Regulation & News

FDA's Interim Peptide Compounding Policy: What We Know So Far (Updated)

Published October 20, 2026 · Last reviewed October 20, 2026 · 11 linked sources · How we source

Status: Policy pending OMB review · Text not public · No peptide added to 503A Bulks List

Last updated: October 20, 2026. This is a developing story. We separate what is confirmed in government records from what has been reported by news outlets, and we will revise this page when the policy text is published.

In mid-October 2026, the federal government took its first concrete step since July's advisory committee votes toward loosening restrictions on certain compounded peptides. A notice titled "Interim Access Policy for Compounding Using Certain Peptides" was sent to the White House for regulatory review. The policy itself has not been published. Below is what can be confirmed today, and what cannot.

What is confirmed

The White House Office of Management and Budget (OMB) publishes a list of agency actions under review. Its entry for regulation identifier number (RIN) 0910-ZD94 shows the following (Reginfo.gov):

• Title: Interim Access Policy for Compounding Using Certain Peptides
• Agency: HHS / FDA
• Received date: 10/14/2026
• Stage: Notice
• Economically significant: No
• Legal deadline: None

The same site lists a meeting on this item scheduled for October 21, 2026, at 3:00 p.m., requested by the American Academy of Peptide Medicine (Reginfo.gov meeting record). These meetings, held under Executive Order 12866, let outside groups present views while a regulatory action is under review.

A note on dates: the OMB record shows the item as received on October 14. Reuters reported on October 15 that FDA "on Thursday submitted" the policy, and the AP described it as posted on a government website on Thursday (Reuters via Yahoo News; AP). The law firm Holland & Knight, in an October 16 client alert, gives the submission date as October 14 (Holland & Knight). We use the government record's date.

What has been reported, but not confirmed

Reuters noted that the OMB filing "does not provide any details of the policy." It also reported that the Associated Press, citing two people familiar with the matter, said the policy would allow pharmacies to make some popular peptides, including BPC-157 (Reuters via Yahoo News). The AP described the plan as one to allow specialty pharmacies to produce certain peptides (AP).

Until the text is released, nobody outside government can say which peptides are covered, under what conditions, through which kinds of pharmacies, or when it would take effect. Treat any article or social post that lists specific peptides as "now legal" with caution.

How we got here

The interim policy follows a series of FDA steps in 2026. The timeline below draws on FDA records and news coverage.

• 2023: FDA placed more than a dozen peptides, including BPC-157, in "Category 2" of its interim bulks policy, its designation for nominated substances that may present significant safety risks (Holland & Knight).
• April 2026: After their nominations were withdrawn, FDA moved a group of peptides off Category 2 to a list labeled "Bulk drug substances nominated but withdrawn." The page still describes the potential safety risks for each, including BPC-157 (FDA). Holland & Knight notes this lifted a safety designation but did not make any peptide eligible for compounding.
• July 23–24, 2026: FDA's Pharmacy Compounding Advisory Committee recommended six of seven peptides for the 503A Bulks List (BPC-157, KPV, TB-500, MOTS-c, Semax and epitalon) and rejected emideltide (AJMC). FDA staff had recommended against listing them (FDA meeting materials). See our full explainer: BPC-157 and the FDA.
• October 14–15, 2026: The interim access policy is received for OMB review (Reginfo.gov).

Why an "interim" policy at all?

The committee's July votes are recommendations. Before a substance can be added to the 503A Bulks List, FDA has to develop that list "through regulations," as the agency describes the statutory requirement (FDA). That means a proposed rule, a public comment period and a final rule (AJMC). Holland & Knight notes there is no legal deadline for that process and that rulemaking on bulk substances has historically taken years; it cites a 2016 proposed rule on 10 bulk substances that was not finalized until 2019 (Holland & Knight).

An interim policy is a way to act sooner. FDA already uses interim policies for bulk substances while the formal lists are being developed; the agency's own summary of compounding law refers to "FDA's final guidance describing its interim policy for compounders using bulk drug substances while the list of bulk drug substances is being developed" (FDA).

What an interim policy would and would not do

Holland & Knight's analysis is that the most likely form is enforcement discretion: FDA signaling it does not intend to take action against state-licensed 503A pharmacies that compound certain peptides for individual patients, subject to conditions. It suggests one possible mechanism would be moving the peptides into Category 1 of the interim bulks policy. This is the firm's expectation, not a published FDA position (Holland & Knight).

If the policy takes that form, the same analysis points out several limits:

• It would not approve any peptide. Covered peptides would remain unapproved drugs.
• It would not change the underlying law, and could be narrowed or withdrawn without a formal public comment process.
• It would not extend to products sold as "research chemicals" or dietary supplements, and would not cover 503B outsourcing facilities.
• It would not bind state pharmacy and medical boards.
• It could be limited to particular routes of administration, since some committee members tied their support to specific routes.

Holland & Knight also reports that pharmaceutical trade groups have argued, in comments to the advisory committee, that FDA cannot lawfully authorize compounding through an interim policy while rulemaking is pending, which suggests a possible legal challenge (Holland & Knight).

Whatever its form, the basic rule still applies: compounded drugs are not FDA-approved, and FDA "does not verify the safety, effectiveness or quality of compounded drugs before they are marketed" (FDA Q&A).

Enforcement has been moving the other way

While access headlines dominated, FDA was also acting against sellers outside the licensed system. According to Holland & Knight, on August 24, 2026, FDA issued five warning letters to online peptide vendors, concluding that "research use only" labels did not outweigh evidence the products were intended for human use (Holland & Knight). The same alert describes illnesses reported by FDA and CDC in August and September 2026 linked to contaminated compounded glutathione injections, a reminder that the licensed compounding channel carries quality risks too.

The practical point: even if an interim policy opens a prescription channel through licensed pharmacies, it would not legitimize the online "research peptide" market. This site does not link to such sellers.

Who wants what

Reuters reported that telehealth company Hims & Hers Health had previously said it plans to offer peptides if regulations permit, and that peptides have been promoted by social media influencers and by HHS Secretary Robert F. Kennedy Jr. (Reuters via Yahoo News). AJMC reported that Kennedy has called himself "a big fan" of peptides (AJMC). On the other side, the consumer group Public Citizen testified to the advisory committee against listing BPC-157, citing the small size and short duration of its human studies (Public Citizen).

What does not change, regardless of the policy

• The evidence. A policy decision does not create clinical trial data. FDA's own reviewers found the human evidence for these peptides limited, and the agency's documented position on BPC-157 is that it "lacks sufficient information to know whether the drug would cause harm when administered to humans" (FDA).
• Approval status. The peptides under consideration "have not been approved by the FDA as safe or effective" (Reuters).
• The 503A Bulks List. As of this update, no peptide has been added (Holland & Knight).

What to watch next

1. The OMB meeting on October 21, 2026 (Reginfo.gov).
2. Completion of OMB review and publication of the policy text, which will show which peptides, which pharmacies, which routes, and what conditions (such as patient disclosures or adverse-event reporting).
3. Whether FDA starts formal rulemaking on the July recommendations.
4. A second advisory committee meeting, which Holland & Knight says is expected before the end of February 2027 to consider remaining peptides; FDA has not set a date.
5. Legal challenges to any interim approach.

We will update this page as each of these happens. For background on the two compounding pathways, read 503A vs 503B Compounding Pharmacies, Explained.