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A substance in no category, including one whose nomination was withdrawn, has no interim permission either.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No longer in Category 2: withdrawn by their nominators

The FDA keeps these on its Category 2 page, with the safety concerns it found, under “nominated but withdrawn”.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

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.