Which peptides are being reclassified by the FDA in 2026?

12 peptides are being removed from the FDA's Category 2 list and referred to the Pharmacy Compounding Advisory Committee (PCAC): BPC-157, TB-500 (Thymosin Beta-4 fragment), Epitalon, GHK-Cu, MOTS-C, DSIP, Dihexa Acetate, Mechano Growth Factor Pegylated (PEG-MGF), Melanotan II, KPV, Semax, and Cathelicidin LL-37. Five additional peptides (CJC-1295, Ipamorelin, Thymosin Alpha-1, AOD-9604, Selank) were previously referred in September 2024.

When will the FDA PCAC meeting on peptides take place?

The first PCAC meeting is scheduled for July 23-24, 2026, at the FDA White Oak Campus in Silver Spring, MD. A second meeting for the remaining peptides is planned before February 28, 2027. The public comment deadline for the July meeting is July 9, 2026.

Are BPC-157 and TB-500 legal to compound now?

Not yet. The Federal Register notice schedules an advisory committee review — it does not authorize compounding. These peptides cannot be legally compounded until the PCAC makes a recommendation and the FDA formally adds them to the Section 503A bulk drug substances list. That process could take months after the July meeting.

What is the difference between FDA Category 1 and Category 2 peptides?

Category 1 peptides can be legally compounded by 503A and 503B pharmacies with a valid prescription. Category 2 peptides are barred from compounding — the FDA has determined they raise significant safety or effectiveness concerns. The current reclassification effort moves 12 peptides out of Category 2 and into PCAC review, which could lead to Category 1 status.

What is the Federal Register notice number for the peptide PCAC meeting?

The Federal Register document number is 2026-07361, filed under Docket No. FDA-2025-N-6895. It was published for public inspection on April 15, 2026, and formally published April 16, 2026.

How can I submit public comments on the FDA peptide reclassification?

Public comments can be submitted through the Federal Register docket (FDA-2025-N-6895) or at regulations.gov. Comments for inclusion in committee meeting materials are due by July 9, 2026. Comments for FDA consideration are due by July 22, 2026.

Official FDA ActionApril 16, 2026

FDA Schedules PCAC Review of 12 Peptides for Compounding Access Under Section 503A

The FDA has published Federal Register notice 2026-07361 scheduling the Pharmacy Compounding Advisory Committee (PCAC) to review 12 peptides previously on the Category 2 restricted list. This is the first formal regulatory action following HHS Secretary Kennedy's February 2026 comments signalling an expected announcement, and could open a pathway for these peptides to be legally compounded with a prescription.

Key Facts

Federal Register Doc.: 2026-07361 (Docket FDA-2025-N-6895)
Published: April 16, 2026 (public inspection April 15)
PCAC Meeting: July 23–24, 2026 — FDA White Oak Campus, Silver Spring, MD
Public Comment Deadline: July 9, 2026 (materials) / July 22, 2026 (FDA consideration)
Peptides Under Review: 12 newly referred + 5 previously referred = 17 total
Current Legal Status: NOT yet legal to compound — PCAC review is advisory only

The 12 Peptides Removed from Category 2

The FDA removed these 12 substances from its Category 2 ("do not compound") list and referred them to the PCAC for Section 503A review. Note that MK-677 (ibutamoren mesylate) is not among them and remains in Category 2:

1. BPC-157
2. TB-500 (Thymosin Beta-4 fragment LKKTETQ)
3. Epitalon (free base and acetate)
4. GHK-Cu (injectable)
5. MOTS-C
6. DSIP / Emideltide
7. Dihexa Acetate
8. Mechano Growth Factor, Pegylated (PEG-MGF)
9. Melanotan II
10. KPV
11. Semax (free base and acetate)
12. Cathelicidin LL-37

5 Peptides Previously Referred (September 2024)

These peptides were removed from Category 2 in September 2024 when their nominators withdrew submissions. They are already referred to the PCAC but have not yet been added to the 503A compounding list:

1. CJC-1295
2. Ipamorelin acetate
3. Thymosin Alpha-1
4. AOD-9604
5. Selank acetate

Timeline: What Happens Next

Feb 27, 2026

HHS Secretary Kennedy says on the Joe Rogan podcast that he expects a peptide announcement within weeks

Apr 15–16, 2026

FDA publishes Federal Register notice scheduling PCAC meeting; 12 peptides formally removed from Category 2

Jul 9, 2026

Public comment deadline for inclusion in PCAC meeting materials

Jul 23–24, 2026

First PCAC meeting reviews DSIP, Semax, Epitalon (and possibly 4 more)

Before Feb 28, 2027

Second PCAC meeting reviews remaining peptides

TBD

FDA decides whether to add reviewed peptides to 503A compounding list

What This Means for Peptide Access

The Federal Register notice is a significant step forward, but it does not immediately legalize compounding of these peptides. Here is the pathway:

Removal from Category 2 — announced but not yet formally published as a guidance update. This removes the explicit ban on compounding.
PCAC review — the advisory committee evaluates each peptide for safety, effectiveness, and suitability for compounding. PCAC recommendations are advisory, not binding.
FDA decision — based on PCAC recommendations, the FDA decides whether to add each peptide to the 503A bulk drug substances list.
Legal compounding — once on the 503A list, licensed compounding pharmacies (503A and 503B) can legally prepare these peptides with a valid prescription.

The earliest any of these peptides could be legally compounded is late 2026, following the July PCAC meeting and subsequent FDA action. The remaining peptides would follow after the second meeting in early 2027.

GLP-1 Drugs Remain Under Enforcement

This reclassification effort does not apply to GLP-1 agonists (semaglutide, tirzepatide). The FDA continues to aggressively enforce against compounded GLP-1 drugs, issuing warning letters in successive waves — 30 in March 2026 and 25 in June 2026, following a wave of 50+ in September 2025. Cumulative totals circulating in trade press aggregate different letter types across years; the FDA does not publish a single running count. Tirzepatide compounding is effectively prohibited; semaglutide compounding is under active enforcement.

Sources

Corrections

Reviewed against primary sources on September 3, 2026. The following errors were found and corrected:

Docket number corrected to FDA-2025-N-6895 (previously given as FDA-2026-N-2979).
MK-677 (ibutamoren mesylate) removed from the list of 12 — it remains in FDA Category 2 and was not deregulated. The 12th substance is PEG-MGF.
Epitalon PCAC tally now shown as disputed — reported as both 7–4–1 and 7–5–1 across trade press, with no official FDA record to settle it.
Vote tallies now attributed to trade-press reporting; the FDA has published no official tally sheet.
GLP-1 warning letters described by documented waves rather than an aggregate "85+" figure.
Removed a dead AP/WRAL source link (HTTP 410).

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