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SIXTEENTH CONGRESS OF THEREPTJBLIC OF THE PHILII'PINESEirct Regular Session

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SENATE

S. B. No.

'13 JUL lU il9:14

\;REr "-'t ': lt\':_fi_

U698

lntroduced bv SenatorFRANCIS G. ESCI'JDERO

HPLANATORYNOTE

This bill proposes In professionalize the practice of pharmacy by setting a

national standard for the profession" likewise creating a Professional regulatory board

to ensure excellent, globally competitive, and accountable Practice of the same.

Pharmacy as a health profession links the health sciences with the chemical

sciences and ir charged with ensuring the safe and effective use of Pharmaceuticaldrug;s. The scope of the pharmacy practice involves haditional roles such as

conipo"nding and dispensing medications, but ds9 includes more modem services

,"Ltud to heilttr care, inctuaing clinical services, reviewing medications for safety and

efltcacy, and providing drug information. Phannacists, therefore, are and should be

"rpu"tr ot d*g therapy, and are the primary health P_rofessionals who oPtimize the use

of ^ medication-to provide patients with positive health outcomes. Education and

experience in the field should therefore be underscored'

This bill seeks to address the competency needs of the profession and also curb

both unintentional or intentional harm that rnay h caused by an unregulated practice'

This proposed measure will fulfill this objective through the:

f. petlnition of the scope of nahrre and regulations of the professional practice of

pharmacY;2. treation of the Professional Regulatory Board of Pharmacy;

3. Setting up of criteria or qualifications for the licensure of practitioners; anc

4. Imposition of penalties for violators of this Act'

In view of the foregoing the passage of this bill is earnestly sought'

&-FRANCIS G. ESCT.IDERO

SilTEENTH CONGRESS CIF TI{EREPI,JBLIC OF fiTE PHILIP.PINESFhst Regular Sessiott

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SENATE

E...ii Sr,'.ti*'ir;;-97 rg'1,r1 1,1 rr.r iilrr::r11

'13 JUL l0 A9:14

s. B. No. 698

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Introduced l.rv Senator FRANCIS G. ESCUDERO

A}IACTREGULATING THE PR.ITCTICE OF PHARMACY IN THE PHILIPPINES'

irPNIr.NC FOR THE PI'JRPOSE REPI,'BLIC ACT NO. sqN, THE PHARMACY

LAW AS AMENDED, ANf, FOR OTHER PURPiOSES.

Be it etuctcd by thc Senatc and the Houx of Repre*ntatkns of the Republic of the

Philippines in C-ongress as*mliled:

ARTICLE IGENERAL PROVISIONS

section 1. - Title. - This Act shall be known as the "Philippine Pharmacy Act".

Sec.3. - Objectioes. - This Act provides for, and shall govem:

(a) the standardization and regulation of Pharmacy educatioru

(b) the examination for registration of graduates of schools and colleges of

pharmacy,

(c) the supervisiorr" conkol, and regulation of the practice of pharmacy in the

Philippines

(d) the enhancement of professional comPetence through continuing professional

developmen! researcb and other related activities and

(e) the integration of the pharmacy profession.

Sec. 4. - Definition of Tenns. - For purposes of this AcL the term:

4 sec. 2. - statencnt of Policy. The state recognizes the vital role or pharmacists in

; [f,utrit healthcare aetvery through their services in providing safe, effective, and

6 oualitv drugs or medicines; drug informatiorl patient medication counseling and

; il;r( p.rniotior,. The pharmacisL' professional service shall, therefore, be promoted

; ." , ""Lp"""", of the iotal healthcare systern" which shall ensure the physical well-

9 being of the FiliPinos.

l0 Hence, the state shall develop and nurture comPetent, productive, morally uprighl and

i i well-rounded pharmacists whose standards of professional practice and service shall be

12 excellent, qn litufi.'", world<lass and intemationally recognized, $oUa-tt1 competitive

13 through regulatory measures, Programs, and activities that foster their continuing

14 professionaldeveloPment.

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(a') Biologic Proilucts are microorganisrrs, sera, toxins and similar products used forthe prevention or cure of human diseases.

$) Brand Name means the proprietary or bade name given by the manufacturer todistinguish its product from those of the competitors.

(c) Cipher me.rns a method of secret *riting that substitutes other letters orcharacters for the letter intended or transPose tlre letter after arranging them inblocks or squares.

(d\ C-ode means a system of words or other symbols arbitrarily used to rePresent

words.

(e) Compounding is the preparation" mixing packaginp or labeling of adrug (i) as the result of a prescription or drug order by a physiciar; dentist,

optometrist, or veterinariarL based on the said practitioner-patient-pharmacistrelationship in the course of professional practice, or (ii) for the purpose of, or inrelation to, researclg teachinp or chemical analysis and not for sale ordispersing.

(f) C-osnetics are (i) products intended to be applie4 poured, sprinkled or sprayed

on, introduced into, or otherwise applied to the human body, or any part thereof

for cleansing beautifying promoting attractiveness or improving the

appearance, or (ii) ingredients or other subetances intended for use as acomponent of any such Product.

(g;) Coun@it drughneilicitulphannaceutical rcfets to medicinal products with the

correct ingredients but not in the amounts as provided wrong ingredientwithout active ingredient/s, with insufficient quantity of active ingredient,

which result in the reduction of the drug's safety, efficacy, quality, strength orpunty. It is a drug that is deliberately and fraudulently mislabeled with respect

to identity and/or source or with fake packaging, and can apply to both brandedand generic products. It shall also refer to:

(t) the drug itself or the container or labeling thereof or any Part of such

drug, container, or labeling bearing without authorization the trademark,trade name or other identification mark or imprint or any likeness to thatwhich is owned or registered in the Bureau of Paten! Trademark and

Technology Transfer (BPffD in the name of another natural or juridical

Person;

(ii) a drug product refilled in containers by unauthorized persons if the

legitimate labels or marks are use{

(ru) an imported drug product not registered with the Food and DrugAdministration (FDA), except drugs brought in the country for personal

use .rs confinned and justified by accompanying medical records; and

(lv) a drug which contains no amount of a different active ingredient or less

than eighty percent (80%) of the active ingredient it purports to Possess as

distinguished from an adulterated drug including reduction or loss orefficacy due to expiration.

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(h) Dangerous drugs irtclude those listed in the Schedules annexed to the 1951 Single

Convention on Niarcotic Drugs as amended by the 197 Protocol, and in theSchedules annexerl to the 192 Single Convention on Psychotropic Substances as

enumerated in the attached annex in Republic Act No. 9165, which is an integralpart of the Act.

(i) Dcoies refers to arry instrunent, aPParatus, implement, machine, implant invitro reagent or calil rrator, software, material or other similar or related article:

(a) intended by the manufacturer to be use4 along or in combination" forhuman beings for ,rne or more of the specific purpose(s) of:

(i) diagnosis, prev,-'ntion" monitoring treaknent, alleviation of diseases

of diseases,

(ii) diagnosis, monitoring treaknen! alleviation of or compensation for aninjury

(iii) investigatior! reftlacernent or modification or support of the anatomy of aphysiological Process,

(iv) supporting or sustaining life

(v) control of concePtiory

(vi) disinfection of medical devices,

(vii) providing information for medical or diagnostic purposes by means of an invitro examination of specimen derived from the human body; and

(b) which does not achieve its primary intended action in or on the human bodyby pharmacological, immunological or metabolic means, but which may be

assisted in their intended function by such means-

$) Oispensing is a process whereby a pharmacist receives and checks a valid-' prescribels medication order or prescription, and makes available drugs and

medicines, with advice on their proper use and other relevant information.

