. Reissuance of Revoked Certificate of Registration, Replacement of Lost or2S Damaged Cert ficate of Registration, Professional Identificatio/l Card or Temporary/Special26 Permit. - The Board may upon petition, reinstate or reissue a revoked certificate of registration27 two (2) years fi Olll the date of its revocation. The Board mayor may not require the pharmacist8 whose certificate had been revoked to take another licensure examination. The petitioner shall

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1 the grant of his/her petition, the Board shall issue a Board Resolution subject to the approval of2 the Commission.3 Duplicate copy of lost or damaged certificate of registration, professional identification4 card or temporary/special permit may be reissued in accordance with rules thereon and npon5 payment ofthe prescribed fee therefor.

7 SEC. 23. NOll payment of the Re Registratio1l Fees. - The Board shall suspend a ,8 registered pharmacist ii om the practice of his/her profession for non-payment of the PRC9 registration fees for more than three (3) consecutive years from its last or previous year of

1 payment. The resumption of his/her practice shall take place only upon payment of delinquency11 fees plus surcharges and interest and in accordance with the rules of the Commission. The12 rur111ing of the three-year period may be interrupted upon written notice about the discontinuance13 of his/her practice and surrender of his/her celiificate of registration with professional14 identification card to the Board and/or the Commission.1516 SEC. 24. Vested Rig/zts; Automatic RegistratioTt. - All phannacists registered before the17 effectivity of this Act shall automatically be registered hereunder, subject to the policy as to18 future requirements. Certificates of registration and professional identification cards or19 temporary/special permits held by such persons in good standing at such effectivity shall have2 the same force and effect as though they were issued on or after the said effectivity.21222324

ARTICLE IVREGULATION OF THE PRACTICE OF PHARMACY

25 SEC. 25. Scope of the Practice of Pharmacy. - A person deemed to be practicing26 pharmacy within the meaning of this Article is one who shall, with or without a fee, salary, ,27 percentage or other rewards, paid or given directly to himself or indirectly through another

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(a) Prepare, compound or manufacture, analyze, assay, preserve, store, distJibute, sell and/ordispense any medicine, drug, chemicals, cosmetics, pharmaceuticals, devices orcontrivances used in pursuance thereof; or,

(b) render services not limited to drug information service and medication managementwhenever the expertise and the technical knowledge of the phannacist is reqnired; or,

(c) render services not limited to regulatory services, pharmaceutical marketing, and theconduct or undertaking of scientific research in all aspects involving drugs andhealthcare in collaboration with other qualified professional; or,

(d) engage in teaching scientific, technical or professional phannacy courses in a school orcollege of pharmacy; or

(e) conduct or undertake scientific research in all aspects involving dlugs and healthcare; orl) dispense drugs during medical missions and in other situations where supervision of

drugs is required; or,(g) provide other services where pharmaceutical knowledge is required.

All govemmcnt and non-govemlUcnt agencies, establislnncnts, institutions, andregulatory body with functions that directly involve the practice of phannacy shall preferably beheacled and managed by a qualified, duly registered and licensed phannaeist.

All pharmacists arc expected to abide by current standards such as the Good Pharmacy ,Practice, Good Laboratory Practice, Good Distribution Practice, Good Manufacturing Practice,and Good Clinical Practice, which are deemed vital in the performance of one s roles andfunctions in different practice areas.

The Board, subject to the approval by the Commission, may add to, delete, or modify theabove acts, services, or activities as the need arises.

25 SEC 26. Prereqllisitesfor tfle Practice o Pharmacy - A pcrson can practice pharmacy26 in the Philippines provided he/she:27 (a) has satisfactorily passed the licensure examination for pharmacists given by the Board28 and the Commission;29 (b) is duly registered with and licensed by the Board and the Commission; and,

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SEC 29. Illdication ofNUIII Jers: Certificate ofRegistration, Professional Tax Receipt ,mi Accredited Integrated National Orgallization AlPO) Afembership. - The pharmacist sball

be required to indicate on any document he/she signs, uses or issues in connection with thepractice ofpham1acy the following infonnation:

a) his/her registration number and date of issuance,b) the expiration dale of his/her professional identification card,c) the Professional Tax Receipt PTR) Number and dale of issuance, andd) thc certificate of AIPO membership annual/lifetime) number and the official receipt of

payment, number and date.

