2.3 - RA 10918 - General Terms

RA 10918

An act regulating and modernizing the practice of pharmacy in the Philippines, repealing for the purpose of Republic Act (5921) otherwise known as the Pharmacy Law

July 17, 2016

When did RA 10918 lapse into law?

Benigno S. Aquino III

Who signed RA 10918?

section 2 Statement of Policy

The State recognizes the vital role of pharmacists in the delivery of quality health care services through the provision of safe, effective, and quality pharmaceutical products, pharmaceutical care, drug information, patient medication counseling, and health promotion. The pharmacists' professional services shall, therefore, be promoted as an indispensable component of the total health care system to ensure the physical well-being of the Filipinos.

section 2 Statement of Policy

the State shall develop and nurture competent, productive, morally upright, and well-rounded pharmacists whose standards of professional practice and service shall be excellent and globally competitive through regulatory measures, programs, and activities that promote and sustain their continuing professional development

PRC

The Professional Regulatory Board of Pharmacy was created and approved by the _____?

PRC Modernization Act of 2000

RA 8981 is known as?

section 10 Compensation and Allowances of the Board

The Chairperson and members of the Board shall receive compensation and allowances comparable to the compensation and allowances received by the members of the other existing professional regulatory boards under the PRC, as provided for in the General Appropriations Act.

section 12 Custodian of its Records, Secretariat and Support Services

All records of the Board, pertaining to the applications for examinations, administrative and other investigative hearings conducted by the Board, shall be under the custody of the PRC. The PRC shall designate a Secretary who shall provide the Board with secretariat and other support services to implement the provisions of this Act.

section 13 Licensure Examination Requirement.

Unless exempted therefrom, all applicants for registration for the practice of pharmacy shall be required to pass a licensure examination, as provided for in this Act and Section 7(d) of Republic Act No. 8981.

section 16 Holding of Examination.

The Pharmacists' Licensure Examination shall be given two (2) times a year in places and dates as the PRC may designate in the Resolution providing for the master schedule of all licensure examinations pursuant to Section 7(d) of Republic Act No. 8981.

75, 50

In order to be registered and Licensed as a pharmacist,

a candidate must obtain a general weighted average of ____%, with no rating lower than ___% in any of the subjects

section 17 The Board shall submit to the PRC the ratings obtained by each candidate within three (3) working days after the last day of the examinationRatings in the Licensure Examination

An applicant who failed in the licensure examination for the third (3rd) time shall not be allowed to take the next succeeding examinations without having undertaken a refresher program in a duly accredited institution. The Board shall issue guidelines on the refresher program requirement.

3

The Board shall submit to the PRC the ratings obtained by each candidate within ____ working days after the last day of the examination

section 18 Report of Rating

the PRC shall send by mail the rating obtained by each examinee at the given address using the mailing envelope submitted during the examination

section 19 Oath of Profession

All successful candidates in the licensure examination shall take their oath of profession before any member of the Board, officer of the PRC, or any person authorized by law to administer oaths, prior to entering the practice of the pharmacy profession.

COR

shall be issued to those who passed the licensure examination, subject to compliance with the registration requirements and payment of the prescribed fees.

section 20 Issuance of Certificate of Registration and Professional Identification Card

The COR shall bear the registration number, the date of its issuance, and the signatures of the Chairperson of the PRC and the members of the Board, stamped with the official seals of the PRC and of the Board, certifying that the person named therein is entitled to the practice of the profession, with all the privileges appurtenant thereto. This COR shall remain in full force and effect until suspended or revoked in accordance with this Act.

PIC

A ____ bearing the registration number and dates of its issuance and expiry, duly signed by the Chairperson of the PRC, shall likewise be issued to every registrant, upon payment of the prescribed fees

3, Certificate of Good Standing (COGS)

PIC shall be renewed every ___ years, upon presentation of the _____ from the APO and proof of completion of the CPD requirements.

Foreign Reciprocity

Unless the country or state of which the foreign pharmacist is a subject or citizen, specifically permits Filipino pharmacists to practice within its territorial limits on the same basis as the subjects or citizens of the said foreign country or state under reciprocity and under international agreements, no foreigner shall be admitted to licensure examinations, given a COR to practice as pharmacist nor be entitled to any of the privileges under this Act.