(k) Drugs anit Mciticines refer to chemical compounds or biological substances, other

than food, intended for use in the treatment, prevention or diagnoois of disease

in humans or animals, including but not limited to:

(r) any article recognized in the official United States Pharmacopoei4-National Formulary, official Homeopathic Pharmacopoeia of the UnitedStates, Philippine Pharmacopoeia, Philippine National Drug Formulary,British Pharmacopoen+ European Pharmacopoeia fapanesePharmacopoeia, and any official compendium or any supplement tothem;

any article intended for use in diagnosis, cure, mitigatioq treahnent, orprevention of disease of man and animals;

any article other than food intended to affect the structure or any functionof the human body or animals;

(ii)

(iii)

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(i") any article intend.ed for use as a component of articles specified in clauses(i), (it), and (iii.) not including devices or their components, parts,accessories; and

(") herbal and/or 'haditional drugs which are articles of plant or animalorigin used in liolk medicine which are: (a) recognized in the PhilippineNational Drug Formulary; (b) intended for use in the treatnent, or cure ormitigation of t lisease symptoms, injury or body defects in humans; (c)

other than foo 4 intended to affect the structure or any function of thehuman body; (d) in finished or ready-to-use dosage form; and (e)

intended for urre as a component of any of the articles specified in clauses(a), (b), (c) or (r).

(l) DruS or Plurmaeutical I'afuratory or Pharmaeutical Maru{actuing Lahratorymeans an establishment where pharmaceutical products, ProPrietary medicines,

or pharmaceutical ,lpecialties are formulated prepared compounded andstandardized.

(m\Drug Establislmrrrtts means FDA-registered companies involved in themanufactue, importation" repacking and/or distribution of drugs or medicines.

(n) Drug Outlcts refer to drugstores, pharmacies, and other business establishments

which are registered with the FDA and which legally sell drugs and medicines.

(o) Drugstarc ot Phmnu,cy mearu a place or establishment licensed by FDA wheredrugs, chemicals, pharmaceutical products, specialties, and devices are legallysold at retail or wholesale and where medical, dental, and veterinaryprescriptions are compounded and dispensed.

Qt) Exprmtion Datu means the date after which the product is not expected to Possessits cLaimed potency, efficacy, quality, and safety; and after which it is not legal tosell or distribute or use the said product.

(q) Eilling of a prescription refers to the act of dispensing or giving out of medicines

in accordance with the doctoy's order,

(r\ Hou*hold Rencdics shall refer to any preparation containing pharmaceuticalsubstances of common or ordinary use to relieve conunon physical ailmentswhich may be dispensed without a medical prescription in original packages,

bottles or containers, the nomenclature of which has been duly approved byFDA in the process of registration as defined in FDA AO No.115 s. 191)

(s) Cncric Nnne means the scientifically and internationally recognized name of theactive ingredient/s as approved by the Food and Drug Administration.

(t) hbel means a display of written, printed or graphic inlormation upon the

immediate container, or attached to or accomPanying any pharmaceuticalproducts.

(\ Labeling means all labels and other written, printed, or graphic matter (1) uponany item or any of its containers or wrapPers or (2) accompanying any such item.

(v) Ooer-the- aunter ilrugs are drugs used for symptomatic relief of minor ailmentswhich may be dispensed without a prescription.

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| (w)Phnrmaeutical proilucts or Phmmaeuticnl specialtics are drugs, preparations, or2 mixture of drugs under a br;md or generic name and intended for the cure,

3 mitigatior! treatrrent, or Prevr:ntion of disease in rvtn or animi s.

4 (x) Phtrmacist-only ooer'the-aun'er ilrugs are FDA<lassified over-the<ounter drugs5 and/or substances which should only be obtained from the drugstore or6 pharmacy with mandatory pharmacist's advice on their selection and proper7 use,

8 (y) Persoz includes an individr ral partnership corporatiorl or any juridical entity.

g (r\ Pharmaeutictl marleting m,zans any activity undertake& organized or sponsored

l0 by a drug establishment which is directed at Promoting the prescription"

l1 recommendatioo supply, ardministration or consumption of its pharmaceutical

lZ product(s) through direct pt:rsonal contact and all media, including the internet.

13 (aa) Pharmacy Assistants are thosr: persons who assist pharmacists in dispensing

14 medicines in community, hospital, industrial settings and in other activities,

15 such as, but not limited to medical missions, under the supervision of the

16 pharmacist and as described irr Sections 17 and'12 of this Act.

l7 pb) Physician's samples reter to medicines given to a physician for free for18 promotional PurPoses.

(cc)Prescription ilrugs are thor,e drugs which can only be dispensed by a pharmacistto a patient upon the presentation of a valid prescription from a physician,dentisL optometrist or veterinarian and for which pharmacist's advice on theirproper use is necessarY.

(dd) Reflling of a prescription refets to the act of dispensing or giving out theremaining balarrce of medicines ordered in the prescription when the wholequantity ordered is not yet completely filled.

(ee)Sectet Kegts means a characteristic style or symbols kept from the knowledge ofothers or disclosed confidentially to a few individuals.

Sec. 5. - Enfotcmrmt. - The Professional Regulatory Board of Pharmacy and theProfessional Regulation Commission are the body responsible for the implementationof the provisions of this Act.

ARTICLE IITFIE PROFESSIONAL REGTJLATORY BOARD OF PHARMACY

33 Sec. 6. - The Boa*l of Phumacy antl its Composition - There is hereby created a34 Professional Regulatory Board of Pharmacy, hereinafter called the Boar4 under the35 administratioru conkol, and supervision of the Professional Regulation Commission36 therein after called the Commissiory composed of a Chairman and four (4) members,37 each of which represent the areas of practice of community, hospital, manufacturing38 academe, and government service, who shall be appointed by the President of the39 Philippines from the recommendees ranked by the Commission from the list of40 nominees submitted by the Accredited Integrated National Organization for4l Pharmacists.

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I Sec. 7. - Qualifieations of Boanl Menbas. -To be appointed as member of the Board2 of Pharmacy, a person shall be:

3 (a) A citizen of the Ptrilippin:s and a resident for at least five (5) years;

4 (b) A duly registered phannacist, preferably a holder of a Master of Science in5 Pharmacy, or its equivalent degree and has been in the practice of pharmacy for6 at least ten years;

Z (c) Of good moral character with a valid certilicate of registratior; valid professional8 identification card and preferably with teaching experience; and preferably9 representing each field of practice;

l0 (d) At the time of appoinhnent not a member of the faculty or administrative office1l of any school, college or university offering degree programs in pharmacy nor12 connected in a review school or center; nor has any direct or indirect pecuniary13 interests in any school, college, or any institution offering pharmacy; and

14 (e) A member of good standing for at Ieast five (5) years of the accredited integrated15 national pharmacy association but, at the tirne of nomination, not an officer or16 trustee thereof.

17 Sec. 8. - Ttm of Office of Boail Memberc, - The chairman and the members of the18 Board shall hold office for three (3) years after appoinknent or until their successors

19 shall have been appointed and duly qualified; Frovide4 the incumbent Board members20 shall finish their terms to complete the membership of the Board. Prwidctl, further, that21 the chairman or any merrrber may be re-appointed for another term but in no case shall22 he/she serve for more than six years.

