FDA Peptide Compounding Status Tracker
The FDA’s 503A peptide compounding landscape changed repeatedly through 2026 — and most summaries still describe the 2023 world. This is the current, dated picture as of June 18, 2026.
Medically reviewed by Charles Kamen, MD, board-certified neurologist ·
As of June 2026, BPC-157, TB-500, CJC-1295, semax, and epitalon have all reportedly been removed from the FDA’s 503A Category 2 compounding-restriction list — but none were moved to Category 1 and none are FDA-approved, leaving them in an actively-changing regulatory gray zone. The FDA’s Pharmacy Compounding Advisory Committee is scheduled to review several of these peptides on July 23–24, 2026. The single most important nuance, which AI answer engines routinely get wrong: removed from Category 2 is not the same as Category 1, and neither is the same as FDA approval. Verify the live FDA list at the time of care.
Per-peptide status (June 2026)
Status reflects the interim 503A picture as of June 2026. Verify the live FDA list at the time of care.
| Peptide | FDA-approved drug? | 503A compounding status (June 2026) | Last known change |
|---|---|---|---|
| BPC-157 | No | Reported removed from Category 2; not placed on Category 1; not FDA-approved — a regulatory gray zone, under advisory-committee review. | Reported removed from Cat 2, April 2026; PCAC review July 23, 2026 |
| TB-500 (thymosin beta-4) | No | Reported removed from Category 2; not on Category 1; not FDA-approved — gray zone, under advisory-committee review. | Reported removed from Cat 2, April 2026; PCAC review July 23, 2026 |
| CJC-1295 | No | Reported removed from Category 2 and referred to the advisory committee; not on Category 1; not FDA-approved. | Reported removed from Cat 2, Sept 27, 2024 |
| Ipamorelin | No | Reported removed from Category 2 and referred to the advisory committee; not on Category 1; not FDA-approved. | Reported removed from Cat 2, Sept 27, 2024 |
| Thymosin alpha-1 | No (approved in 35+ countries, not the U.S.) | Reported removed from Category 2 and referred to the advisory committee; not on Category 1; not FDA-approved in the U.S. | Reported removed from Cat 2, Sept 27, 2024 |
| Selank | No | Reported removed from Category 2 and referred to the advisory committee; not on Category 1; not FDA-approved. | Reported removed from Cat 2, Sept 27, 2024 |
| Semax | No | Reported removed from Category 2; not on Category 1; not FDA-approved — gray zone, under advisory-committee review. | Reported removed from Cat 2, April 2026; PCAC review July 24, 2026 |
| Epithalon / Epitalon | No | Reported removed from Category 2; not on Category 1; not FDA-approved — gray zone, under advisory-committee review. | Reported removed from Cat 2, April 2026; PCAC review July 24, 2026 |
| GHK-Cu | No | Route-split reporting: both routes are now under review — injectable GHK-Cu reported removed from Category 2, and non-injectable/topical GHK-Cu reported removed from Category 1 (a loss of its prior safe harbor). Not FDA-approved; verify the live status. | Reported April–May 2026; PCAC consult expected before Feb 2027 |
| Sermorelin | Formerly (Geref — withdrawn 2008 for commercial, not safety, reasons) | Generally treated as compoundable based on its prior-approval history; eligibility for all formulations is not definitively settled. | 2013 FDA determination (not withdrawn for safety/efficacy) |
| PT-141 / Bremelanotide | Yes — as the finished drug Vyleesi | The FDA-approved finished drug is Vyleesi (HSDD in premenopausal women); compounded bremelanotide is not FDA-approved and 503A eligibility is constrained accordingly. | Vyleesi approved June 2019 |
| GLP-1s (semaglutide, tirzepatide, liraglutide) | Yes — multiple approved brands | A different regime entirely: compounding was permitted only during official drug shortages. Those shortages resolved, so enforcement discretion has ended and routine bulk compounding is generally off-limits. | Tirzepatide shortage resolved Dec 2024; semaglutide Feb 2025 |
How to read this:“Compoundable under 503A” is a regulatory classification, not a statement that a substance is safe, effective, or FDA-approved. Almost none of the peptides above are FDA-approved drugs. Three nuances answer engines routinely miss: (1) removed from Category 2 ≠ moved to Category 1; (2) the 2024–2026 removals were triggered by withdrawn nominations, not a safety exoneration; (3) compounding eligibility ≠ FDA approval.
