Updated Oct 29, 2026.

Last checked: Oct 29, 2026. Newest change: on Oct 28, 2026, HHS filed an interim policy saying it won't take enforcement action against licensed compounders of six peptides: BPC-157, TB-500, MOTS-c, epitalon, semax and KPV. It publishes in the Federal Register Oct 30, 2026 [19]. Sources: FDA, HHS, the federal review log at reginfo.gov, and the law firms and news outlets cited below.

Part of The Sommar Peptide Guide. Every FDA move on peptides in 2026, newest first. Each entry has a date and a source. Education only.

Where things stand today

None of these peptides is approved by FDA for any use. None is on the 503A bulks list [2]. Coming off Category 2 does not change either fact. Neither does the HHS policy [19]. The full explainer: Are Peptides Legal?

The 2026 log, newest first

Oct 28, 2026. HHS files the interim peptide policy

HHS filed its "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" for public inspection (docket HHS-OASH-2026-0496, FR Doc 2026-22192). It is scheduled to publish in the Federal Register on Oct 30, 2026, with comments open for 2 weeks after that [19].

HHS says it does not intend to take enforcement action against a state-licensed pharmacy, a federal facility or a licensed physician that compounds one of six peptides, when every condition is met [19][20]:

• BPC-157 acetate: under the skin, into muscle, oral or topical

• TB-500 acetate: under the skin or into muscle

• MOTS-c acetate: under the skin or into muscle

• Epitalon acetate: under the skin or into muscle, in intermittent courses

• Semax free base: nasal

• KPV acetate: topical or oral

These are the six the panel voted for in July. Conditions include one active ingredient per product, a bulk ingredient from an FDA-registered maker that follows good manufacturing practice, reporting serious side effects and quality problems to FDA and states, and the label "This is a compounded drug product. Not for resale" [20].

It is interim and not binding. It lasts while the 503A bulks list goes through rulemaking, and HHS may revisit it if a safety signal or quality problem shows up [19]. It approves nothing, puts no peptide on the 503A list and does not name outsourcing facilities (503B) [19]. Every other peptide on this page keeps its prior status. Read the full breakdown in HHS's Oct 28 peptide policy.

Oct 21 to 27, 2026. Four review meetings logged

The White House review office's public log lists four scheduled meetings on the policy: Oct 21, Oct 23 and two on Oct 27 [12]. Outside groups can ask for these meetings while a draft is under review. The log shows dates, not what was said.

Oct 22, 2026. Legal summary: still pending

A legal summary dated Oct 22 said the federal record still listed the policy as pending review, with no text, peptide list or conditions disclosed [11].

Oct 15, 2026. AP reports what's in it

AP, citing two people familiar with the plan, reported the policy would use enforcement discretion and include BPC-157 [10]. No full list was public. Treat the details as reported, not confirmed.

Oct 14, 2026. Interim peptide policy sent for review

HHS and FDA sent an "Interim Access Policy for Compounding Using Certain Peptides" to the White House Office of Management and Budget [9]. It is filed at the notice stage, RIN 0910-ZD94 [12]. Until it publishes, nobody outside the review can say which peptides it covers or on what terms.

Aug 24, 2026. Four more research-peptide warning letters

FDA dated warning letters to four online peptide sellers on Aug 24 and posted them Sept 1 [15]. Products named included tesamorelin, SS-31 and retatrutide. Each letter said that despite "research use only" labels, "evidence obtained from your website establishes that your products are intended to be drugs for human use" [15]. FDA cited them as unapproved new drugs. More: Prescription vs Research Peptides.

Jul 24, 2026. Panel day two

FDA's Pharmacy Compounding Advisory Committee voted to recommend semax (8 yes, 5 no, 1 abstain) and epitalon (7, 4, 1) for the 503A bulks list. It voted against DSIP (6, 7, 1) [7]. The semax and epitalon counts come from a single source [7].