SEC 30. Registry ofPharmacists. - The Board shall prepare and maintain a registry ofthe nmnes, residences and/or office addresses of all registered phannacists which shall beupdated annually in cooperation with the Accredited Integrated Professional OrganizationAIPO), indicating therein the status of the certificate of registration, professional identification

card anel Accredited Integrated Professional Organization AIPO) membership, whether valid orinactive due to death, or other reasons, delinqnent, suspended or with revoked certiflcate ofregistration. The said registry of pharmacists shall be conspicuow;ly posted within the premisesof the Commission and the infonnation therein made available to the public upon inquiry orrequest.

I.SEC. 31. Display fCertificate ofRegistration. I t shall be the duly of every p larmaClst

engaged in the practice of phannacy either on his/her own account or under the employ ofanother to display his/her original certificate of registration in a prominent and conspicuous placein a retail drug outlet or drug estahlishment which he operates or in which he/she is employed inhis/her professional capacity as pharmacist. No pharmacist shall, with hisfher knowledge, allowhis/her certificate of registration to be displayed in such establishment when he/she is notactually employed or operating therein in his/her professional capacity.

A photocopy of the registration celiificate duly certified by the Board shall be displayedin Category B establishments as described in Section 33 of this Act.

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2 SEC 32. Sale Drugs Medicines Pharmaceuticals Biopharmaceuticals Medicated3 Cosmetics nd Medical Devices. - No drug medicines phannaceuticals biophannaceuticals4 medicated cosmetics and medical devices of whatever nature and kind shall be compounded5 dispensed sold or resold or otherwise be made available to the consuming public except through6 a FDA-licensed retail drug outlet or other business establishments which are duly established in7 accordance with the provisions of applicable laws.8 Prescription drugs and pharmacist-only over-the-counter drugs medicines or9 pharmaceutical products shall be dispensed by a duly registered pharmacist except only in

1 emergency case where the services of a registered and licensed pharmacist are not available.11 Provided that prescription drugs and phannacist-only over-the-counter drugs medicines or12 pharmaceutical products are sourced only in pharmacies under the direct control supervision and13 responsibility of a registered pharmacist.14 Compounding and dispensing shall be done only by duly registered and licensed15 pharmacists in accordance with current good manufacturing practice good laboratory practice16 and good pharmacy practice with the safety and protection of individual patients as ultimate17 objective. A registered and licensed phannacist may refuse to compound dispense or sell drugs18 and phannaceutical products if not in accordance with this Act.19 Licensed manufacturers importers distributors and wholesalers of chugs medicines2 medicated cosmetics phannaceutical and biophannaceuticals are authorized to sell their21 products only to duly licensed dlUg outlets wholesalers and other dlUg establislunents.2223 SEC 33. Pharmacist Requirement and Compensation. -24 Category A Establishments where the direct and immediate control supervision and25 responsibility of a registered and licensed phannacist is required at all times when open for26 business include:27 i. Every drug establishment/outlet selling prescription dlUgs andmedicilles ethical28 products pharmacists-only over-the-counter dlUgs and medicines and medicated

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13141516

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2021

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cosmetics whether owned by the govemment or a private person or firm, whethersold at wholesale or retail,

l l Each operation of pharmaceutical laboratories, pharmaceutical manufacturinglaboratories or other establishments with processes involving the preparation, fmanufacture, quality control, repacking, impOitation, exportation, distribution, ,sale or transfer of pharmaceutical products and medicated cosmetics in quantitiesgreatly in excess of single therapeutic doses

ategory B Establishments where supervision and oversight of a registered and licensedphannacist is required pursuant to the provision ofpertinent laws inclucle:

i. Retail outlets selling over-the-counter dtugs only11 Establishments involved in the manufacture, importation, exportation, distribution

and sale ofmedical devices.iii Institutional pharmacies providing medicines to employees and their relativesiv. Gove 1lment agencies including local govelluuent units, city and municipal health

units, and, private establishments involved in the procurcment, distribution,dispensing and storage of dtugs and medicines

v. Institutions providing telepharmacy servicesvi. Other non-traditional outlets of dtugs and medicines provided no prescription or

ethical products are soldThe Board, subject to the approval by the Commission, may add, delete, or modify the

above list of establishments as the need arises in order 0 be able to keep pace with developmentsin the industry.

