FDA Sends Interim Peptide Compounding Policy to White House Review

# FDA Sends Interim Peptide Compounding Policy to the White House for Review

Short answer: On October 14, 2026, HHS and the FDA sent a document titled *"Interim Access Policy for Compounding Using Certain Peptides"* to the White House Office of Management and Budget (OMB) for review. The policy has not been issued, and its text and the list of covered peptides have not been made public.

> TL;DR: A draft FDA policy on pharmacy compounding of certain peptides is under OMB review. Reporting suggests it could give state-licensed pharmacies a temporary pathway, likely through enforcement discretion. Nothing has changed yet, the peptide list is undisclosed, and formal rulemaking is still ongoing.

What was filed

According to the OMB regulatory review listing (RIN 0910-ZD94), the FDA submitted the item on October 14, 2026. It is categorized as a Notice, with no legal deadline, and it is not marked economically significant. The listing gives only the title, with no details of the policy itself.

Reuters reported the submission on October 15, noting that the filing does not describe the policy's contents.

What it may do

Inside Health Policy reports that the FDA asked OMB to approve an "interim access policy" that could create a temporary pathway for state-licensed pharmacies to compound certain peptides that are not currently eligible for compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. Legal commentary, including a Holland & Knight analysis, expects this kind of interim approach to take the form of enforcement discretion for 503A pharmacies rather than a final rule.

Which peptides?

The covered peptides have not been disclosed. Reuters, citing the Associated Press and two people familiar with the matter, reported that the policy would include some popular peptides, including BPC-157. None of the peptides under consideration has been approved by the FDA as safe or effective.

How we got here

• July 2026: The FDA's Pharmacy Compounding Advisory Committee (PCAC) reviewed seven peptides and recommended that the agency loosen restrictions on six of the seven, according to Reuters.
• October 14–15, 2026: The interim access policy was sent to OMB for review.
• Expected by end of February 2027: A second PCAC meeting is reportedly expected to cover additional peptides, including GHK-Cu, LL-37, Dihexa, Melanotan II, and PEG-MGF.

What happens next

OMB review has no fixed end date for an item like this, and the policy could change or stall before it is published. Separately, the formal rulemaking for the 503A bulk drug substances list continues, and those processes have historically taken a long time. Until the FDA publishes the policy, the current compounding rules stay in place.

What this does and doesn't cover

This policy concerns prescription compounding by licensed pharmacies for individual patients. It does not cover research-use-only (RUO) products. Those are a separate category: they are sold for in-vitro laboratory research only and are not for human or animal consumption. A change to compounding policy does not change how RUO materials are regulated or labeled.

Frequently asked questions

Has the FDA changed the peptide compounding rules? Not yet. The policy is in OMB review and has not been issued.

Which peptides are included? The list has not been published. BPC-157 has been reported as included, citing unnamed sources.

Does this affect research-use-only peptides? No. The policy is about pharmacy compounding under prescription. RUO products are a separate category.

*This article is news reporting, not medical, legal, or regulatory advice. Last updated: October 16, 2026.*