Legal basis and prior arrangement
- Republic Act No. 9711 is the Food and Drug Administration Act of 2009, amending Republic Act No. 3720 (Food, Drugs and Devices and Cosmetics Act), as amended by Executive Order No. 175.
- Section 30, paragraph 5 of Republic Act No. 3720, as amended by Republic Act No. 9711, empowers the FDA to call upon assistance from any department, office, or agency in regulation-related functions.
- A Memorandum of Agreement (MOA) executed on September 25, 1991 between DOH-Bureau of Food and Drugs (now FDA) and DA-Bureau of Animal Industry (BAI) defines functions in regulating veterinary drug manufacture, distribution, and registration under Republic Act No. 3720, as amended.
- This order supersedes the September 25, 1991 DOH-BFAD and DA-BAI MOA.
- For penalties, the order uses the penalty regime under Republic Act No. 9711.
Policy objectives and partnership rationale
- The order facilitates licensing and registration and enables effective regulation of manufacture, distribution, and monitoring of veterinary drugs and products and veterinary biological products.
- The order aims to avoid overlapping regulatory functions of FDA and BAI.
- The order sets a policy direction for licensing and registration of veterinary drugs and products, veterinary biological products, and establishments selling the same for use exclusively for veterinary use or for both veterinary and human use.
- The FDA and BAI agree and recommend continuing their partnership to maintain effective regulation of existing establishments and efficient supply in the market.
- The order directs FDA and BAI to collaborate through Technical Working Groups (TWG) for implementation and periodic review.
Core definitions for regulation
- “Registration” is the process of approval for the manufacture, importation, exportation, sale, offer for sale, distribution, labeling, advertising, or transfer of veterinary drugs and products with active ingredient(s) of known chemical structures and properties determined to be safe, efficacious, and of good quality according to BFAD/BAI standards.
- “Veterinary Drugs and Products” are any substance, including biological products, applied or administered to food producing, companion, aquatic, laboratory and exotic animals for therapeutic, prophylactic, diagnostic purposes, or modification of physiological functions or behaviors.
- “Veterinary Drug and Product Establishment” is any organization or company involved in the manufacture, importation, repacking, labeling (and related establishment operations described under the regulatory definitions framework used in the order).
- “Veterinary Drug and Product Manufacturer” is an establishment engaged in operations involved in production, including propagation, processing, compounding, finishing, filling, repacking, labeling, advertising, storage, distribution or sale, and compounding and filling of prescription by drugstores is not considered production operations for this regulation.
- “Veterinary Drug and Product Traders” are registered owners who procure raw materials and packaging components and provide production monographs, quality control standards and procedures, but subcontract manufacture to a licensed manufacturer; traders may also engage in distribution and/or marketing.
- “Veterinary Drug and Product Distributor/Importer” imports raw materials, active ingredients, and/or finished products for its own use or for wholesale/distribution to other drug establishments or outlets.
- “Veterinary Drug and Product Distributor/Exporter” exports raw materials, active ingredients, and/or finished products to another country.
- “Veterinary Drug and Product Distributor, Wholesaler” procures raw materials, active ingredients, and/or finished products from local establishments for local distribution on wholesale basis.
- “Veterinary Drug Outlet” includes drugstores, pharmacies, livestock and poultry supply stores and other business establishments selling veterinary drugs and products.
- “Drugstore, Pharmacy and Botica and drug outlets where registered veterinary drugs and products… are compounded and/or dispensed” includes establishments holding executive veterinary hospitals, clinic and farm storage store where drugs and products are stored for their exclusive use.
- “Veterinary and agricultural supply store, livestock and poultry supply store and any other outlets selling prescription veterinary drugs and products” are veterinary drug outlets under this framework.
- “Retail outlet for non-prescription drugs” refers to drug outlets selling registered non-prescription/over-the-counter (OTC) or self-service (SS) veterinary drugs and products in their original packages/containers or in mail quantities not in their original containers.
