FDA peptide compounding "interim access policy" goes to White House review

The Food and Drug Administration has sent the White House a policy titled "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94) [1]. The Office of Information and Regulatory Affairs received it on October 14, 2026 [1], and lists it as pending review under Executive Order 12866 [1]. The listing gives its stage as a notice, not a rule [1]. It is not marked economically significant and has no legal deadline [1].

Nothing has changed yet. The review listing gives a title and a status only. The policy's text is not public while it is under review, so which peptides it covers, and what it would let pharmacies do, are not stated in any official document.

Background

FDA's Pharmacy Compounding Advisory Committee met on July 23 and 24, 2026 [2]. On the first day it discussed BPC-157, KPV, TB-500 and MOTs-C for the 503A Bulks List [2]. On the second it discussed emideltide (also called DSIP), Semax and Epitalon [2].

That list matters because a pharmacy compounding under section 503A may use a bulk substance with no USP monograph, which is not part of an approved drug, only if the substance is on a list the Secretary develops through regulations [2]. An advisory committee does not add a substance to the list itself; that takes regulations. The meeting's public docket is FDA-2025-N-6895 [2].

Also reported: STAT, Trump administration advances plan for peptide drugs favored by RFK Jr.; Associated Press (via ABC News), Trump administration advances plan for peptide drugs favored by RFK Jr..

References

1. Pending EO 12866 Regulatory Review: Interim Access Policy for Compounding Using Certain Peptides (RIN 0910-ZD94) — Office of Information and Regulatory Affairs (OMB), on reginfo.gov
2. Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List — Federal Register