Peptide rules

Peptide rules: what FDA's compounding list says, peptide by peptide

Short answer

FDA keeps a list of bulk drug substances that compounding pharmacies may use while it reviews them, updated May 14, 2026. Popular peptides such as BPC-157, TB-500 and KPV are not on it: their nominations were withdrawn. An FDA advisory committee discussed adding several back in July 2026, but FDA has not issued a final rule.

FDA list checked May 14, 2026Page checked September 26, 2026

Every peptide we track

Where each peptide stands on FDA's 503A compounding list, updated May 14, 2026. Tap a name for the full page, with sources and what it means if you're looking for a clinician.

Peptides tracked on FDA's 503A compounding lists
PeptideFDA list statusJuly 2026 review
AOD-9604
Nominated, then withdrawn: not in any category
 
BPC-157
Nominated, then withdrawn: not in any category
Reviewed by FDA's advisory committee, July 23, 2026
CJC-1295
Nominated, then withdrawn: not in any category
 
DSIP
Nominated, then withdrawn: not in any category
Reviewed by FDA's advisory committee, July 24, 2026
Epitalon
Nominated, then withdrawn: not in any category
Reviewed by FDA's advisory committee, July 24, 2026
GHK-Cu
Category 1: may be used while FDA reviews it
 
GHRP-2
Category 3: not enough information for FDA to review
 
GHRP-6
Category 3: not enough information for FDA to review
 
Ipamorelin
Nominated, then withdrawn: not in any category
 
Kisspeptin-10
Category 2: significant safety risks
 
KPV
Nominated, then withdrawn: not in any category
Reviewed by FDA's advisory committee, July 23, 2026
MOTS-c
Nominated, then withdrawn: not in any category
Reviewed by FDA's advisory committee, July 23, 2026
Selank
Nominated, then withdrawn: not in any category
 
Semax
Nominated, then withdrawn: not in any category
Reviewed by FDA's advisory committee, July 24, 2026
TB-500
Nominated, then withdrawn: not in any category
Reviewed by FDA's advisory committee, July 23, 2026
Thymosin alpha-1
Nominated, then withdrawn: not in any category
 

What the categories mean

  • Category 1

    FDA's list, updated May 14, 2026, puts two peptides in Category 1: GHK-Cu (for uses other than injection) and vasoactive intestinal peptide. FDA took GHK-Cu off on April 22, 2026, then put it back for non-injection uses after one nominator said it meant to withdraw only the injectable form. FDA says it intends to ask its Pharmacy Compounding Advisory Committee about GHK-Cu before the end of February 2027.

  • Category 2

    Among peptides, FDA's Category 2 (significant safety risks) lists kisspeptin-10.

  • Category 3

    These peptides are in Category 3, meaning they were nominated without enough information for FDA to review them: GHRP-2, GHRP-6, mechano growth factor (MGF), cibinetide (ARA-290) and thymulin acetate.

  • Nominated, then withdrawn

    FDA had placed these peptides in Category 2 (significant safety risks). The people who nominated them then withdrew the nominations, so FDA lists them as nominated but withdrawn, and they do not appear in any category on FDA's May 14, 2026 list. (GHK-Cu here means the injectable form.)

FDA's full list, updated May 14, 2026

The July 2026 advisory committee meeting

On July 23 and 24, 2026, FDA's Pharmacy Compounding Advisory Committee met to discuss adding BPC-157, KPV, TB-500, MOTS-c, emideltide (DSIP), Semax and Epitalon to the list of ingredients pharmacies may use. FDA's meeting page, last updated August 6, 2026, does not post a result. Source

The National Community Pharmacists Association reported on July 31, 2026 that the committee voted to recommend BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax, and voted against emideltide (DSIP). It also reported that the votes are advice, not binding on FDA, that the Secretary of Health and Human Services must still approve any addition, and that pharmacies may not compound these peptides until a final rule is in place. NCPA, July 31, 2026

What this means if you're looking for a clinician

Ask which peptides a clinic prescribes, whether each one is FDA-approved or compounded, and which state-licensed pharmacy fills it. Rules can change, so check the linked FDA pages yourself.

Find a licensed clinician for my state Online peptide doctors

Frequently asked questions

Where does this list come from?

FDA's list of bulk drug substances nominated for use in pharmacy compounding under section 503A, updated May 14, 2026, plus FDA's own withdrawn-nominations page and its July 2026 advisory committee meeting page.

What does it mean if a peptide is not on FDA's list at all?

Some peptides were nominated, then the nomination was withdrawn, so they are not in Category 1, 2 or 3. That is different from being approved or banned: a compounding pharmacy compounding it would not be relying on this particular FDA review process.

Has FDA made a final decision on the peptides discussed in July 2026?

Not on the FDA pages we checked on September 26, 2026. The votes are advice to FDA, not binding, and FDA has not issued a final rule.

Do these rules apply to FDA-approved peptide drugs like Wegovy?

No. FDA-approved drugs go through a separate approval process. This page is only about bulk peptide ingredients that pharmacies compound (custom-make) for a specific patient.

This page explains public FDA information in plain words. It is not legal or medical advice.