Compounding
Compounding is when a pharmacist or doctor mixes or changes ingredients to make a medicine for one person's needs, for example a liquid version for someone who cannot swallow tablets. Compounded medicines are not approved by the FDA. The FDA does not check their safety, how well they work, or their quality before they are sold.
For experts
FDA describes compounding as combining, mixing or altering ingredients of a drug to create a medication tailored to an individual patient, performed by a licensed pharmacist, a licensed physician, or, in an outsourcing facility, a person under a pharmacist's supervision. Compounded drugs are not FDA-approved and are not generics: a generic is approved under section 505(j), a compounded drug is not. Quality standards differ by setting, and biological products cannot be compounded under sections 503A or 503B.
Sources (2)
- 01Human Drug CompoundingU.S. Food and Drug Administration · 2026-06-15 · accessed 2026-09-29
- 02Compounding and the FDA: Questions and AnswersU.S. Food and Drug Administration · 2025-09-16 · accessed 2026-09-29