January 15, 2018


 FDA revokes draft compounding guidance

Posted Jan. 3, 2018

The federal government has revoked draft guidance that described when animal drugs could be compounded from bulk substances.

A new draft should be available for public comment in early 2018, a Food and Drug Administration announcement states.

The FDA's announcement, published Nov. 7, 2017, lacks any description of how the new and old drafts will differ.

"In developing the new draft, the FDA will carefully consider the issues that are specific to compounding of animal drugs, including the significance of using compounded drugs as a treatment option in various veterinary settings and animal species," the announcement states.

The new guidance will replace the draft document "Compounding Animal Drugs from Bulk Drug Substances," which was published in May 2015. It described FDA interpretations of the legality of compounding animal drugs from bulk pharmaceutical substances and indicated when the FDA would withhold action on compounding that violated federal law.

Compounding is a type of drug manufacturing generally treated the same as other manufacturing methods under the Food, Drug, and Cosmetic Act, the draft guidance document stated. The law contains exemptions for compounded human-use drugs but not animal-use ones.

"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 approval/indexing requirements," the draft stated.

But agency officials also acknowledged that approved drugs are not available for conditions in all animal species. "FDA recognizes that there are circumstances where there is no drug available to treat a particular animal with a particular condition, because either no drug is approved for a specific animal species or no drug is available under the extralabel drug use provisions," the draft stated. "In those limited circumstances, an animal drug compounded from bulk drug substances may be an appropriate treatment option."

The draft included other conditions for compounding from bulk drug substances: Those drugs should be compounded in response to prescriptions or expected demand because of recent orders, intended for nonfood species, and different enough from FDA-approved drugs to give patients clinical benefits. Other guidance described specific manufacturing requirements for veterinarians, pharmacists, and other compounders.

Related JAVMA Content 

Some compounding may be allowed, even if still illegal (July 1, 2015)

Unraveling the confounding world of compounding (March 1, 2013)