[DRUG COMPOUNDING]: FDA's Human Drug Compounding Progress Report

Today, FDA issued a document titled, “FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act.”

This report provides a brief overview of the history of drug compounding regulation, as well as FDA’s regulatory oversight of drug compounders, implementation of the compounding provisions of federal law, and state and stakeholder collaboration since enactment of the Drug Quality and Security Act on November 27, 2013. It also discusses the need for ongoing efforts to protect patients from the risks associated with compounded drug products that are not produced in accordance with applicable requirements of federal law, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.

FDA's website has more information on human drug compounding.