Twelve Peptides Left FDA's Category 2 List. None of Them Became Legal.

If you have shopped for peptides in the last few months, you have probably seen some version of this: BPC-157 is off the FDA's restricted list. It is one of the few pieces of peptide marketing that is built on something real. FDA did change the list, on a specific date, and BPC-157 is no longer on it.

The conclusion drawn from it is backwards.

What changed

October 1 correction: Four peptides remain in the active Category 2 table, including GHRP-2 and GHRP-6; our initial count of two was incomplete. Section 503A also has monograph and approved-drug-component routes, not only the Bulks List. Withdrawal itself establishes none of these.^[1][3]

On April 22, 2026, FDA restructured the page where it publishes safety findings for nominated bulk drug substances. Before that date it was one table. After, it is two.^[1][2]

Twelve peptides moved from the first table to the second:

• BPC-157
• Cathelicidin LL-37
• Dihexa acetate
• Emideltide (DSIP)
• Epitalon
• GHK-Cu (injectable routes only)
• KPV
• Melanotan II
• Mechano growth factor pegylated (PEG-MGF)
• MOTS-c
• Semax (heptapeptide)
• Thymosin beta-4 fragment (TB-500)

The other five substances in the new table — AOD-9604, CJC-1295, ipamorelin acetate, selank acetate, and thymosin alpha-1 — were already in a separate holding area before April and simply got a clearer heading.

Why "removed from Category 2" is not good news for the buyer

Read FDA's own heading for the new table. These substances "were withdrawn by the nominators."^[1]

Nobody at FDA reviewed the safety evidence and decided these peptides were fine. Whoever had asked FDA to consider them stopped asking.

To see why that is worse rather than better, you need the structure underneath, which vendors reliably skip:^[3]

1. A compounding pharmacy can use a bulk drug substance under Section 503A if it meets an applicable USP/NF monograph; otherwise, if it is a component of an FDA-approved drug; otherwise, if it is on the 503A Bulks List. All other statutory conditions still apply.
2. Getting onto it starts with a nomination.
3. While a nomination is pending, FDA sorts substances into interim categories describing how it intends to exercise enforcement discretion in the meantime. Category 2 means: we have found significant safety risks, do not compound this while we work.
4. Withdrawal is not eligibility. For substances without another statutory route, the 503A Bulks List remains the route that requires FDA rulemaking.

So a peptide that leaves Category 2 by withdrawal has not cleared a hurdle. It has left the queue. The withdrawn nomination no longer provides a pending route to inclusion. A later nomination or advisory review is a separate event.

What is still in Category 2

Fourteen substances remain in the active table. Four are peptides:

Ipamorelin is the one substance that appears in both tables at once: its 503A nomination was withdrawn, while its 503B Category 2 placement stands. This is why "ipamorelin was removed from Category 2" is half true and reliably misleading. FDA's stated basis for keeping it there is unchanged and blunt — a published study identified serious adverse events including death when ipamorelin was given intravenously for gastric motility.

The part that confuses everyone

Six of the twelve withdrawn peptides came back three months later.

BPC-157, KPV, TB-500, MOTS-c, Semax, and Epitalon were all on the agenda of FDA's Pharmacy Compounding Advisory Committee meeting on July 23-24, 2026, where the committee voted to recommend all six for the 503A Bulks List — over the objection of FDA's own review team, which had recommended against all seven substances it considered.^[4]

So the sequence for those six peptides in 2026 reads:

1. April: nominations withdrawn, substances leave Category 2.
2. July: substances re-nominated and reviewed; advisory committee recommends inclusion.
3. Today: FDA has published no proposed rule and taken no action. Nothing is on the 503A Bulks List that was not on it in March.

Two separate regulatory events, three months apart, involving the same molecules and pointing in opposite directions. Marketing copy tends to merge them into one story of steady progress toward legality. The record does not support that story.

What is actually true today

How to check this yourself

This is worth doing, because the same trick works on every future version of this story.

• Read the table, not the headline. FDA's page names each substance and which list it sits on. It takes two minutes.
• Check the "content current as of" stamp — then check the content. This is the mistake we made. A stamp tells you when FDA last touched the page. It does not tell you what changed, and an unchanged stamp on a page you have not re-read is not verification. The Internet Archive keeps snapshots of FDA pages; comparing two of them is how this article got written.
• Ask which list. "Category 2," the "503A Bulks List," and the "503B Bulks List" are three different things, and 503A and 503B can disagree about the same substance — as they do for ipamorelin.
• Only the Federal Register changes the law. A committee recommendation is not a proposed rule, a proposed rule is not a final rule, and a final rule is what makes compounding lawful. Everything else is commentary.

For per-substance status, see the legal status tracker. For the July meeting, see the PCAC hub. For the claim this article grew out of, see our correction on the Kennedy reclassification story.

---

References

1. [1]

   U.S. Food and Drug Administration. “Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks.” FDA.gov. 2026. LinkRegulatory document

   The live FDA page, read line by line on August 22, 2026. FDA-stamped content current as of April 22, 2026. Two tables: 'Bulk drug substances under category 2 of the interim policies' (14 substances) and 'Bulk drug substances nominated but withdrawn' (17 substances).

2. [2]

   U.S. Food and Drug Administration (archived by the Internet Archive). “Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — snapshot of April 4, 2026.” Internet Archive Wayback Machine. 2026. LinkRegulatory document

   The same URL eighteen days before the change, stamped content current as of July 8, 2025. Category 2 table holds 26 substances; there is no 'nominated but withdrawn' section. The diff between this and the live page is the evidence for everything in this article.

3. [3]

   U.S. Food and Drug Administration. “Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act.” FDA.gov. 2026. LinkRegulatory document

   FDA's page defining the statutory 503A Bulks List and the interim-policy categories. Content current as of May 14, 2026 when rechecked October 1, 2026. Explains that category placement describes enforcement discretion during evaluation, not statutory eligibility.

4. [4]

   U.S. Food and Drug Administration. “July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee.” FDA.gov. 2026. LinkRegulatory document

   FDA's meeting page for the July 2026 peptide agenda. Six of the twelve withdrawn peptides reappear here as re-nominated substances, which is the main reason coverage of this has been confused.

---

Related content

Tool

Peptide Legal Status Tracker

Per-substance status for every peptide we track, with the FDA source and check date behind each one.

News

The July 2026 PCAC Peptide Vote

What the advisory committee actually recommended, the vote tallies as reported, and why FDA's own reviewers disagreed.

News

Correction: The Kennedy Peptide Reclassification Story

The unverifiable February 2026 announcement this change keeps getting confused with.

News

Understanding Peptide Categories

What Category 1, 2, and 3 mean, and how they differ from the statutory 503A Bulks List.