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FDA Extends Educational Period for New Policy on Compounding Animal Drugs from Bulk Drug Substances

The Food and Drug Administration has delayed enforcement of its finalized guidance regarding compounding animal drugs from bulk drug substances until April 2023.

The Food and Drug Administration issued final guidance, unveiled in April, on the use of bulk drug substances for compounding animal medications. Under Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances, the FDA delineates the circumstances under which it will exercise enforcement discretion related to violations of the Federal Food, Drug, and Cosmetic Act for drug approval, labeling, and manufacturing when pharmacists and veterinarians compound drugs from bulk drug substances for animal patients.

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Breaking Biosecurity: The First U.S. Case of H5N1 in Pigs and What It Means for Producers

Video: Breaking Biosecurity: The First U.S. Case of H5N1 in Pigs and What It Means for Producers

Dr. Gisele Ravagnani provides insights into the recent detection of H5N1 in an Oregon pig, marking the first U.S. case in swine. H5N1, a highly pathogenic avian influenza, primarily affects birds but has now crossed into swine. This development raises concerns for both swine and poultry producers due to potential interspecies transmission. Producers are advised to enhance biosecurity measures, such as controlling farm access and monitoring animal health. While the risk to human health remains low, it's crucial to protect workers through proper hygiene and protective equipment. Producers should watch for symptoms like respiratory distress in their herds and consult veterinarians promptly if infections are suspected.