FDA Category 2

A regulatory classification for compounded drugs that the FDA has determined present significant safety risks. As of September 2023, several research peptides (BPC-157, TB-500, ipamorelin, MT-II) were placed in Category 2, restricting their compounding by 503A pharmacies.

What does FDA Category 2 mean in peptide research?

A regulatory classification for compounded drugs that the FDA has determined present significant safety risks. As of September 2023, several research peptides (BPC-157, TB-500, ipamorelin, MT-II) were placed in Category 2, restricting their compounding by 503A pharmacies. This term is part of the broader field of peptide research, which encompasses both FDA-approved therapeutic peptides and research-grade compounds used in scientific investigation.

Why this term matters

Understanding FDA Category 2 is foundational for anyone reviewing peptide research literature, comparing different research compounds, or following regulatory developments in this field. The term appears across pharmacology textbooks, FDA documentation, and clinical trial reports.

Where to learn more

For deeper context, see our peptide research articles:

• What Are Peptides? Comprehensive Introduction
• Research-grade vs Clinical-grade Peptides
• FDA Peptide Regulatory Status 2026
• Full Peptide Glossary Article