FDA proposes guidelines for veterinarians, pharmacies on compounding from bulk substances
Although current law does not permit compounding of animal drugs from bulk drug substances, the U.S. Food and Drug Administration (FDA) says it does recognize that there are limited circumstances when an animal drug compounded from bulk drug substances may be an appropriate treatment option. As such, the FDA has released Guidance for Industry No. 230, "Compounding Animal Drugs from Bulk Drug Substances" to outline specific conditions under which FDA generally would deem compounding acceptable.
FDA says in cases where there are no drugs 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, an animal drug compounded from bulk drug substances may be appropriate. “This draft guidance, once finalized, will help to ensure that animal drugs compounded from bulk drug substances are available for patient care without compromising the animal drug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,” says Bernadette Dunham, DVM, PhD, director of the FDA’s Center for Veterinary Medicine, in an FDA press release.
Despite the guidance draft, FDA hopes to encourage the use of approved alternatives that can be used as labeled or in an extralabel manner when possible instead of compounded bulk drug substances. "Compounded drugs have not undergone premarket FDA review of safety, effectiveness, or manufacturing quality. The unrestricted compounding of animal drugs from bulk drug substances has the potential to compromise food safety, place animals or humans at undue risk from unsafe or ineffective treatment, and undermine the incentives to develop and submit new animal drug applications to FDA containing data and information to demonstrate that the product is safe, effective, properly manufactured, and accurately labeled," FDA states in the draft guidance.
FDA says it does not intend to take action against state-licensed pharmacies, veterinarians or "outsourcing facilities" that compound animal drugs in accordance with the conditions of the proposed guidelines as long as the drug is not otherwise adulterated or misbranded. Read the guidance draft for conditions outlined specifically for veterinarians.
The public currently has the opportunity to submit comments concerning the draft guidance in the Federal Register. FDA is also accepts nominations for a list of bulk drug substances that may be used by outsourcing facilities to compound drugs. To comment, go to regulations.gov. Search for docket No. FDA-2003-D-0202 to comment on the Draft Guidance for Industry No. 230, "Compounding Animal Drugs from Bulk Drug Substances," and docket No. FDA-2013-N-1524 to nominate drug substances.