Peptide access policy goes to White House review

The Food and Drug Administration has sent a document titled “Interim Access Policy for Compounding Using Certain Peptides” to the White House Office of Management and Budget for review. OMB’s public dashboard lists it under regulation identifier number (RIN) 0910-ZD94, from HHS/FDA, with a received date of October 14, 2026. The stage is listed as “Notice.” It is not marked economically significant.

That is the whole of the public record so far. The document’s text has not been published, and neither FDA nor HHS has said which peptides it covers or when it would take effect.

What reporting says the policy would do

The Associated Press, in a report carried by NBC News on October 16, said HHS had submitted a peptides “interim access policy” to the White House for review, and that the filing “doesn’t give specifics of the new policy.” AP cited two people familiar with the plan who said it is meant to let pharmacies temporarily compound some popular peptides, including BPC-157. AP described the approach as enforcement discretion: an assurance that FDA will not target compounding pharmacies for preparing certain substances, rather than a finding that the substances are safe or effective.

Earlier, on October 9, the trade newsletter FDAnews summarized a Washington Post report that officials were considering such a policy. It said the Alliance for Pharmacy Compounding had urged temporary enforcement discretion, with patient disclosures and serious-adverse-event reporting as possible conditions.

Why it matters

Under section 503A of the Federal Food, Drug, and Cosmetic Act, pharmacies may compound from a bulk drug substance only if it has a USP or NF monograph, is a component of an FDA-approved drug, or appears on FDA’s 503A bulks list. The bulks list is set by notice-and-comment rulemaking. AP noted that formally adding peptides to it “could take years.”

An interim enforcement-discretion policy would sit outside that rulemaking. It would not approve any drug, would not set doses, and would not change the status of products sold online as “research use only.” Those are sold outside the pharmacy system entirely, and FDA has kept sending warning letters to such sellers through 2026. See our August 24 report.

How we got here

• 2023: FDA placed a group of peptide bulk substances in Category 2 of its interim compounding framework, citing immunogenicity, impurity and data concerns (explainer).
• April 15, 2026: FDA gave notice that 12 peptide substances would leave Category 2 because their nominations had been withdrawn. As the law firm Orrick noted, that did not put them on the 503A bulks list.
• July 23-24, 2026: The Pharmacy Compounding Advisory Committee voted to recommend six of seven peptides for the bulks list, against FDA staff recommendations (report).
• October 14, 2026: The interim access policy reached OMB.

What to watch

OMB review under Executive Order 12866 has no fixed deadline for a notice of this kind. When the document is published, the details to check are: which substances are listed; whether it covers 503A pharmacies only or also 503B outsourcing facilities; what sourcing and testing conditions apply to the bulk ingredient; and whether FDA also starts formal rulemaking. We will update this article and the tracker when the text is public.