MODULE 4: PHARMACY REGULATION Flashcards
A pharmacist before being able to practice the profession must pass the licensure examination as required by the R.A. 10918
PHARMACY LICENSURE EXAMINATION
Republic Act 10918
PHILIPPINE PHARMACY ACT
PHARMACY LICENSURE EXAM
REQUIREMENTS FOR APPLICATION
(1) A citizen of the Philippines or of a foreign country which has a law or policy on reciprocity for the practice of the pharmacy profession
Required Documents
➢Original and photocopy of the Philippine Statistics Authority-issued Certificate of Live Birth
➢Original and photocopy of the Philippine Statistics Authority-issued Marriage Certificate (for female applicant)
PHARMACY LICENSURE EXAM
REQUIREMENTS FOR APPLICATION
(2) Of good moral character and reputation
Required Documents
➢Certification of Good Moral Character issued by any of the following: barangay, church, School of Pharmacy or employer
➢National Bureau of Investigation (NBI) Clearance
PHARMACY LICENSURE EXAM
REQUIREMENTS FOR APPLICATION
(3) A degree holder of Bachelor of Science in Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of learning in a foreign country duly recognized by the CHED
Required Documents
➢Certified true copy of the Transcript of Records of BS Pharmacy or its equivalent degree conferred by an HEI in the Philippines or an institution of learning in a foreign country duly recognized by the CHED
PHARMACY LICENSURE EXAM
REQUIREMENTS FOR APPLICATION
(4) Has completed an internship program approved by the Board, pursuant to such guidelines as may herein after be promulgated, in consultation with the duly recognized associations of Pharmacy school and the CHED
Required Documents
➢Certificate of Completion of the internship program duly signed by the dean/program head
- It is given 2x per annum
> March
> August
PHARMACISTS LICENSURE EXAM (PLE)
PHARMACY LICENSURE EXAM
It requires:
- GWA of 75%
- No 50% in any subjects
- NB: 3rd failure = refresher course for 1 year in the school
TO BE AN RPh
PHARMACY LICENSURE EXAM
Will be issued with:
- Certificate of Registration (COR)
- Professional Identification Card (PIC)
UPON PASSING THE PLE
PHARMACY LICENSURE EXAM
ISSUANCE OF COR AND PIC:
- Issued to those who passes the licensure examination, subject to compliance with the requirements and payment of the prescribed fees.
- Bears the following:
+ Registration number
+ Date of issuance
+ Signature of the PRC Chairperson, Board chairperson, and Members, stamped with the seal of the Board and PRC
- Shall remain in full force and effect until suspended or revoked
CERTIFICATE OF REGISTRATION (COR)
PHARMACY LICENSURE EXAM
ISSUANCE OF COR AND PIC:
- Bears:
+ Registration number
+ Date of issuance and expiry
+ Signature of the PRC Chairperson
- Renewal: Every 3 years; On-line renewal
- Requirements for renewal:
+ Certificate of Good Standing (COGS) from the Integrated Association of the Professional Organization (IAPO)
+ Proof of completion if the CPD requirements
+ Payments of renewal fee
PROFESSIONAL IDENTIFICATION CARD (PIC)
LAWS AFFECTING THE PHARMACY PRACTICE
- Lapsed into Law (July 21, 2016)
- IRR: PRC Res. No. 52 s. 2017
- IRR Effectivity: 5/30/2017
R.A. 10918
PHILIPPINE PHARMACY LAW
LAWS AFFECTING THE PHARMACY PRACTICE
- It is an act regulating and modernizing the practice of pharmacy in the Philippines. It provides for and shall govern the following
+ Standardization and regulation of pharmacy education
+ Administration of licensure examination, registration and licensing of pharmacists
+ Supervision, control, and regulation of the practice of pharmacy in the Philippines
+ Development and enhancement of professional competence of pharmacists through continuing professional development, research and other related activities
+ Integration of the pharmacy profession
REPUBLIC ACT 10918
LAWS AFFECTING THE PHARMACY PRACTICE
- The Professional Regulatory Board of Pharmacy, under the administrative control and supervision of the PRC, shall be responsible for the full implementation of the law
REPUBLIC ACT 10918
LAWS AFFECTING THE PHARMACY PRACTICE
- Signed into law on June 22, 1963
- Amendments:
+ E.O. No. 851 on December 2, 1982
+ E.O. No. 175 on May 22, 1987
REPUBLIC ACT 3720
THE FOODS , DRUGS, DEVICES, AND COSMETICS ACT
LAWS AFFECTING THE PHARMACY PRACTICE
- It is an act to ensure the safety and purity of foods, drugs, and cosmetics being made available to the public by creating the Food and Drug Administration which shall administer and enforce the law pertaining thereto.
