Regulation desk · FDA compounding categories
FDA Category 1 peptides: which ones are on it and what Category 1 allows
Which peptides are in FDA's 503A Category 1 (GHK-Cu non-injectable, glutathione, VIP), what Category 1 means for pharmacies, and why BPC-157 isn't on it.
The short answer ·
Category 1 is FDA's interim list of nominated bulk substances it is still evaluating, where it generally does not intend to act against 503A compounding if the guidance conditions are met. FDA's list updated May 14, 2026 includes only a few peptides: GHK-Cu (except injectable routes), glutathione, vasoactive intestinal peptide and the dipeptide alanyl-L-glutamine.
BPC-157, TB-500 and the other peptides that left Category 2 in 2026 did not move to Category 1. FDA also stopped placing substances nominated on or after January 7, 2025 into any category.
What Category 1 is
Section 503A lets state-licensed pharmacies compound from a bulk drug substance only if it is a component of an approved drug, has a USP or NF monograph, or is on FDA’s 503A bulks list. The bulks list is built by rulemaking, which is slow. While it works through nominations, FDA uses an interim policy with three categories. FDA’s page describes them:
| Category | FDA’s description | Enforcement posture |
|---|---|---|
| 1 | “May be eligible for inclusion on the 503A bulks list, were nominated with sufficient supporting information for FDA to evaluate them, and do not appear on any other list” | FDA “does not intend to take action against a compounder” using them, if the guidance conditions are met |
| 2 | Raise significant safety risks | FDA may act under its general enforcement policies |
| 3 | Nominated without adequate support | FDA may act under its general enforcement policies |
Category 1 is not approval and not a listing. FDA says Category 1 substances “may continue to be within the scope of the interim enforcement policy … until the agency decides on inclusion of these substances on the 503A bulks list or unless the agency removes the substances from category 1 based on, for example, information about safety risks.”
Which peptides are in Category 1
FDA’s Category 1 list (updated May 14, 2026) has about 50 entries, mostly vitamins, botanicals and small molecules. The peptides and peptide-like entries are:
| Substance | What it is | Note |
|---|---|---|
| GHK-Cu (except for injectable routes of administration) | Copper-binding tripeptide | Removed April 22, 2026; added back after a nominator clarified on May 5, 2026 that it withdrew only the injectable route |
| Glutathione | Tripeptide (glutamate, cysteine, glycine) | |
| Vasoactive intestinal peptide | 28-amino-acid neuropeptide | |
| Alanyl-L-glutamine | Dipeptide |
L-theanine, an amino acid derivative rather than a peptide, is also in Category 1, even though FDA’s advisory committee voted 1-12 against listing it in October 2024 (report). A committee vote does not by itself move a substance between categories.
Which popular peptides are not in Category 1
BPC-157, TB-500, KPV, MOTS-c, Semax, Epitalon, emideltide (DSIP), CJC-1295, AOD-9604, thymosin alpha-1, LL-37, dihexa, Melanotan II, PEG-MGF and injectable GHK-Cu are not in Category 1. FDA lists them among substances “previously in category 2” whose nominations were withdrawn (Category 2 explainer). That table carries no enforcement discretion.
Kisspeptin-10 and ibutamoren are in active 503A Category 2. GHRP-2, GHRP-6, mechano growth factor (MGF), thymulin acetate and cibinetide (ARA-290) are in Category 3.
Why the categories are frozen
FDA’s page says it issued guidance under which it “does not intend to place bulk drug substances nominated on or after January 7, 2025, into these categories.” A peptide nominated today will not get interim Category 1 treatment. Its route to lawful 503A compounding is the bulks list itself, by rulemaking, or whatever enforcement approach FDA adopts in its pending interim access policy (explainer).
The bulks list, for comparison
The actual 503A bulks list, at 21 CFR 216.23(a), has six substances, none of them peptides. See FDA status by peptide for every popular peptide in one table.
Frequently asked questions
Is BPC-157 category 1?
No. As of FDA's May 14, 2026 list, BPC-157 is not in Category 1. It sits in FDA's table of substances previously in Category 2 whose nominations were withdrawn.
Is GHK-Cu category 1?
Only for non-injectable routes. FDA's list says GHK-Cu (except for injectable routes of administration) was removed on April 22, 2026 after nominations were withdrawn, then added back after a nominator clarified on May 5, 2026 that it withdrew only the injectable route.
Does category 1 mean a peptide is FDA approved?
No. Category 1 is an enforcement policy for compounding pharmacies while FDA evaluates a nomination. It is not approval and not a place on the 503A bulks list.
Can new peptides be added to category 1?
FDA's guidance says it does not intend to place bulk drug substances nominated on or after January 7, 2025 into the interim categories. Newer nominations are evaluated for the bulks list without that interim treatment.
Sources
3 linked records- [1] Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (category lists, updated May 14, 2026) U.S. FDA · Primary record
- [2] Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act U.S. FDA (content current as of May 14, 2026) Primary record
- [3] 21 CFR 216.23 eCFR Primary record
This explainer is general information about law and laboratory methods, not legal or medical advice. Amino Wire does not provide dosing information. Spotted an error? See our corrections policy.