New FDA Guidance on GFI #265 for Veterinary Compounding
Veterinary Compounding Receives New Guidance From FDA
The FDA Center for Veterinary Medicine (CVM) released new guidance in April for compounding drugs from bulk substances for veterinary uses. They state it will help protect animal health by recognizing the need for access to certain compounded medications for animals.
The guidance is intended for veterinarians, state-licensed pharmacies and federal facilities that compound animal drugs from bulk drug substances for use in nonfood-producing animals, as antidotes in food-producing animals, or as sedatives or anesthetics in free-ranging wildlife when no other medical treatment option exists. The guidance describes the FDA’s approach where veterinarians may use unapproved compounded drugs and intends that the guidelines will cover those situations.
Animal Drug Compounding
FDA-approved drugs are used as the starting point for animal drug compounding, which is already allowed under today’s existing laws and regulations. Currently, there are over 1,600 FDA-approved or conditionally approved or indexed drugs for animals and about another 20,000 FDA-approved human drugs that can be prescribed for animal use.
The FDA hasn’t approved bulk drug substances for compounded animal drugs, and the agency hasn’t evaluated them to be sure they are safe, effective, correctly manufactured to guarantee reliable quality, and that labeling is exact and complete.
FDA GFI #265 Guidelines
In 2019, FDA released guidance but received comments from veterinarians and compounders. They decided to respond by making final changes to be “flexible” for veterinarians, so they can access animal drugs compounded from bulk substances for the animals that may need them.
According to the FDA:
“Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), 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 animal drug approval, conditional approval, or indexing requirements (sections 512, 517, and 572 of the FD&C Act). In addition, all animal drugs are required to, among other things, be made in accordance with current good manufacturing practice (cGMP) requirements (section 501(a)(2)(B) of the FD&C Act) and have adequate directions for use (section 502(f)(1) of the FD&C Act).”
The final guidance (found on the FDA website):
Addresses compounding of unapproved animal drugs from bulk drug substances, which is the practice of preparing a medication without using an FDA-approved or indexed drug as the starting point.
Outlines flexibilities for pharmacists and veterinarians who compound animal drugs from bulk drug substances for individual patients, as well as for those essential drugs needed for immediate or emergency use that they need to keep in their inventory (also known as “office stock”).
Balances the need for accessing animal drugs compounded from bulk drug substances for the patients that need them, while also providing ways to better identify safety issues associated with compounded products.
Describes the types of animal drugs compounded from bulk drug substances that the FDA believes pose the greatest risk to human and animal health. The agency will prioritize these products for enforcement action, as well as those made under poor compounding practices.
Explains FDA’s policy on animal drugs compounded from bulk drug substances that are copies (same active ingredient and route of administration) of marketed FDA-approved or indexed drugs. The agency generally intends to prioritize these products for enforcement action when the compounding pharmacy has not recorded a medical rationale for prescribing a copy instead of an FDA-approved or indexed drug.
The new guidance should provide flexibility for pharmacists and veterinarians to compound animal drugs for individual patients or as needed for emergencies or to keep in offices as stock. It also enforces that action will be conducted for compounded drugs made with poor compounding practices, and for drugs that are copies of FDA-approved or indexed drugs on the market.
“We are taking this step because we recognize the need for veterinarians to have access to compounded animal drugs that aren’t available as approved products and that would make a clinical difference in patient care,” said Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine. “We believe this policy strikes the right balance between maintaining access to drugs veterinarians need to treat diverse animal populations, while ensuring human and animal health is protected from poorly-compounded products, or ones that attempt to copy existing FDA-approved drugs.”
Pushback On The New Guidelines
As reported by the APC, Dr. Bill Flynn noted that "the law does not lay out a clear pathway for compounding on the animal side" and that the agency has sought "to develop a framework that enables compounding for animal use, including from API."
The American Veterinary Medical Association, AVMA, has been involved in helping develop and revise GFI #265 since May 2015. Their remarks on the new guidelines state, "Compounding is a critical tool for veterinarians, including compounding from bulk drug substances. AVMA has made this clear to federal officials throughout the FDA's development and revision of GFI #256, and continues to communicate with FDA CVM about the guidance."
The association submitted comments to the FDA in 2020 and was instrumental in conveying the many challenges veterinarians may face if they cannot carry office stock of compounded products. The AVMA supported some provisions of the draft FGI #256 but did oppose others.
Questions and Concerns About the New Guidelines
According to the FDA's website, they are committed to a "proactive outreach and education period for veterinarians and animal drug compounding pharmacies." They intend to continue meeting about content and implementation and have created a library of tools to help share information. The FDA agency plans to conduct outreach and guidance before enforcing and implementing the new guidance in fiscal 2023. You can direct questions to the agency by email at askcvm@fda.hhs.gov.
Get Guidance for This Guidance
Whether you’re a 503A compounding pharmacy or a 503B outsourcing facility, consultants at Restore Health Consulting LLC can help you navigate the veterinary compounding sector to promote operational efficiency and regulatory compliance at your facility.
Resources:
· APC, CVM leaders meet, discuss GFI #256
· FDA Issues Final Guidance on Animal Drug Compounding from Bulk Drug Substances
· FDA Guidance Document: CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances
· Understanding federal guidance: GFI #256
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