Ted Yoho (R-FL), Mark Pocan (D-WI), and Donald Norcross (D-NJ), members of the U.S. House of Representatives, are the lead sponsors of a letter sent to Food and Drug Administration Commissioner, Stephen Hahn, M.D., expressing their concerns about the FDA’s draft Guidance for Industry #256 - Compounding Animal Drugs from Bulk Drug Substances.
The letter, co-signed by a total of 34 Congressional members, notes that “We are concerned that no existing statute gives FDA the authority to implement the provisions set forth in GFI #256. Congress has raised similar concerns regarding the need for any guidance documents related to animal compounding to be grounded in statute in final appropriation conference reports for FY2017, FY2018 and FY2019.”
The letter asks that “… unless FDA can identify the specific statutory authority that supports the provisions of GFI #256, that this draft guidance be modified or withdrawn so that it is in compliance with existing laws, does not increase the cost of animal health care, or restrict safe pharmaceutical options available for veterinarians treating their animal patients. We also ask that FDA engage all stakeholders, including pet owners, zoos, rescue shelters, veterinarians, compounding pharmacists and others as this process moves forward.”
Other original sponsors of the letter are Henry Cuellar (D-TX), John Carter (R-TX), and Buddy Carter (R-GA).
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