2

The Board may, upon petition, reinstate or reissue a revoked COR after the expiration of ____ years from the date of its revocation.

section 24 Reissuance of Revoked Certificate of Registration, Replacement of Lost or Damaged Certificate of Registration, Professional Identification Card or Special/Temporary Permit

The Board may, in its discretion, require the applicant to take another licensure examination. The petitioner shall prove to the Board that there is a valid reason for such reinstatement. For the grant of the petition, the Board shall issue a Board Resolution, to be approved by the PRC.

section 25 Vested Rights; Automatic Registration.

All pharmacists registered before the effectivity of this Act shall automatically be registered hereunder, subject to compliance as to future requirements.

section 25 Vested Rights; Automatic Registration

The CORs, PICs or ST Pa held by such persons in good standing shall have the same force and effect, as though they were issued on or after the effectivity of this Act

section 26 Affixing RPh After a Registered Pharmacist's Name

Only duly registered and licensed pharmacists shall have the right to affix to one's name, the title "Registered Pharmacist" or "RPh".

section 27 Indication of Information

A pharmacist shall be required to indicate the serial numbers, the date of expiry of the pharmacist's PIC and APO Certificate of Membership on all pertinent documents signed by him/her.

section 28 Registry of Pharmacists

The Board and the PRC shall prepare and maintain a registry of the names, residences or office addresses, or both, status of registration and area of practice of all registered pharmacists, which shall be updated annually, in coordination with the APO.

section 28 Registry of Pharmacists

This registry shall be made available to the public upon inquiry or request, subject to such guidelines that shall be established therefor.

section 29 Display of Certificate of Registration

It shall be the duty of every pharmacist engaged in the practice, whether in private or under the employ of another, to display the original copy of one's COR in a prominent and conspicuous place in the drug establishment in which one is employed in a professional capacity as pharmacist.

section 29 Display of Certificate of Registration

When employed in establishments under Category B, as defined in Section 31 of this Act, the duplicate copy of the pharmacist's COR shall also be displayed therein.

section 29 Display of Certificate of Registration

No pharmacist shall knowingly allow the COR to be displayed in an establishment where one is not actually employed as a professional pharmacist.

section 30 Dispensing/ Sale of Pharmaceutical Products

No pharmaceutical product, of whatever nature and kind, shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public, except through a retail drug outlet duly licensed by the FDA.

Prescription drugs and pharmacist-only OTC medicines

shall be dispensed only by a duly registered and licensed pharmacist, except in emergency cases, where the services of a registered and licensed pharmacist are not available

24

When dispensing Rx drugs and Pharmacist only OTC meds, a report shall be made to the supervising pharmacist within____ hours after the occurrence of the emergency so that product recording in the prescription books can be done.

section 30 Dispensing/ Sale of Pharmaceutical Products

Compounding and dispensing shall be done only by duly registered and licensed pharmacists, in accordance with current Good Manufacturing Practice, laboratory practice, Philippine Practice Standards for Pharmacists and dispensing guidelines.

section 30 Dispensing/ Sale of Pharmaceutical Products

A registered and licensed pharmacist may refuse to compound, dispense or sell drugs and pharmaceutical products, if not in accordance with this Act and the abovementioned standards.

section 30 Dispensing/ Sale of Pharmaceutical Products

Licensed manufacturers, importers, distributors, and wholesalers of pharmaceutical products are authorized to sell their products only to duly licensed pharmaceutical outlets.

section 31 Pharmacist Requirement Category A

Pharmaceutical establishments/outlets where the direct and immediate control and supervision of a duly registered and licensed pharmacist is required, per establishment, whether in-store or online

section 31 Pharmacist Requirement Category B

Pharmaceutical establishments/outlets where the supervision and oversight of a duly registered and licensed pharmacist is required under pertinent provisions of law

section 32 Responsibility for Quality of Pharmaceutical Products

It shall be the duty of a duly licensed and registered pharmacist of a pharmaceutical establishment and outlet to ensure that all pharmaceutical products conform to standards of safety, quality and efficacy, as provided for in this Act and other pertinent rules and regulations and issuances.

section 32 Responsibility for Quality of Pharmaceutical Products

It shall be unlawful for any person to manufacture, prepare, sell, or dispense any pharmaceutical product under a fraudulent name, or pretense or to adulterate any pharmaceutical product offered for sale.

