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While 503B facilities are required to follow current Good Manufacturing Practices (cGMP), the compounded drugs themselves are not FDA-approved. If semaglutide and tirzepatide are removed from the 503B bulks list, the availability of compounded GLP-1s would drop significantly, Michael Snyder, MD, FACS, FASMBS, DABOM, medical director of the Bariatric Surgery Center at Rose Medical Center, founder and director of the Denver Center for Bariatric Surgery Foundation, and in-house obesity specialist at FuturHealth, told MNT

When will the FDA inspect the 39 uninspected 503B outsourcing facilities

Blachier F, Beaumont M, Kim E