Compounded medication
Also called Compounded drug, compounded preparation
A compounded medication is a drug that a licensed pharmacist, a licensed physician or an outsourcing facility prepares by combining, mixing or altering ingredients to meet the needs of an individual patient, rather than one made by a manufacturer as an approved product. The classic reasons are an allergy to an ingredient in the approved version, or a need for a different form, such as a liquid for someone who cannot swallow a tablet.
Compounded medications are not FDA-approved. The FDA does not review them for safety, effectiveness or quality before they reach patients, and a compounded drug is not a generic: a generic is itself FDA-approved after showing it matches the brand, while a compounded drug is not equivalent to or interchangeable with any branded product. Federal law sets out two routes, the patient-specific 503A pharmacy and the 503B outsourcing facility, with different oversight.
Why it matters after 45
Many of the medicines people consider in midlife, including hormone preparations, some weight-loss drugs and several peptides, are offered in compounded form, often by telehealth services. Knowing the term is how you tell what has and has not been reviewed by the FDA, and what a price on a compounded product does and does not imply.
Where it comes up
- What "compounded" meansACT 2's full explanation, the 503A and 503B distinction and the questions worth asking
- Compounded semaglutide vs Wegovyhow a compounded preparation differs from the approved brand
- Compounded vs FDA-approved estradiol creamthe same question for a hormone
- Safety and side effects FAQcommon questions about compounded treatments
References
- U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
- U.S. Food and Drug Administration. Is It Really "FDA Approved"? https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
- U.S. Food and Drug Administration. Human Drug Compounding Laws. https://www.fda.gov/drugs/human-drug-compounding/human-drug-compounding-laws
Definitions here are educational and are not medical advice. They explain what a term means; the pages linked above cover what it means for you, and a clinician reviews your own results. Editorial & medical review policy · All glossary terms