Regulatory Watch · Reviewed by Thomas Okafor, Peptide Chemist · Published October 16, 2026

Last week we covered a Washington Post report that the administration was drafting a stopgap for certain restricted peptides. This week that idea took its first visible step. A filing posted on the Office of Management and Budget’s regulatory review site shows HHS and FDA sent the White House an “interim access policy for compounding using certain peptides” on Thursday, October 15, according to Reuters and the Associated Press.

What’s confirmed

  • The filing exists. OMB reviews significant federal actions before they’re released, and the interim policy is now in that queue [1][2].
  • The title. It’s described as an interim access policy for compounding using certain peptides [1].
  • No text yet. The public listing doesn’t say which peptides, which pharmacies or which conditions would apply [1][2].
  • No comment. HHS didn’t immediately respond to requests for comment, according to the AP [2].

What’s reported, but not confirmed

According to two people who spoke to the AP on condition of anonymity, the policy would let pharmacies temporarily compound some of the most popular peptides, and they named BPC-157 [2]. Coverage describes the likely mechanism as enforcement discretion, meaning FDA would choose not to act against pharmacies compounding certain peptides while formal rules are written [2][3].

That would be a faster route than the one FDA normally uses. The usual path to the 503A Bulks List runs through formal rulemaking, with a draft rule, public comments and then a final version, which the AP said could take years [2]. It’s not yet clear whether the administration still plans to pursue that full rulemaking alongside the interim policy [2].

How we got here

Date Step
April 2026 Twelve peptides, including BPC-157, TB-500 and KPV, left FDA’s Category 2 compounding list after their nominations were withdrawn (our recap)
July 23–24, 2026 FDA’s outside advisers recommended six peptides for the 503A Bulks List, against the advice of FDA staff reviewers (our coverage)
October 7, 2026 The Washington Post reported a draft stopgap for some restricted peptides
October 15, 2026 HHS and FDA sent the interim access policy to OMB

Kennedy, who leads HHS, has argued that compounding pharmacies should be allowed to sell peptides because Americans are otherwise buying “gray market” products made overseas, the AP reported [2]. The AP also noted that FDA staff scientists had concluded none of the July peptides had been studied enough to establish safety and effectiveness, and that most data on them come from animal studies [2].

Telehealth companies have taken notice. Hims & Hers and Noom have said they plan to offer peptides if access is eased, and Wall Street analysts estimate the market at $2 billion to $3 billion, according to the AP [2].

What hasn’t changed

  • The 503A Bulks List is unchanged this week, and no draft rule on it has appeared in the Federal Register.
  • None of the peptides under discussion is an FDA-approved drug.
  • An interim compounding policy, if released, would apply to licensed pharmacies filling prescriptions. It wouldn’t change how research-use-only products are classified or sold.

What to watch next

  1. Publication of the policy text, which would show which peptides, routes and conditions it covers.
  2. Any Federal Register proposed rule on the 503A Bulks List.
  3. FDA’s next compounding advisory meeting, expected by late February 2027, where advisers are due to review GHK-Cu and four other peptides.

For background, read our coverage of the Washington Post stopgap report and the July advisory vote. Our KLOW legal status page tracks where each KLOW ingredient stands.

This article reports on a policy under review and isn’t legal advice. We’ll revise this page once the policy text is released.

Sources

  1. Reuters via Yahoo News, “US FDA takes step to change peptide compounding policy,” October 15, 2026. https://www.yahoo.com/news/politics/articles/us-fda-takes-step-change-213124893.html
  2. Associated Press via ABC News, “Trump administration advances plan for peptide drugs favored by RFK Jr.,” October 15, 2026. https://abcnews.com/Business/wireStory/trump-administration-advances-plan-peptide-drugs-favored-rfk-137299803
  3. Inside Health Policy, “FDA Sends Interim Peptide Access Policy To OMB As Rulemaking Continues.” https://insidehealthpolicy.com/daily-news/fda-sends-interim-peptide-access-policy-omb-rulemaking-continues
  4. Office of Management and Budget, regulatory review dashboard (pending reviews). https://www.reginfo.gov/public/do/eoReviewSearch