August 6, 2021

Strong language in Senate approps bill

There’s strong language about animal compounding in the proposed Senate’s Ag/FDA appropriation bill. That’s thanks in part to APC’s work with the Senate Appropriations Committee to have senators include a strong admonition to FDA to not exceed what the statute allows related to proposed guidance on animal compounding from pure ingredients.

The committee note to the FDA appropriation reads as follows:

Animal Drug Compounding. The Committee is concerned that the Guidance for Industry [GFI] #256, Compounding Animal Drugs from Bulk Drug Substances, issued on November 20, 2019, raises similar issues to the GFI #230, which has been withdrawn. The Committee encourages the FDA to draft and finalize guidance on compounding animal drugs that is consistent with statutory authority and will ensure access to appropriate treatment is available for veterinarians, animal shelters, zoos and other stakeholders.

The bill awaits action by the Senate.