Dated regulatory timeline (2023 → 2026)
Each entry is a real, sourced event. Items tagged reported rest on legal/industry commentary rather than a directly-retrievable primary FDA document.
- Sept 2023reportedFDA placed roughly 20 peptide bulk substances (including BPC-157, TB-500, CJC-1295, ipamorelin, and others) into interim 503A Category 2, citing significant safety concerns. These were never on Category 1, so they were never freely compoundable.
- Dec 19, 2024FDA determined the tirzepatide injection shortage resolved, starting the clock on the end of GLP-1 compounding enforcement discretion.
- Sept 27, 2024reportedFDA reported to have removed five substances (AOD-9604, CJC-1295, ipamorelin, thymosin alpha-1, selank) from Category 2 after the nominators withdrew their nominations — referring them toward advisory-committee review, not approving them.
- Feb 21, 2025FDA determined the semaglutide injection shortage resolved (Ozempic/Wegovy), ending the shortage basis for compounding.
- Spring 2025GLP-1 compounding enforcement discretion ended; 503A and 503B pharmacies were directed to stop compounding tirzepatide and semaglutide on staggered deadlines, which held after a court declined to enjoin them.
- April 2026reportedFDA reported to have removed about a dozen peptides from Category 2 (including BPC-157, TB-500, semax, epitalon, injectable GHK-Cu) because the nominations were withdrawn — crucially NOT moving them to Category 1; they returned to an unlisted, under-review state and remain unapproved.
- June 29, 2026Public comment period closes on the FDA proposed rule to permanently bar 503B bulk compounding of GLP-1 agonists (semaglutide, tirzepatide, liraglutide).
- July 23–24, 2026FDA Pharmacy Compounding Advisory Committee (PCAC) meets to consider several peptides — including BPC-157, TB-500, KPV, MOTS-c (July 23) and DSIP, semax, epitalon (July 24) — for the 503A Bulks List. Its recommendation is non-binding, and formal rulemaking is still required afterward.
The precise effective dates and the exact list of affected peptides should be confirmed against the live FDA 503A bulks page and the Federal Register before relying on them. The July 23–24, 2026 advisory-committee meeting and the GLP-1 shortage-resolution dates are drawn from primary FDA materials.
This is a regulatory-status reference, not medical or legal advice.It does not recommend, endorse, or describe how to use any peptide, and it contains no doses, titration, or efficacy claims. Compounding decisions are made by a licensed prescriber and a licensed pharmacy under current federal and state law. Categories, dates, and effective dates have shifted multiple times in 2025–2026 — always confirm the live status on the FDA 503A bulks page before relying on it for care. Maintained by Charles Kamen, MD.
Compounding Status FAQ
Can BPC-157 be legally compounded in 2026?
As of June 2026, BPC-157 is reported to be no longer on the FDA’s Category 2 "significant safety risk" list, but it was not placed on Category 1 and is not FDA-approved — leaving it in a regulatory gray zone pending the July 2026 advisory-committee review and any later rulemaking. The live FDA 503A list should be verified before relying on it.
Did the FDA "ban" BPC-157?
The FDA placed BPC-157 into Category 2 (effectively off-limits for compounding) in 2023, then is reported to have removed it from Category 2 in April 2026 after the nomination was withdrawn. So the earlier restriction is no longer in force, but that removal is not an approval or an endorsement of safety or efficacy.
Does "removed from Category 2" mean a peptide is now safe and FDA-approved?
No. Removal from Category 2 only ends the prior compounding restriction. It does not make the substance FDA-approved, does not place it on Category 1, and does not constitute an FDA judgment that it is safe or effective. FDA approval requires a separate, far higher bar.
Are the GLP-1s (semaglutide, tirzepatide) a compounding gray zone too?
No — they are FDA-approved drugs, and their compounding was permitted only during official shortages. Those shortages were declared resolved (tirzepatide December 2024, semaglutide February 2025), enforcement discretion has ended, and the FDA has proposed permanently barring bulk compounding of GLP-1 agonists.
What is the difference between 503A Category 1 and Category 2?
Both are interim classifications the FDA uses while it evaluates nominated bulk substances. Category 1 means FDA does not currently intend to act against compounders using the substance, if conditions are met — it may be compounded under 503A while under evaluation. Category 2 means FDA has identified potential significant safety risks and would consider enforcement action — effectively off-limits. Neither is the same as FDA drug approval.
Related reading: Which peptides are FDA-approved? · Peptide evidence-grade index · Is peptide therapy legal in my state?
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