23 Sec.9.- Compensationof thcBoardof Phannacy.-AsprovidedforinR.A.No.898L,24 known as the "PRC Modemization Act of 2000", the members of the Board shall receive25 allowances and benefits equivalent to at least two salary grades lower than the salary26 grade of the Commissioner, while the chairman of the Board shall receive a monthly27 compensation equivalent to two steps higher than the members of the Board. The28 chaixnan and members shall be entitled to other allowances and benefits provided29 under existing laws.

30 Sec. 10. - Pouters, Eunctiotts anil D#ies of the Boanl. - The Board shall exercise these3l specific powers, functions, and duties:

32 (a) Conduct licensure examination for pharmacists;

33 (b) Approve the registration of pharmacists and the certification of drug handlers as34 covered bySec.42 of this AcU

35 (c) Prepare, adopt, and issue the Table of Specifications for the subjects in the board36 licensure examination for pharmacists in consultation with the academe;37 detenrrine and prepare the questions therefor; score and rate the examination38 papers with the name and signature of the Board member concerned appearing39 thereon and submit the results in all subiects duly signed by the members of the40 Board to the Commission no later than three (3) days from the last day of4l examination unless extended by the Commission for justifiable cause/s;

42 (d) Review and/or amend the scope of liceruure examinatiory

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(e) Ad4 delete, modify the scope, definition and standards of practice of pharmacy;

($ Reprimand any plnarmacisf suspend, or revoke his/her certificate of registrationon the grounds a,s provided for in Sec. tl6 hereof, after a formal administrativeinvestigation;

(g) Promulgate from, time to time the necessary rules and regulations for theeffective enforcen rent of this Ac9

(h) Monitor the cond itions affecting the practice of pharmacy in the Philippines andadopt measures that may be deemed proper for the enhancement of theprofession and/or the naintenance of high professional, academic, ethical andtechnical standar<ls;

(i) Verify or conffurn the qualificatioru and conditions of pharmacists employed indrugstores, hospital drug or pharmaceutical laboratories, drugtraders, importers, cr:smetics and medical device establishments for which theBoard may designatr: inspectors from the Food and Drug Adminiskation andother related institutions for such purpose;

O Investigate cases aris ing from violations of this Acg the rules and regulationspromulgated thereunder and the Pharmacist's Code of Ethics, technicalstandards, and other Board i$uances and for this purpose, may issue sur nons,subpoena ilues ad hstifcanifum and subpoena dues tecum to the respondentsand/or witnesses to compel tlreir attendance in such investigations or hearings:Ptwided rlvt, tl:re decision of the Board shall, unless appealed to the Commission"becomes final and executory after fifteen (15) days from receipt of notice ofjudgment or decision;

(k) Cite a person in conternpt for failure or refusal to obey the lawful order of theBoard in accordance with the Revised Rule of Courb

(l) Delegate the hearing or investigation of administrative cases filed before themwhereat the hearing shall be presided over by at least one (L) member of theBoard concemed assisted by a Legal or Hearing Officer of the Commissior;provided that if the charge is not related to the technical practice of theprofession, the hearing may be conducted without a member of the Board;

(m) Conduct, through the kgal Officers of the Commission" summary proceedingson minor vioLations of the respective regu.latory laws, as determined by theBoard. Violations of the rules and regulations issued by the Board toimplement this Act, violations of the general instructions toexaminees committed by examinees, and render summary judgment thereonwhich shall, unless appealed to the Commissioru become final and executoryafter fifteen (15) days from receipt of notice of judgment or decision;

(n) Subject to the final approval by the CommissiorL recommend registrationwithout examirution and the issuance of conesponding certificate of registrationand professional identification card to foreign pharmacists duly licensed incountries with agreement of reciprocity with the Philippine govenunenq

(o) Prepare an annual report of accomplishments on programs, projects, andactivities of the Board during the year for submission to the Commission after

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the close of each calendar year including appropriate recommendations on issuesor problems affecting the practice of pharmacy;

(p) Issue and promulgate guidelines on continuing professional developmenteducation in coordination with the accredited professional organization;

(q) Recommend to the CFtrED for the closure of the program or course of pharmacyoffered by a school/college pursuant to the latte/s policy thereon; and

7 (r) Perform any implit:d incidental, necessary Power for the effective8 implementation of this Act.

9 Sec. l1.. - Grcunils for Stspension ot Termitetion of Term of Office of the Chairman or10 Mmrber of thc Boaril lrom fuis/her Olffce. - The President of the Philippines, upon the

ll recommendation of the Commission" after giving the Chairman or the member of the

12 Board an opportunity to defend himself/herself in an administrative investigation13 conducted by the Commfu;sion" may remove or suspend him/her on any of the14 following grounds:

15 (a) Gross neglec! incornpetence or dishonesty in the discharge of his/her duty;

t6 (b) Violation of any of the causes/grounds/ and the prohibited acts provided in17 this Act and the offenses in the Revised Penal Code, the Anti4raft and18 Comrption Practices and other laws;

19 (c) lnvolvement in the manipulation, tampering or rigging of the licensure

20 examinatior! its questions and/or its results and the disclosure of classified and2l confidential information pertaining to the licersure examination.

22 (d) Conviction of an offense involving moral turpitude by a court of jurisdiction.

23 The Commission in the conduct of investigation shall be guided by Section Z and24 Section 15 of R.A. No. 8981 and the rules on adminiskative investigation thereof,

25 and the applicable provisions of the New Rules of CourL

26 ARTICLE III27 EXAMINATION,REGISTRATION,CERTIFICATION,ANDLICENSURE

28 Sec. 12. - Passing of Licensurc Examination Requitetnett. - Except as otherwise29 specifically allowed under this Act applicants for registration for the practice of30 pharmacy shall be required to pass a licersure examination as provided for in this Act3l and in accordance with Sec. 7 (d) of R.A. No. E981.

32 Sec. 13. - Qualificatiotts of Applicants. - An applicant for the licensure examination for33 pharmacy shall satisfactorily show that he/she possesses the following qualifications:

(a) Citizen of the PhilipPines or a foreign citizen whose country,/state has

reciprocity with the Philippines in the practice of pharmacy;

(b) Of good moral characbr and reputation;

(c) A holder of a Bacheloy's degree in pharmacy duly recognized or accredited bythe Commission on Higher Education (CHED) and conferred by a school/college/university duly authorized by the government or its equivalent degree

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obtained by either 'r Filip,ine ot loreign citizen from an irutitution of leaming in aforeign country/state, ftrovided it is duly recognized and/or accredited byCHED;

(d) Not convicted of an offe nse involving moral turpitude by a court of competentjurisdiction; and

(e) He must have completerl an Internship Program which shall consist of at least

nine hun&ed sixty hours (960 hours), six hundred hours (6fl) hours) of whichshall be spent equally distn buted in a community pharmacy, hospital Pharmacy,or pharmaceutical indushy - manufacturing regulatory, marketing or research

- and other related fields, while three hundred sixty hours (360 hours) ofinternship shall be sPent ili any of the accredited pharmacy establishments orentity chosen bY the candi&rte.

For this purpose, the atrov,:mentioned community pharmacy, pharmaceuticalcompany, and hospital pharrn.rcy shall keep a seParate record of pharmacy students

who underwent said internshiP program directly under their control and as a resultthereof, shall issue the proper certificate of said hours of intemship. It shall also be

the duty of said establishmenrts to submit semi-annually a complete report of the

names of those who have uI rdergone training under their supervision and thecorresponding number of hcrurs of intemship credit of each of the pharmacystudents to their respective col.,leges or schools and to the Board.

