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A compounded medication is a custom-made medicine prepared for a specific patient. A pharmacist or clinician can make it by combining, mixing, altering, or re-forming ingredients. Compounded medications can be used when an FDA-approved product is not suitable for a patient's needs. They are not FDA-approved, so the FDA does not verify safety, effectiveness, or quality before use.
read more about compounded medication ...Compounding changes a medicine or ingredients into a form that matches an individual prescription. A pharmacy might make a different strength, remove an inactive ingredient, create a liquid, or combine compatible ingredients when appropriate. The final product is made for the patient named in the prescription. Because the medicine is custom prepared, instructions and quality controls can differ from standard manufactured products.
Compounded medications can be used when a patient cannot tolerate an ingredient in a commercial product, needs a different dosage form, or needs a strength that is not commercially available. They can also be used when a medicine is temporarily unavailable or when a child or pet needs a more usable form. Compounding should be based on a legitimate medical need. It should not be used simply to copy an available FDA-approved drug without a valid reason.
FDA-approved drugs go through FDA review for safety, effectiveness, quality, labeling, and manufacturing standards. Compounded medications do not go through that same approval process. This means the prescriber, pharmacist, and patient need to discuss why compounding is needed and what risks apply. A compounded medication can be useful, but it carries different quality and safety considerations.
Compounded medications can carry risks such as incorrect strength, contamination, dosing mistakes, or ingredient problems. Patients should use licensed pharmacies and avoid products from questionable online sellers. Ask the prescriber or pharmacist how to take the medicine, how to store it, and when to discard it. Report unexpected side effects, lack of response, allergic symptoms, or dosing confusion promptly.
No, compounded medications are not FDA-approved. The FDA does not verify their safety, effectiveness, or quality before they are given to patients.
A patient might need one because of an allergy, swallowing problem, unavailable strength, or need for a different dosage form. The reason should be tied to a specific medical need.
No, a generic drug is FDA-approved and compared with a reference drug. A compounded medication is custom made and does not go through the same FDA approval process.
Yes, compounded medications can cause side effects, allergic reactions, or dosing problems. Contact the prescriber or pharmacist if symptoms are unexpected or concerning.
Compounding and the FDA: Questions and Answers. U.S. Food & Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers. Date Accessed June 3, 2026.
Understanding the Risks of Compounded Drugs. U.S. Food & Drug Administration. https://www.fda.gov/drugs/human-drug-compounding/understanding-risks-compounded-drugs. Date Accessed June 3, 2026.
An Overview of Compounding. NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK562881/. Date Accessed June 3, 2026.
Clinical and Legal Considerations in Pharmaceutical Compounding. PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC10453396/. Date Accessed June 3, 2026.
Compounding. U.S. Pharmacopeia. https://www.usp.org/compounding. Date Accessed June 3, 2026.