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Still time to comment on FDA drug compounding guidance

Alan Newport Cattle injections
FDA's proposes a short list of drugs that could be compounded.
Industry survey on FDA’s Draft GFI 256 shows veterinarians not happy with restrictions these “regulations” would enact.

FDA’s new guidance for industry proposal on compounding drugs is not faring well in an industry survey. Veterinarians can still comment in that survey, and on FDA’s proposed guidance until February 18.

Early in January The Business Wire reported this survey reports the responses of 1,849 veterinary professionals in the US. At that time, more than 99% of those responding said access to compounded medications when they are necessary in their medical judgement is important.

Under the circumstances of Draft GFI #256, only bulk drug substances on an approved list can be compounded into drugs for office stock or for antidotes for food-producing animals. Some of the veterinarian responses say this list is very limiting.

In FDA's request for public comment, it says the draft guidance would advise veterinarians on circumstances under which the FDA does not plan to take action for certain violations of the Federal Food, Drug, and Cosmetic Act when pharmacists and veterinarians compound animal drugs from bulk drug substances. Although the guidance is not a law and would not be binding for FDA, compounding pharmacies, or veterinarians, the FDA uses non-binding guidance as the basis for its enforcement actions.

One source said instead of the current 450 active pharmaceutical ingredients (APIs) that can be used for compounding, the proposed guidelines would limit approval APIs to seven.

You can use this link to comment on FDA’s proposed GFI#256 by February 18, 2020.

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