What Changed for Peptides in 2026

This page summarizes public reporting as of September 2026. Rules are still changing. It is not legal advice.

Background: Category 1 and Category 2

US pharmacies that compound drugs for individual patients (under section 503A of the Food, Drug, and Cosmetic Act) may use certain bulk substances that are not in an approved drug. The FDA sorts nominated substances into categories while it reviews them. Category 1 substances can generally be compounded during review. Category 2 means the FDA has flagged significant safety concerns, and pharmacies should not compound them. In 2023 the FDA placed a group of popular peptides, including BPC-157 and TB-500, in Category 2.

Timeline

• February 27, 2026. HHS Secretary Robert F. Kennedy Jr. said publicly that about 14 of the 19 restricted peptides were expected to return to a legal compounding pathway.
• April 15, 2026. The FDA announced it would remove 12 peptides from Category 2 after the original nominations were withdrawn. The removal took effect after a seven-day notice period.
• July 23–24, 2026. The FDA's Pharmacy Compounding Advisory Committee reviewed seven of them: BPC-157, KPV, TB-500, MOTS-c, emideltide (DSIP), Semax and Epitalon. It was reported to have voted 8–6 to recommend adding BPC-157 and KPV to the list of substances pharmacies may compound, for specific uses.
• Before February 2027. Five more are scheduled for committee review: cathelicidin LL-37, dihexa acetate, injectable GHK-Cu, PEG-MGF and melanotan II.

What removal does not mean

Coming off Category 2 does not make a peptide FDA-approved, and it does not by itself make it eligible for compounding. The FDA has said the status of these substances is still under evaluation. Until a final decision, many sit in a gray zone. Products sold online as "research chemicals, not for human use" remain outside the pharmacy system entirely.

GLP-1 medicines

Semaglutide and tirzepatide are FDA-approved drugs; their shortages were declared resolved in 2025 and late 2024 respectively, which narrowed when pharmacies may compound them. Retatrutide has reported strong phase 3 results but is not approved.

How this site handles it

PeptideCalc does arithmetic. It does not sell peptides, recommend doses or tell you whether a product is legal where you live. We update this page when the rules change; the date at the top shows the last review.