FDA Category 2 Peptides in 2026: Status by Compound and the April 22 List Changes

The FDA Category 2 peptides list in 2026 holds four peptides: ipamorelin acetate (503B), kisspeptin-10 (503A), GHRP-2 (503B) and GHRP-6 (503B), each with a date added of September 29, 2023. A second table on the same FDA page, headed "Bulk drug substances nominated but withdrawn", holds 17 entries that were previously in Category 2, among them BPC-157, TB-500 (as the fragment LKKTETQ), CJC-1295, emideltide (DSIP), epitalon, KPV and MOTs-C. This page is a dated ledger of those FDA documents: anchored rows for 21 peptides Pepta Labs lists, the entry name exactly as FDA writes it, and the status on each document, all checked on September 24, 2026.

What is the status of each listed compound, row by row?

Fourteen peptides that Pepta Labs lists appear on the FDA significant-safety-risks page: 13 only in its nominated-but-withdrawn table and one, ipamorelin acetate, in both that table and the Category 2 table. Each row below has its own anchor (for example #bpc-157), so a guide or product page can link straight to one compound. A dash means the compound is not named on that document.

Six other peptide or peptide-derived entries on the same FDA page name compounds Pepta Labs does not list. Cathelicidin LL-37, dihexa acetate and PEG-MGF sit in the nominated-but-withdrawn table. Kisspeptin-10 (503A), GHRP-2 (503B, for the specific entries FDA names) and GHRP-6 (503B) sit in the Category 2 table, each with a date added of September 29, 2023; kisspeptin-10 is also in Category 2 of the May 14, 2026 503A list, and GHRP-2 and GHRP-6 are in Category 2 of the March 21, 2025 503B list.

Where do other peptides Pepta Labs lists appear on the category lists?

Several listed peptides are absent from the significant-safety-risks page but appear on the 503A or 503B category list, and two in the table below, tesamorelin and PT-141, are named on none of the three documents.

Neither tesamorelin nor PT-141 appears in either table of the April 22, 2026 significant-safety-risks page. SS-31, Melanotan-I, SNAP-8, FOXO4-DRI, Livagen, N-acetyl Semax amidate and N-acetyl Selank amidate were not found by name on any of the three documents either.

What are the FDA 503A and 503B category lists?

The FDA 503A and 503B category lists are two FDA documents that sort bulk substances nominated for pharmacy compounding into three categories while FDA evaluates each one for the 503A or 503B bulks list. The 503A document is titled "Bulk Drug Substances Nominated ... Under Section 503A" and is updated May 14, 2026; the 503B document carries the same title for section 503B and is updated March 21, 2025.

• Category 1: bulk substances under evaluation by FDA.
• Category 2: substances FDA identified as raising significant safety risks for compounding.
• Category 3: substances nominated without the information FDA needs to evaluate them.

The 503A lists apply to compounding by state-licensed pharmacies and physicians under section 503A of the FD&C Act. The 503B lists apply to compounding by outsourcing facilities registered with FDA under section 503B. Both lists concern compounding; Pepta Labs sells its listings as chemical reference materials labelled research use only, and the labelling facts are recorded on the legal status of research peptides page.

FDA keeps a third document, a compounding page on bulk substances that may present significant safety risks. Its content is current as of April 22, 2026, and it has two tables: "Bulk drug substances under category 2 of the interim policies", with 14 entries of which four are peptides, and "Bulk drug substances nominated but withdrawn", with 17 entries. The page prints a date added for each entry in the Category 2 table; the withdrawn table prints names only, beside FDA's safety-risk text for each.

Which listed peptides hold Category 1, 2 or 3?

Category 1 means FDA is still evaluating a nominated substance for a bulks list; Category 2 means FDA identified significant safety risks for compounding with it. The table sorts the peptides Pepta Labs lists by the category each one holds on the current lists.

Which names does the FDA give listed compounds?

The entry names on the FDA documents often differ from the names on research listings: FDA may give a nonproprietary name, a salt form, a code or a different spelling. The mapping below pairs each FDA entry with the Pepta Labs listing name and, based on the sequence recorded on the listing, states where the two names do or do not describe the same sequence.

Registry identifiers for these compounds (CAS, PubChem CID, UNII, formula and molecular weight) are collected on the CAS numbers and molecular weights reference, and cases where registries disagree are on the registry discrepancies page. What a research peptide is, and how these reference materials are documented, is set out in what research peptides are.

