The regulatory landscape surrounding therapeutic peptides has undergone dramatic shifts since 2023. In late 2023, the FDA placed 19 widely discussed peptides—including BPC-157, Ipamorelin, CJC-1295, and TB-500—onto the Bulk Drug Substances Category 2 list, effectively banning compounding pharmacies from preparing them.
### What is the Bulk Drug Substances List?
Under Section 503A of the Federal Food, Drug, and Cosmetic Act, compounding pharmacies are permitted to compound custom medications using bulk drug substances, provided those substances meet specific criteria. The FDA maintains three categories for nominated substances:
- Category 1: Substances under evaluation that do not raise significant safety concerns.
- Category 2: Substances that raise significant safety concerns, effectively restricting them from clinical compounding.
- Category 3: Nominated substances for which there is insufficient data to evaluate.
### The April 2026 Reversal
In a major policy shift, the FDA began removing peptides from Category 2 in early 2026. Following announcements from HHS Secretary RFK Jr. and subsequent FDA action effective April 15, 2026, approximately 12-14 peptides were removed from Category 2 restrictions. These include BPC-157, TB-500, GHK-Cu, CJC-1295, Ipamorelin, Thymosin Alpha-1, AOD-9604, MOTS-C, and others.
These peptides are now under review by the Pharmacy Compounding Advisory Committee (PCAC), with formal hearings scheduled for July 23-24, 2026. The PCAC will evaluate whether these substances should be placed on the 503A Bulks List, which would formally authorize their use in compounding.
### What This Means for Patients and Compounding Pharmacies
The removal from Category 2 signals that the FDA no longer considers these peptides to pose the level of safety concern that justified the original restriction. However, they are not yet formally approved for compounding—the PCAC review process must be completed first. A small number of the original 19 peptides remain restricted pending further evaluation.
Fully approved, prescription-only peptide medications (such as Semaglutide or Sermorelin) remain unaffected by these updates and continue to be legally available via prescription. Patients and clinicians should monitor the July 2026 PCAC meeting outcomes for final determinations.