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Compounding Animal Drugs from Bulk Drug Substances

The FDA issues a GFI (Guidance For Industry) to tell various sectors, like compounding pharmacists and veterinarians, what to expect from FDA. The proposed GFI#256 deals with Compounding Animal Drugs from Bulk Drug Substances.  We seek clarification on the new draft guidance and question the scientific basis for the requirement in the draft GFI that animal drugs be compounded from FDA-approved manufactured drugs, instead of from the bulk drug substance, ie, API. An API (Active Pharmaceutical Ingredient), is a substance such as a powder or injectable containing only the "drug", without additives such as binders and fillers which are in manufactured drugs and prohibit a pharmacist or veterinarian from properly preparing compounds like topical and transdermal creams or poison antidotes. And, some manufactured drugs made for humans but used to treat animals contain ingredients such as xylitol that can be toxic to animals. Therefore, it’s usually better for the animal to compound using a Bulk Drug Substance versus a manufactured drug.

You can read GFI #256 here:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-256-compounding-animal-drugs-bulk-drug-substances 

We welcome your questions. Any interested party may submit comments directly to FDA here: https://www.regulations.gov/comment?D=FDA-2018-D-4533-0001 The proposed Public Comment Deadline is June 17, 2020. 



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