What changed on the FDA pages on April 22, 2026?

The FDA significant-safety-risks page whose content is current as of April 22, 2026 lists 17 entries as nominated but withdrawn, entries that FDA describes as previously in Category 2 of the interim policies and withdrawn by their nominators. The dated facts from the three documents are these:

• September 29, 2023: the date added that FDA prints for all four peptides still in the Category 2 table: ipamorelin acetate, kisspeptin-10, GHRP-2 and GHRP-6.
• April 22, 2026: the content date of the significant-safety-risks page, which shows 17 entries in the withdrawn table and 14 in the Category 2 table. Ipamorelin acetate is the one entry in both; FDA notes it is still in Category 2 under the 503B interim policy.
• April 22, 2026: per the 503A list, a GHK-Cu entry was removed from 503A Category 1 on this date because its nominations were withdrawn.
• May 5, 2026: per the 503A list, one nominator clarified that it had withdrawn only part of its GHK-Cu nomination.
• May 14, 2026: the 503A list update returns that GHK-Cu entry to Category 1 and states that FDA intends to consult the Pharmacy Compounding Advisory Committee on GHK-Cu before the end of February 2027.

The withdrawn table on the FDA page dated April 22, 2026 names 17 entries: AOD-9604, BPC-157, cathelicidin LL-37, CJC-1295, dihexa acetate, emideltide (DSIP), epitalon, one GHK-Cu entry, ipamorelin acetate, KPV, PEG-MGF, Melanotan II, MOTs-C, selank acetate (TP-7), Semax (heptapeptide), thymosin-alpha 1 (Ta1) and the thymosin beta-4 fragment (LKKTETQ) known as TB-500.

Frequently asked questions

Is BPC-157 still on the FDA Category 2 list?

No. On the FDA significant-safety-risks page dated April 22, 2026, BPC-157 is in the table of bulk substances nominated but withdrawn, not in the Category 2 table, and it is on neither the May 14, 2026 503A category list nor the March 21, 2025 503B category list (checked September 24, 2026).

What is the difference between Category 1 and Category 2?

Category 1 holds nominated bulk substances that FDA is evaluating for the 503A or 503B bulks list, and Category 2 holds substances FDA identified as raising significant safety risks for compounding. Among peptides Pepta Labs lists, one GHK-Cu entry, glutathione, VIP and sermorelin acetate are in Category 1, and ipamorelin acetate (503B) is in Category 2.

What does 'nominated but withdrawn' mean on the FDA page?

It is the heading of a table on the FDA significant-safety-risks page dated April 22, 2026, which FDA describes as bulk substances previously in Category 2 of the interim policies whose nominations were withdrawn by the nominators. An entry there is no longer in the Category 2 table, and FDA keeps its safety-risk text beside the name.

Under which names does the FDA list DSIP, epitalon and TB-500?

The FDA page dated April 22, 2026 writes DSIP as "Emideltide (DSIP)", epithalon as "Epitalon", and TB-500 as "Thymosin beta-4, fragment (LKKTETQ), also known as TB-500". The FDA TB-500 entry names the seven-residue fragment, while the Pepta Labs TB-500 listing records the full 43-residue thymosin beta-4 sequence.

When were the FDA category lists last updated?

As checked on September 24, 2026, the 503A category list was updated May 14, 2026, the significant-safety-risks page carries content current as of April 22, 2026, and the 503B category list was updated March 21, 2025.

Did the July 2026 PCAC meeting change any list?

Not on the FDA documents checked on September 24, 2026: the 503A list is still dated May 14, 2026, the significant-safety-risks page April 22, 2026 and the 503B list March 21, 2025, all earlier than the Pharmacy Compounding Advisory Committee meeting of July 23-24, 2026. The meeting agenda is recorded on the research peptide legal status page.

Sources

• FDA, "Certain Bulk Drug Substances ... Significant Safety Risks", content current as of April 22, 2026 (fda.gov), both tables.
• FDA, 503A category list ("Bulk Drug Substances Nominated ... Under Section 503A"), updated May 14, 2026.
• FDA, 503B category list ("Bulk Drug Substances Nominated ... Under Section 503B"), updated March 21, 2025.
• Pepta Labs listing records for sequence and CAS values, as shown on each linked listing.

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