Pharmacists in government service shall receive a starting salary equivalent to SalaryGrade 15 as provided in R.A. 6758 (Compensation and Position Classification Act of 1989) andits amendments. Pharmacists in the private sector shall receive an entry-level salary in pesoeqnivalent of at least 35% above the prevailing minimum wage.

A pharmacist working in a Category A establishment may be allowed to simultaneonslywork or rencler pharmacy services in not more than two Category B establishments, providedthat the Category B establishments are within a ten l0) kilometer radius from the Category B

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1 Partial filling of prescription is dispcnsing units less than the total quantity indicated in2 the prescription. The prescription should contain information as to how many units were served3 and shaH be returned [0 the buyer after being recorded in the appropriate book or equivalent4 system. The drugstore, which completes the filling of the prescription, shall keep the prescription5 on file for a prescribed period of time.6 Ethical preparations may be dispensed only with a valid prescJiption by a doctor, dentist7 or veterinarian.89 SEC 36. Physician s sample. - Drugs, biologic products, devices or proprietary

1 medicines, given or intended to be given free to the physician and other qualified person by any11 manufacturer or distributor or its medical representative as part of its program or promotion,12 should not be sold.13 The statement Sample, not for sale shall appear conspicuously on the container,14 package, or carton of the drug or device to be given. t shaH be unlawful to remove, erase, deface15 already marked original labels of samples.16 No physician's sample for drugs classified as antibiotics or anti-infectives, including anti-17 TB may be given or distributed.1819 SEC 37. Prohibition against use o cipher or unusual terms in prescriptions and2 prescription switching - Pharmacists should not componnd or dispense prescriptions, recipes or21 formulas which are written in ciphers, codes or secret keys or prescriptions of dmgs using22 unusual names which differ from those in standard phat111acopeias or formularies.23 The phannacist dispensing or compounding prescriptions should not substitute the drug24 or drugs called for in the prescription with any other drug or substance or ingredient without25 pJior consultation with, and a written consent of the person prescribing, except in accordance26 with RA 6675, known as the Generics Act of 1988, and other pertinent laws and regulations. I27

22 SEC 38. Label o Dispensed Medicines. - Upon every box, bottle or package containing29 medicine compounded or dispensed by a registered and licensed phar111acist based on

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1 prescription, there shall be pasted, affixed or imprinted a sea or label bearing, among others,2 name of patient, generic name of dmg; brand name, if any, strength, expiry date, directions [or3 nse, and name and address of dmgstore and other reqnirements prescribed by the Cheaper4 Medicines Act (RA 9502) and its implemcnting mles and regulations.5 Every prescription which in its preparation contains any quantity of a dmg, which is

habit-forming, or a derivative of such dmg, shall have an auxiliary label or a notation, Warning7 - May be habit forming . Such prescriptions should comply with the requirements of the RA8 9165, the Comprehensive Dangerous Drugs Act of2002, or other applicable laws.9 Prescription for external use shall be filled with an auxiliary label bearing, For External

10 Use.1112 SEC. 39. Record Books or Prescription - All prescriptions dispensed in the drugstore13 shall be recorded in thc book or an equivalent recording system approved by FDA for this14 purpose indicating therein, among others, the prescription number, name of prescriber, generic15 name and brand, dosage strength, quantity of dmg, name of the patient and address, and initials16 of pharmacist. t shall be open to inspection by the proper authorities at any time of the day when17 the pharmacy is open to the public and must be preserved for a period of not less than two (2)18 years after the last entry. I19 All prescriptions shall be attached to the prescription book or compiled and numberecl '2 consecutively and shall be preserved for the same period of time as required.21 All required information on dangerous drugs dispensed by a phannacy shall be recorded22 in the Dangerous Drugs book or an equivalent recording system as required by R.A. 9165, or23 other applicable laws.

