The U.S. Food and Drug Administration today made good on a decade-old promise to provide updated guidance on the regulatory complexities of compounding animal drugs from bulk substances.
A draft of the policy would replace "Compounding of Drugs for Use in Animals," a compliance policy guide initiated in 1996 and last updated in 2003.
"This draft guidance, once finalized, will help to ensure that animal drugs compounded from bulk drug substances are available for patient care without compromising the animal drug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 ...," Dr. Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine, said in a news release.
Stakeholders have 90 days to offer comments. The FDA also is inviting the public to submit a list of bulk drug substances important to animal health and veterinary medicine.