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In episode 83, Jonathan Stern talks with Scott Brunner, CEO of the Alliance for Pharmacy Compounding, the trade group for more than 600 compounding businesses, about the WaPo report that the administration may let pharmacies sell certain peptides before a formal rule is finished. Brunner says he thinks an announcement is "highly likely" before EOY, and he wants conditions on it: ingredients only from FDA-registered wholesalers, a clearer warning to patients, and reports of serious side effects.
00:00 - Sponsors
01:22 - Peptides may be "imminent"
09:36 - The guardrails the Scott is advocating for
14:00 - RFK is driving this through
19:26 - Pharmacies may need 2-3 months to get ready
23:08 - Which peptides would be included?
25:57 - What about 503B facilities?
28:22 - How long formal rulemaking takes
30:45 - U.S. peptide API capacity will take time
32:56 - Future of the gray market
35:52 - The Empower warning letter and future of compounded GLP-1s
39:28 - Congressional bills Scott is watching
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