Compounding drugs is a critical tool for veterinarians, including compounding from bulk drug substances. While drugs compounded from bulk substances are considered to be unapproved, the Food and Drug Administration’s Center for Veterinary Medicine recognizes that veterinarians need these compounded drugs. On April 13, 2022, the agency published final guidance describing the conditions or situations under which the FDA does not intend to take enforcement action against entities compounding animal drugs from bulk drug substances. FDA has indicated that it will focus on education and stakeholder engagement before shifting resources...
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