Compounded drug

A compounded drug is prepared by a licensed pharmacy or an outsourcing facility rather than manufactured under an FDA approval. Compounding is lawful in defined circumstances and is a real part of medical practice; a compounded preparation is nonetheless not an approved drug.

The consequence is stated on every page of this site: compounded drugs are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, or manufacturing quality. Lawful and reviewed are different properties, and a molecule can hold the first without the second.

Compoundable in this index today

Five of the 40 molecules this index covers are filed as compoundable under section 503A: a pharmacy may prepare them for an individual patient with a valid prescription.

• SermorelinGH secretagogues · Subcutaneous injection
• NAD+Mitochondrial · Injection; IV infusion
• GlutathioneMitochondrial · Injection; IV infusion
• GHK-CuRepair peptides · Topical (cosmetic); injectable has no lawful route
• Vasoactive intestinal peptideGut peptides · Compounded preparation only; there is no approved product

Approved products are filed separately; a compounded version of an approved drug is restricted, not permitted by default.

Where this term is used