Nationwide: FDA removes 12 peptides from Category 2, but they're not cleared

Key facts:

• On April 22, 2026, the FDA removed 12 peptides from Category 2 of its 503A bulk drug substances list.
• The removal happened because nominators withdrew their nominations, not a new safety finding.
• Removal does not mean the peptides are eligible for compounding.
• Several go to Pharmacy Compounding Advisory Committee review, with meetings expected through February 2027.

What did the FDA do?

On April 22, 2026, the FDA removed 12 peptide substances from Category 2 of its 503A bulk drug substances list. The list includes BPC-157, LL-37 (Cathelicidin), Dihexa acetate, DSIP (Emideltide), Epitalon, injectable GHK-Cu, KPV, PEG-MGF, Melanotan II, MOTs-C, Semax, and TB-500. You can see the FDA 503A bulk drug substances list.

Does removal mean they're approved for compounding?

No, and this is the part that trips people up. The substances came off Category 2 because the parties who nominated them withdrew their nominations, not because the FDA decided they're safe to compound. Removal does not establish that they meet the criteria for compounding under section 503A. They remain under evaluation.

What happens next?

Several go to the Pharmacy Compounding Advisory Committee for review, with meetings expected through the end of February 2027. The committee gives non-binding recommendations, and the FDA acts after that. Existing 503A rules stay in effect. See the advisory committee meeting page.

What it means for your med spa

Don't read the headline as a green light. Verify each peptide's eligibility under section 503A before sourcing or using it, audit your compounding pharmacy partners, and keep prescriber documentation for patient-specific prescriptions. Watch the advisory committee outcomes through early 2027.

FAQs

Can I use these 12 peptides now?

Not on the basis of this change. Removal from Category 2 is not approval for compounding, and they remain under review.

Why were they removed?

The nominators voluntarily withdrew their nominations. It was not a new safety determination.

Fresh Clinics helps med spa owners stay on top of compounding eligibility and sourcing. Learn more about Fresh Clinics membership.