Read from the FDA’s own lists
Category 1 and 2 peptides
The short answer
Category 2 now holds one peptide for pharmacies: Kisspeptin-10.
Category 1, the substances the FDA leaves pharmacies to compound with while it evaluates them, holds 4 peptides: Alanyl-L-glutamine, GHK-Cu, Glutathione and Vasoactive intestinal peptide (VIP).
BPC-157, CJC-1295, TB-500 and 14 other peptides are no longer in Category 2: their nominators withdrew them. That did not put them in Category 1, so it did not make them legal to compound.
FDA category list updated May 14, 2026 (ET) · Category 2 page Apr 22, 2026 (ET) · checked Oct 15, 2026 (ET)
What the categories mean
- Category 1: under evaluation
- The FDA is evaluating the substance for its 503A bulks list and does not intend to take action against a pharmacy compounding with it, if the conditions in its guidance are met.
- Category 2: significant safety risks
- The FDA found significant safety risks and would consider taking action against a compounder using it.
- Category 3: nominated without enough support
- Nominated without enough information for the FDA to evaluate it, and not covered by the Category 1 policy.
A substance in no category, including one whose nomination was withdrawn, has no interim permission either. The FDA stopped sorting new nominations into these categories on January 7, 2025.
Category 1 peptides 4 of 49 substances
- Alanyl-L-glutaminedipeptide · FDA lists it as “Alanyl-L-Glutamine”
- GHK-CuIn limbocopper-bound tripeptide · FDA lists it as “GHK-Cu (except for injectable routes of administration)”
- Glutathionetripeptide
- Vasoactive intestinal peptide (VIP)28-amino-acid peptide · FDA lists it as “Vasoactive Intestinal Peptide”
Also on Category 1 and sold alongside peptides, though not peptides: NAD and NADH.
Category 2 peptides
- Kisspeptin-10Pharmacies (503A)10-amino-acid peptide · added Sep 29, 2023
- GHRP-2Outsourcing facilities (503B)6-amino-acid peptide · added Sep 29, 2023
- GHRP-6Outsourcing facilities (503B)6-amino-acid peptide · added Sep 29, 2023
- IpamorelinOutsourcing facilities (503B)5-amino-acid peptide · added Sep 29, 2023
Also in Category 2 and sold alongside peptides, though not peptides: Ibutamoren (MK-677).
No longer in Category 2: withdrawn by their nominators
The FDA keeps these on its Category 2 page, with the safety concerns it found, under “nominated but withdrawn”. None is in Category 1. Where Peptlas tracks one, its current U.S. status is shown.
- AOD-9604In limboWithdrawn from Category 2 in Sep 2024; PCAC voted 0-12 against the 503A list; not compoundable
- BPC-157In limboPCAC recommended listing (8-6, Jul 23, 2026) - advisory only; still not on the 503A list
- LL-37 (cathelicidin)In limboRemoved from Category 2 Apr 22, 2026, not on the 503A list; PCAC review expected before end of Feb 2027 · FDA lists it as “Cathelicidin LL-37”
- CJC-1295In limboPCAC voted against listing (Dec 2024); off Category 2, not on the 503A list
- Dihexa acetateIn limboRemoved from Category 2 Apr 22, 2026, not on the 503A list; PCAC review expected before end of Feb 2027
- Emideltide (DSIP)In limboPCAC voted against listing (6-7, Jul 24, 2026); not on the 503A list
- EpitalonIn limboPCAC recommended listing (reported 7-4, Jul 24, 2026) - advisory only; still not on the 503A list
- GHK-CuIn limboInjectable removed from Category 2, not on the 503A list; PCAC review expected before end of Feb 2027 · FDA lists it as “GHK-Cu (for injectable routes of administration)”
- IpamorelinIn limboPCAC voted against listing (Oct 2024); off Category 2, not on the 503A list · FDA lists it as “Ipamorelin acetate”
- KPVIn limboPCAC recommended listing (8-6, Jul 23, 2026) - advisory only; still not on the 503A list
- PEG-MGFpegylated IGF-1 splice-variant peptide · FDA lists it as “Mechano growth factor pegylated (PEG-MGF)”
- Melanotan IIIn limboOff Category 2, not on the 503A list; PCAC review expected before end of Feb 2027
- MOTS-cIn limboPCAC recommended listing (7-5, Jul 23, 2026) - advisory only; still not on the 503A list · FDA lists it as “MOTs-C”
- SelankIn limboRemoved from Category 2 (2024); not on the 503A list; no scheduled review · FDA lists it as “Selank acetate (TP-7)”
- SemaxIn limboPCAC recommended listing (8-5, Jul 24, 2026) - advisory only; still not on the 503A list · FDA lists it as “Semax (heptapeptide)”
- Thymosin alpha-1In limboOff Category 2, never in Category 1; PCAC declined Dec 2024 · FDA lists it as “Thymosin-alpha 1 (Ta1)”
- TB-500 (thymosin beta-4 fragment)In limboPCAC recommended listing (8-6, Jul 23, 2026) - advisory only; still not on the 503A list · FDA lists it as “Thymosin beta-4, fragment (LKKTETQ), also known as TB-500”
Category 3 peptides 7 of 311 substances
- Cibinetide (ARA-290)11-amino-acid peptide
- GHRP-26-amino-acid peptide
- GHRP-66-amino-acid peptide
- L-carnosinedipeptide
- Mechano growth factor (MGF)IGF-1 splice-variant peptide
- Secretin (human)27-amino-acid peptide hormone
- Thymulin9-amino-acid peptide
Asked and answered
- What peptides are in Category 2?
- Category 2 now holds one peptide for pharmacies: Kisspeptin-10. For outsourcing facilities (503B), Category 2 also lists GHRP-2, GHRP-6 and Ipamorelin. BPC-157, CJC-1295, TB-500 and 14 other peptides are no longer in Category 2: their nominators withdrew them. That did not put them in Category 1, so it did not make them legal to compound.
- What peptides are in Category 1?
- Category 1, the substances the FDA leaves pharmacies to compound with while it evaluates them, holds 4 peptides: Alanyl-L-glutamine, GHK-Cu, Glutathione and Vasoactive intestinal peptide (VIP). Category 1 means the FDA is evaluating them and does not intend to take action against pharmacies compounding them, if the conditions in its guidance are met.
- Is BPC-157 still a Category 2 peptide?
- No. Its nomination was withdrawn, so the FDA lists it under “nominated but withdrawn” on its Category 2 page, and it is not in Category 1 either. Its U.S. status on Peptlas: In limbo (PCAC recommended listing (8-6, Jul 23, 2026) - advisory only; still not on the 503A list).
- Is TB-500 still a Category 2 peptide?
- No. Its nomination was withdrawn, so the FDA lists it under “nominated but withdrawn” on its Category 2 page, and it is not in Category 1 either. Its U.S. status on Peptlas: In limbo (PCAC recommended listing (8-6, Jul 23, 2026) - advisory only; still not on the 503A list).
- Does leaving Category 2 make a peptide legal?
- No. Only Category 1 substances fall under the FDA’s interim policy for pharmacies. A peptide whose nomination was withdrawn is in no category, so a pharmacy compounding it has no FDA permission to rely on.
Sources
- FDA - 503A Categories Update for May 2026.pdf (updated May 14, 2026)
- FDA - Certain bulk drug substances that may present significant safety risks (Category 2 page, current as of April 22, 2026)
- FDA - Bulk drug substances used in compounding under section 503A
A watcher reads both FDA documents every six hours. When a list changes, a person reviews it and this page is updated. Which substances count as peptides is Peptlas’s own classification.