Title
Supreme Court
Adoption of Philippine Pharmacopeia as Official Standard
Law
Executive Order No. 302
Decision Date
Mar 29, 2004
Executive Order No. 302 establishes the Philippine Pharmacopeia as the official book of standards for pharmaceutical products and crude plant drugs in the Philippines, ensuring the establishment of an effective regulatory and healthcare delivery system in the country.

Law Summary

Constitutional Basis for the Order

  • Article II, Section 15 of the 1987 Philippine Constitution mandates the State to protect and promote the right to health and encourage health consciousness.
  • Article XIII, Section 12 requires the establishment of an effective food and drug regulatory system with health manpower development and research tailored to national health needs.
  • The creation and adoption of a national pharmacopeia align with and fulfill these constitutional mandates.

Use of Alternative Pharmacopeias for Unlisted Drugs

  • For pharmaceutical products and crude plant drugs not included in the Philippine Pharmacopeia, reference may be made to other recognized pharmacopeias, including:
    • United States Pharmacopeia/National Formulary (USP/NF)
    • Japanese Pharmacopeia (JP)
    • British Pharmacopeia (BP)
    • European Pharmacopeia (EP)
    • International Pharmacopeia (IP)
  • Additional books of standards may also be recognized and adopted by the Bureau of Food and Drugs (BFAD) as necessary.

Modification and Repeal of Inconsistent Issuances

  • All existing orders, rules, regulations, or parts thereof that conflict with this Executive Order are repealed or modified to ensure consistency.

Effectivity Clause

  • The Executive Order shall take effect fifteen (15) days after its publication in the Official Gazette, ensuring official dissemination and compliance.

Signatories and Formalization

  • Signed by the President of the Philippines and the Executive Secretary, effectuating the order as a formal and binding government directive.

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