Sec. 14. - Scope of Examinatiott - The licensure examination for pharmacists shall be

divided into two major divisic'ns: Pharmacy as Science and Pharmacy as Practice.

Pharmacy as Science shall consist of subjects in Group I (Public Health, Pharmaceutical

Microbiology and Parasitology), Group II (Drug Delivery Systems, Physical Pharmacy,

Manufacturing Pharmacy, Q'taltty Control I, Quality Control II), Group III(Pharmaceutical Biochemistry, Pharmacognosy, Plant Chemistry, and PhilippineMedicinal Plants, Pharmacy and Chemistry of Medicinals I and Pharmacy andChemistry of Medicinals II.

Pharmacy as Practice shall be made up of the following subjects: Group [V(Pharmaceutical Calculations, Hospital Pharmacy, Clinical Pharmacy, Dispensing andMedication Counseling), Group V (Biopharmaceutics and Pharmacokinetics,Pharmacology L Pharmacology II, Clinical Toxicology), and Group VI (Pharmaceutical

furisprudence and Ethics, Pharmaceutical Marketing and Entrepreneurship andPharmaceutical Administration and lvlanagement).

The subjects shall be weighed as follows: Group I, 10%; GrouP ll,20%; Group III, 20%;

Group IV,20%; Group V,20%; and Group VI, 10 %.

The Board subject to the approval by the Commission may introduce relevant changes,as the need arises, to the content of the examination and the relative weight attributedto each subject in the examination may be made after consultation with the dulyrecognized association of schools or colleges of pharmacy and the CHED.

Sec. 15. - Hokling ol Examinstion. - Examination for registration to practice pharmacyin the Philippines shall be given twice a year in such places and dates as theCommission may designate in the Resolution thereof on the Master Schedules for alllicensure examinations in accordance with Sec. 7 (d) of R.A. No. 8!)81. The said placesand dates may be subject to change under valid circumstances and reasons.

I Sec. 16, - Ratings in the Licansuv Examinntkn. - ln order to be registered and licensed

2 as a pharmacis! a candidate must obtain a ge.neral weighted average of seventy-five per3 cent (75%) or over with no ratings of fifty percent (50%) in more than two (2) subjects.

4 Sec. 17. Registration anil Licetsue of Phatmaq Assistant' - A general weighted5 average &low 75o/o but not lower than 70i6, with no ratings of fifty percent (50%) in6 more than two subjects, shall qualify an ex,aminee to be registered and licensed by the

7 Professional Regulation Commission to pra<:tice as a pharmacy assistant who shall work8 under the supervision of :r registered pharmacist. To be [censed as a pharmacist a

9 pharmacy assistant must pass succeeding lnard Iicensure examination for pharmacists

10 with a general average rating as provided in Section 16.

11 Sec. 18. - Rqort of Rding. -The Board shall submit to the Commission the ratings12 obtained by each candidate within ten (10) calendar days after the examination, unless

13 extended for just cause. Upon the rel ease of the results of the examinatiory the14 Commission shall send by mail the ratinlg received by each examinee at his/her given15 address using the mailing envelope submitted during the examination.

16 Sec. 19. - Oath of Ptofession. - All succe ssful candidates in the liceruure examinationl7 shall take their oath of profession before the Chairman or any member of the Board or18 any authorized officer of the Commission to administer oaths, prior to entering the19 practice of PharmacY.

20 Sec. 20. - Isstance of Certilicate of Regisbation and Prcfessional fuI.entification Caril. -2l A certificate of registration shall be issued to those who are registered upon payment of22 fees prescribed by the Commission. It shall bear the signatures of the Chairperson and23 the Commissioners of the Commission and the Chairnnn and Members of the Boar424 stamped with the official seal of the Commission and of the Board, certifying the person25 named therein is entitled to the practice of the profession with all the privileges26 appurtenant thereto. Until revoked or suspended in accordance with this Act it shall27 remain in full force and effect.

A professiohal identification card bearing the registration number and date, its validityand expiry duly signed by the Chairperson of the Commission shall likewise be issuedto every registrant who has paid the prescribed fee. It shall be reissued uponcompliance with ttrc continuing professional development education requirement as

specified in Article IV, Sec. 27 (d) of this Act and upon payment of the prescribed three'year registration fees therefor.

Sec. 21. - Affbing Wh after a Regbteted Phatmacisf s Name. - Ottly pharmacists whoare duly registered and licensed by the Board and the Commission has the right to affixthis title, "Registered Pharmacist" or "R.Ph." after his/her name.

Sec. ZL - Grounds fot Non-registtetioz. - The Board shall not register any successfirlexaminee for regiskation who has been:

39 (a) Convicted of an offense involving mord turpitude by a court of competent40 jurisdictior;

4l (b) Found guilty of immoral or dishonorable conduct by the Board,

42 (c) Summarily adjudged guilty for violation of the General Instructions to43 Examinees by the Board

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I (d) Declared of unsound mind by the court of competent jurisdiction" and

2 (e) Found addicted to danJ;erous drugs.

3 In refusing such registration, the Board shall give the applicant a written statement4 setting forth the reasons there:for and shall file a copy in its records.

5 Sec. 2?. - Reissuancc of Raookcil Ceftilictte of Registuatio4 Replacement of Lost ot6 Datnageil Crtificate of Regbtratio4 Prcfessional lilentification Catd or7 TempomryfSpecial Permit. - The Board may upon petitior; reinstate or reissue a8 revoked certificate of regislration after two (2) years from the date of the revocation of9 the certificate of registrati on or the surrender of the revoked certificate and/or the

l0 professional identification card if still vali4 to the Board and/or the Commission. Thell Board may or rnay not reluire the pharmacist whose certificate had been revoked to12 take another licensure exat nination. The petitioner shall prove to the Board that he/she13 has valid reason/s to be re instated to the practice of phamncy. For the grant of his/her14 petition, the Board shall issue a Board Resolution subject to the approval of the15 Commission.

16 Duplicate copy of lost or d amaged certificate of registration, professional identification17 card or temporary/special permit may be reissued in accordance with rules thereon and18 upon payment of the prescribed fee therefor.

19 Sec. 2rL - Non-pagrmett of thc PRC Regbbation Fees. - The Board shall suspend a20 registered pharmacist from the practice of his/her profession for non-payment of the2l PRC regiskation fees for more than three (3) consecutive years from its last or previous22 year of payment. The resumption of his/her practice shall take place only upon23 payment of delinquency fees plus surcharges and interest and in accordance with the24 rules of the Commission. The running of the three-year period may be intemrpted upon25 written notice about the discontinuance of his/her practice and surrender of his/her26 certificate of registration with professional identification card to the Board and/or the27 Commission.

28 Sec. 25. - Vesteil Rights: Autonatic Registrction. - All pharmacists registered before29 the effectivity of this Act shall automatically be registered hereunder, subject to the30 policy as to future

3l Certificates of registration and professional identification cards or temporary/special32 permits held by such persoru in good sbnding at such effectivity shall have the same33 force and effect as though they were issued on or after the said effectivity.

