Salvatore Dileo, RPh, Director of Pharmacy, Westmed Medical Group in New York, discusses the differences between compounded medications versus FDA-approved drugs.

Compounded drugs can serve an important medical need for patients, but they do not have the same safety, quality, and effectiveness assurances as approved drugs. Unnecessary use of compounded drugs can expose patients to potentially serious health risks.

Compounded drugs are not FDA-approved, which means that FDA does not verify the safety or effectiveness of these medications. Consumers and health professionals rely on the drug approval process for verification of safety, effectiveness, and quality. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed.

The FDA encourages health care professionals to report adverse events and product quality defects associated with compounded drugs to FDA’s MedWatch Adverse Event Reporting program: Complete and submit the report online at

For more information drug compounding including FDA resources, visit the CheckRare drug compounding page.