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1 SEC. 40. Requirements for the Opelling and Operation o Retail Drug Outlet or2 Establishment. - The minimum requiremcnts necessary for the opening of retail drug outlet or3 establishment shall be in accordance with the rules and regulations prescribed by the Food and4 Drug Administration in accordance with the provisions of this Act.5 The application for the opening of a retail drug outlet or other business establishments6 should not be approved unless applied for by a Filipino registered pham1acist either as owner or7 as pharmacist-in-charge pursuant to the provisions of this Act.89

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SEC. 41 Halldling ofDrugs y Persons Other than a Pharmacist, - For the purposeof this section, persons handling drugs other than the phannacist are: professional medical ,representatives, pharmacy assistants, pharmacy aides/clerks, and other persons who assistpharmacists in dispensing medicines or any other person performing [unctions involving thehandling of drugs and drug products, t is prefen ed that these positions are occupied by thosewho finished pharmacy degree, not necessarily licensed as phannacists and who have undergonethe prescribed training from a Commission-accredited provider,

No person, except pharmacy graduates, shall be allowed to render such services withoutundergoing comprehensive standardized training programs approved and accredited by theBoard, A reasonable fee shall be assessed by the accreditation board for the examination andaccreditation,

ARTICLE VACCREDITED INTEGRATED PROFESSIONAL ORGANIZATION

4 SEC. 42. The ACCI edited Integrated Professional Organization (AIPO) of Pharmacists25 - The pharmacists shall be integrated under one national Accredited Integrated Professional6 Organization (AIPO) of pharmacists which is duly registered with the Securities and Exchange

27 Commission (SEC), The Board, subject to the approval by the COlmnission, shall accredit the28 said organization as the only integrated national organization for registered pharmacists, All29 pharmacists whosc names appear in the registry shall ipso facto or automatically become f

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members thereof and shall receive all the benefits and privileges accorded to its members upon2 payment of the required fees and dues Membership to the foregoing shall not be a bar to3 membership in any other association of pharmacists.4 All pharmacy assistants shall be accredited by the Board and shall ipso facto become5 members of the AIPO and included in the registry of phannacy assistants.6

7 SEC. 43. Membership in the Accredited Integrated Professional Organization o8 Pharmacists - All registered pharmacists and pharmacy assistants must be members of the9 AIPO and must maintain membership throughout the duration of the practice of the profession.

10 Professional identification card shall not be renewed if the requirements for membership with11 AIPO are not met including credit units for attendance at duly accredited continuing professional12 development CPD) education activities.1314 SEC. 44. Specialty Boards n Various Areas of Pharmacy Practice. - Specialty15 Boards shaH be created within the affiliate organizations and societies for recognition of the16 AIPO. The Board, subject to the approval of the Commission, shall accredit specialties in17 various areas of practice, set standards of practice within different specialties, and establish the18 qualifications and requirements for certification of practitioners under each specialty.19

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ARTICLE VIVIOLATIONS, ADMINISTRATIVE SANCTIONS, AND PROCEDURES

22 SEC. 45. Revocation or Smpension o the Certificate o Registration and Cancellation23 o Temporary or Special Permit - The Board shall have the power, upon notice and hearing to4 revoke or suspend the certificate of registration of a registered pharmacist or to cancel a

2S temporary or special permit granted to a foreign pharmacist on the basis of the following:6

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a) Violation of this Act on unauthorized practice of phannacy, violation of anyprovision of this Act, the Implementing Rules and Regulations IRR) thereof, theCode of Ethics for Phal1nacists, Code of Good Governance. Code of Teclmical

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1 n) Practicing pharmacy while under suspension;2 (0) Practicing with an expired professional identification card;3 p) Operating and or dispensing drugs through online pharmacy.45 SEC. 46. Grounds for Non renewal o license. - The following are the grounds for the6 non-renewal of professional identification card:7 (a) Refusal to join or to remain a member of good standing of the AIPO;8 (b) Non-payment of allliual registration fees for three (3) continuous years;9 (c) Non-compliance with the continuing professional development requirement, for the

10 renewal ofll is/her professional identification card; and11 The Board shaIl periodically evaluate the aforementioned grounds and revise as the need12 arises subject to the approval of the Commission.13 Any person, entity or orgallization may file charges according to the provision of this section14 against any registrant, or the Board may investigate violation of any of the abovementioned

15 causes. Affidavit of complaint under oath shall be filed together with the affidavits of witnesses16 and other documentary evidence with the Board through the Legal and Investigation Office. The17 move to conduct an investigation shall be embodied in a formal chal ge to be signed by at least a18 majority of the members of the Board. The rules on administrative investigation issued by the19 Commission shall govern the hearing or investigation subject to applicable provisions of this20 Act, R.A. No. 8981 and its rules and regulations thereof, and Rules of Court.21222324

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SEC. 47. Administrative Investigation/Sanctions. - Administrative investigations sha1lbe conducted by the Board assisted by the Legal or Hearing Officer of the Commission. The fexisting rules of evidence shall also be obs :,TVed and applied during administrativeinvestigations.

