The PEPTIDE-L Wave Reaches HHS: Enforcement Discretion … Not the Finish Line October 28, 2026 By Karla L. Palmer & Charles D. Snow —

https://www.thefdalawblog.com/2026/10/the-peptide-l-wave-reaches-hhs-enforcement-discretion-not-the-finish-line/?utm_source=rss&utm_medium=rss&utm_campaign=the-peptide-l-wave-reaches-hhs-enforcement-discretion-not-the-finish-line The PEPTIDE-L Wave Reaches HHS: Enforcement Discretion … Not the Finish Line October 28, 2026 By Karla L. Palmer & Charles D. Snow — Well, readers, we finally have an answer. Or at least an interim answer. And, yes, it comes with “guardrails.” After the July 23-24, 2026, Pharmacy Compounding Advisory Committee (PCAC) meeting left compounders asking whether (and when) FDA enforcement discretion would follow the favorable peptide votes, HHS has announced a limited Interim Policy. See our previous posts covering the PCAC meetings (here and here). But keep the champagne on ice: This is conditional enforcement discretion while rulemaking proceeds, not final placement on the Section 503A bulks list. That final rulemaking could take quite a while, if FDA’s 503A bulk substance rulemaking process is any indicator of the Agency’s timeliness to action. After 15 years of waiting and since nomination, only six bulk substances have been moved from FDA’s interim 503A list via the required notice-and-comment rulemaking.