Title
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.

Constitutional Policy and Purpose

  • Article II, Section 15 of the 1987 Constitution establishes the State policy to protect and promote the right to health of the people and instill health consciousness among them.
  • Article XIII, Section 12 of the 1987 Constitution requires the State to establish and maintain an effective food and drug regulatory system and to undertake appropriate health manpower development and research responsive to the country’s health needs and problems.
  • The order treats a national pharmacopeia establishing standards for drug/drug products and crude drugs available for commerce in the Philippines as essential to an effective regulatory and health care delivery system.

Official Adoption: Philippine Pharmacopeia

  • Section 1 declares the Philippine Pharmacopeia (PP) 1st edition April 2004 as the official book of standards and references.
  • Section 1 provides that any supplement thereto is likewise adopted as part of the official standards and references.
  • Section 1 limits the official purpose to determination of the identity, purity, and quality of pharmaceutical products and crude plant drugs in the Philippines.

Reference Standards for Unlisted Products

  • Section 2 applies when pharmaceutical products and crude plant drugs are not listed in the Philippine Pharmacopeia.
  • Section 2 authorizes reference to the latest editions of United States Pharmacopeia/National Formulary (USP/NF), Japanese Pharmacopeia (JP), British Pharmacopeia (BP), European Pharmacopeia (EP), and International PharmacopeiaM (IP).
  • Section 2 also authorizes reference to other books of standards and references recognized and adopted by the Bureau of Food and Drugs from time to time.

Repeal or Modification of Inconsistent Issuances

  • Section 3 repeals or modifies all orders, issuances, rules and regulations, or parts thereof that are inconsistent with Executive Order No. 302.
  • Section 3 applies to inconsistencies generally, covering any overlapping rules, regulations, or directives governing pharmacopeial standards and references.

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