{"id":3958,"date":"2022-05-06T12:59:03","date_gmt":"2022-05-06T16:59:03","guid":{"rendered":"https:\/\/a4pc.org\/?p=3958"},"modified":"2022-05-06T13:01:46","modified_gmt":"2022-05-06T17:01:46","slug":"cc-may-6-2022-issue","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2022-05\/cc-may-6-2022-issue\/","title":{"rendered":"CC: May 6, 2022 issue"},"content":{"rendered":"
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News about what’s happening in our industry<\/span><\/div>\n<\/div>\n<\/td>\n<\/tr>\n
The voice for pharmacy compounding | May 6, 2022<\/span><\/div>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
From APC\u2019s President<\/span><\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
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Animal compounding takes center stage at APC<\/span><\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
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Like most compounders, I am happy to serve my local veterinarians. I have pets of my own and know how important customized medicine is to them.<\/div>\n
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Unfortunately, our ability to serve our furry or slithering patients may be in jeopardy.<\/div>\n
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In 2015, FDA released a guidance for industry (also known as a GFI) #230. This GFI is a \u201cnon-binding resolution which gives the FDA\u2019s thoughts on a subject\u201d at that time. GFI 230 would have placed restrictions on the type of compounding we could do for pets and restated FDA\u2019s long held policy that compounding for animals from bulk ingredients was illegal. The agency withdrew GFI 230 in 2017.<\/div>\n
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In 2019, FDA released a draft GFI 256, which was a revision of GFI 230. Again, the agency stated that it was illegal to compound from bulk APIs but that it would practice \u201cregulatory discretion\u201d (meaning turning a blind eye) if some conditions were met. Find a copy of GFI 256 here<\/a>.<\/div>\n
On Wednesday, APC leaders met with officials from FDA\u2019s Center for Veterinary Medicine to enunciate concerns about what APC sees as ambiguity and uncertainty in CVM\u2019s final GFI #256, regarding animal compounding.<\/span><\/div>\n
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The hour-long virtual Q&A session was the result of an invitation from CVM\u2019s Deputy Director of Science Policy Dr. Bill Flynn, who participated along with CVM\u2019s Drs. Cindy Burnsteel and Amber McCoig.<\/span><\/div>\n
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Leaving aside any questions of FDA\u2019s statutory authority <\/span>for the regulatory framework GFI #256 imposes, APC Board Chair Michael Blair noted that the GFI goes well farther than restrictions placed on human compounding in DQSA. <\/span><\/div>\n
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Flynn replied that \u201cthe law does not lay out a clear pathway for compounding on the animal side\u201d and that the agency has sought \u201cto develop a framework that enables compounding for animal use, including from API.\u201d<\/span><\/div>\n
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Much of the discussion in the meeting focused on the GFI\u2019s restrictions on compounding for from bulk API. In addition, Also raised was the issue of how CVM\u2019s \u201ctrust us\u201d approach to enforcement discretion might not be shared by state boards of pharmacy, who may likely seek more restrictive enforcement in their state regulations and inspection regime. <\/span><\/div>\n
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Flynn indicated that the agency is aware of the concern and plans to \u201ccoordinate with state boards,\u201d understanding there may be variations in enforcement. <\/span><\/div>\n
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\u201cThat response was not a particularly reassuring one,\u201d said APC\u2019s CEO Scott Brunner after the call.<\/span><\/div>\n
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The allocated hour was insufficient for covering APC\u2019s extensive list of questions; the group agreed to schedule a follow-up meeting for later this month to take up, among other issues, concerns about adverse event reporting in the GFI. After that second meeting, APC will share publicly the document containing all our questions of CVM. APC will also be formally commenting on GFI #256 shortly.<\/span><\/div>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n
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