Regulatory
FDA Compounding Category 2
FDA designation for bulk substances that cannot be used in compounded drugs due to safety concerns.
Definition
In 2023, the FDA placed multiple peptides on the Compounding Category 2 list (substances that may not be compounded due to serious safety risks). This effectively restricted U.S. compounding pharmacy sales of BPC-157, CJC-1295, ipamorelin, and several others.
Related terms
Back to the full peptide glossary.