Regulatory
FDA's Interim Peptide Compounding Policy: Where It Stands at the White House (Live Tracker)
As of October 22, 2026, the FDA's Interim Access Policy for Compounding Using Certain Peptides (RIN 0910-ZD94) is still pending review at the White House Office of Management and Budget, where it arrived on October 14. It has not been issued and its text is not public. The OMB public log shows five meetings with outside groups on the policy between October 21 and 28. This page is updated as the review moves.
Quick answer
As of October 22, 2026, the FDA's Interim Access Policy for Compounding Using Certain Peptides is still pending review at the White House Office of Management and Budget (OMB), where it has been since October 14. It has not been issued, and its text is not public. OMB's public log lists five meetings with outside groups on the policy between October 21 and October 28, including the Alliance for Pharmacy Compounding, Hims & Hers Health, and the Center for Science in the Public Interest. Reporting indicates the policy would use enforcement discretion to let 503A pharmacies compound certain peptides such as BPC-157, without approving any product.
Key takeaways
- →Status on October 22, 2026: "Pending Review" at OMB's Office of Information and Regulatory Affairs (OIRA). The FDA submitted it on October 14, 2026 as a notice (RIN 0910-ZD94), not marked economically significant, with no legal deadline. Nothing has been published in the Federal Register.
- →OIRA's public log shows five meetings with outside parties on the policy: the American Academy of Peptide Medicine (October 21), Hims & Hers Health (October 23), the Alliance for Pharmacy Compounding and the Center for Science in the Public Interest (both October 27), and Carmen Group, Inc. for its client Medivant Healthcare (October 28).
- →Executive Order 12866 generally gives OIRA up to 90 calendar days to finish a review, which would run to January 12, 2027, and that window can be extended. A review can also end well before the limit. No release date has been announced.
- →Reporting describes the expected mechanism as enforcement discretion for state-licensed 503A pharmacies. That would not approve any peptide, would not add any peptide to the 503A Bulks List, and could be narrowed or withdrawn without rulemaking.
- →The policy follows the July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting, where outside advisers recommended six of seven peptides, including BPC-157, for the 503A list against the advice of FDA staff scientists.
The federal decision that could reshape how Americans get peptides is sitting at the White House. On October 14, 2026, the FDA sent a draft Interim Access Policy for Compounding Using Certain Peptides to the Office of Management and Budget for review. As of October 22 it is still there: not issued, not published, and its terms not public. This page tracks where the review stands, who is meeting with the White House about it, and what the policy is expected to do and not do. We update it each time the public record changes, and the update history at the bottom lists every change.
Latest update: October 22, 2026
TeleRanked checked OMB's list of submissions under review on October 22. The policy is still listed as Pending Review. The new development is on OIRA's meeting log, which now shows five meetings requested by outside parties, the first held October 21 and the last scheduled for October 28. A search of the Federal Register and its public inspection desk on October 22 found no document on peptide compounding, so nothing has been released for publication.
Status at a glance
- Title: Interim Access Policy for Compounding Using Certain Peptides
- Agency and identifier: HHS, Food and Drug Administration, RIN 0910-ZD94
- Received by OIRA: October 14, 2026
- Stage: Notice (not a proposed or final rule)
- Economically significant: No
- Legal deadline: None
- Current status: Pending Review (checked October 22, 2026)
- Policy text public: No
- Published in the Federal Register: No
Who is meeting with the White House about it
While a regulatory action is under review, OIRA meets with outside groups that ask to discuss it. Executive Order 12866 requires that a representative of the issuing agency, here the FDA, be invited to each such meeting, and OIRA posts each one on a public log with the date and the requesting organization. The log for this policy lists five:
- October 21, 2026: American Academy of Peptide Medicine (requestor listed as Lee Rosebush)
- October 23, 2026: Hims & Hers Health
- October 27, 2026: Alliance for Pharmacy Compounding (requestor listed as Scott Brunner)
- October 27, 2026: Center for Science in the Public Interest
- October 28, 2026: Carmen Group, Inc., with Medivant Healthcare listed as its client
The list spans a peptide-medicine organization, the compounding pharmacy trade association, a publicly traded telehealth company, a consumer advocacy nonprofit, and a firm representing a corporate client. The log records who asked for time, not what anyone argued. Hims & Hers is among the telehealth companies that have said they would offer peptides if access eases. The Alliance for Pharmacy Compounding has followed the policy publicly since it reached OMB.
