Compounding of Animal Drugs
To be legally marketed, new animal drugs must be approved under section 512 of the FD&C Act, conditionally approved under section 571 of the FD&C Act, or included on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species under section 572 of the FD&C Act. The FD&C Act does not generally distinguish between compounding and other methods of animal drug manufacturing. Animal drugs that are not approved or indexed are considered “unsafe” under section 512(a)(1) of the FD&C and adulterated under section 501(a)(5) of the FD&C Act. Animal drugs compounded from bulk drug substances are new animal drugs.
On May 19, 2015, FDA revoked Compliance Policy Guide, Section 608.400, “Compounding of Drugs for Use in Animals” and published a draft guidance that provides information to compounders of animal drugs and other interested stakeholders on FDA’s enforcement approach with respect to the compounding of animal drugs from bulk drug substances. Compliance Policy Guide 608.400 was withdrawn because it was no longer consistent with FDA’s current thinking. Until we publish final guidance on this issue, FDA intends to look at the totality of the circumstances when determining whether to take enforcement action for unlawful animal drug compounding activities. The draft guidance is available here: Draft Guidance for Industry #230 – Compounding Animal Drugs from Bulk Drug Substances.
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