34 ARTICLE IV35 REGULATION OFTHE PRACTICE OF PHARMACY

36 Sec. 26. - Scope of thc Prudice of Phannaq. - A person deemed to be practicing37 pharmacy within the meaning of this Article is one who shall, with or without a fee,38 salary, percentage or other rewards, paid or given directly to hirnself or indirectly39 through another -40 (a) Itepare, compound or manufacture, analyzn, ass.ly, preserve, store, distribute,4l sell and/or dispense any medicine, drug chemicals, cosmetics, pharmaceuticals,42 devices or contrivances used in pursuance thereof; or

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1 (b) render services, such as but not limid to (i) regulatory services, (ii)2 pharmacerrtical marketing, (iii) drug information service and (iv) medication3 managemcrrt which covers the following: drug selection and procurement,4 storage and distribution" dispensing medication counseling and medication5 therapy monitoring whenever the expertise and the technical knowledge of the6 pharmacist is require4 in any drug establishment/outlet or healthcare7 institution or

8 (c) provide other services where pharmaceutical knowledge is required; or

9 (d) engage in teaching scientific, technical or professional pharmacy courses in al0 school or college of PharmacY; or

l l (e) conduct or undertake scientific research in all aspects involving drugs and

12 healthcare, or

13 (f) dispense drugS during medical missions and in other situations where

14 supervision of drugs is required.

15 All govenrment and non-government agencies, establishments, institutions, and

16 r"goLtory body with ftrnctions that involve the practice of pharmacy shall be headed

17 and managed only by a qualifie4 duly registered and licensed pharmacist.

18 All pharmacists are expected to abide by current standards such as the Good Pharmary

19 Practice, Good l,aboratory Practice, Good Distribution Practice, Good Manufacturing

20 Practice, and Good Clinical Practice, which are deemed vital in the performance of one's

2l roles and functions in different practice areas.

22 The Boar4 subject to the approval by the Commission' may add to, delete, or modify

23 the above acts, services, or activities as the need arises.

24 sec.xl. - Prcrequisites fot the Practice of Phatmeq. - A person can practice pharmacy

25 inthe Philippines provided he/she:

26 (a) has satisfactorily passed the licensure examination for pharmacists given by the

27 Board and the Commissior\

28 (b) is duly registered with and licensed by the Board and the Commission,

29 (c) is an active member of the accredited integrated national professional

30 organization

31 (d) has submitted continuing professional development education units as required32 by the Continuing Professional Education Council for pharmacists or pertinent33 laws and regulations for the renewal of his/her professional identification card,

34 and/or

35 (e) a holder of a valid temporary/special permit issued by the Board and the

36 Commission to foreign licensed pharmacists pursuant to this Act.

37 Sec. 28. - Foreign Reciptocity, - No foreigner shall be allowed to take the licensure

38 examination for pharmacists, regrster, receive his/her certificate of registration and39 professional identification card, and practice pharmacy in the Philippines unless the40 requirements for the licensirre examination and registration and practice of pharmacy

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1 imposed under the laws and the reguilations in his/her foreign. country or state are

2 substantially the same as those required and contemPlated by the Philippine laws and

3 regulations, and unless the said foreign laws and regulations allow Filipino citizens to4 practice within the territory of the said foreign country/state on the sanne

5 basis and grant the same privileges arr those enjoyed by the citizens, subjects or6 nationals thereof.

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Sec. 29. - Pructice thtough TempontgElreciel Permit. - A temporary/ special permitmay be issued by the Board su$ect to the approval of the Commission and payment ofapplicable fees to the following:

(a) licensed pharmacists from foreign corurtries whose services whether for free or afee

(1) if they are intemationally renowrred pharmacists or experts in any field orspecialtY of PharmacY,

(2) if their services are deemed necessary for lack of specialists or experts in aparticular field

(b) licensed pharmacists from foreign countries or states whose services shall be forfree and limited to indigent patients as beneficiaries; or

(c) licensed pharmacists from foreign countries or states emPloyed as visitingfaculty in a field or specialty of pharmacy.

The permit shall, among other things, contain these limitations and conditions for a

period of no more than one year, subject to renewal, the field or sPecialty of pharmacnand the specific place of practice including clinics, hospitals, and schools of pharmacy.The Board subject to the approval by the Commission shall promulgate rules andregulations on the implementation of this particular Section.

Sec. iXl. - lnilication of Numberc: Certiflcate ol Regislvatiog Professional Tax Receiptanl Accteilitetl Integrateil National Organization (NNO) Membership, - Thepharmacist shall be required to indicate on any document he/she signs, uses or issuesin connection with the practice of pharrracy the following information:

(a) his/her registration number and date of issuance,

(b) the expiration date of his/her professional identification car4

(c) the Professional Tax Receipt (PTR) Number and date of issuance, and

(d) the certificate of AINO mernbership (annual/lifetime), number and the officialreceipt of payment, number and date.

Sec. 31. - Registty of Phatmacbts. - The Board shall prepare and maintain a registry ofthe names, residences and/or office addresses of all registered pharmacists which shallbe updated annually in cooperation with the Accredited lntegrated NationalOrganization (AINO), indicating therein the status of the certificate of registratior;professional identification card and Accredited lrtegrated National Organization(AINO) membership, whether valid or inactive due to deatb or other reasons,delinquent suspended or with revoked certilicate of registration. The said registry of

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I pharmacists shall be conspicuously posted within the premises of the Commission and2 the information therein made available to the public upon inquiry or request.

3 Sec. 32. - Display of Ce*ificate of Regbtntioz. - It shall be the duty of every4 pharmacist engaged in the practice of pharmacy either on his/her own account or5 under the employ of another to display his/her original certificate of registration in a6 prominent and conspicuous place in a retail drug outlet or drug establishment which he7 operates or in which he/she is employed in his/her professional capacity as

8 pharmacist. No pharmacist shall, with his/her knowledge allow his/her certificate of9 regiskation to be displayed in such estabtshment when he/she is not actuallyl0 employed or operating therein in his/her professional capacity.

1 1 Sec. 33. - Compounding aail Dispensing. - No drug or pharmaceutical product of12 whatever nature and kind shall be compounde4 dispensed, sold or resold or otherwise13 be made available to the consuming public except through a FDA-licensed retail drug14 outlet or other business establishments which are dulv established in accordance with15 the provisions of applicable laws.

16 Prescription drugs and pharmacist-only over-the<ounter drugs shall be dispensed only17 by registered pharmacists.

l8 Prescription drugs shall be dispensed only upon presentation of a valid prescription.

19 Compounding and dispensing by duly registered and licensed pharmacists shall be in20 accordance with current good manufacturing practice, good laboratory practice, and2l good pharmacy practice, with the safety and protection of individual patients as22 ultimate objective.

23 Licensed pharmaceutical manufacturers, importers and wholesalers are authorized to24 seU their products only to duly licensed drug outlets, wholesalers and other drug25 establishments.

26 A registered and licensed pharmacist may refuse to compound, dispense or sell drugs27 and pharmaceutical products, if not in accordance urith this Act.

28 Sec. U. - Phatmacist Reqdrcnmt anil Compensetion - Every drug29 establishment/outlet selling prescription and pharmacist only over-the<ounter drugs30 whether owned by the government or a private person or firm shall at all times when3l open for business be under the direct control, supervision" and responsibilrty of a32 registered and licensed pharmacist. For retails outlets selling only over-the-counter33 drugs, they shall be under the supervision of a registered and licensed pharmacist.

34 Processes involving the preparation" quality control or repacking of pharmaceutical35 products in quantities greatly in excess of single therapeutic doses shall for each36 respective operation be under the direct and immediate supervision of a registered and37 licensed pharmacist. In the sale of pharmaceutical products, medicines and drugs, at38 wholesale such business shall be conducted under the immediate supervision of a39 registered and licensed pharmacist.