How long the review can take
Executive Order 12866, which governs OIRA review, generally gives the office 90 calendar days to complete review of a submitted action. Counted from October 14, that limit falls on January 12, 2027. The order allows one extension of up to 30 days with the OMB Director's approval, and further extensions at the request of the agency. Reviews can also conclude much sooner, and OIRA does not announce a target date. Under the same order, the FDA may not issue the policy until OIRA completes or waives its review, or the review period runs out, so a change in the OIRA status is the clearest early signal that release is near.
Enforcement discretion, not approval
Legal analysts expect the policy to rely on enforcement discretion: a decision by the FDA not to pursue certain compounding of named peptides by state-licensed 503A pharmacies, rather than a formal authorization. Reporting indicates the intent is to assure those pharmacies they will not be targeted for preparing peptides such as BPC-157. Enforcement discretion does not approve any product, does not change the underlying statute, and does not bind state pharmacy or medical boards. Because it is a policy choice rather than a rule, the agency could narrow or withdraw it without going through rulemaking.
The expected scope is narrow in important ways. Reporting and legal summaries indicate it would apply to 503A pharmacies, which prepare patient-specific prescriptions, and not to 503B outsourcing facilities that compound in larger batches, nor to research-use-only or dietary-supplement channels. None of this can be confirmed until the text is published.
What it would not do: the bulks list and rulemaking
An interim access policy is distinct from adding a substance to the 503A Bulks List, the FDA's roster of bulk drug substances that 503A pharmacies may use in compounding without an FDA-approved starting product. Formally listing a peptide requires notice-and-comment rulemaking, a process that can run for years and include multiple comment rounds. The FDA has not issued a proposed or final rule granting peptide access, and whether the administration still intends to complete that longer process is not clear from the public record.
How this connects to the July 2026 advisory vote
The policy follows the July 23-24, 2026 meeting of the FDA's Pharmacy Compounding Advisory Committee (PCAC), which reviewed seven peptides for the 503A list. The committee recommended adding six: BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax, and voted against emideltide (DSIP). Those recommendations are advisory only, and the FDA's own review scientists had recommended against adding any of the seven, citing gaps in safety characterization and clinical evidence rather than proof of harm. An interim access policy would give pharmacies a near-term pathway while the slower listing question remains unsettled. For background, see how the July PCAC vote turned out and our explainer on the 503A Bulks List.
Why the administration is moving
HHS Secretary Robert F. Kennedy Jr. has been the policy's most visible advocate. He has argued that compounding pharmacies should be able to supply peptides because patients are otherwise turning to a gray market of products made overseas with no oversight, and he directed the FDA to reconsider a short list of substances promoted heavily by wellness influencers. The peptides at the center of the debate, including BPC-157, are marketed for goals such as muscle building, injury recovery and anti-aging, none of which is an FDA-approved use.
What it means for telehealth and patients
Peptides reach most consumers through telehealth and wellness clinics, so a policy that eases supply would land directly on that channel. Telehealth companies including Hims & Hers and Noom have said they would offer peptides if the government loosens access, and analysts have put the potential market at $2 billion to $3 billion. If the policy issues as described, the practical change for patients would be a clearer legal footing for obtaining certain peptides by prescription through a licensed 503A pharmacy, rather than from research-chemical vendors that sell vials labeled not for human use. Until it issues, nothing about the legal status of compounding these peptides has changed.
Open questions and safety context
The exact terms, the list of covered peptides, and any limits by route of administration are unknown until the policy is published, and the version that clears OMB may differ from the one the FDA submitted. The legal footing is also contested: pharmaceutical trade groups argued in PCAC comments that the FDA cannot lawfully authorize compounding through an interim policy while rulemaking is pending, which raises the prospect of a court challenge. The FDA has previously flagged peptides, including BPC-157, for compounding risks such as contamination, allergic reactions and effects on tumor growth, and much of the available data comes from animal studies rather than human trials.
