ArticleRegulatoryPHN-06242026-11-02 16:49 CT

Peptides first, paperwork later: HHS clears six for compounding ahead of Bulks List rulemaking

Source · McDermott Will & Schulte

TLDR

McDermott Will & Schulte reports that HHS issued an interim policy on October 28, 2026, providing conditional enforcement discretion for compounding six peptides. The policy requires all 10 specified circumstances to be met and is intended to apply pending formal 503A Bulk Drugs List rulemaking; it does not constitute FDA approval.

01—Key points

01The policy covers BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax.
02The article distinguishes this policy from FDA’s January 2025 interim compounding guidance and says HHS may amend it.
03HHS says the policy aims to discourage research-use-only peptide use and provide a more controlled alternative.

Why it matters Editorial

The reported policy changes the interim enforcement framework for compounding six peptides while formal list additions remain pending.

Read the original at McDermott Will & Schulte↗

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