[fthe Board, by a majority yote of the members, shall find that the charges are sustainedby evidence adduced, it may, at its discretion reprimand the respondent or revoke or suspend hiscertificate of registration.

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1 SEC. 48. Procedure and Rules. - The Board upon receipt of a formal complaint under2 oath against any phannacist shall furnish the latter a copy of the complaint, which shall be3 answered in writing within ten 10) days from receipt thereof. Ifthe Board, after careful study of4 the records, finds that there is a valid ground to the chaxge, it shall conduct a formal investigation5 and set the dates of the hearing thereof. For this purposc, a subpoena and/or subpoena duces6 tecum may be issued by the chairman of the Board or by the Chief, Legal and Investigation7 Division. Thc investigation proceedings shall at all times be recorded. The investigation shall8 have been terminated and resolved within ninety 90) days fi-om the time the first date of hearing9 shall be set and heard.

1011 SEC. 49. Rights o Respondent. - The respondent phmmacist is entitled to be heard or be12 represented by counsel; to have speedy public hearing, to confront, and to cross-examine the13 witness or witnesses against him; to summon and present witness or witnesses in his behalf; or to14 avail himself/herself of any other process for the protection of his/her constitutional rights.15 ,16 SEC. 50. Motion for Reconsideration. - A motion for reconsideration within the,17 prescribed period may be made based on any of the following grounds:18 a) Grave abuse of discretion by the Board;19 b) Findings not suppOited by substantial evidence; and,20 c) Irregularity in the conduct of investigation.2122 SEC. 51 Appeal/Finality o Decision - The decision of the Board shall automatically23 become final and executory fifteen \5) days from the appropriate service of the decision to the24 respondent, unless the latter within the same period, has appealed the decision to the25 Commission; provided that said decision of the Commission may be appealed to the Court of26 Appeals.

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1 (i) Preparation and compounding of pharmaceutical products in quantities greatly in excess2 of single therapeutic doses without a registered pharmacist3 D Non-compliance with the labeling requirement for dispensed medicines by a drug outlet4 (k) Allowing pharmacy assistants to dispense without the supervision of a pharmacist5 I) Manufacturing and selling of phannaceutical products under fraudulent name and6 address7 (m) Adulteration and misbranding ofdrugs8 (n) Manufacturing and selling of unsafe, substandard and counterfeit drugs9 (0) Operating an online phannacy service or selling of drugs online (Section 32)

1 Requirement o Pharll/acist Sections 33, 35)11 (p) Category A establislunents which open for business without a licensed pharmacist12 (q) Category B establishments which are not under the supervision of a licensed pharmacist13 (r) Compounding by a non-registered pharmacist or a pharmacist with an expired license14 (s) Filling of prescription by a non-phannacist or a non-registered phannacist or a15 pharmacist with expired license.1617 SEC 53. Other Penalties. - Any person who shall violate any of the following provisions of18 this Act shall upon conviction, be sentenced to a fine of not less than One Hundred Thousand19 PhpIOO,OOO.OO) Pesos but not exceeding Two Hundred Thousand Php200,OOO.OO) Pesos or to20 an imprisonment of not less than Thirty (30) days but not more than One (1) year, or both21 penalty and fine at the discretion of the court, thus:22 (a) Affixing of the litie, R.Ph. by a person who is not a pharmacist duly registered by the23 Board (Section 20)24 (b) Practice ofpharmacy in the Philippines by a foreigner without special pennit (Section 28)25 (c) Non-indication by a pharmacist of his/her registration number and Professional Tax26 Receipt number in official documents requiring such information (Section 29)27 (d) Failure to display original certificate of registration of a pharmacist 111 a drug28 establislunent requiring such (Section 31)

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1 (e) Refusal to display certificate of registration of a phannacist a prominent and2 conspicuous place by an establislunentioutlet (Section 31)3 0 Refusal by an establishment to comply with compensation requirement as provided in4 Section 33 of this Act5 (g) Non-compliance by a pharmacist with the requirement on the filling of prescription6 (Section 35)7 (h) Non-compliance by a registered pharmacist on the requirement for partially filled8 prescription (Section 35)9 (i) Selling ofphysician s samples (Section 36)

