FDA Peptit Yeniden Sınıflandırması 2026: Hangi Peptitler Geri Dönüyor

Summary

On February 27, 2026, HHS Secretary Robert F. Kennedy Jr. announced that approximately 14 of 19 peptides previously restricted under the FDA’s Category 2 list would return to Category 1 status. This reverses a September 2023 decision that effectively banned compounding pharmacies from preparing widely used therapeutic peptides.

What’s Changing

• 14 peptides returning to legal compounding including BPC-157, TB-500, Thymosin Alpha-1, Ipamorelin, Selank, Semax, and GHK-Cu
• 5 peptides likely staying restricted including Melanotan II, GHRP-2, GHRP-6, LL-37, and PEG-MGF
• Category 1 means licensed compounding pharmacies can legally prepare these peptides under physician prescription
• This is NOT FDA approval — no peptide on this list has completed the clinical trial process required for drug approval

Current Status (March 30, 2026)

The FDA has not yet published its formal updated list. Kennedy’s announcement signals what is coming, but compounding pharmacies technically remain unauthorized to compound these substances until the official publication drops.

Check interactions between any of these peptides →

The 19 Peptides: Where They Stand

In September 2023, the FDA moved 19 peptides from Category 1 to Category 2 on its Bulk Drug Substances Under Evaluation list. The stated rationale: “immunogenicity risk, peptide-related impurities, and limited human safety data.”

The impact was immediate. Compounding pharmacies pulled these peptides from their shelves. Clinics that had built practices around peptide therapy lost access to their most prescribed compounds. Patients mid-protocol had their treatments interrupted. The gray market exploded.

Kennedy’s position on the original decision was blunt: “The Category 2 designations effectively created and accelerated the very gray market they were designed to prevent.”

Returning to Category 1 (Legal Compounding)

These peptides are expected to regain compounding eligibility:

Likely Staying Restricted (Category 2)

Five peptides appear likely to remain on the restricted list due to safety concerns, misuse potential, or proximity to existing FDA-approved drug categories: