November 19, 2019

The U.S. Food and Drug Administration is requesting public comment on new draft guidance for industry (GFI) #256, entitled “Compounding Animal Drugs from Bulk Drug Substances.” The new draft guidance, if finalized, would advise veterinarians on circumstances under which FDA does not intend to take action for certain violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances.  FDA believes this policy, if finalized, would allow the legitimate veterinary medical needs of their animal patients to be met by providing access to drugs compounded from bulk 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.

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 The draft guidance addresses particular situations, such as when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances:

• to fill patient-specific prescriptions for nonfood-producing animals;
• to compound “office stock” from bulk drug substances for nonfood-producing animals; and
• to compound antidotes for food-producing animals.

Compounded animal drugs do not undergo review by the FDA, meaning that the FDA has not determined 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 However, the draft guidance acknowledges that, where there is no medically appropriate drug that is FDA-approved, conditionally approved, or on the Index of Legally Marketed Unapproved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.  Although the FD&C Act prohibits the marketing of unapproved drugs, the draft guidance describes the conditions under which, if the guidance is finalized, the FDA does not intend to take action against state-licensed pharmacies and veterinarians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.

The 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 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, the FDA will actively engage stakeholders to gather feedback and comment on the agency’s position as 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?

The FDA is accepting public comments on draft GFI #256 beginning on November 20, 2019. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2018-D-4533 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2018-D-4533 on each page of your written comments.

Comments on draft GFI #256 will be accepted at any time but should be submitted no later than February 18, 2020, to ensure that the FDA takes the information into consideration before making further decisions on this issue.

To electronically submit comments to the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals, visit www.regulations.gov and type FDA-2018-N-4626 in the search box. You may also submit comments by mail using the address below, and should include FDA-2018-N-4626 on each page of your written nomination. There is no deadline for nominations: this docket will remain open indefinitely.

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

For more information:

• FDA In Brief: FDA issues draft guidance on compounding certain animal drugs from bulk drug substances
• Animal Drug Compounding
• FR Notice for Guidance for Industry #256: Compounding Animal Drugs from Bulk Drug Substances
• GFI #256: Compounding Animal Drugs from Bulk Drug Substances
• FR Notice for Nominations to List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals
• Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals
• List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals
• Regulations.gov: please note that the public comment period for GFI #256 opens on November 20, 2019 and closes on February 18, 2020.