What to watch next
This is general information, not medical or legal advice. These are the markers TeleRanked is tracking:
- A change in the OIRA status from Pending Review to concluded. Under Executive Order 12866, the FDA cannot issue the policy before that happens unless the review period runs out.
- Additional meetings on the OIRA log after October 28, which would suggest the review is still active.
- Publication of the policy by the FDA or in the Federal Register, the first point at which its conditions and covered peptides become knowable.
- Any FDA move toward formal rulemaking to add peptides to the 503A Bulks List, the step that would make access durable rather than discretionary.
- Litigation from trade groups contesting the interim approach.
- For anyone considering peptides, sourcing through a licensed clinician and a verified compounding pharmacy that can provide a certificate of analysis, rather than through unregulated vendors, regardless of how the policy lands.
Update history
- October 22, 2026: Still Pending Review at OIRA. Added the five outside meetings on OIRA's log (October 21 through 28), the Executive Order 12866 review window, and the October 22 Federal Register check. Converted this article into a running tracker.
- October 18, 2026: First published after the FDA submitted the policy to OMB on October 14, 2026.
Frequently asked questions
Has the White House approved the FDA's peptide compounding policy?+
No. As of October 22, 2026, the Interim Access Policy for Compounding Using Certain Peptides is still listed as Pending Review at OMB's Office of Information and Regulatory Affairs, where it has been since October 14, 2026. It has not been issued or published.
Who has met with OMB about the peptide policy?+
OIRA's public log lists five meetings: the American Academy of Peptide Medicine on October 21, Hims & Hers Health on October 23, the Alliance for Pharmacy Compounding and the Center for Science in the Public Interest on October 27, and Carmen Group, Inc., representing Medivant Healthcare, on October 28, 2026. The log shows who requested each meeting, not what was said.
When will the policy be released?+
There is no announced date. Executive Order 12866 generally gives OIRA up to 90 calendar days, which would run to January 12, 2027, and the review can be extended. It can also finish sooner. The FDA cannot issue the policy until OIRA completes or waives its review, or the review period runs out.
What is enforcement discretion in this context?+
It is the FDA choosing not to pursue certain conduct, here, compounding of named peptides by state-licensed 503A pharmacies. It does not grant FDA approval, does not change the statute, and can be narrowed or withdrawn without formal rulemaking.
Which peptides would the policy cover?+
The policy text is not public, so the exact list is unknown. Reporting names BPC-157 as an example. The July 2026 advisory committee recommended six peptides for the 503A list: BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax.
Does this apply to 503B outsourcing facilities?+
Reporting and legal summaries indicate the expected policy would apply to 503A pharmacies that prepare patient-specific prescriptions, not to 503B outsourcing facilities, and not to research-use-only or supplement channels. That cannot be confirmed until the text is published.
Are these peptides FDA-approved drugs?+
No. Peptides such as BPC-157 are not FDA-approved. They have circulated through compounding and the research-chemical market, and the FDA has cited safety concerns including contamination, allergic reactions and effects on tumor growth, with much of the data drawn from animal studies.
Sources
- 1.Executive Order Submissions Under Review (RIN 0910-ZD94 listed as Pending Review) · Office of Information and Regulatory Affairs, OMB
- 2.EO 12866 meetings for RIN 0910-ZD94 · Office of Information and Regulatory Affairs, OMB
- 3.Executive Order 12866: Regulatory Planning and Review · National Archives, Federal Register
- 4.Trump administration advances plan for peptide drugs favored by RFK Jr. (AP) · Associated Press via STAT
- 5.Peptide policy now under White House review · Alliance for Pharmacy Compounding
- 6.Peptides at a Crossroads: What Wellness Providers Need to Know About HHS and FDA Actions · Holland & Knight
- 7.Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks · U.S. Food & Drug Administration
- 8.Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act · U.S. Food & Drug Administration