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GUIDANCE DOCUMENT

CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances November 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-4533


Docket Number:
FDA-2018-D-4533
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This draft guidance is intended for veterinarians, State-licensed pharmacies, and Federal facilities interested in compounding animal drugs from bulk drug substances for use in nonfood-producing animals or for use as antidotes in food-producing animals under limited circumstances when no other medically appropriate treatment options exist.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the compounding of an animal drug from bulk drug substances results in a “new animal drug” that must comply with the FD&C Act’s animal drug approval, conditional approval, or indexing requirements (sections 512, 517, and 572 of the FD&C Act). In addition, all animal drugs are require to, among other things, be made in accordance with current good manufacturing practice (cGMP) requirements (section 501(a)(2)(B) of the FD&C Act) and have adequate directions for use (section 502(f)(1) of the FD&C Act).

Animal drugs that are compounded from bulk drug substances do not meet the FD&C Act’s new animal drug approval, cGMP, or adequate directions for use requirements. However, FDA has generally exercised enforcement discretion with regard to animal drug compounding from bulk drug substances under certain circumstances. This draft guidance is a continuation of this practice and is intended to provide additional information and clarity to veterinarians and pharmacists about FDA’s current thinking on this matter. The guidance describes the circumstances under which FDA, at this time and based on our current understanding of the risks of animal drugs compounded from bulk drug substances, does not intend to take enforcement action for violations of the FD&C Act with respect to the compounding of animal drugs from bulk drug substances.   
 

Questions?

Contact Point
Eric Nelson