The voice for compounding pharmacy | December 20, 2019
FDA draft GFI on animal compounding: By what authority?
As noted above, we've posted a new brief on FDA's draft guidance document on Compounding Animal Drugs from Bulk Substances and solicitation of nominations for a positive bulks list for compounded veterinary office stock.
We believe FDA lacks specific statutory authority in this area, and we will be offering formal comments on that and other concerns at the proper time. Please send your thoughts on this GFI or bulks list request to [email protected]. Your input can help inform APC's comment letter.
