FDA Releases Draft Guidance on Animal Drug Compounding from Bulk Drug Substances

As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.” Current law does not permit compounding of animal drugs from bulk drug substances, but the FDA recognizes that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option. FDA’s GFI #230 outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians, and facilities registered as outsourcing facilities when drugs are compounded for animals from bulk drug substances.

The Drug Quality and Security Act, which amended the human drug compounding provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and created a new section 503B of the FD&C Act for outsourcing facilities, provides certain statutory exemptions for compounded human drugs, but the law does not apply to drugs compounded for animal use.

There are circumstances where there is no approved drug that can be used or modified through compounding to treat a particular animal with a particular condition. In those limited situations, an animal drug compounded from bulk drug substances may be an appropriate treatment option.

“This draft guidance, once finalized, will help to ensure that animal drugs compounded from bulk drug substances are available for patient care without compromising the animal drug approval process or jeopardizing the safety of the food supply,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.

In addition, the FDA is developing a list of bulk drug substances that facilities registered as outsourcing facilities under section 503B can use to compound drugs for an individual animal patient or veterinarian office use under specified conditions. In a separate Federal Register notice, the FDA is requesting public input on which bulk drug substances should be placed on this list.

The agency also withdrew Compliance Policy Guide Section 608.400 Compounding of Drugs for Use in Animals because it is no longer consistent with the FDA’s current thinking on these issues.

The FDA welcomes comments on the draft guidance and nominations to the list of bulk drug substances that may be used by outsourcing facilities to compound drugs. The public comment period for both documents closes on November 16, 2015.

To electronically submit comments to the docket, visit www.regulations.gov and type the docket number in the search box.

  • FDA-2015-D-1176: Draft Guidance for Industry #230: Compounding Animal Drugs from Bulk Drug Substances
  • FDA-2015-N-1196: Request for Nominations: List of Bulk Drug Substances That May be Used by an Outsourcing Facility to Compound Drugs for Use in Animals

To submit comments to the docket by mail, use the following address. Be sure to include the appropriate docket number on each page of your written comments.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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