10 j) Distribution of physician s samples of dmgs classified as antibiotics, anti-infectives or ,11 anti-TB (section 36)12 Ie) The removal, erasure and alteration ofmark or label ofphysici all s sample (Section 36)13 1) The use of cipher, codes or secret leeys or unusual names or terms in prescriptions (Sec4 37)

15 (m) Filling of Prescriptions where cipher, codes, secret keys or unusual names and terms are16 used (Sec 37)17 (n) Non-compliance with the Provisions on Record Books for Prescription by a drug outlet18 (Section 39)19 (0) Employment o[persons in a phannacy orphatmaceutica1 operation without the provision20 of the required training and certification (Section 41)21 (p) Rendering dispensing-related services by non-pharmacists a dmg establishment22 without undergoing the required training (Section 41 )

23 Any person other than the citizens of the Philippines having been found guilty of any24 violation as provided for in this and the preceding section shal1, after having paid the fine or25 having served his sentence or both when so adjudged, be also subject to immediate deportation.26 For any violation of the provisions of this Act penalized under this and the preceding27 section, which also constitutes or considered as punishable offense or described as a violation of

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1 other laws, thc applicable penalty sha1l be that of the law providing for a higher fine and/or2 imprisonment.3 For any violation of the rules and regulations implementing the provisions of this Act,4 appropriate penalty sha1l be imposed.56 ARTICLE VIII7 FINAL PROVISIONS89 SEC. 54. ETl/orcemellt. - The Commission shall be the enforcement agency of this Act.

10 As such, the Commission sha1l implement the appropriate provisions of this Act, enforce its11 implementing rulcs ancl regulations as adopted by the Board, assist the Board in the investigation12 of complaints against violators of this Act, its rules and regulations, Code of Ethics for13 pha1111acists, professional standards, and other policies of the Board and the Commission.14 The Commission and/or the Board sha1l call upon or request any department,15 instrumentality, office, bureau, institution or agency of the govenU11ent, including local16 govermnent units to render such assistance as t may require, or to coordinate or cooperate in17 order to carry out, enforce or implement the prOVisions ofthis Act.1819 SEC. 55. Appropriations. - The Chairperson of the PRe shall immediately include in its20 programs on the implementation of this Act, the funding of which shall be charged against their

Icurrent years appropriations and thereafter, in the annual General Appropriations Act.1

22 SEC. 56. TraTlsitory Provisions. The incumbent Chairman and members of the Board3 Shall, in an interim capacity, continue to function as such until the Chairman and members o1 tl1e

24 new Board created under this Act shall have been appointed, constituted and/or organized25 pursuant thereto.267 SEC. 57. Implementing Rules amI Regulations. - Within Olle hundred and twenty (120)

28 days after the approval of this Act, the Board subject to the approval by the Commission, in33


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1 consultation with the AIPO, shall issue and formulate the implementing rules and regulations, aswell as the Code of Ethics and professional standards for pharmacists, to effectively implement

3 this Act.45 SEC 58. Separability Clause. - If any clause, provisions, paragraph or part hereof shall6 be declared unconstitutional or invalid, such judgment shall not affect, invalidate, impair any7 other part thereof, but such judgment shall be merely confined to the clause, provision, paragraph8 or part directly involved in the controversy in which such judgment has been rendered.9

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SEC 59. Repealing clallse. - R.A. No. 5921, known as the Phannacy Law, as amendedby E.O. No. 174, and PD No. 1363, and all other laws inconsistent herewith are hereby repealed,Presidential decrees, executive orders, and other administrative issuances and parts thereof whichare inconsistent with the provisions of this Act are hereby modified, amended, superseded and/orrepealed accordingly.

6 SEC. GO Eff ectil,ity. - This Act shall take effect after fifteen 15) days following the full17 and complete publication thereof in the Official Gazette or in two 2) major daily newspaper of18 general circulation in the Philippines.

Approved,

f

SBN-3140 (Per Ctte. Rpt. No. 129)

Documents

Transcript of SBN-3140 (Per Ctte. Rpt. No. 129)