FDA's interim peptide compounding policy reaches White House review, with its text not yet public

On October 14, 2026, the Office of Information and Regulatory Affairs (OIRA), part of the White House Office of Management and Budget, received an FDA action titled "Interim Access Policy for Compounding Using Certain Peptides." The government's regulatory review site, reginfo.gov, lists it as pending review. [1]

What the listing shows

The entry gives the regulation identifier number 0910-ZD94, lists the stage as "Notice," and states that there is no legal deadline and that the action is not economically significant. [1] It carries no abstract or description of the policy. [5]

That means the title is the only part of the policy that is public. OIRA's own FAQ states that "draft documents under review are considered deliberative and are not available for public release during review." [3] The same FAQ says review under Executive Order 12866 is limited to 90 days, has no minimum, and can be extended. [3]

A meeting is already scheduled

Outside parties can ask to meet OIRA about an action under review. Reginfo.gov lists one such meeting on this policy, set for October 21, 2026 at 3:00 p.m., requested by the American Academy of Peptide Medicine. [2]

The July advisory committee meeting

The nearest public FDA record on the same subject is the Pharmacy Compounding Advisory Committee meeting held on July 23 and 24, 2026. The committee discussed seven peptides "being considered for inclusion on the 503A Bulks List": BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and Epitalon, each in a free base and an acetate form. [4]

In its briefing materials, FDA stated for each of the 14 forms that it was "proposing" the form "NOT be included" on the list. The briefing also notes that the nominations for these peptides had been withdrawn by their nominators, and that FDA was "electing to proceed" with the presentations anyway. [6] FDA said it did not intend to issue a final determination until the committee's input had been considered and all reviews were finalized. [6] The committee's recommendations are advisory and do not themselves change the list. [7]

No public record read for this article links the new interim policy to the July meeting beyond the shared subject. [5]

What is still unknown

Law firm Buchanan Ingersoll & Rooney, writing on October 16, set out the open questions: which peptides would qualify, whether the policy would apply only to Section 503A compounders, and whether it would add sourcing, testing, documentation or reporting conditions. [7] The firm also noted that a policy reaching White House review does not by itself create a new basis for compounding, and that FDA does not approve compounded drugs. [7] When, or whether, the policy will be published is not stated anywhere on the record. [1][5]

Why the testing details matter

Whatever the policy says, FDA's July documents put analytical characterization at the center. In its BPC-157 briefing, the agency described the free base as "not well-characterized" from a physical and chemical perspective, citing missing or inadequate data on peptide-related impurities and aggregates and on microbial quality, including bioburden and bacterial endotoxins. [8] The law firm likewise pointed to the existing 503A requirements on manufacturer registration and valid certificates of analysis. [7] For research laboratories, it is a useful reminder of what identity, purity and impurity data should accompany any peptide reference material.

BioLabs Research will update this item when OIRA concludes its review or FDA publishes the policy.

Key points

• OIRA received FDA's "Interim Access Policy for Compounding Using Certain Peptides" on October 14, 2026.
• Draft documents under OIRA review are deliberative and not released, so the policy's contents remain unknown.
• FDA's July briefing proposed that none of 14 peptide forms be added to the 503A Bulks List.

Related: US peptide regulation in 2026: what changed and what is pending · What research-use-only means

All BioLabs Research products are sold strictly for laboratory research use only. Not for human or veterinary use. This article summarizes public regulatory records and makes no claims about any BioLabs product.

For research use only. Not for human or veterinary use. Not a drug, food, or cosmetic.

This summary is for research-community awareness only and is not legal advice.

BioLabs Research has no affiliation with, and no endorsement from, any person named.