Jul 23, 2026. Panel day one

The committee voted yes on BPC-157, TB-500 and KPV (each 8, 6, 1) and MOTS-c (7, 5, 2) [7][8]. FDA staff had recommended against all 7 peptides on the two-day agenda [6][7]. The votes are advice. FDA decides, and adding a substance to the list takes notice-and-comment rulemaking [7].

Jun 17, 2026. Warning letter, "research use only" peptides

FDA warned an online seller that its "research use only" products, gonadorelin among them, were intended for human use and were unapproved new drugs [14].

May 14, 2026. Topical GHK-Cu back in Category 1

FDA's list put GHK-Cu back in Category 1 for non-injectable routes only. The nominator had clarified on May 5 that it withdrew only the injectable route [3]. Injectable GHK-Cu stays off Category 2 and waits for the next panel. Details: GHK-Cu.

Apr 22, 2026. 12 peptides off Category 2

FDA's Category 2 page, current as of this date, no longer lists 12 peptides: BPC-157, TB-500, KPV, MOTS-c, semax, epitalon, DSIP, LL-37, dihexa, PEG-MGF, melanotan II and injectable GHK-Cu [1]. FDA's list also showed GHK-Cu taken off Category 1 that day [3].

Apr 16, 2026. July panel announced

A Federal Register notice set the advisory committee meeting for Jul 23 to 24, 2026, to consider 7 of the 12 peptides for the 503A bulks list [5].

Apr 15, 2026. FDA says 12 peptides will come off

FDA announced it would remove 12 peptides from Category 2 "within seven calendar days," because their nominators withdrew them [4]. It also said the committee would meet again before the end of Feb 2027 for the other 5 [5].

Mar 31, 2026. Warning letter, "research use only" GLP-1 peptides

FDA warned an online seller whose retatrutide and tirzepatide carried "Research Use Only" and "not intended for human consumption" labels. FDA said the website showed the products were drugs for human use [13].

Coming up

• Oct 30, 2026. The HHS policy publishes in the Federal Register. Comments open for 2 weeks after that [19].

• Second panel meeting. Before the end of Feb 2027, no date set: LL-37, injectable GHK-Cu, dihexa, melanotan II and PEG-MGF [5].

• FDA's decision on the July votes. Any addition to the 503A bulks list needs notice-and-comment rulemaking [7].

Before 2026, for context

• Sept 29, 2023. FDA put kisspeptin-10, GHRP-2, GHRP-6, ipamorelin and others on Category 2 [1].

• Sept 27, 2024. 5 peptides came off after nominators withdrew: AOD-9604, CJC-1295, ipamorelin (503A side), thymosin alpha-1 and selank [18].

• Oct 29, 2024. Panel voted against ipamorelin (0, 12, 1) and kisspeptin-10 (0, 11, 0) [17].

• Dec 4, 2024. Panel voted against CJC-1295, AOD-9604 (0, 12) and thymosin alpha-1 (4, 17) [16].

How this page works

• Checked every Friday, and the day FDA posts peptide news.

• Every entry needs an FDA page, a federal record, or a named law firm or news source. Reports from people "familiar with the plan" are marked as reported.

• New entries go on top. Older entries are never edited, only corrected, with the correction dated.

FAQ

What changed with FDA and peptides in 2026? 12 peptides came off Category 2 in Apr. The advisory panel voted yes on 6 of 7 in Jul. On Oct 28, HHS filed an interim policy covering the six that got a yes [1][7][19].

Did FDA approve BPC-157? No. The panel voted 8 to 6 for it, with 1 abstention, in Jul 2026. That vote is advice. BPC-157 is not approved by FDA for any use and not on the 503A bulks list [2][7]. HHS's Oct 28 interim policy is enforcement discretion, not approval [19].

What is the interim access policy for peptides? The name it carried during review. HHS filed it Oct 28, 2026 as an enforcement discretion policy. HHS says it won't take action against state-licensed pharmacies, federal facilities or licensed physicians that compound six peptides under its conditions: BPC-157, TB-500, MOTS-c, epitalon, semax and KPV. It is interim, not binding, and not approval [19][20].

