Question & AnswerQ&A (JOINT DOH AND DA ADMINISTRATIVE ORDER NO. 2013-0026)
The Order aims to regulate veterinary drugs and products, veterinary biological products, and establishments manufacturing or selling the same, to facilitate licensing and registration, avoid overlapping regulatory functions between FDA and BAI, and ensure effective monitoring and supply management.
The Food and Drug Administration (FDA) and the Bureau of Animal Industry (BAI) are the two main regulatory agencies involved.
It covers veterinary drugs and products, veterinary biological products, and the establishments manufacturing, importing, distributing, or selling such products under the regulatory mandate of the FDA and BAI.
Veterinary drugs and products refer to any substance, including biological products, applied or administered to food-producing, companion, aquatic, laboratory, and exotic animals for therapeutic, prophylactic, diagnostic purposes, or for modification of physiological functions or behaviors.
They include manufacturers, traders, distributors/importers, distributors/exporters, wholesalers, and veterinary drug outlets like drugstores, pharmacies, and supply stores.
The FDA regulates registration of finished pharmaceutical dosage forms such as oral dosages, injectables, external preparations, ophthalmic or otic products, active pharmaceutical ingredients, and excipients used in these products.
The BAI regulates products such as feed additives, veterinary vaccines, diagnostic kits, biological products, grooming products, disinfectants, probiotics for animals, and other veterinary products intended exclusively for animal use.
Penalties are as provided under Republic Act No. 9711, which governs the Food and Drug Administration, including sanctions for violations related to manufacture, importation, distribution, and sale of covered veterinary drugs and products.
The Order remains in force for five (5) years from effectivity or until sooner terminated by consensus of the parties involved.