REPUBLIC ACT 3720
LAWS AFFECTING THE PHARMACY PRACTICE
- This law was Signed on August 18, 2009
- Also known as ‘Food and Drug Administration act of 2009’
REPUBLIC ACT 9711
FOOD AND DRUG ADMINISTRATION ACT OF 2009
LAWS AFFECTING THE PHARMACY PRACTICE
- It is an act strengthening and rationalizing the regulatory capacity if the Bureau of Food and Drugs (BFAD) by establishing adequate testing laboratories and field offices, upgrading it equipment, augmenting its human resource complement, giving authority to retain its income, renaming it the Food and Drug Administration (FDA)
REPUBLIC ACT 9711
LAWS AFFECTING THE PHARMACY PRACTICE
- Signed on September 13, 1988
- Known as ‘Generics act of 1988’
REPUBLIC ACT 6675
GENERICS ACT IF 1988
LAWS AFFECTING THE PHARMACY PRACTICE
- It is an act to promote, require and ensure the production of an adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names.
REPUBLIC ACT 6675
LAWS AFFECTING THE PHARMACY PRACTICE
- Signed on September 4, 1996
- It is an act prohibiting counterfeit drugs, providing penalties for violations and appropriating funds therefor
REPUBLIC ACT 8203
SPECIAL LAW ON COUNTERFEIT DRUGS
LAWS AFFECTING THE PHARMACY PRACTICE
- Medicinal products with the correct ingredients but not in the amounts as provided hereunder, wrong ingredients, without active ingredients, with sufficient quantity of active ingredient, which results in the reduction of the drug’s safety, efficacy, quality, and strength or purity
COUNTERFEIT DRUG
LAWS AFFECTING THE PHARMACY PRACTICE
- A drug which is deliberately and fraudulently mislabeled with respect to identity and/or source or with fake packaging, and can apply to both branded and generic products
COUNTERFEIT DRUGS
LAWS AFFECTING THE PHARMACY PRACTICE
- A drug itself or the container or labeling thereof of 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 which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person;
COUNTERFEIT DRUGS
LAWS AFFECTING THE PHARMACY PRACTICE
- A drug refilled in containers by unauthorized persons if the legitimate labels or marks are used
- An unregistered imported drug product, except drugs brought in the country for personal use as confirmed and justified by accompanying medical records;
COUNTERFEIT DRUGS
LAWS AFFECTING THE PHARMACY PRACTICE
- A drug which contains no amount of or 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 of efficacy due to expiration.
COUNTERFEIT DRUGS
LAWS AFFECTING THE PHARMACY PRACTICE
- Signed on June 7, 2002
- Repealed R.A. 6425 - “Dangerous Drugs Act of 1972”
REPUBLIC ACT 9165
COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002
LAWS AFFECTING THE PHARMACY PRACTICE
- A Philippine law that was created to safeguard the integrity of its territory and the well-being of its citizenry particularly the youth, from the harmful effects of dangerous drugs on their physical and mental well-being, and to defend the same against acts or omissions detrimental to their development and preservation.
REPUBLIC ACT 9165
LAWS AFFECTING THE PHARMACY PRACTICE
- Signed on June 6, 2008
- Known as ‘Universally Accessible Cheaper and Quality Medicines Act of 2008’
REPUBLIC ACT 9502
UNIVERSALLY ACCESSIBLE CHEAPER AND QUALITY MEDICINES ACT OF 2008