Perspective Laws

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Perspective in Pharmacy

REGULATION OF PHARMACY PRACTICE


schedule of all licensure examinations
PROFESSIONAL LICENSURE EXAMINATION pursuant to section 7D of RA 8981.
Section 13 of Philippine Pharmacy Act
D. Ratings in the Licensure Examination
Unless exempted from, all applicants for o In order to be Registered and Licensed as
a Pharmacist, a candidate must obtain
registration for the practice of pharmacy shall be required a
to pass a licensure examination as provided for this act and o general weighted average of 75% with no
section 7D of R.A 8981. rating lower than 50% in any of the
A. Qualifications for the Licensure examination subjects.
1. Citizen of the Philippines or a foreign country o An applicant who failed for the 3rd time
which has a law or policy on reciprocity for the shall
practice of Pharmacy profession. o not be allowed to take the next
2. Of good moral character and reputation succeeding
3. Degree holder of BS Pharmacy or its equivalent o examinations without having undertaken a
degree conferred by an HEI in the Philippines or refresher program in a duly accredited
an institution of learning in a foreign country duly institution.
recognized by the CHED
• LAWS AFFECTING PHARMACY PRACTICE
4. Has completed an internship program approved by
the Board, pursuant to such guidelines as may 1. Philippine Pharmacy Act (RA 10918)
hereinafter be promulgated, in consultation with o An act regulating and modernizing the
the duly recognized associations of pharmacy Practice of Pharmacy in the
Philippines,
schools and the CHED.
o repealing for the purpose of RA 5921,
otherwise known as the Pharmacy Law.
B. Scope of Examination Multiple choice type of
o This act provides for and shall govern the:
exam consisting of 600 items in total.
▪ Standardization and regularization
1. Module 1 (20%): Pharmaceutical Chemistry
o Organic Pharmaceutical and Medicinal of
chemistry ▪ Pharmacy education
o Qualitative Pharmaceutical chemistry ▪ Administration of licensure
examination, registration and
o Inorganic Pharmaceutical and Medicinal licensing of Pharmacists
▪ chemistry ▪ Development and enhancement of
professional competence of
Pharmacists
2. Module 2 (15%): Pharmacognosy
▪ through continuing professional
• Biochemistry
development, research and other
• Plant chemistry related activities
▪ Integration of the Pharmacy
3. Module 3 (17.5%): Practice of Pharmacy
profession
• Compounding and dispensing 2. Food, Drug and Cosmetics Act (RA 3720)
• Clinical and Hospital Pharmacy o An Act to ensure the safety and purity of
• Pharmaceutical Calculations foods, drugs and cosmetics being made
o available to the public by creating the food
4. Module (15%): Pharmacology and and drug administration which shall
Pharmacokinetics administer and enforce the laws pertaining
thereto.
• Toxicology, Incompatibilities and ADRs
5. Module 5 (17.5%): Pharmaceutics o In the implementation of the foregoing policy,
o the Government shall in accordance with the
• Manufacturing Pharmacy
o provisions of this act:
• Pharmaceutical Dosage Forms ▪ Establish standards
• Physical Pharmacy and quality
measures for food, drug and
• Jurisprudence and Ethics cosmetic
6. Module 6 (15%): Quality Assurance/ Quality ▪ Adopt measures to insure pure and
Control safe supply of food, drug and
cosmetic in the
• Drug testing and instrumentation
▪ country.
• Microbiology and Public health
C. Holding of Examination
o PhLE shall be given twice a year in places • An act to promote, require and ensure the
and dates as the PRC may designate in production of an adequate supply,
the distribution, use and acceptance of drugs and
o Resolution providing for the master medicines identified by their generic names.
Generics Act of 1988 (RA 6675 • Counterfeit: Refers to medicinal products with
the correct ingredients but not in the amounts
✓ To promote, encourage and require the
use of generic terminology in the as provided hereunder, wrong ingredients,
importation, manufacture, distribution, without active ingredients, with sufficient
marketing, advertising and promotion, quantity of active ingredient, which results in
prescription and dispensing of drugs. reduction of the drug’s safety, efficacy, quality,
✓ To ensure the adequate supply of drugs strength or purity. It is a drug which is
with generic names at the lowest deliberately and fraudulently mislabeled with
possible cost and endeavor to make them respect to identity and/ or source or with fake
free to indigent patients packaging, and can apply to both branded and
✓ To encourage the extensive use of drugs generic products.
with generic names through a rational
system of procurement and distribution 4. Comprehensive Dangerous Drugs Act of
✓ To emphasize the scientific basis for the 2002 (RA 9165)
use of drugs, in order that health • An act instituting the comprehensive
professionals may become more aware dangerous drugs act of 2002, repealing RA
and cognizant of their therapeutic 6425 otherwise known as the Dangerous
effectiveness Drugs Act of 1972, as amended, providing
✓ To promote drug safety by minimizing funds therefore, and for other purposes.
duplication in medications and/ or use of • It clearly identifies:
drugs with potentially adverse drug ✓ The drugs classified as dangerous
interactions. drugs, controlled precursors and
essential chemicals
✓ The unlawful acts and penalties
✓ The participation of the family,
students, teachers and school
authorities in the enforcement of this
act
✓ The participation of different
government agencies and private
sectors in the enforcement of this act
✓ The programs for the treatment and
rehabilitation of drug dependent
✓ The role and responsibilities of the
DDB and PDEA

5. Universally Accessible Cheaper and Quality


Medicines Act of 2008 (RA 9502)
o An act providing for cheaper and
quality
• medicines, amending for the purpose of
o RA 8293 or the Intellectual Property
Code, Generics Act of 1988,
Pharmacy Law, and for other purposes.

6. Food and Drug Administration of 2009 (RA


9711)
o An act strengthening
Generic name: the regulatory
• Identification of drugs and medicines by their • capacity of Bureau of Food and Drugs by
scientifically and intentionally recognized active o establishing adequate testing
ingredients or by their official generic name as laboratories and field offices,
determined by the Bureau of Food and Drugs of upgrading its equipment, renaming it
the DOH. into Food and Drug Administration,
• Active ingredient: Chemical component amending certain sections of RA 3720
responsible for the claimed therapeutic effect of as amended and appropriating fund
the pharmaceutical product. o This act has the following objectives:
▪ To enhance and strengthen the
3. Special Law on Counterfeit Drugs (RA 8203) ▪ administrative and technical
• It is an act prohibiting counterfeit drugs, capacity of
providing penalties for violations and ▪ the FDA in the regulation of
establishments and products
under its jurisdiction.
• To ensure the FDA’s monitoring and regulatory
coverage over establishment
▪ and products under its jurisdiction and
• To provide coherence in the FDA’s regulatory
system for establishments and products under
its jurisdiction.

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