FDA Category 2 Peptides: Full List & What It Means for 2026

In September 2023, the FDA placed 17 peptides on its "Category 2" list under the interim policy for bulk drug substances used in compounding. This single regulatory action reshaped the entire research peptide market. Here's what Category 2 means, which compounds are affected, and what it means for researchers in 2026.

What Is Category 2?

The FDA categorizes bulk drug substances used by compounding pharmacies into three categories under its interim policy:

Category 1: Substances that may be used in compounding under section 503A/503B of the FD&C Act. These are permitted for pharmacy compounding.

Category 2: Substances for which the FDA has identified a significant safety risk, lack of adequate published safety/efficacy data, or other concerns. Compounding pharmacies are prohibited from using these substances.

Category 3: Substances under active FDA evaluation. Their status may change to Category 1 or 2 after review.

Complete Category 2 Peptide List

What Category 2 Prohibits (and Doesn't Prohibit)

What it prohibits: Compounding pharmacies (both 503A patient-specific and 503B outsourcing facilities) from compounding these substances into patient formulations. A doctor cannot write a prescription for BPC-157 and have it filled at a compounding pharmacy.

What it does not prohibit: The sale of these compounds as chemical reference materials for in-vitro laboratory research. Research chemical suppliers that maintain proper RUO labeling, make no therapeutic claims, and do not position products for human use operate in a different regulatory category than compounding pharmacies.

The 2024–2026 Enforcement Wave

Category 2 was the starting gun for broader FDA enforcement against the peptide industry. In the 30 months since the September 2023 listing, the FDA has issued 50+ warning letters to GLP-1 compounders (September 2025), raided Amino Asylum's warehouse (June 2025), and worked with the ITC to issue exclusion orders against tirzepatide importers. Multiple major vendors — including Peptide Sciences and Science.bio — have shut down.

The pattern is clear: vendors that made therapeutic claims, sold compounds with human-use positioning, or lacked compliance infrastructure were targeted. Vendors that maintained strict RUO labeling and transparent operations continue to operate.

TB-500 and BPC-157 FDA Status in 2026

As of April 2026, neither compound has been reclassified. Both remain on Category 2. No clinical trials for either compound are registered on ClinicalTrials.gov.

Research Availability

Pepta Labs carries 15 of the 17 Category 2 compounds as research chemical reference materials. All are labeled "Research Use Only — Not for Human or Animal Consumption." Every batch is third-party tested at ≥99% HPLC purity with COA available upon request. We now accept credit and debit cards.