40 All govemment and non-govemment agencies and units which handle the procurement41 and distribution of drugs should have a supervising pharmacist. All rural health unis42 dispensing medicin€s should be supervised by a pharmacist or a pharmacy assistant as43 defined in this Act.

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Pharmacists in government sen'ice shall receive a starting salary equivalent to Salary

Grade 15 as provided in R.A. 6758 (Contpensation and Position Classification Act of1989) and its amendments. Tho'se pharm acists in the private sector shall receive anentry-level

""l"ry ir peso equiva lent of Salary Grade 15 being received by govenrment

pharmacists.

Sec. !t5. - Resporsibility for Qr'r'lity ol Drugs' Costnetie anil Meilical Dcoices. - lt7 shall be the duty of the register:d pharmacist of drug outlet/establishment to ensure

8 that all drug products, cosmetic.s and medical devices conform to standards of safety,

9 quality and efficacy and strictly adht're to the guidelines as provided for in this Act and

l0 other pertinent rules and re gulations and issuances. Owners, nvuragerri, and/orI I pharmacisS in charge of the oy:eratiorr of drug outlets and drug establishments shall be

12 held responsible.

13 It shall be unlawful for any Person to manufacture, PrePare, sell or dispense any14 prescription drug, pharmaceutj.cal, mer lical devices, or cosmetics under any fraudulent15 name, direction or Pretense or to adult(:rate any drug, pharmaceutical, medical deviceg16 or cosmetics offered for sale. Any dru1'" pharmaceutical Product, medical device/s or17 cosmetics shall be held to be aclulterat ed or deteriorated within the meaning of this

18 section if it differs from the standard r:r quality or purity given in the United States

19 Pharmacopeia/National Formulary anri Philippine Pharmacopeia, in its latest edition,20 or any standard reference for drugs and medicines given official recognitiog and those

2l which fall within the meaning as provided for in the Food Drug Cosmetic and Devices

22 Act R.A. No. 372O as amended by pertinent laws and the Food and Drug23 Administration AcL R.A. 0711.

24 ln cases of drug products sold in their original packings, the seal of which has not been

25 brokm or tampered witlr, the liability that may arise because of their quality and purity,26 rests upon the manufacturer or importer, the distributor, representative, or dealer who27 is responsible for their distribution or sale.

28 Sec. %. - Filling antl Putial Eilling of Prcsniption. - Nl prescriptions shall be filled or29 compounded only by a registered and licensed pharmacist following the standards of30 purity, safety and quality. Completely filled prescriptions should be surrendered to the31 pharmacist for recording.

32 Partial filling of prescription is dispensing units less than the total quantity indicated in33 the prescription. The prescription should contain information as to how many units34 were served and shall be refumed to the buyer after being recorded in the appropriate35 book or equivalent system. The drugstore, which completes the filling of the36 prescriptiory shall keep the prescription on file for a prescribed period of time.

37 Sec. 37. - Plrysician's sample. - Drugs, biologic products, devices or proprietary38 medicines, given or intended to be given free to the physician and other qualified39 person by any manufacturer or distributor or its medical representative/detailman as40 part of its program or promotior; should not be sold.

4l The statement "Sample, not for sale" shall appear conspicuously on the container,42 package or carton of the drug or device to be given- It shall be unlawful to removg43 erase, deface already marked original labels of samples.

44 Sec. !f8. - Prohibition against use of ciph,a or unusual tmns in ptesctiptions anil45 ptesctiptiott sutitching - Pharmacists should not compound or dispense prescriptions,

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1 recipes or formulas which are writben in ciphers, codes or secret keys or prescriptions of2 drugs using unusual names which differ from those in standard pharmacopeias or3 formularies.

The pharmacist disperrsing or c ompounding prescriptions should not substitute thedrug or drugs called for, in thr: prescription with any other drug or substance oringredient without prior consuJtation witlu and a written consent of the personprescribing except in accordancre wi*r RA 666 known as the Generics Act of 1988, andother pertinent laws and regula'tions.

Sec. 39. - Label of Dispenseil Nleilicincs. - Upon every box, bottle or package containingmedicine compounded or dis pensed by a registered and licensed pharmacist based onprescriptio+ there shall be p'rste4 affixed or a seal or label bearing amongothers, name of patient, gene ric name of drug brand name, if any, strengtlu exprry date,directions for use, and na,me and address of drugstore and other requirementsprescribed by the Cheaper Medicines Act (RA 9502) and its implementing rules andregulations.

16 Every prescription which in its preparation contains any quantity of a drug which isl7 habit-forming or a derivative of such drug shall have an auxiliary label or a notatior!18 "Waming - May bu habit forming". Such prescriptions should comply with the19 requirements of the R. 4.9765, the Comprehensive Dangerous Drugs Act of 2OZ and20 any future amendments ther,:to.

2l Filled prescription for exterrral use shall bear the auxiliary label "For External Use".

22 Sec. tlO. - Recotil Boolcs fot Prcsctiption - All prescriptions dispensed in the drugstore23 shall be recorded in the book or an equivalent recording system approved by FDA for24 this purpose indicating thereuu among others, the prerription numbet name of25 prescrihr, generic name and brand, dosage skengtlg quantity of drug name of the26 patient and address, and initials of pharmacist. It shall be open to inspection by the27 proper authorities at any time of the day when the pharmacy is open to the public and28 must be preserved for a period of not less than two (2) years after the last entry in it has29 beenmade.

30 All prescriptions shall be attached to the prescription book or compiled (for equivalent3l recording system) and numbered consecutively and shall be preserved for the same32 period of time as required.

33 All required information on dangerous drugs dispensed by a shall be34 recorded in the Dangerous Drugs book or an equivalent recording system as required35 by R.A.9155.

36 Sec. 41. - Requitemcnts for the Opning arril O?erutiol of Retail Dtag Outlct or37 Establisfunent, - The minimum requirements n€cessary for the opening o{ retail drug38 outlet or establishment shall be in accordance with the rules and regulations prescribed39 by the Food and Drug Administration in accordance with the provisions of this Act.

40 The application for the opening of a retail drug outlet or other business establishments4l should not be approved unless applied for by a Filipino registered pharmacist either as42 owner or as pharrnacist-in<harge pursuant to the provisions of this Act.

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I Sec. A - Harulling of Drugs by )?ercons Othn than a Phatmacist. - For the purpose of2 this section, persons handling dn.rgs other than the pharmacist are: professional medical3 representatives, phasnacy assisl,ants, pharmacy aides/clerks, and other persons who4 assist pharmacists in dispensinl; medicines or any other person performing functions5 involving the handling of drugs; and drug products. It is preferred that these positions6 are occupied by those who fi nished pharmacy degree, not necessarily licensed as

7 pharmacists and who has unclergone the prescribed training from a Commission-8 accredited provider.

9 The professional medical repres:ntative or detailman is one who represents any duly10 authorized manufacturer, distribr rtor, trader and wholesaler of drugs, pharmaceuticals,ll biologic products and devices, I vhose primary duty is to introduce said products to12 legitimate prescribers and whi,ch forms part of their program for promotion by13 describing its use, compositic'rL actiorg dosage administratiorL conkaindication,14 advantages and other relevant information about the drugs being Promoted.

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The pharmacy assistant is one w,\o helps the pharmacist in compounding dispensingof medicines and giving of information on proper use of medicines while the pharmacyaide/clerk is involved in other aspec'ts of operation assigned by the pharmacist.

