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HHS Sends a Peptide “Interim Access” Policy to the White House: What Is Known So Far

Published October 15, 2026 · 6 min read

Scope: This is a summary of public reporting and FDA documents, written so the facts can be separated from the speculation. It does not recommend any compound or any use. Details of the policy have not been published and may change. Compound Brief is published by DAAVY Research, which supplies laboratory research materials; that relationship is noted here because this topic touches the broader peptide market.
Update, October 26, 2026: Since this article was published, the HHS Secretary has described the aim as “a regulated marketplace” and a drug-safety group has filed a citizen petition asking FDA to block compounding of these peptides. See Peptide Compounding Policy: Citizen Petition and HHS Update. The policy text was still not public.
Update, October 28, 2026: HHS has now announced and published an interim enforcement policy covering six peptides. See HHS Interim Policy on Six Peptides: What the Document Says.

What happened

On Thursday, October 15, 2026, the U.S. Department of Health and Human Services submitted a peptides “interim access policy” to the White House for review, according to the Associated Press. A federal government website posted the submission, which went to the Office of Management and Budget, the office that reviews federal rules with potentially significant economic effects. The filing itself does not describe the policy in detail.

Two people familiar with the plan, speaking anonymously, told the AP it would let pharmacies temporarily compound some of the most popular peptides, including BPC-157. HHS officials did not immediately comment on the record. Until the policy text is public, everything beyond the filing itself rests on those anonymous accounts.

What “enforcement discretion” means

The reported mechanism is enforcement discretion: the FDA would choose not to take action against compounding pharmacies that make certain peptides, without changing the underlying rules. That is different from approving a drug or formally adding a substance to the list of bulk ingredients pharmacies may compound. Adding a substance to that list would require rulemaking, a process that can take years and includes public comment. The AP reported it is unclear whether the administration still intends to pursue that formal route.

A policy of discretion is also easier to reverse than a rule, since it describes what the agency will choose to do rather than what the regulations say.

The FDA’s compounding categories, briefly

Pharmacies compounding under section 503A of the Federal Food, Drug, and Cosmetic Act may generally use bulk ingredients that are components of approved drugs, covered by a monograph, or on the FDA’s 503A bulks list. While the agency evaluates nominated substances, it applies interim policies that sort them into categories. “Category 2” is for substances the agency says may present significant safety risks.

The AP describes BPC-157 and more than a dozen other injectable peptides as being on the FDA’s list of substances too risky to compound. The FDA’s own page on the category 2 list, last updated April 22, 2026, is more granular. It lists several peptides in the current category 2 table, including GHRP-2, GHRP-6, ipamorelin acetate and kisspeptin-10, citing concerns such as immunogenicity (the potential to provoke an immune response), impurities, and limited safety information. BPC-157 appears on that page in a separate table of substances whose nominations were withdrawn from category 2. For BPC-157 the FDA states that it “may pose risk for immunogenicity” for certain routes of administration, notes complexities in characterizing peptide impurities, and says it has no, or only limited, safety-related information. The two descriptions differ in how they frame BPC-157’s status, so the FDA’s page, which changes over time, is the document to check directly.

The July advisory committee vote

In July 2026 the FDA’s Pharmacy Compounding Advisory Committee recommended removing restrictions on six of seven peptides it considered, according to the AP and trade reporting. The AP noted that the panel was selected by HHS and included physicians, pharmacists and consultants who work in the peptide field. Reporting by the American Journal of Managed Care (AJMC) says FDA staff scientists opposed the recommendation unanimously, citing an absence of human clinical data for four of the seven nominated peptides. The AP likewise reports that staff scientists reiterated that none of the peptides had been studied enough to establish safety and effectiveness. Vote tallies and the names of all six peptides were not given in the articles reviewed for this piece.

The arguments being made

Supporters of broader access argue that demand does not disappear when access is restricted and instead moves to unregulated sources. HHS Secretary Robert F. Kennedy Jr. has said compounding pharmacies must be allowed to supply peptides because people are turning to “gray market” products made in China and elsewhere. Some argue that legal channels could bring physician oversight, lab monitoring and sourcing standards.

Critics point to the limits of the evidence and the quality of the product supply. AJMC quotes physicians citing a scoping review in the American Journal of Sports Medicine that found 67% of peptide publications were preclinical, mostly in rats, with human studies scarce and largely uncontrolled. Analyses of unregulated peptide products, which are not the same as pharmacy-compounded products, have reported contents ranging from 5% to 75% of the labeled amount and, in some cases, arsenic above acceptable levels. Some clinicians have raised conflict-of-interest concerns about panel members who sell these products. AJMC also reports that more than 40 state attorneys general sent the FDA a coordinated letter raising safety concerns, though it does not say whether the letter addressed the July vote specifically. One physician proposed that, if access expands, patients be enrolled in a formal research framework with outcome tracking and adverse-event reporting.

The market context

The telehealth companies Hims & Hers and Noom have said they plan to offer peptides if federal policy eases access. Wall Street analysts quoted by the AP estimate the market could be worth $2 billion to $3 billion. The AP also notes that unregulated peptide products remain widely available online, including through social media.

What is still unknown

Because the policy is under review, details could change before anything is final. This article will be updated if the policy text is published.

Sources

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