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The U.S. Food and Drug Administration issued a final guidance, entitled “Compounding Animal Drugs from Bulk Drug Substances,” that will help protect animal health by recognizing the need for access to certain compounded animal drugs. The guidance describes the agency’s approach to situations where veterinarians use unapproved compounded drugs to provide appropriate care for the medical needs of the diverse species they treat. The FDA recognizes that this final guidance covers a wide range of stakeholders and plans to focus on education and stakeholder engagement before shifting resources toward inspectional activities in Fiscal Year 2023.
Animal drug compounding is the process of combining, mixing or altering ingredients to create a medication tailored to the needs of an individual animal or a small group of animals. Animal drug compounding using an FDA-approved drug as the starting point is already allowed under existing law and regulations. Animal drugs compounded from bulk drug substances are not FDA-approved and the agency has not evaluated them to ensure that they are safe, effective, properly manufactured to ensure consistent quality, and the labeling is complete and accurate.
The final guidance:
- Addresses compounding of unapproved animal drugs from bulk drug substances
- Outlines flexibilities for pharmacists and veterinarians who compound animal drugs from bulk drug substances for individual patients
- 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.
- 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.
April 13, 2022/ FDA/ United States.
https://www.fda.gov/
