The U.S. Food & Drug Administration is requesting public comment on new draft Guidance for Industry (GFI) 256, “Compounding Animal Drugs from Bulk Drug Substances.”

FDA said the new draft guidance, if finalized, would advise veterinarians on circumstances under which FDA does not intend to take action for certain violations of the Federal Food, Drug & Cosmetic Act (FD&C Act) when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances.

FDA said it believes this policy, if finalized, would allow the legitimate veterinary medical needs of animal patients to be met by providing access to drugs compounded from bulk substances in appropriate circumstances without undermining the demonstrated safety and effectiveness of approved animal drugs.

The agency is also developing the “List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals.” Under the circumstances of draft GFI 256, only bulk drug substances on this list can be compounded into drugs for office stock or for antidotes for food-producing animals, FDA explained.

Animal drug compounding is generally a practice in which a state-licensed pharmacist or state-licensed veterinarian combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The draft guidance addresses particular situations, such as when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances:

Compounded animal drugs do not undergo review by FDA, meaning that FDA has not determined that these drugs are safe or effective for the intended use. However, the draft guidance acknowledges that, where there is no medically appropriate drug that is FDA approved, conditionally approved or on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed) to treat the animal, an animal drug compounded from bulk drug substances may be a medically necessary treatment, FDA said.

Although the FD&C Act prohibits the marketing of unapproved drugs, the draft guidance describes the conditions under which, if the guidance is finalized, FDA does not intend to take action against state-licensed pharmacies and veterinarians compounding animal drugs from bulk drug substances for violations of the FD&C Act requirements for animal drug approval, adequate directions for use and current good manufacturing practices.

FDA previously published draft guidance on this issue for public comment in May 2015 (Draft GFI 230, “Compounding Animal Drugs from Bulk Drug Substances”). Based on feedback from the veterinary community and compounding industry, as well as other stakeholders, FDA said it decided to withdraw the May 2015 draft guidance and publish this new draft guidance for public comment. In addition to the open public comment period, FDA will actively engage stakeholders to gather feedback and comment on the agency’s position described in draft GFI 256.

The agency is also accepting nominations to the “List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals.” For a complete list of information required for a bulk drug substance nomination, see the appendix in draft GFI 256 or Part II of the Federal Register notice requesting nominations under the header: "What Information Should I Submit with the Nomination?"

FDA is accepting public comments on draft GFI 256 beginning Nov. 20. Comments on draft GFI 256 will be accepted at any time but should be submitted no later than Feb. 18, 2020, to ensure that the agency takes the information into consideration before making further decisions on this issue.

To electronically submit comments to the docket, visit www.regulations.gov, and type FDA-2018-D-4533 into the search box.

To submit comments to the docket by mail, include docket number FDA-2018-D-4533 on each page of the written comments, and send to the address listed below.

To electronically submit comments to the list of bulk drug substances, visit www.regulations.gov, and type FDA-2018-N-4626 into the search box. Comments may also be submitted by mail using the address below and should include FDA-2018-N-4626 on each page. There is no deadline for nominations; this docket will remain open indefinitely.

Dockets Management Staff
HFA-305
Food & Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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