Any person who shall be employed or engaged as professional medical representativeor pharmacy aide/derk shall undergo comprehensive standardized training programsapproved by the Board with providers approved and/or accredited by the Board inaccordance with criteria established therefor.

ARTICLEVACCREDITED INTEGRATED NATIONAL ORGANZATION FOR PHARMACISTS

Sec. 4f. - The Acctediteil Integmteil National Prcfessional Organization (NNO) ofPharmacists - The pharmacists are integrated under one national accreditedprofessional organization that is duly registered with the Securities and ExchangeCommission (SEQ. The Board subject to the approval by the Commission shall accreditthe said organization as the only integrated national organization for registeredpharmacists (and phamacy assistants). All pharmacists (and pharmacy assistants)whose names appear in the registry shdl ipn futo or automatically become merrbersthereof and shall receive all the benefits and privileges accorded to its members uponpayment of the required fees and dues. Membership to the foregoing shall not be a barto membership in any other association of pharmacists.

Sec. 41. - Mmfuaship to the Acctediteil Integmteil National PrcfessionalOtganizatiotr. - All registered pharmacists (and pharmacy assistants) must be membersof the AINO and must maintain membership throughout the duration of the practice ofthe profession. Professional identification card shall not be renewed if the requirementsfor membership with AINO are not met including crcdit units for attendance to dulyaccredited continuing professional development (CPD) education activities.

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41 Sec. tlS. - Specialty Boar& in Various Areag of Pharnracy Practice. - Specialty Boards42 created within the atriliate organizations and societies for recognition of the AINO (1)43 for the Board, subject to the approval of the Commissioner shall accredit specialties in44 various areas of practice, (2) setting standards of practice within different specialties,45 and (3) establishing qualifications and requirements for certification of practitioners46 under each specialty.

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I ARTICLEVI2 VIOLATIONS ADIVINISTRATWESANCTIONS, AND PROCEDURES

3 Sec. 46. - Reoocation or Stspensiott of the Certificate of Registration anil Cancellation4 of Tmryorury ot Special Pennit - The Board shall have the power, upon notice and5 hearing to revoke or suspend the certificate of registration of a registered pharmacist or6 to cancel a temporary or sperial permit granted to a foreign pharmacist on the basis of7 the following:

8 (a) Violation of this Act on unauthorized practice of pharmacy, violation of any9 provision of this l\ct, th.e Rules and Regulations (RR) thereof, the Code of

l0 Ethics for Pharmacists, Code of Good Govemance, Code of Technicalll Standards for the practice of pharmacy, policy, and me.rsure of the Board12 and/or the Commission;

13 (b) lvlalpractice or gross in<:ompetence; negligerrce, or imprudence resulting to14 deathorinjuryofthepatien!

15 (c) Dishonorable conduct aird/or conviction by a compeGnt court of any16 criminal offense involving moral turpitude;

17 (d) Fraud or deceit in the acquisition of the certificate of registration, professional18 identification card or temporary/special permit or renewal of license;

19 (e) Display of certificate of regisbation of a pharmacist who is not actually20 employed in such an establishment as required by law.

2l (0 Addiction to alcoholic beverages or to any habit-forming drug rendering him22 incompetent to practice his/her profession;

23 (g) Aiding or abetting the illegal practice of a non-registered and licensed person24 by allowing him,/her the use of his/her certificate of registration and,/or25 professional identification card or his/her special/temporary permi!

26 (h) Acting as a dummy of an alien or a per:son who is not qualified to establish27 and operate a rsfail drugsfsls;

28 (i) Insanity or any mental disorder that would render the person incompetent to29 practice his/her profession;

30 0) False, extravagant or unethical advertisements and product endorsements3l where the pharmacist's name, professional organization he/she represents,32 and similar information are used;

33 (k) lvlanufacture, sale, offering for sale of counterfeit drugs and committing other34 acts in violation of Sec. 4 of the Special Law on Counterfeit Drugs, R.A. No.35 8203;

36 (l) Illegal manufacturing, sale, possessior; dispensing of dangerous drugs and37 other pertinent acts in violation of Dangerous Drugs Act, R.A. No. 9165;

38 (m) Commifting acts in violation of sec. 5 of p.D. No. 881 on Flazardous39 Substances; and

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I (n) Practicing pharmacy while under suspension.

2 (o) Practicing with an expired professional identification card.

3 Section 47. - Non-renewal of license. - The following are the grounds for the non-4 renewal of professional identification card:

(a) Refusal to jorn or to renrain a member of good standing of the AINO;

(b) Non-payment of annual registration fees for three (3) continuous years;

G) Non-compliance with the continuing professional development requirementfor the renewal of his/her professional identification card; and

The Board shall periodically evaluate the aforementioned grounds and revise as theneed arises subject to the approval of the Commission.

ll Any persory entity or organization may file charges according to the provision of this12 section against any regishant or the Board may investigate violation of any of the13 abovementioned causes. Affidavit of complaint under oath shall be filed together with14 the affidavits of witnesses and other documentary evidence with the Board through the15 hgal and lnvestigation Office. The move to conduct an investigation shall be embodied16 in a fonnal charge to be signed by at least a majority of the members of the Board. The17 rules on administrative investigation issued by the Commission shall govern the18 hearing or investigation subject to applicable provisions of this Act R.A. No. 8981 and19 its rules and regulations thereof, and Rules of Court.

20 Sec. r18. - Ailministtatioe lnoestigatiottl9anctions. - Administrative investigations shall2l be conducted by the Board assisted by the Legal or Hearing Officer of the Commission.22 The existing rules of evidence shall also be observed and applied during adminisbative23 investigatioru.

24 If the Board by a majority vote of the members, shall find that the charges are sustained25 by evidence adduce4 it may, at its discretion reprimand the respondent or revoke or26 suspend his certificate of registration

27 Sec. 49. - Proczdute anil Rules, - The Board upon receipt of a formal complaint under28 oath against any pharmacist shall fumish the latter a copy of the complain! which shall29 be answered in writing within ten (10) days from receipt thereof. If the Board, after30 careful study of the records, finds that there

3l is a valid ground to the charge it shall conduct a formal investigation and set the dates32 of the hearing thereof. For this purpose, a subpoena and/or subpoena iluces tccum ntay33 be issued by the chairman of the Board or by the Chief, kgal and Investigation34 Division. The investigation proceedings shall at all times be recorded. The investigation35 shall have been terminated and resolved $rithin ninety (90) days from the time the first36 date of hearing shall be set and heard.

37 Sec. 50. - Rights of Respondent. - The respondent pharmacist is entitled to be heard or38 be represented by counsel; to have speedy public hearing, to confront, and to cross-39 examine the witness or witnesses against him; to summon and present witness or40 witnesses in his behalf; or to avail himself/herself of any other process for the4l protection of his/her constitutional rights

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1 Sec. 51. - Motion fot Reconsiileration. - A motion for reconsideration within the2 prescribed period may be made based or. any of the following grounds:

3 (a) Grave abuse of discretion by the lloard,

4 (b) Findings not supported by substar rtial evidence, and Irregularity in the conduct5 of investigation.

6 Sec. 52. - AppeaWinality of Decisioz" - The decision of the Board shall automatically7 become final and executory fifteen (15) days from the appropriate service of the8 decision to the respondent, unless the lat:ter within the same period has appealed the9 decision to the Commission; provided that said decision of the Board and/ or thel0 Commission may be appealed to the Cotut of Appeals.

