QuestionsQuestions (JOINT DOH AND DA ADMINISTRATIVE ORDER NO. 2013-0026)
The Order is anchored on Republic Act No. 9711 (Food and Drug Administration Act of 2009) which amended RA 3720, and it recognizes a prior MOA between DOH-BFAD and DA-BAI. Its purpose is to enhance regulation of veterinary drugs and related products and to strengthen administrative and technical capacity of the FDA while ensuring clear allocation of regulatory functions between FDA and BAI to avoid overlap.
The Order aims to facilitate licensing and registration and ensure effective regulation of manufacture, distribution, and monitoring of veterinary drugs and biological products and establishments selling them, while setting policy direction for licensing/registration, including products used exclusively for veterinary use or both veterinary and human use.
It covers veterinary drugs and products, veterinary biological products under the regulatory mandate of FDA and the establishments that manufacture, import, or distribute them.
Registration is the process of approval for manufacture, importation, exportation, sale, offer for sale, distribution, labeling, advertising, or transfer of veterinary drugs and products containing active ingredient(s) of known chemical structures and properties determined to be safe, efficacious, and of good quality according to BFAD/BAI standards.
Any organization or company involved in the manufacture, importation, repacking, and labeling (as described in the text) of veterinary drugs and products.
A manufacturer is engaged in production operations such as propagation, processing, compounding, finishing, filling, repacking, labeling, advertising, storage, distribution or sale; however, compounding and filling of prescription by drugstores is not considered production. A trader is a registered owner that procures raw materials/packaging components and provides production monographs/QC standards/procedures but subcontracts manufacture to a licensed manufacturer; a trader may also engage in distribution and marketing.
Distributor/Importer imports raw materials, active ingredients, and/or finished products for its own use or for wholesale/distribution to other drug establishments/outlets. Distributor/Exporter exports raw materials, active ingredients, and/or finished products to another country.
The FDA continues to register veterinary drugs in pharmaceutical dosage forms except those intended for feeds. The BAI continues to register veterinary drugs and products intended solely for animal use.
The FDA regulates finished pharmaceutical dosage forms such as oral dosage forms (capsules, tablets, bolus, paste, suspensions, granules, solutions, syrups, emulsions), injectables (solutions/suspensions/powder for injections/granules for injections), and external preparations (creams, ointments, lotions, aerosols, sprays, gels, medicated soaps and shampoos), including ophthalmic or otic forms.
The BAI regulates products such as feed-added preparations (pre-mixes, water soluble powders and other non-specified forms added to feeds/water, feed supplements/additives, mass medication solutions), veterinary vaccines/diagnostic kits and biological products, non-medicated grooming products (e.g., soaps/shampoos/toothpaste/colognes/conditioners), dips and eggs, disinfectants for veterinary/aquaculture use, and probiotics intended for animal facilities/environment.
FDA monitors the products and establishments identified under FDA's A.1 and A.2, except veterinary drug outlets. BAI monitors products identified under B.1 and establishments under B.2, and is responsible for regulation of veterinary outlets whether or not they carry products classified as B.1.1.
FDA issues import permits for imported active pharmaceutical ingredients and other raw materials intended for use as components of FDA-regulated products (A.1). BAI issues import permits for all veterinary products classified under B.1 and their respective APIs.
DA-BAI adopts and uses existing rules of procedure and requirements/standards currently implemented by DOH-FDA for licensing and registration, including applicable generic labeling regulations. If no applicable standards exist, BAI provides technical input and recommends the same to FDA for issuance of guidelines and policies.
FDA and BAI, through Technical Working Groups (TWG), conduct activities necessary for effective implementation and perform periodic review as provided in Item XI (including recommendations for appropriate and future action).
BAI assists FDA in investigation and hearing of violations involving manufacture, importation, distribution, sale, and establishments covered by the Order. FDA and BAI must formulate procedures within 30 days following the Rules of Procedure implementing RA 9711. Penalties are as provided under RA 9711.
It takes effect immediately after publication in a national newspaper of general circulation and filing with the UP Law Center. It remains in force for five (5) years or until sooner terminated by consensus of the parties.