FDA proposes new rules for animal drug compounding

FDA Center for Veterinary Medicine director Bernadette Dunham

The Drug Quality and Security Act, which was signed into law in late 2013, gave the FDA new power to oversee compounded drugs, which are specially formulated versions of existing drugs that are made and sold by pharmacists. The law provides certain exemptions, including circumstances when compounders can make drugs from bulk substances. Problem is, the law only applies to drugs that are compounded for people--a major shortcoming, since compounding is a huge presence in veterinary care, as well.

The FDA is now on its way to closing that gap. On May 18, the agency announced that it released a draft guidance that sets out rules for compounding animal drugs from bulk substances. In so doing, the FDA is recognizing that in some situations, treating animals with specially formulated versions of approved drugs would be impossible.

"This draft guidance, once finalized, will help to ensure that animal drugs compounded from bulk drug substances are available for patient care without compromising the animal drug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, veterinarian and director of the FDA's Center for Veterinary Medicine, in a press release.

The FDA is also developing a list of bulk drug substances that compounders can use in making animal drugs. But those pharmacies would have to be registered as "outsourcing facilities" with the FDA, according to the release.

The Drug Quality and Security Act was passed in response to the 2012 meningitis outbreak that was linked to the now-defunct New England Compounding Center, which is facing a 131-count indictment from the Justice Department accusing pharmacists there of dangerously cutting corners on safety to save money. The FDA has been cracking down on compounders ever since the law was passed, including those who market their products for animal care. Last fall, for example, the agency sent warning letters to three compounders that were mass-marketing ulcer drugs for horses without the proper approvals.

The FDA will be taking public comments on the new animal drug compounding rule for the next three months. The agency has also invited the public to nominate bulk drug substances for inclusion in the list of allowed ingredients for compounding.

- here's the FDA's press release
- access the FDA's guidance document here