FDA Peptide Compounding Policy Tracker 2026

Last updated: October 24, 2026. This page restates the public record only. Every point links to its source. We update it when the record changes.

The short version

On October 14, 2026, the White House Office of Information and Regulatory Affairs (OIRA) received an FDA notice titled "Interim Access Policy for Compounding Using Certain Peptides" (RIN 0910-ZD94). As of October 24, 2026, it is still listed as pending review, and its text has not been published [1]. Until it is published, nobody outside government knows which peptides it covers or what conditions it sets [1][5].

No peptide has been added to FDA's 503A bulks list as a result of the July 2026 advisory committee votes. Those votes were recommendations only [4][6][10].

No published FDA notice lists six peptides. The number six comes from the advisory committee's July 2026 recommendations [9][10]. Separately, OIRA's log lists six outside-party meetings about the notice [3]; that count is unrelated to the six recommended peptides.

What is happening right now

The reginfo.gov entry for RIN 0910-ZD94 shows [1]:

• Received by OIRA: October 14, 2026
• Stage: Notice
• Legal deadline: None
• Economically significant: No
• Status: Pending review

The action has not been published in the Unified Agenda [2]. OIRA's meeting log lists six meetings with outside parties about this notice, scheduled for October 21, October 23, October 27 (two) and October 28 (two), 2026 [3]. The log shows who asked to meet and when, not what was said.

Law firms reading the record describe the open questions the same way: which peptides would qualify, whether the policy would apply only to Section 503A compounders, and whether it would add sourcing, testing, documentation or reporting conditions [5]. One firm notes that a policy reaching White House review does not by itself create a new basis for compounding [5]. Another writes that the most likely form is enforcement discretion, which would not approve any product and would not cover research-use-only channels [6]. Both are legal analyses, not FDA statements.

Timeline of key events

According to ABC News, the BPC-157 vote on July 23 was 8–6 with one abstention, and the votes are non-binding [9]. Bass, Berry & Sims reports margins across the six recommended peptides ranging from 7–4 to 8–6 [10].

What is the 503A bulks list?

Section 503A of the Federal Food, Drug, and Cosmetic Act covers compounding by state-licensed pharmacists and physicians. Under FDA's summary, they may compound only with bulk drug substances that [11]:

1. comply with an applicable USP or NF monograph, if one exists;
2. are components of FDA-approved drug products, if no monograph exists; or
3. appear on FDA's "503A bulks list", if neither of the above applies.

Each bulk substance must also come with a valid certificate of analysis and be made by an FDA-registered establishment [11].

Substances are added to the list through notice-and-comment rulemaking, not by an advisory committee vote [10][11]. FDA issued a final rule in February 2019 that placed six substances on the list, and a proposed rule in September 2019 covering more [11].

Category 1 vs Category 2 vs Category 3

While FDA evaluates nominated substances, an interim policy sorts them into three categories [11]:

• Category 1: nominated with enough supporting information to evaluate, and may be eligible for the list. FDA does not intend to take action against compounders using these substances, provided the guidance conditions are met.
• Category 2: nominated with enough information, but FDA has identified significant safety risks pending further evaluation. These are outside the Category 1 policy, and FDA would consider action under its general enforcement policies.
• Category 3: nominated with insufficient supporting information. These are also outside the Category 1 policy and may be re-nominated.

FDA states it does not intend to place substances nominated on or after January 7, 2025, into these categories [11]. Being in any category is an enforcement position, not an FDA approval.

Current status table

Last updated: October 24, 2026

FAQ

Is BPC-157 legal in 2026? On regulatory status only: BPC-157 is not on FDA's 503A bulks list, and the July 2026 committee vote to recommend it is advisory and did not add it [9][6]. FDA's Category 2 page lists it as nominated but withdrawn [7]. The OIRA notice's contents are not public [1]. This is not legal advice.

Did the FDA approve any peptides at the July 2026 meeting? No. The Pharmacy Compounding Advisory Committee only makes recommendations. Adding a substance to the 503A bulks list requires FDA rulemaking [10][11].

Which peptides were voted on? BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and Epitalon, each in free base and acetate forms [4][8]. The committee voted in favor of all except emideltide [9][10].

What is the "Interim Access Policy for Compounding Using Certain Peptides"? An FDA notice under White House review since October 14, 2026 [1]. Its text, covered substances and conditions have not been published [1][5].

When will the interim policy be published? No date is on the public record. OIRA's FAQ says review under Executive Order 12866 is limited to 90 days, has no minimum, and can be extended [12].

Does this change anything for research-use-only materials? One law firm's analysis states that an enforcement-discretion policy would not cover research-use-only channels [6]. FDA has not published the policy, so its scope is unknown [1].

Related coverage

• FDA's interim peptide compounding policy reaches White House review
• White House review log now lists six outside meetings
• US peptide regulation in 2026: what changed and what is pending
• How regulators, journalists and lawyers are reshaping the peptide market

Sources

1. reginfo.gov, Pending EO 12866 Regulatory Review, RIN 0910-ZD94: https://www.reginfo.gov/public/do/eoDetails?rrid=1568964
2. reginfo.gov, Unified Agenda view, RIN 0910-ZD94: https://www.reginfo.gov/public/do/eAgendaViewRule?RIN=0910-ZD94

3. reginfo.gov, EO 12866 meetings, RIN 0910-ZD94: https://www.reginfo.gov/public/do/eom12866SearchResults?rin=0910-ZD94

4. FDA, July 23–24, 2026 Meeting of the Pharmacy Compounding Advisory Committee: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026

5. Buchanan Ingersoll & Rooney, Oct 16, 2026: https://www.bipc.com/fda-submits-interim-peptide-compounding-policy-for-white-house-review-what-pharmacies-should-know
6. Holland & Knight, "Peptides at a Crossroads", October 2026: https://www.hklaw.com/en/insights/publications/2026/10/peptides-at-a-crossroads-what-wellness-providers-need-to-know
7. FDA, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of Apr 22, 2026): https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
8. FDA, PCAC briefing materials, July 2026: https://www.fda.gov/media/193342/download
9. ABC News, Jul 23, 2026 and follow-up: https://abcnews.com/Health/fda-advisory-committee-votes-add-popular-peptide-bpc/story?id=134913891 ; https://abcnews.com/Health/fda-advisers-narrowly-vote-add-6-peptides-drug/story?id=135064915
10. Bass, Berry & Sims, Jul 31, 2026: https://bassberry.com/news/fda-advisory-committee-recommends-six-peptides-for-compounding-what-the-evaluation-criteria-tell-us-about-the-road-ahead/
11. FDA, Bulk Drug Substances Used in Compounding Under Section 503A (content current as of May 14, 2026): https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
12. reginfo.gov, OIRA FAQ: https://www.reginfo.gov/public/jsp/Utilities/faq.myjsp

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