July 24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (PCAC)
FDA / PCAC — official records & coverage — July 24, 2026 Meeting of the Pharmacy Compounding Advisory Committee (PCAC)
Channel: U.S. Food and Drug Administration · Our label: Government proceedings and coverage of them · OFFICIAL — government record · Source: youtube.com/watch?v=xXM5ecHxlMU
What this video covers
Welcome back for those who were here yesterday. I would first like to remind everyone to please mute your line when you’re not speaking. All members of the public are reminded to silence their phones and other devices and to otherwise refrain from disrupting the meeting. Loud talking or applause may make it difficult for meeting participants and observers to hear the proceedings.
Summary drawn from this video’s own transcript (banked in our research library, pulled 2026-11-07). Claims below are the speaker’s — attributed, not endorsed. This site publishes no dosing, protocol, or sourcing information.
Key points, in the speaker’s own framing
- Real world evidence is the clinical evidence about usage and potential benefits or risks of a medical product derived from analysis of real world data.
- We have guidance documents, compounding risk alerts, compounding inspections and recall information and information provided by our compounding quality uh center of excellence.
- But outside of compounding, it’s not only completely normal, it really runs no risks because all this is done before that substance is dosed in human subjects in a clinical trial.
- In addition, the nominator did not submit and FDA did not identify in the literature nonclinical toxicity studies to inform safety considerations for potential clinical uses of emidelide related BDS’s.
- Compounding with epalone can be traced back to at least 2018 when a compounding pharmacy and its owner were sentenced for unlawful distribution of compounded prescription drugs, including epalone.
- We saw in the clinical studies that much higher doses are used in clinically uh in in clinical practice if if those doses are reflecting clinical practice and higher doses were also used in the published clinical studies.
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Educational information only — not medical advice. Peptides discussed on this page include substances that are not FDA-approved.