The Food and Drug Administration (FDA) is inviting public comments on their proposal to collect information regarding the compounding of animal drugs from bulk substances. This aligns with the requirements of the Paperwork Reduction Act of 1995, which mandates federal agencies to provide a 60-day notice for public feedback on information collection proposals. The FDA is particularly interested in comments about the necessity, accuracy, and efficiency of its information collection practices. The guidance, GFI #256, outlines situations where the FDA does not intend to enforce actions against pharmacists and veterinarians who compound these drugs, as long as no other appropriate treatments exist.
Simple Explanation
The FDA wants to know what people think about how they collect information when making animal medicines from big batches of ingredients. They promise not to bother vets and pharmacists if they make the medicines this way only when no other treatment works. They’re asking for suggestions on how to make their rules clear and easy.