Which peptide is still on the 503A Category 2 list? Kisspeptin-10, as of FDA's page dated Apr 22, 2026 [1].

When is the next FDA peptide panel? Before the end of Feb 2027. No date was set as of Oct 28, 2026 [5].

Sources

1. 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

2. FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (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

3. FDA. Bulk drug substances nominated for use in compounding under section 503A, Categories 1 to 3 (updated May 14, 2026). https://www.fda.gov/media/94155/download

4. Frier Levitt. FDA Peptides "Do Not Compound" List Update (Apr 16, 2026). https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/

5. Hyman, Phelps and McNamara, FDA Law Blog. FDA's Pep(tide) Rally! What Compounders and Industry Need to Know, Post 1 of 2 (Apr 21, 2026). Cites Federal Register document 2026-07361 (Apr 16, 2026). https://thefdalawblog.com/2026/04/fdas-peptide-rally-what-compounders-and-industry-need-to-know-post-1-of-2

6. FDA. July 23 to 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

7. Bass Berry. FDA Advisory Committee Recommends Six Peptides for Compounding (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/

8. AJMC. FDA Panel Backs 6 Peptides for Compounding (Jul 31, 2026). https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding

9. Holland & Knight. Peptides at a Crossroads: What Wellness Providers Need to Know (Oct 16, 2026). https://www.hklaw.com/en/insights/publications/2026/10/peptides-at-a-crossroads-what-wellness-providers-need-to-know

10. AP via ABC News. Trump administration advances plan for peptide drugs (Oct 15, 2026). https://abcnews.com/Business/wireStory/trump-administration-advances-plan-peptide-drugs-favored-rfk-137299803

11. Mondaq. FDA Submits Interim Peptide Compounding Policy For White House Review: What Pharmacies Should Know (Oct 22, 2026). https://www.mondaq.com/unitedstates/healthcare/1858180/fda-submits-interim-peptide-compounding-policy-for-white-house-review-what-pharmacies-should-know

12. Office of Information and Regulatory Affairs. EO 12866 meetings, Interim Access Policy for Compounding Using Certain Peptides, RIN 0910-ZD94 (checked Oct 28, 2026). https://www.reginfo.gov/public/do/eom12866SearchResults?rin=0910-ZD94

13. FDA. Warning letter 721806 (Mar 31, 2026). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gram-peptides-721806-03312026

14. FDA. Warning letter 729447 (Jun 17, 2026). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wholesale-peptide-729447-06172026

15. FDA. Warning letters 735127, 734884, 735063 and 735067 (Aug 24, 2026). https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026 ; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026 ; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 ; https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026

16. FDA. Dec 4, 2024 Pharmacy Compounding Advisory Committee, voting results. https://www.fda.gov/media/185642/download

17. FDA. Pharmacy Compounding Advisory Committee, Oct 29, 2024, meeting minutes. https://www.fda.gov/media/185412/download

18. Reed Smith. FDA removes certain peptide bulk drug substances from Category 2 (2024). https://www.reedsmith.com/de/perspectives/2024/10/fda-certain-peptide-bulk-drug-substances-category-2-503a-bulks-pcac

19. HHS. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Docket HHS-OASH-2026-0496, FR Doc 2026-22192 (filed for public inspection Oct 28, 2026; scheduled to publish in the Federal Register Oct 30, 2026). https://public-inspection.federalregister.gov/2026-22192.pdf

20. Hyman, Phelps and McNamara, FDA Law Blog. The PEPTIDE-L Wave Reaches HHS: Enforcement Discretion … Not the Finish Line (Oct 28, 2026). https://www.thefdalawblog.com/2026/10/the-peptide-l-wave-reaches-hhs-enforcement-discretion-not-the-finish-line/

Sommar Club does not prescribe or sell any peptide named on this page. This page is for education only. It is not medical or legal advice. FDA statuses change; check the date on every entry.