FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance The following is attributed to Patrizia Cavazzoni, M.D., Acting Director, FDA Center for Drug Evaluation and Research.

 

FDA Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance The following is attributed to Patrizia Cavazzoni, M.D., Acting Director, FDA Center for Drug Evaluation and Research. Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration’s drug compounding program, and we are committed to protecting patients. While compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product, these drugs have not been reviewed by the FDA for safety, effectiveness or quality. The FDA through its oversight of compounded drugs strives to help improve the quality of compounded drugs and reduce risk to patients. Under federal law, a drug is considered adulterated if it is prepared, packed or held under insanitary conditions that could cause the drug to become contaminated with filth or rendered injurious to health. While some compounders work hard to meet quality standards, too often, FDA investigators continue to...