FDA’s interim peptide compounding policy: what’s known, what isn’t
Status on October 24, 2026: under review at OMB since October 14, 2026 · not issued · no legal deadline.
What is under review
On October 14, 2026, the White House Office of Management and Budget received a notice from HHS and FDA titled “Interim Access Policy for Compounding Using Certain Peptides” (RIN 0910-ZD94). OMB’s public record lists the stage as “Notice”, no legal deadline, and not economically significant. The record carries no text and names no substance (OMB’s record, reginfo.gov).
What a notice at OMB is, and isn’t
Before some agency documents are issued, OMB’s Office of Information and Regulatory Affairs reviews them under Executive Order 12866. During a review, outside parties can ask to meet. Reginfo.gov lists six such meetings on this notice between October 21 and October 28, 2026, and does not list who attended (reginfo.gov, EO 12866 meetings for RIN 0910-ZD94). These are review meetings at OMB, not FDA meetings, hearings or announcements. Executive Order 12866 sets time limits for a review that can be extended at the agency head’s request (Executive Order 12866, section 6(b)(2)), and OMB’s record gives no end date for this one.
What people say it would do
The Associated Press, citing two people familiar with the plan, reported on October 15, 2026 that the plan is intended to let pharmacies temporarily compound some popular peptides (AP, October 15, 2026). The Washington Post, citing two unnamed people, reported on October 7 that the administration was crafting a plan to allow temporary sale of certain previously restricted peptides (The Washington Post, October 7, 2026). Law firms that follow FDA read it as pointing to an enforcement-discretion policy for pharmacy compounding under section 503A: a stated decision not to take action in stated circumstances (Holland & Knight, October 16, 2026; Buchanan Ingersoll & Rooney, October 2026, which adds that the title alone “does not establish the enforcement approach FDA intends to adopt”). None of this is the text. Kalios has not seen the text, and none of the reports cited here quotes it.
What a policy like this cannot do
An enforcement policy approves no drug. FDA’s own words for its existing Category 1 policy: FDA “does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met.” (FDA, 503A bulk drug substances page, content current as of May 14, 2026) In Kalios’s plain-language reading, that is a statement about enforcement, not an approval, and the same reading would apply to any interim access policy. A policy about pharmacy compounding also says nothing about products sold as “research use only”: FDA’s 2026 warning letters to sellers of such products say the products “are unapproved new drugs under section 505(a)” whatever the label says (FDA warning letters, August 24, 2026: MARCS-CMS 735067, 734884, 733652, 735063, 735127; March 31, 2026: 721088, 721806, 721805, 721600, 721709). Those letters changed no compound’s legal status.
How we got here
- January 7, 2025. FDA’s 503A page says FDA “does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories.” (FDA, 503A page)
- April 16, 2026. A Federal Register notice (91 FR 20465) announces a Pharmacy Compounding Advisory Committee meeting on July 23 and 24, 2026 and opens docket FDA-2025-N-6895 (Federal Register, April 16, 2026).
- Content current as of April 22, 2026. FDA’s page on bulk substances that may present significant safety risks lists BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon, DSIP and others under “Bulk drug substances nominated but withdrawn”: substances “previously in category 2 of the interim policies” whose nominations were withdrawn (FDA, safety-risks page).
- May 11, 2026. The date on FDA staff’s evaluation of BPC-157 for the meeting. Staff wrote that they “believe the evaluation criteria weigh against placing both BPC-157 (free base) and BPC-157 acetate on the list” (FDA, staff evaluation).
- July 23–24, 2026. The committee met on seven substances: BPC-157, KPV, TB-500 and MOTS-c on the first day; emideltide (DSIP), Semax and Epitalon on the second. FDA’s meeting page says the committee’s recommendations are “non-binding” and posts no vote record (FDA, meeting page). Reuters reported that eight members voted in favor of adding BPC-157, KPV and TB-500, six against, with one abstention; that MOTS-c passed 7–5 with two abstentions; and, the next day, that emideltide failed, seven against and six in favor with one abstention (Reuters, July 23 and July 24, 2026). Each substance’s row, with its sources, is on the FDA Tracker.
- August 24, 2026. FDA issued five warning letters to online sellers of research peptides; each says the products named “are unapproved new drugs under section 505(a)” (FDA warning letters, August 24, 2026: MARCS-CMS 735067, 734884, 733652, 735063, 735127).