The FDA's Peptide Interim Access Policy: What We Know So Far

The policy is listed on reginfo.gov, the government site that tracks agency actions under review by the White House Office of Management and Budget. The listing shows:

Field	What it says
Title	Interim Access Policy for Compounding Using Certain Peptides
Agency	HHS / FDA
Regulation ID (RIN)	0910-ZD94
Received for review	October 14, 2026
Stage	Notice
Legal deadline	None
Economically significant	No

As of October 27, 2026, the listing shows the review as pending.

The listing gives a title and nothing more. It doesn't say which peptides the policy covers, what conditions pharmacies would have to meet, or when it might be released. The policy could also change during review. There is no legal deadline for finishing it.

A US compounding pharmacy can generally use an ingredient only if it has an official drug monograph, is part of an FDA-approved drug, or is on the FDA's 503A bulks list. Adding a substance to that list requires formal rulemaking, which takes time.

While nominated substances are under evaluation, the FDA sorts them into interim categories. Only Category 1 substances benefit from the FDA's interim policy, under which the agency generally doesn't take action against pharmacies that compound them, subject to conditions.

The popular wellness peptides aren't in Category 1. By April 2026, the FDA listed BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon, and others as nominated substances that had been withdrawn from Category 2. Its May 14, 2026 categories list doesn't include them in Category 1. In July 2026, an FDA advisory committee recommended six of them for the bulks list, but the FDA hasn't proposed a rule. See our explainer on the July vote.

Because the text isn't public, any description of its effect is an expectation, not a fact. The law firm Holland & Knight has written that the most likely approach is interim enforcement discretion, such as treating certain peptides like Category 1 substances. If that happens, licensed pharmacies could compound the covered peptides for individual patients with prescriptions, under whatever conditions the policy sets.

Even if the policy is issued and covers a given peptide:

• It wouldn't be FDA approval. The FDA states that compounded drugs are not FDA-approved.
• It wouldn't make "research use only" sales legal. In its August 2026 warning letters, the FDA treated research-labeled peptides sold online as unapproved new drugs intended for human use. See what that label really means.
• It wouldn't change anti-doping rules. The World Anti-Doping Agency's 2026 Prohibited List bans BPC-157 and TB-500 at all times, regardless of how they're obtained.

The review is finished when the reginfo.gov listing changes from pending to concluded. The policy itself would then be published, most likely on the FDA's website or in the Federal Register. We'll update this page and our FDA status tracker when either happens.

This article is for general education and isn't legal or medical advice.