Bloomberg News reported on 22 October 2026, citing people familiar with the matter, that the FDA peptide compounding notice under White House review would let compounding pharmacies make certain peptides without FDA enforcement only if they certify the substances' purity and identity and report serious adverse events. FDA and HHS have not confirmed this. The notice (RIN 0910-ZD94) was still pending at reginfo.gov on 26 October, and its text, covered substances and conditions are unpublished. Purity and identity are the two core results on a lot-level certificate of analysis. A pending review is not a published policy or an FDA approval.
The Partnership for Safe Medicines, a drug-safety advocacy group, has filed a citizen petition (21 CFR 10.30, marked submitted via Regulations.gov on 23 October 2026) asking FDA not to allow compounding with any of the seven peptide bulk drug substances its Pharmacy Compounding Advisory Committee reviewed in July, whether by rule, by a Category 1 interim-policy listing or by enforcement discretion. FDA reviewers had recommended against all seven; the committee voted for six. The group alleges the committee was improperly constituted, which FDA has not ruled on. A petition is a request, not an FDA decision; the related White House-reviewed notice remains unpublished.
For research-community awareness only. Not legal advice.