- “Dosage Form” is the pharmaceutical form of the preparation based on an official pharmacopoeia.
Scope and who is covered
- The order covers veterinary drug and products and veterinary biological products under the regulatory mandate of FDA, and covers the establishments manufacturing, importing, or distributing the same.
- The order establishes division of regulatory responsibilities for registration, licensing, and monitoring between FDA and BAI based on the product categories listed under specific guidelines.
- FDA continues to register veterinary drugs in pharmaceutical dosage forms except those intended for feeds, and licenses establishments manufacturing, distributing, importing, exporting, and selling the same.
- BAI continues to register veterinary drugs and products intended solely for animal use and licenses establishments manufacturing, distributing, importing, exporting, and selling the same.
- FDA monitoring covers products and establishments identified for FDA oversight except veterinary drug outlets.
- BAI monitors products under BAI oversight and regulates veterinary outlets whether or not they carry products classified under B.1.1.
FDA and BAI regulatory functions
- FDA regulates registration of veterinary drugs and products consisting of: finished pharmaceutical dosage forms (including oral, injectables, external preparations, and ophthalmic or otic preparations as enumerated), and active pharmaceutical ingredients and excipients intended as components for those products.
- FDA regulates licensing of manufacturers, traders, and/or distributors (including importers, exporters, wholesalers) of products classified under FDA registration categories.
- FDA monitors FDA-identified products and establishments and conducts such monitoring except veterinary drug outlets.
- FDA issues import permits for imported active pharmaceutical ingredients and other raw materials intended for use as components in the manufacture of FDA-classified products.
- BAI regulates registration of veterinary drugs and products consisting of: feed-related preparations for mass medication; veterinary vaccines, diagnostic kits and reagents, veterinary medical devices and other biological products; specified non-medicated grooming products; dips; specified veterinary and aquaculture disinfectants; and probiotics for animal facilities/environment (including pond or pond water and related products).
- BAI regulates registration of active pharmaceutical ingredients and other raw materials intended as components for products under BAI registration categories exclusively intended for veterinary use.
- BAI regulates licensing for veterinary drug manufacturers, traders, importers, distributors, exporters, wholesalers, and outlets of products classified under BAI registration categories, in compliance with applicable rules and regulations.
- BAI monitors BAI-identified products and establishments and regulates veterinary outlets whether or not they carry products classified under B.1.1.
- BAI issues import permits for all veterinary products classified under BAI registration categories and their respective API.
Procedures, implementation, penalties
- The DA-BAI adopts and uses the existing rules of procedure and requirements/standards currently implemented by DOH-FDA for licensing and registration of veterinary drugs and products, including applicable regulations related to generic labeling of veterinary drug products.
- If there are no applicable requirements, procedure, or standards, BAI provides technical input and recommends the same to FDA for subsequent issuance of guidelines and policies.
- The BAI assists the FDA in investigations and hearings of cases involving violations involving the manufacture, importation, distribution, and sale of products and/or establishments covered by the order.
- The FDA and BAI must formulate within thirty (30) days the procedures for implementation, following the Rules of Procedure provided in the Rules and Regulations Implementing Republic Act No. 9711.
- Penalties for violations involving products within the order’s scope are imposed as provided under Republic Act No. 9711.
- FDA and BAI through Technical Working Groups (TWG) conduct activities and perform functions necessary for effective implementation, including periodic review for recommendations.
Administrative continuity, repeals, separability
- The current system and procedure of the respective agencies for licensing establishments and registering products covered by the order remain operative until definitive guidelines, rules, and regulations are established for full implementation.
- The order includes a supplimentary clause: existing and applicable laws are deemed suppletory to the order.
- The order contains a repealing clause: it supersedes the September 25, 1991 DOH-BFAD and DA-BAI MOA.
- The order contains a separability clause: if any part is declared unconstitutional, the remaining portions remain valid and in effect.