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 A petition is a request, not an FDA decision; the related White House-reviewed notice remains unpublished.
The White House Office of Information and Regulatory Affairs (OIRA) still listed the FDA notice 'Interim Access Policy for Compounding Using Certain Peptides' (RIN 0910-ZD94) as pending review on 24 October 2026, ten days after receiving it. OIRA's public log now shows six meetings with outside parties between 21 and 28 October, requested by a peptide-medicine academy, a telehealth company, a compounding trade group, a consumer-advocacy group and two consultancies for their clients. The records show who asked to meet, not what was said; the notice text, covered substances and any conditions remain unpublished, and a pending review is not a published policy or an FDA approval.
For research-community awareness only. Not legal advice.
