FDA releases draft compounding guidance

Historically, when a veterinarian needed to compound drugs from bulk substances to meet a patient’s needs, he was breaking a federal law. Now, the Federal Drug Administration (FDA) is recognizing the need for that “lawless” act.

On May 18, the FDA released Guidance for Industry #230 (GFI #230) on animal drug compounding from bulk drug substances. It also admitted that in limited circumstances, an animal drug compounded from bulk drug substances may be an appropriate treatment option.

According to the American Veterinary Medical Association (AVMA), compounding occurs when a drug is manipulated in ways other than what is stated on the drug’s label. That includes mixing two injectable drugs, creating an oral drug suspension from crushed tablets of an injectable solution, or adding flavoring to a commercially available drug.

The 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 FDA has also drafted a Federal Register notice requesting nominations of bulk drugs to create a “positive list” that outsourcing facilities can use to develop compounds to dispense to clients, or to veterinarians for administering in-office, per a veterinarian’s order or prescription.

For those nominations, the FDA requires the names of the needed drugs, and specific scientific evidence that supports their safety and efficacy, as well as other information.

The deadline for electronic comments regarding GFI #230 and the “positive list” is August 17. However, the American Veterinary Medical Association (AVMA) has requested a 90-day extension.

The AVMA is also putting out a call to its members to provide the comments to the AVMA so they can craft a response that meets veterinarians’ varied needs, and provide a collective voice.

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