section 32 Responsibility for Quality of Pharmaceutical Products

In cases of pharmaceutical products sold in their original package, the seal of which has not been broken or tampered with, the liability that may arise because of their quality and purity rests upon the manufacturer or importer, the distributor, representative, or dealer who is responsible for their distribution or sale.

section 33 Filling and Partial Filling of Prescription

All prescriptions and pharmacist-only OTC medicines shall be filled, compounded and dispensed only by a registered and licensed pharmacist, in accordance with the Philippine Practice Standards for Pharmacists, Dispensing Guidelines and other standards pertaining to purity, safety and quality. Completely filled prescriptions should be surrendered to the pharmacist for recording.

section 33 Filling and Partial Filling of Prescription

Partial filling of prescription less than the total quantity indicated in the prescription shall be allowed, subject to dispensing guidelines as provided in the immediately preceding paragraph. It is the responsibility of the pharmacist dispensing the last quantity completing the prescription to keep the prescription according to proper prescription recording guidelines.

section 33 Filling and Partial Filling of Prescription

Prescription medicines may be dispensed only by a duly registered and licensed pharmacist and only with a valid prescription of a physician, dentist, or veterinarian.

section 34 Physician's Sample

Pharmaceutical products given or intended to be given free to any health professional by a manufacturer or distributor or its professional service representative as part of its program or promotion shall not be sold to any pharmaceutical outlet or the consuming public.

Sample, Not for Sale

shall appear conspicuously on the primary and secondary' packaging of the drug or combination products (medical device and drug) classified as drug according to the primary intended mode of action to be given

Pharmaceutical products (antimicrobials), anti-TB medicines

shall not be given or distributed as physician’s samples

section 35 Prohibition Against the Use of Cipher, Codes, or Unusual Terms in Prescriptions and Prescription Substitution

Pharmacists shall not compound or dispense prescriptions, recipes, or formulas which are written in ciphers, codes or secret keys or prescriptions of pharmaceutical products with unusual names which differ from those in standard pharmacopeias or formularies

section 35 Prohibition Against the Use of Cipher, Codes, or Unusual Terms in Prescriptions and Prescription Substitution.

The pharmacist dispensing or compounding prescriptions shall not substitute the medicine called for in the prescription with any other drug, substance or ingredient, without prior consultation with, and written consent of the person prescribing, except in accordance with Republic Act No. 6675, as amended, otherwise known as the "Generics Act of 1988", and other pertinent laws and regulations.

section 36 Label of Dispensed Medicines

Upon every box, bottle, or package of medicines compounded or dispensed by a registered and licensed pharmacist based on prescription, there shall be pasted, affixed, or imprinted a seal or label bearing, among others, the name of patient and generic name of drug; brand name, if any, strength, expiry date, directions for use; and name and address of pharmacy, name of the doctor, the dispensing pharmacist and other requirements prescribed

Auxiliary labels containing special pharmacists' instructions

shall be required as prescribed for dangerous drugs, external-use-only drugs, drugs with special storage and administration instructions and such other drugs as may be required by law.

section 37 Recording of Patient Medication Profile

prescriptions dispensed in the pharmacy shall be recorded in an appropriate recording system indicating therein, among other things, the name and address of the patient, name of prescriber, generic name and brand, dosage strength, quantity of drug and initials of pharmacist.

Board, FDA, 2

Records of Patient Medication Profile shall be open for inspection by the representatives of the ____ or the ____, or both, at any time of the day, when the pharmacy is open, and must be kept for a period of not less than ____ years after the last entry.

Dangerous Drugs Book, 9165

All required information on dangerous drugs dispensed by a pharmacy shall be recorded in the _______ or an equivalent recording system as required by Republic Act No. ____ and other applicable laws and issuances.

section 38 Requirements for the Opening and Operation of Retail Pharmaceutical Outlet or Establishment

The opening of a retail pharmaceutical outlet or establishment shall be subject to requirements provided for in this Act and the rules and regulations prescribed by the FDA.

section 38 Requirements for the Opening and Operation of Retail Pharmaceutical Outlet or Establishment

The application for the opening and operation of a retail drug outlet or other similar business establishments shall not be approved, unless applied for by a Filipino registered and licensed pharmacist, either as owner or as pharmacist-in-charge, pursuant to the provisions of this Act.

section 39 Handling of Pharmaceutical Products by Persons Other Than a Pharmacist

