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GADA Joins AHI in Urging Compounding Enforcement
February 22, 2023
GADA has joined the Animal Health Institute (AHI) in a letter to CVM Director Tracey Forfa urging enforcement action now against compounding pharmacies’ copying approved medicines through bulk compounding practices. GFI #256 was published in October 2022, followed by announcement of delayed enforcement until April 2023. The letter to Director Forfa states that this grace period, granted to allow stakeholders time to amend their practices to comply with the Guidance, is being abused: some compounding pharmacists are pushing efforts to copy approved animal medicines.
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GADA Supports FDA Restructuring; CVM to Remain Stand-Alone Center
February 20, 2023
GADA supports the FDA restructuring announced by Commissioner Robert Califf on January 31, 2023, which creates a Human Foods Program while maintaining the Center for Veterinary Medicine (CVM) as a stand-alone center. Relevant food safety activities will be coordinated between CVM and the newly created Human Foods Program. “The restructuring announced by Commissioner Califf emphasizes the importance of the responsibilities of the Center for Veterinary Medicine to not only animal health, but human health as well,” said GADA Chair Stephanie Batliner. “Animal medications approved by CVM are used to treat both companion animals and food animals. GADA Member organizations look forward to continued interaction with CVM as we work to bring more affordable medications to market.”
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FDA Warns About Risk of Xylazine Exposure in Humans
November 8, 2022
The FDA is communicating to health care professionals about serious risks associated with xylazine exposure in humans. FDA is aware that xylazine is increasingly detected in the illicit drug supply and in drug overdoses. Xylazine is an FDA-approved animal drug used as a sedative and analgesic in veterinary medicine, but is not approved for use in humans. The FDA has issued an Alert and a letter to stakeholders to communicate the risks and considerations for management.
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FDA Announces Delay in GFI #256 Enforcement
September 22, 2022
On September 9, 2022, FDA announced a six-month delay in enforcement for its GFI #256, Compounding Animal Drugs from Bulk Drug Substances. Routine inspectional activities were to begin on October 1, 2022. The delay was requested by the Alliance for Pharmacy Compounding, American College of Veterinary Pharmacists, American Pharmacists Association, National Community Pharmacists Association, and Society of Veterinary Hospital Pharmacists, among others, who say pharmacies need additional time to review the recommendations or make suggested changes to processes, and to submit nominations for bulk drug substances for compounding office stock.
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GADA Hails Introduction of Generic Animal Drug Advancement Act
September 15, 2022
The Generic Animal Drug Advancement Act, H.R. 8857, will update the Federal FD&C Act to correct current limitations to the approval of generic animal drug applications. The legislation would expand pathways for generic animal drugs to be approved as combination products, and update FDA animal drug labeling requirements to allow generic animal drugs to gain approval for a single species, rather than all species, labeled on a pioneer drug. MORE
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