Peptide Legal Status Tracker: Where Every Major Peptide Stands With the FDA

Peptide regulatory status changes often enough that most published guidance is wrong within months of writing. This page is our attempt at a maintained reference rather than a snapshot. It reflects the position as of August 9, 2026.

Before the tables, four distinctions that most confusion traces back to.

Four Categories People Routinely Conflate

1. FDA-approved as a drug. Completed clinical trials and formal review for a specific indication. Semaglutide, tirzepatide, tesamorelin, and bremelanotide are here. This is the only tier where efficacy and safety have been formally established.
2. Permitted for compounding. Not approved as a drug, but a pharmacy may lawfully use the bulk substance in patient-specific preparations. Approval and compounding eligibility are entirely different determinations.
3. Restricted (Category 2). Reviewed and found to present significant safety risks; not eligible for compounding.
4. Unaddressed. On neither list. Not prohibited, not permitted. This is a real and under-recognized state, and it is where BPC-157 currently sits.

"Legal" is used loosely across all four. When a clinic says a peptide is legal, ask which of these they mean.

Tier 1 — FDA-Approved Peptide Drugs

Peptide	Brand	Approved for
Semaglutide	Ozempic, Wegovy, Rybelsus	Type 2 diabetes; chronic weight management. Oral form approved for weight loss Dec 2025.
Tirzepatide	Mounjaro, Zepbound	Type 2 diabetes; chronic weight management
Tesamorelin	Egrifta	HIV-associated lipodystrophy
Bremelanotide (PT-141)	Vyleesi	Hypoactive sexual desire disorder in premenopausal women
Octreotide	Sandostatin, Mycapssa	Acromegaly and related conditions

Note: orforglipron (Foundayo), approved April 1, 2026 for chronic weight management, is a small molecule rather than a peptide. It competes in this space but does not belong to this chemical class.

Tier 2 — Awaiting FDA Decision After Favorable Advisory Vote

On July 23-24, 2026, the FDA's Pharmacy Compounding Advisory Committee voted to recommend the following for the 503A permitted list — against the recommendation of FDA staff reviewers. These votes are advisory and non-binding. The FDA has not acted. Legal status has not changed for any of them.

Peptide	Status before the vote	Vote
BPC-157	Removed from Category 2 Apr 22, 2026; on neither list	In favor, 8-6-1 (Jul 23)
KPV	Category 2	In favor (Jul 23)
TB-500 (thymosin beta-4)	Category 2	In favor (Jul 23)
MOTS-c	Not on the permitted list	In favor (Jul 23)
Epitalon	Category 2	In favor (Jul 24)
Semax	Category 2	In favor (Jul 24)
Emideltide	Nominated	Rejected (Jul 24)

Tier 3 — Restricted Under Category 2, No Favorable Vote

These remain on the restricted list and were not part of the July 2026 agenda:

• AOD-9604 — fat loss
• DSIP — sleep
• Follistatin 315 / 344 — myostatin inhibition
• GHK-Cu — skin, hair, anti-aging (note: topical cosmetic use is a separate regulatory question from injectable compounding)
• Selank — anxiolytic, nootropic
• Thymalin — immune modulation
• Thymosin Alpha-1 — immune support
• Dihexa — cognitive
• Melanotan I and II — pigmentation

Tier 4 — Generally Available for Compounding

These were not part of the 2023 reclassification and have generally remained available through licensed compounding pharmacies:

• Sermorelin
• CJC-1295
• Ipamorelin
• Gonadorelin
• GHRP-2 and GHRP-6

Availability still varies by pharmacy and state, and inclusion here is not a clinical endorsement — it is a statement about regulatory posture only.

Special Case — Compounded Semaglutide and Tirzepatide

These are approved drugs, so the question is not whether they are permitted substances but whether copying them is allowed. The answer has narrowed sharply:

• The shortage pathway is closed. All four brands are commercially available, so the exemption that enabled 2023-2025 mass compounding no longer applies.
• 503B is being closed. The FDA proposed removing both from the outsourcing facility bulks list on April 30, 2026. Comments closed June 29, 2026; a final decision is expected in the second half of 2026.
• 503A survives, narrowly. Requires base rather than salt form, patient-specific prescription from an in-state licensed prescriber, appropriate licensure, and a documented clinical reason the commercial product is unsuitable.

How to Use This Page

If a clinic or vendor tells you a peptide's status, check it here first. The most common errors we see in the wild:

• Treating the April 2026 BPC-157 removal from Category 2 as legalization. It was not — it moved to neither list.
• Treating the July 2026 advisory votes as FDA approval. They were recommendations; the FDA has not responded.
• Describing peptides as "FDA approved" when they are at most compoundable. Different tier entirely.
• Quoting compounded GLP-1 pricing as though the shortage pathway were still open.
• Citing semaglutide's 2026 patent expiry as imminent US generic availability. Those expiries were outside the US; domestic generics are expected around 2033-2036.

We update this page as the FDA acts. The next meaningful event is the agency's formal response to the July 2026 recommendations, which may arrive as a full adoption, a conditional adoption with dose or route restrictions, a partial adoption covering some peptides but not others, or no action at all.

Nothing here is legal or medical advice. Compounding rules also vary by state, and a pharmacy's practices in one state may not be lawful in another.