Report: Administration Drafting a Stopgap to Allow Sales of Some Unapproved Peptides

Regulatory Watch · Reviewed by Thomas Okafor, Peptide Chemist · Published October 10, 2026

In July, FDA’s Pharmacy Compounding Advisory Committee voted to recommend six peptides for the 503A Bulks List: BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. Those votes started a process that normally ends with a proposed rule, a public comment period and a final rule. According to the Washington Post, the administration is now drafting a stopgap that would allow some compounding pharmacies to sell certain previously restricted peptides before that process is finished [1][2].

What the report says

• Who: the plan is being drafted within the administration, according to two people familiar with the matter. HHS did not comment [1][2].
• What: a temporary policy allowing some compounding pharmacies to sell certain restricted peptides while new rules are written [1].
• Guardrails: officials are reportedly looking at conditions on the policy. Coverage of the report mentions possible patient disclosures, adverse-event reporting and data collection [3].
• Open questions: the timing, the final list of peptides and the details could all still change [1][3].

The concerns on record

FDA’s own scientists recommended against adding any of the seven peptides reviewed in July, citing a lack of evidence on safety and effectiveness [3]. After the vote, the patient-safety organizations ECRI and ISMP said those data gaps remain unresolved [3]. Supporters, including HHS Secretary Robert F. Kennedy Jr., have argued for wider access to compounded peptides [4].

What hasn’t changed

• No peptide has been added to the 503A Bulks List, and FDA has not published a proposed rule.
• None of the six recommended peptides is an FDA-approved drug.
• Any stopgap, if announced, would apply to compounding pharmacies. It would not change the status of products sold as “research use only”.

For background, see our July update on the advisory committee vote, and BPC-157 vs TB-500 for the research on two of the peptides involved.

This article reports on a news story about a draft policy and is not legal advice. We will update it when HHS or FDA publishes an official document.