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Alliance for Pharmacy Compounding Asks FDA to Extend GFI #256 Comment Period Again.


On May 5, 2020, Scott Brunner, CEO of the Alliance for Pharmacy Compounding (formerly the International Academy of Compounding Pharmacists) wrote to Dr. Steven Solomon, DVM, Director of the Center for Veterinary Medicine of the Food and Drug Administration, and requested a further 180-day extension of the comment period for FDA’s draft GI #256, Compounding Animal Drugs from Bulk Drug Substances. In his letter, Brunner explained, “Because many of our members and other pharmacy stakeholders have been focused on working with the hospitals, physicians and other front-line responders treating COVID-19 patients, we have been unable to receive and process the level of input necessary to provide substantive comments into the docket on this draft guidance. Unfortunately, we anticipate this to be the case for the next few months until infection rates flatten and decline.”
In the letter, Brunner also asked Solomon to address five questions that had been submitted in advance of Brunner’s online conference with APC members the previous week, but had not been addressed during that conference.

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