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FDA extends comment period for revised drug compounding guidance

New deadline for comments will be June 17.

In response to requests to extend the comment period for the revised draft guidance “Compounding Animal Drugs from Bulk Drug Substances,” the Food & Drug Administration said it plans to provide an additional 120 days for the public to submit comments.

The initial comment period is scheduled to end on Feb. 18, 2020, but FDA will be reopening the comment period using the same docket number. Otherwise, the submission process remains unchanged.

The new deadline to receive comments will be June 17, 2020.

FDA said a Federal Register notice for the reopening of the comment period is forthcoming and is expected on or shortly after Feb. 20.

When FDA issued the new draft guidance in November 2019, the agency said if finalized, the guidance would advise veterinarians on circumstances under which FDA does not intend to take action for certain violations of the Federal Food, Drug & Cosmetic Act when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances.

FDA said it believes this policy, if finalized, would allow the legitimate veterinary medical needs of animal patients to be met by providing access to drugs compounded from bulk in appropriate circumstances, without undermining the demonstrated safety and effectiveness of approved animal drugs.

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