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The Department of Health and Human Services has submitted an interim access policy for peptides to the White House Office of Management and Budget for review. People familiar with the plan say it would temporarily allow pharmacies to compound some popular peptides, but the filing does not specify which products or how the policy would work.
The Department of Health and Human Services has sent an interim policy on peptides to the White House Office of Management and Budget for review, a step toward potentially easing access to some injections that are not approved for the wellness uses promoted online. Two people familiar with the plan told MedPage Today it is intended to let pharmacies temporarily compound some popular peptides, though the government filing does not identify them or spell out the policy.
The submission appeared in a government website posting on Thursday, October 15, 2026. The Office of Management and Budget reviews federal rules and regulations that may have significant economic effects. HHS did not immediately respond to MedPage Today’s request for comment. The filing describes an “interim access policy” but provides no public details about which peptides might qualify, when a policy could take effect, or how long temporary access would last.
Two people familiar with the plan, who spoke anonymously because they were discussing confidential deliberations, said it could cover BPC-157, a peptide promoted by some wellness and fitness figures for muscle building and injury healing. Those uses have not been approved by the FDA. The sources said the approach would give pharmacies some assurance that the FDA would not target them for compounding the specified substances. That would amount to enforcement discretion, not necessarily formal approval of the drugs or a finding that they are safe and effective.
Compounding pharmacies prepare customized medications, often when a suitable product is not available from a conventional drugmaker. The FDA has listed BPC-157 and more than a dozen other injectable peptides as substances that pose risks if compounded. The agency has cited possible contamination, allergic reactions and tumor growth. FDA staff scientists have also said the peptides have not been studied enough to establish their safety and effectiveness.
A Shift in Pharmacy Enforcement
If adopted, the policy could change how readily U.S. pharmacies provide certain peptides, despite the absence of established evidence for the wellness claims associated with them. It would also mark a practical shift in federal enforcement: pharmacies might be allowed to compound listed substances without the government first formally adding them to the FDA’s compounding rules. That distinction matters because a decision not to enforce restrictions is not the same as FDA approval or a determination that a product is safe.
The move has potential commercial consequences. MedPage Today reported that major telehealth companies Hims & Hers and Noom have announced plans to offer peptides if federal access rules ease. Wall Street analysts cited in the report estimate the market could reach $2 billion to $3 billion. That is an estimate, not a confirmed market value, and the size or timing of any business opportunity depends on the policy’s final terms and future regulatory decisions.
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Kennedy’s Review of Peptide Rules
Peptides are short chains of amino acids that can act as signaling molecules in the body. Some peptide-based drugs have undergone FDA review and are used as treatments, including medicines for diabetes and weight management. The products at issue in this proposal are different: they have not gone through the same review process for the uses promoted by online wellness sellers. Most available data cited in the report come from animal studies, and the advertised benefits are not FDA-approved indications.
Before becoming health secretary, Robert F. Kennedy Jr. said the FDA’s “war” on peptides and other wellness products would end. As secretary, he argued that U.S. compounding pharmacies should be allowed to sell them as consumers increasingly turn to products from overseas “gray markets.” Earlier this year, he directed the FDA to reconsider a short list of peptides. In July, an external advisory panel recommended lifting restrictions on six of seven peptides it reviewed. The panel was selected by Kennedy’s health department and included people with experience in the peptide industry; its recommendation differed from the conclusions of FDA staff scientists.
Formally adding substances to the FDA list of drugs that may be compounded would require federal rulemaking, including public comment, and could take years. The proposed interim route is distinct: according to the people familiar with it, it would rely on enforcement discretion while leaving open whether the administration will also pursue formal rule changes.
“FDA’s war”
— Robert F. Kennedy Jr., before joining the administration, as quoted by MedPage Today
Policy Details Still Pending
The White House filing does not reveal which peptides would be covered, the policy’s proposed duration, when a decision might come, or what conditions pharmacies would have to meet. The reported inclusion of BPC-157 comes from two people familiar with the plan, not from a public list released by HHS or the FDA. The administration has not publicly explained the policy’s precise legal scope.
It is also unclear whether HHS or the FDA will begin the separate rulemaking process needed to formally change the list of substances eligible for compounding. The proposal itself does not establish that the peptides are effective or safe for the uses promoted by wellness influencers. The FDA’s stated concerns and its staff scientists’ assessment remain part of the record, while the advisory panel’s recommendations were recommendations rather than a final agency determination.
OMB Review and FDA Decisions
The immediate next step is review by the Office of Management and Budget. The source report did not give a timetable for that review or say whether the White House would approve, revise, or return the proposal. HHS and the FDA could provide further details as the review proceeds, including which substances might qualify and how pharmacies would be treated.
Readers should watch for a public policy document or agency announcement clarifying whether the administration will use enforcement discretion, pursue formal rulemaking, or take both steps. Until those details are released, the reported plan remains a proposal under review, and the scope and timing of any change in access are unsettled.
Key Questions
What has the Trump administration done so far?
HHS submitted an interim peptide access policy to the White House Office of Management and Budget for review. The submission is a step in the process, not confirmation that the policy has been approved or put into effect.
Which peptides could be covered?
The public filing does not name any substances. Two people familiar with the plan told MedPage Today it could include BPC-157, but that has not been confirmed in an official policy document.
Would this make peptides FDA-approved?
Not on the information currently available. The reported approach would use enforcement discretion toward some pharmacy compounding; that is different from FDA approval or proof that a product is safe and effective.
What risks has the FDA identified?
The FDA has cited possible contamination, allergic reactions and tumor growth for certain injectable peptides. FDA staff scientists have said the substances have not been studied enough to establish safety and effectiveness.
What happens next?
The OMB review is the next identified step. The timing, final policy terms, and whether the administration will pursue formal rulemaking remain unknown.
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