Official FDA Action

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 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-2026-N-2979)
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

HHS Secretary Kennedy confirmed these 12 substances are being removed from the FDA's Category 2 ("do not compound") list and referred to the PCAC for Section 503A review:

  1. 1. BPC-157
  2. 2. TB-500 (Thymosin Beta-4 fragment LKKTETQ)
  3. 3. Epitalon (free base and acetate)
  4. 4. GHK-Cu (injectable)
  5. 5. MOTS-C
  6. 6. DSIP / Emideltide
  7. 7. Dihexa Acetate
  8. 8. Ibutamoren Mesylate (MK-677)
  9. 9. Melanotan II
  10. 10. KPV
  11. 11. Semax (free base and acetate)
  12. 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. 1. CJC-1295
  2. 2. Ipamorelin acetate
  3. 3. Thymosin Alpha-1
  4. 4. AOD-9604
  5. 5. Selank acetate

Timeline: What Happens Next

Feb 27, 2026

HHS Secretary Kennedy announces on Joe Rogan that 14 peptides will be reclassified

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:

  1. Removal from Category 2 — announced but not yet formally published as a guidance update. This removes the explicit ban on compounding.
  2. PCAC review — the advisory committee evaluates each peptide for safety, effectiveness, and suitability for compounding. PCAC recommendations are advisory, not binding.
  3. FDA decision — based on PCAC recommendations, the FDA decides whether to add each peptide to the 503A bulk drug substances list.
  4. 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, having issued 85+ warning letters and threatening seizure actions. Tirzepatide compounding is effectively prohibited; semaglutide compounding is under active enforcement.

Sources

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