FDA table of bulk drug substances nominated for compounding and subsequently withdrawn
U.S. Food and Drug AdministrationFDA compounding communications
- Objective
- To record FDA's published compounding position.
- Endpoint investigated
- Compounding classification
Listed on the withdrawn-nominations table. FDA's published concerns reference serious adverse events reported in association with CJC-1295, including increased heart rate and systemic vasodilatory reaction. The entry does not distinguish DAC from non-DAC forms.
Limitations. FDA's entry does not resolve which chemical form a given commercial product is. Identity still has to be checked by formula on a certificate.
FDA — Certain bulk drug substances for use in compounding may present significant safety risksReviewed 12 September 2026
