QuestionsQuestions (Republic Act No. 9242)
It cites Article II, Section 15 of the 1987 Constitution (right to health) and Article XIII, Section 12 (effective food and drug regulatory system and health manpower development/research).
The Philippine Pharmacopeia (PP) 1st edition, April 2004, and any supplement thereto.
It is the official book of standards and references for determining the identity, purity, and quality of pharmaceutical products and crude plant drugs in the Philippines.
Pharmaceutical products and crude plant drugs.
Reference may be made to the latest editions of USP/NF, JP, BP, EP, IP, and other recognized standards/references as adopted by the Bureau of Food and Drugs.
United States Pharmacopeia/National Formulary (USP/NF), Japanese Pharmacopeia (JP), British Pharmacopeia (BP), European Pharmacopeia (EP), and International Pharmacopeia (IP).
The Bureau of Food and Drugs (BFAD), as stated: “as maybe recognized and adopted by the Bureau of Food and Drugs from time to time.”
The identity, purity, and quality of pharmaceutical products and crude plant drugs.
All orders, issuances, rules and regulations, or parts thereof inconsistent with the EO are repealed or modified accordingly.
Fifteen (15) days after publication in the Official Gazette.
Gloria Macapagal-Arroyo signed as President, and Alberto G. Romulo signed as Executive Secretary (by the President).
“Declaring and adopting the Philippine Pharmacopeia as the official book of standards and reference for pharmaceutical products and crude plant drugs in the Philippines.”
Because a national pharmacopeia establishing standards for drugs/drug products and crude drugs available for commerce is essential to achieving an effective regulatory and health care delivery system and fulfilling constitutional mandates.
They may reference the latest editions of USP/NF, JP, BP, EP, or IP, and other recognized standards adopted by the Bureau of Food and Drugs.
Section 1 adopts the PP 1st edition April 2004 “and any supplement thereto,” meaning supplements are part of the official standard/reference.
The policy to protect and promote the right to health and instill health consciousness, and to establish and maintain an effective food and drug regulatory system.