Regulation · 9 min read · Published September 8, 2026

FDA Peptide Status in 2026: The Category 2 Removals, the July Votes, and What Actually Changed

A dated tracker of where BPC-157, TB-500, KPV, MOTS-c, Epitalon, Semax and DSIP stand with the FDA after the April 2026 list change and the July 23 to 24 advisory committee votes, with links to every source document.

Are peptides like BPC-157 legal in the US in 2026?

BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax are not FDA-approved. On July 23 and 24, 2026 an FDA advisory committee voted to recommend them for the 503A compounding list, against FDA staff advice. The vote is non-binding. Until the FDA finalizes rulemaking, none can be legally compounded, and vials sold 'for research' remain unapproved drugs.

That is the whole story in five sentences, and it is worth holding onto because most of what ranks for these searches is written by clinics and vendors with a commercial stake in the answer. What follows is the timeline, the vote-by-vote results, what each category actually means, and what would have to happen next. Every claim links to the FDA's own pages or to reporting that quotes them.

What the 503A bulk list and 'Category 2' mean

Compounding pharmacies operating under section 503A of the Food, Drug and Cosmetic Act can only use bulk drug substances that are the subject of an approved drug, appear in an official pharmacopeia monograph, or sit on the FDA's 503A Bulks List. Substances nominated for that list are sorted into interim categories while the FDA evaluates them. Category 1 substances may be compounded while under review. Category 2 substances have raised significant safety concerns and may not be compounded. In September 2023 the FDA placed BPC-157 and a group of other peptides into Category 2, which is what pushed them out of many clinics and telehealth programs.

The FDA's 503A bulk drug substances page is the primary reference for all of this.

What happened in April 2026

In April 2026 the FDA announced the removal of a group of peptides from Category 2 after the original nominations were withdrawn, with the changes taking effect between April 15 and 23, 2026. Removal from Category 2 does not authorize compounding; it returns the substances to unreviewed status pending new nominations and an advisory committee review.

Law-firm summaries at the time listed twelve substances. Published lists disagree on two of the twelve (some name PEG-MGF, others MK-677), so we list only the ones every source agrees on: BPC-157, TB-500, KPV, and the peptides that then went to the July meeting. See the Orrick summary, FDA Announces Removal of 12 Peptides from Category 2 and Schedules PCAC Meetings, and the April 2026 FDA Law Blog coverage.

What did the FDA peptide panel vote in July 2026?

At its July 23 to 24, 2026 meeting the Pharmacy Compounding Advisory Committee voted 8 to 6 to recommend BPC-157, KPV and TB-500 for the 503A bulk list, 7 to 5 for MOTS-c, and yes on Epitalon and Semax. It voted no on DSIP (emideltide). FDA staff briefing documents had recommended against every nominee.

The meeting page and briefing documents are on the FDA site: July 23 to 24, 2026 PCAC meeting. The BPC-157 briefing document (FDA media 193343) is worth reading in full: FDA reviewers found no adequate human clinical data and reported market products whose certificates of analysis did not match the labeled substance.

What this does not mean

• It does not mean any of these peptides is approved, safe, or effective. Advisory committees vote on whether a substance should be eligible for compounding; they do not review products or set doses.
• It does not mean a clinic can compound them today. The FDA must go through rulemaking to add substances to the 503A Bulks List, a process that has historically taken years.
• It does not change the status of vials sold online. A product labeled 'for research use only' is an unapproved drug the moment it is sold for human use, and that labeling is a marketing device, not a legal category (see Johns Hopkins on how the FDA regulates peptides and Healthline on peptide legality).
• It does not create human evidence. The evidence base for BPC-157 in people is still one uncontrolled 12-patient case series, per a 2025 systematic review.

What would have to happen next

1. The FDA decides whether to accept or reject the committee's recommendations. It is not bound by them.
2. If it accepts any, it proposes a rule adding the substance to the 503A Bulks List, opens a comment period, and issues a final rule.
3. Compounding pharmacies could then prepare the substance for individual prescriptions. Even then it would not be an approved drug with a label, a standard dose, or manufacturer liability.

We will update this page and its dateModified stamp when any of those steps occurs. The change log is at the bottom.

Which peptides are FDA-approved in 2026?

Approved peptide drugs include semaglutide (Ozempic, Wegovy, the Wegovy pill), tirzepatide (Mounjaro, Zepbound), liraglutide, teriparatide, and, newly, orforglipron (Foundayo, April 2026, a small molecule rather than a peptide), elamipretide (Forzinity, September 2025, for Barth syndrome only) and navepegritide (Yuviwel, February 2026, for achondroplasia). None of the compounding-list peptides above is on that list.

For the full list with evidence grades, filter the compound database by FDA status, or read the profiles for orforglipron, elamipretide and navepegritide.

Change log

• September 8, 2026: first published. Covers the April 2026 Category 2 removals and the July 23 to 24, 2026 PCAC votes.