1l ARI'ICLE VII12 PENAL PROVISIONS

13 Sec.53. - Panal Prcoisiozs. - Any person who shall violate any of the provisions of the14 practice of pharmacy as defined in the following provisions of Article IV:

l5 Registration ertifcntc (Section 32)

16 (a) AUowing the display of his/her registration certificate in an outlet or17 establishment by a pharmacist where he/she is not employed

18 (b) Display of a pharmacist's registration certificate by an outlet or establishment19 when the pharmacist is not employed

20 Dispensing and a nryouniling (Sections 27, 33, 38, 42)

2l (c) Dispensing done iq or offering for sale of prescription drugs in a place not22 licensed by FDA as drug outlet

23 (d) Dispensing of prescription of and pharmacist-only over-the-counter drugs by a24 person other than a registered pharmacist

25 (e) Dispensing of prescription drugs without presentation of a valid prescription

26 (f) Compounding of prescription drugs and pharmacist-only over-the-counter27 drugs done by a person other than a pharmacist

28 (g) Selling of prerription and pharmacist-only over-the-counter drug;s by29 manufacturers, importers, and wholesalers to unlicersed drug outlets and other30 drug establishments

3l (h) Substitution of prescription drugs which are not generically equivalent to what32 was on the prescription without the consent of the prescriber

33 (i) Compounding not in accordance with the current Good Manufacturing Practices34 and Good Pharmacy Practice

35 (i) Forcing, coercing or intimidating a registered pharmacist to compound or36 dispense drugs not in accordance with this Act

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ft) Preparation and compounding of pharrnaceutir:al products in quantities greatlyin excess of single therapeutic doses without a r.egistered pharmacist

(l) Non-compliance with the labeling requirem,:nt for dispensed medicines by adrug outlet

(m) Allowing pharmacy assistants to disperure r rithout the supervision of a

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Requirenunt of Phannacist (Scctions 33,34' 36)

(n) Establishment/ outlet selling prescription and pharmacist-only over-the-counterdrugs which operu for business without a licensed pharmacist

(o) Compounding W a non-registered ph'armacist or pharmacist withexpired/ revoked/ suspended license

(p) Fi[ing of prescription by a non-pharmacist or 9y a non-registered pharmacist or- pharmacistwithexpired/revoked/suspenderl license

(q) Wholesale of pharmaceutical prcducts without the direct and immediatesupervision of a registered Pharmac:ist

(r) Rurat Health Units dispensing prescription drugs and pharmacist-only over-the-counter drugs without the supervision of a registered pharmacist ldanufacfuingand xlling of phnmaeutical Wiluch under frm&tbnt name and addrcss (Section 35)

Afutlterution onil misbnniling of d*gt (Section 35) Mmufutunng and xlling ofunsafe anil substanilaril drugs (Section 35) shall upon conviction thereof, be

sentenced to a fine of not less than Two Hundred Fifty Thousand(Php250,000.00) Pesos but not exceeding Five Hundred Thousand

. (Php500,000.00) Pesos and/or to an imprisorunent of not less than one year andone day but not more than six years, or both fine and penalty, at the discretion ofthe court.

Sec. 54. - Otha Penalties, - Any person who shall violate any of the followingprovisions of this Act:

(a) Affixing of the title, R.Ph. by a person who is not a pharmacist and a graduate ofpharmacy degree who is not registered with PRC (Section 21)

(b) Practice of phalrracy in the Philippines by a foreigner without special permit(Section 28)

(c) Non-indication by a pharmacist of his/her regisbation number and ProfessionalTax Receipt number in official documents requiring such information (Section30)

(d) Non-display of certificate of regisbation of a pharmacist in drug establishmentrequiring such (Section 32)

(e) Non-display of certificate of registration of a pharmacist by anestablishment/ outlet (Section 32)

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($ Non-compliance with thirr Act's provision on the required salary for a registeredpharmacist (Section 34)

(g) Non<ompliance by a ph armacist with the requiement on the filling ofprescription (Section 36)

(h) Non-compliance by a regis"tered pharmacist on the requirement for partiallyfilled prescription (Section 3t;)

(i) Selling of physician's sample s (Section 37)

O The removal erasure and alteration of mark or label of physician's sample(Section 37)

(k) Non-compliance with the filling up of Record Books by a drug outlet (Section 40)

(l) Employment of persons in a pharmacy without the provision of the requiredtraining (Section 42)

(m) Rendering dispensing-related services by non-pharmacists in a drug outletwithout undergoing the required training (Section t12) shall upon convictionthereof, be sentenced to a fine of not less than One Hundred Thousand(Php100,000.00) Pesos but not exceeding Two Hundred Thousand(Php20O000.00) Pesos or to an imprisonment of not less than Thirty (30) daysbut not more than One (1) year, or both fine and penalty at the discretion of thecourt.

Any person other than the citizens of the Philippines having been foundguilty of any violation as provided for in this and the preceding section shall,after having paid the fine or having served his sentence or both when soadjudged, be also subject to immediate deportation.

For any violation of the provisions of this Act penalized under this andthe preceding section" which also constitutes or considered as punishableoffense or described as a violation of other laws, the applicable penalty shall bethat of the law providing for a higher fine and/or imprisonment.

For any violation of the rules and regulations implementing theprovisions of this Act, appropriate penalty shall be imposed.

ARTICLEVIIIFINALPROVISIONS

Sec. 55. - Enfotcenent. - The Commission shall be the enforcement agency of this Act.As suclu the Commission shall implement the appropriate provisions of this Act,enforce its implementing rules and regulations as adopted by the Board, assist theBoard in the investigation of complaints against violators of this Act, its rules andregulations, Code of Ethics for pharmacists, professional standards, and other policiesof the Board and the Commission.

The Commission and/or the Board shall call upon or request any department,instrumentality, office, bureaq institution or agency of the governmen! including localgovernment units to render such assistance as it may recluire, or to coordinate orcooperate in order to carry ou! enforce or implement the provisions of this Act.

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I Sec. 56. - Apptopriafions. - The Chairp' erson of the PRC shall immediately include in its2 programs on the implementation of tl\is Act, the funding of which shall be charged3 against their curent years' approf,riartions and thereafter, in the annual General4 Appropriations Act.

5 Sec. 57. - Implemmting Rules and Regdationrs. - Within one hundred and twenty (120)

6 days after the approval of this Act, the Board subject to the approval by the7 Commission, in consultation with the: AINO, shall issue and formulate the rules and8 regulations, the Code of Ethics arrd professional standards for pharmacists, to9 effectively implement this Act.

l0 Sec.SE. - Sepambirity Clause. - If an'y cliause, provisions, ParagraPh or Part

ll hereof shall be declared unconstittrtional or invalid, such judgment shall not affect,12 invalidate impair any other part the reof, but such judgment shall be merely confined to13 the clause, provision" paragaPh or Part directly involved in the controversy in which14 such judgment has been rendered.

15 Sec. 59. - Repealing clntse. - R.A. Nct. 5921, known as the Pharmacy Law, as amended16 by E.O. No. 174 and PD No. 1363, and all other laws are hereby repealed, Presidential17 decrees, executive ordef,s, and. other administrative issuances and parts thereof whichl8 are inconsistent with the provisions of this Act are hereby modified, amende419 superseded or repealed accordingly.

20 Sec. 60. - Efrectloity. - This Act shall take effect afber fifteen (15) days following the full2l and complete publication thereof in the Official Gazette or in any major daily22 newspaper of general circulation in the Philippines.

23 Approved,

23