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The Department of Health and Human Services has sent a proposed peptide interim access policy to the White House Office of Management and Budget for review. People familiar with the plan say it would let pharmacies temporarily compound some popular peptides, but the filing does not specify which substances or the policy’s details. The proposal comes amid safety concerns and a wider review of restrictions on peptide compounding.
The Department of Health and Human Services has submitted a proposed policy on peptide access to the White House for review, a step that could allow pharmacies to temporarily compound some popular injectable peptides. The government filing does not spell out the proposal’s terms; two people familiar with the plan told MedPage Today it is intended to cover certain peptides, including BPC-157.
The proposal, described in a government website posting as a peptide “interim access policy,” went to the Office of Management and Budget, which reviews federal rules and regulations with potentially significant economic effects. HHS did not immediately respond to MedPage Today’s request for comment on Thursday afternoon. The people who described the plan spoke anonymously because they were discussing confidential government deliberations.
According to those sources, the policy would use enforcement discretion: the Food and Drug Administration could choose not to enforce certain restrictions against pharmacies compounding the covered peptides. That would not be the same as formally adding them to the FDA’s list of drugs that are safe for compounding. Formal changes would require federal rulemaking, which can take years and includes public comment. It is not clear whether the administration also intends to pursue that process.
The substances at issue have not gone through the FDA review used to establish a drug’s safety and effectiveness. Although some peptides are approved medicines, including treatments for diabetes and weight loss, the products under discussion are promoted for uses such as muscle-building, injury recovery, and increased energy. Those uses are not FDA-approved, and the source report says much of the available research on these peptides comes from animal studies.
A Shift in Access, Not FDA Approval
If adopted, the plan could change how readily U.S. patients obtain certain peptides from specialty compounding pharmacies, businesses that prepare customized medications. It could also affect companies considering peptide offerings: telehealth providers Hims & Hers and Noom have announced plans to offer peptides if federal access rules ease, according to the report.
The proposal would not, on the information available, establish that the peptides are safe or effective, nor would it amount to FDA approval for their promoted uses. That distinction matters to consumers weighing products sold through medical or wellness channels against products marketed online. Wall Street analysts cited in the report estimate the peptide market could reach $2 billion to $3 billion; the estimate is a forecast, not a confirmed measure of current sales.
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FDA Safety Review and Kennedy’s Push
Before joining the administration, Health Secretary Robert F. Kennedy Jr. said the FDA’s restrictions on peptides and other wellness products would end. As secretary, he argued that U.S. compounding pharmacies should be allowed to sell peptides because Americans were turning to “gray market” products made in China and elsewhere. Such products remain available through online platforms, the report says.
The FDA had previously placed BPC-157 and more than a dozen other injectable peptides on a list of substances considered too risky for compounding. The agency cited possible risks including contamination, allergic reactions, and tumor growth. Earlier in 2026, Kennedy directed the FDA to reconsider a short list of peptides promoted by wellness and fitness figures.
In July, an external FDA advisory panel recommended removing restrictions on six of seven peptides it reviewed. That recommendation differed from the position of FDA staff scientists, who said the substances had not been studied enough to establish safety and effectiveness. The panel was selected by Kennedy’s health department and included people who work in the peptide field, according to the report.
““FDA’s war” on peptides and other wellness products would soon end.”
— Robert F. Kennedy Jr., before becoming health secretary
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Policy Details Still Under Review
The White House filing does not identify the peptides that would be covered, set out eligibility requirements, or give a timeline for a decision. BPC-157 is among the substances named by people familiar with the plan, but the full proposed list has not been disclosed. HHS had not provided a public response to the report’s request for comment.
It is also unclear whether the administration will seek formal rulemaking in addition to possible enforcement discretion, how long any temporary policy would last, or what safeguards pharmacies would have to follow. The available material does not establish that the proposal has been approved or put into effect. The dispute over evidence also remains: an advisory panel favored easing restrictions on most of the peptides it reviewed, while FDA staff said safety and effectiveness were not adequately established.
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OMB Review and Possible FDA Action
The immediate next step is review by the Office of Management and Budget. The filing’s public description does not provide a decision date, and the administration has not publicly released the policy’s full text. Any change in pharmacy enforcement would depend on the proposal’s final terms and subsequent agency action.
Readers should watch for a public statement from HHS or the FDA clarifying which peptides may be covered, whether the approach is temporary, and whether a separate rulemaking process will follow. Until those details emerge, the reported plan describes a possible shift in enforcement—not a completed change in access or a finding that the products are safe and effective.
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Key Questions
What has the Trump administration done so far?
HHS submitted an interim access policy on peptides to the White House Office of Management and Budget for review. The filing signals a proposed policy, not a confirmed change already in force.
Which peptides could be covered?
The filing does not list them. Two people familiar with the plan told MedPage Today that it could cover some popular peptides, including BPC-157, but the full list has not been made public.
Would the proposal mean the peptides are FDA-approved?
No. The reported approach would involve possible enforcement discretion for pharmacies, not FDA approval of the peptides or their promoted uses. Formal changes to the compounding list would require a separate rulemaking process.
What safety concerns has the FDA raised?
The FDA has cited possible contamination, allergic reactions, and tumor growth in placing BPC-157 and other injectable peptides on a list of substances considered too risky for compounding. FDA staff scientists have said the substances have not been studied enough to establish safety and effectiveness.
When could pharmacies begin compounding the peptides?
No start date has been announced. The proposal is under OMB review, and its details, approval status, and any implementation timeline remain unknown.
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