The FDA's Peptide 'Interim Access Policy' Is at the White House: What the Filing Shows and Who Has Asked to Meet on It

Two weeks after the Washington Post first reported a plan for "the temporary sale of certain previously restricted peptides", the plan has its first official trace. It is not a rule and not an announcement. It is a short entry on reginfo.gov, the government's regulatory review site, showing that the FDA has sent an action on peptide compounding to the White House. Here is what that entry says, what it does not say, and what has been reported around it, as of 22 October 2026.

What the filing says

The record sits on the list of actions under review at the White House Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget, which reviews significant agency actions under Executive Order 12866. We read it on 20 October. This is every substantive field on the page:

Source: reginfo.gov listing for RIN 0910-ZD94 and the OIRA list of submissions under review, read on 20 October 2026 and again on 22 October 2026.

What the listing does not contain: the text of the policy, the peptides it covers, the conditions it sets, or a release date. The Alliance for Pharmacy Compounding, the pharmacy trade group that has asked the FDA for this kind of policy, wrote on 16 October: "we don't yet know what the policy says, which peptides it covers, or what conditions FDA may attach to their compounding. The text has not been made public. Nor do we know when it will be released."

Who has asked to meet the White House reviewers

Executive Order 12866 lets people outside government meet OIRA about an action under review. The issuing agency must be invited, and OIRA must keep a public log with the dates and the names of those involved. The log for this policy lists five meetings, all marked as scheduled when we checked on 22 October:

Source: reginfo.gov EO 12866 meeting log for RIN 0910-ZD94, read on 22 October 2026. The log gives no time zone, and its meeting pages do not say what any party will argue; the attached documents would not download when we checked.

Two of the five have said where they stand in public. The chairman of the American Academy of Peptide Medicine, Lee Rosebush, told the Washington Post for its 7 October report: "We would encourage the HHS to use temporary enforcement discretion to allow access to these as soon as possible to help eliminate the gray and black market that currently exists." Hims & Hers is a telehealth company. The Associated Press reported on 15 October that it and Noom "recently announced plans to offer peptides to their customers if the federal government eases access."

What the policy is reported to do

The AP notes that "the White House filing doesn't give specifics of the new policy". Citing "two people familiar with the plan", who spoke on condition of anonymity, the AP reported that it "is intended to allow pharmacies to temporarily compound some of the most popular peptides, including BPC-157", and that it would assure compounding pharmacies "that they won't be targeted for producing certain peptides". That approach is known as enforcement discretion. The AP adds that formally adding the peptides to the FDA's list "would require federal rulemaking, a process that could take years and involves multiple rounds of public comment", and that "it was not immediately clear if the administration still plans to pursue that process."

Enforcement discretion is not new in compounding. The FDA already runs an interim policy for bulk substances it is still evaluating. For substances in its "category 1", the agency says it "does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in category 1, provided that the conditions described in the guidance document are met." Substances in which it has found significant safety risks go into "category 2" and are left out of that policy. A policy of this kind does not approve a drug. It says when the FDA does not intend to act.

Where the July peptides stand on the FDA's own page today: BPC-157 and the six other peptides the FDA's advisers reviewed in July (TB-500, KPV, MOTS-c, Semax, epitalon and emideltide) appear in a list of 17 substances "previously in category 2 of the interim policies" that "were withdrawn by the nominators" (page current as of 22 April 2026). In July the advisory panel recommended the agency drop its restrictions on six of the seven, which, the AP reports, "went against the scientific conclusion of FDA's staff scientists". The full tallies are in our page on the July advisory vote.

Who it would and would not cover, as reported

Everything reported so far describes a pharmacy and prescription route. The Post reported that the plan "would allow some compounding pharmacies to dispense certain peptides". The Alliance for Pharmacy Compounding told the Post it has asked the FDA for interim enforcement discretion "to let state-licensed compounding pharmacies prepare the drugs for patients with a prescription", with conditions "including enhanced disclosures to patients, serious adverse event reporting and data collection on peptide use". No report describes any change for vendors selling peptides labelled for research use only.

The plan is also not settled inside government. Pink Sheet reported on 8 October that "FDA drug center staff said they will not recommend allowing temporary compounding of unapproved peptides", and that FDA staff said the move "raises patient safety concerns and weakens the drug approval process."

How long the review could take

There is no public timetable. Executive Order 12866 tells OIRA to finish review within 10 working days for preliminary actions taken before a proposed rule, and within 90 calendar days for other actions, and allows one extension of up to 30 days with the OMB director's written approval, as well as extensions at the agency head's request. The listing does not say which limit applies. The queue is long: on 20 October the OIRA list showed 175 actions under review, 47 of them from HHS and 13 from the FDA. Some FDA items have been waiting much longer than six days:

Source: OIRA list of executive order submissions under review, 20 October 2026. Day counts are our arithmetic. Past waits do not tell us how long this one will take.

What has not happened

• No Federal Register document. The Federal Register API returns no FDA document mentioning "peptide" published since 14 October (queried 22 October).
• No announcement. The FDA press announcements list (current as of 19 October) and the HHS press room have no peptide item. HHS officials "did not immediately respond to requests for comment", the AP reported on 15 October.
• No list of peptides, no conditions and no start date have been published.
• No change in legal status. Until a text is published, any claim that a particular peptide "is now legal" is ahead of the record.

We will update this piece, and our fact check of the temporary sale plan, the day a document is published. For the rules as they stand today, see are peptides legal in the US.

What to watch

• 23, 27 and 28 October: the remaining scheduled OIRA meetings.
• The reginfo.gov status for RIN 0910-ZD94 changing from "Pending Review" to concluded.
• A Federal Register notice or an FDA guidance page with the text, the peptides covered and the conditions. Under the executive order, once the action is issued, OIRA must make public the documents exchanged with the agency during review.
• 29 October: Eli Lilly reports third-quarter 2026 results, with a conference call at 10 a.m. Eastern.

Questions readers ask

Sources

1. reginfo.gov: Pending EO 12866 Regulatory Review, RIN 0910-ZD94, Interim Access Policy for Compounding Using Certain Peptides, received 14 October 2026, read 20 and 22 October 2026
2. reginfo.gov: EO 12866 meetings for RIN 0910-ZD94, read 22 October 2026
3. reginfo.gov: OIRA executive order submissions under review, 20 October 2026
4. Associated Press: Trump administration advances plan for peptide drugs favored by RFK Jr. (as published by NBC News), 15 October 2026 (NBC copy posted 16 October)
5. Alliance for Pharmacy Compounding: Peptide policy now under White House review, 16 October 2026
6. Washington Post: Trump administration paving way for temporary sale of some unapproved peptides (Rachel Roubein), 7 October 2026
7. Pink Sheet: US FDA staff push back against Trump administration interim peptide dispensing order (Maaisha Osman, Sue Sutter), 8 October 2026
8. FDA: Bulk drug substances used in compounding under section 503A of the FD&C Act, content current as of 14 May 2026
9. FDA: Certain bulk drug substances for use in compounding that may present significant safety risks, content current as of 22 April 2026
10. Executive Order 12866, Regulatory Planning and Review (Federal Register, Vol. 58, No. 190), 4 October 1993
11. Federal Register API: FDA documents mentioning "peptide" published since 14 October 2026, queried 22 October 2026
12. FDA: Press announcements, content current as of 19 October 2026
13. Eli Lilly: Lilly confirms date and conference call for third-quarter 2026 financial results announcement, 15 October 2026