For the purpose of this section, persons handling pharmaceutical products, other than the pharmacist,….or any other person performing functions involved in the handling of pharmaceutical products, shall be duly certified by appropriate government agencies after undergoing an accredited training program.

section 39 Handling of Pharmaceutical Products by Persons Other Than a Pharmacist

No person, except pharmacy graduates, shall be allowed to render such services without undergoing a comprehensive standardized training program: Provided, That the job description is defined in the implementing rules and regulations of this Act.

section 40 Administration of Adult Vaccines

In addition to the requirement provided in Section 4, paragraph (g) of this Act, licensed and trained pharmacist who shall administer adult vaccines shall ensure that the vaccine to be administered shall have a doctor's prescription which is not more than seven (7) days old and submit a monthly vaccination report and AEFI report to DOH regional offices using the prescribed form.

section 41 The Integrated and Accredited Professional Organization (APO) of Pharmacists

The pharmacy profession shall be integrated into one (1) national organization registered with the Securities and Exchange Commission (SEC) which shall be recognized by the Board and the PRC as the one and only integrated and accredited professional organization of pharmacists

section 41 The Integrated and Accredited Professional Organization (APO) of Pharmacists

A pharmacist duly registered with the Board shall automatically become a member of the integrated and accredited professional organization of pharmacists, and shall receive the benefits and privileges appurtenant thereto upon payment of the required fees and dues.

section 41 The Integrated and Accredited Professional Organization (APO) of Pharmacists

Membership in the integrated APO shall not be a bar to membership in other associations of pharmacists.

section 42 Membership to the Integrated and Accredited Professional Organization

All registered pharmacists must be members of the APO and must maintain membership throughout the duration of the practice of the profession. The PIC shall not be renewed if the requirements for membership with the APO are not met including credit units for attendance to duly accredited CPD.

section 42 Membership to the Integrated and Accredited Professional Organization

All pharmacy support personnel must be registered as affiliate members of the APO and must likewise maintain membership throughout the duration of employment in pharmaceutical establishments and outlets.

section 43 Specialty Boards in Various Areas of Pharmacy Practice

Specialty Boards in various areas of pharmacy practice shall be created, subject to accreditation by the Board and the PRC.

section 43 Specialty Boards in Various Areas of Pharmacy Practice

The Board shall issue guidelines in the accreditation of specialty boards in various areas of pharmacy practice, which shall include the standards of practice within different specialties, qualifications, and requirements for the certification of practitioners under each specialty, among others.

section 44 Revocation or Suspension of the Certificate of Registration and Cancellation of Special/Temporary Permit

The Board shall have the power, upon notice and hearing, to revoke or suspend the COR of a registered pharmacist or to cancel an STP of a foreign pharmacist on any of the following grounds:..

250,000 - 500,000
1, 1, 6

Any person who shall commit any of the following acts shall, upon conviction, be sentenced to pay a fine of not less than _____, but not exceeding _____ or imprisonment of not less than ___ year and ___ day but not more than ___ years, or both

section 47 Enforcement

It shall be the primary duty of the Board and the PRC to effectively enforce the provisions of this Act. All duly constituted law enforcement agencies and officers of the national, provincial, city or municipal government or of any political subdivision thereof shall ensure the effective enforcement and implementation of the provisions of this Act.

section 49 Transitory Provisions

The Chairperson of the PRC shall immediately include in its programs the implementation of this Act, the funding of which shall be charged against their current years' appropriations and thereafter, in the annual General Appropriations Act.

section 50 Implementing Rules and Regulations

Within one hundred twenty (120) days after the approval of this Act, the Board, subject to the approval by the PRC, and in consultation with the APO, shall formulate and issue the rules and regulations to implement the provisions of this Act.

section 51 Separability Clause

If any clause, provision, paragraph or part hereof shall be declared unconstitutional or invalid, such declaration shall not affect, invalidate, or impair the other provisions otherwise valid and effective.

section 52 Repealing Clause

Republic Act No. 5921, as amended, is hereby repealed. All other laws, presidential decrees, executive orders and other administrative issuances or parts thereof which are contrary to or inconsistent with the provisions of this Act are hereby repealed, amended, or modified accordingly.

section 53 Effectivity

This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in a newspaper of general circulation.

House of Representatives

This Act was passed by the _____

5616, May 23, 2016

This act was passed as House Bill No. ____ on ____

2436, May 30 2016

This act was adopted by the Senate as an amendment to Senate Bill No. ____ on ____