FDA Seeks Feedback on Drug Compounding Hurdles, Opportunities

The FDA is seeking to better understand the challenges and opportunities drug compounders face when making copycat medicines, following the agency’s findings of safety and quality problems during inspections of outsourcing facilities.

The agency said Wednesday in the Federal Register that it submitted to the Office of Management and Budget a proposed collection of information to support the Food and Drug Administration’s research about challenges pertaining to human prescription drug compounding by outsourcing facilities.

Drug compounding is the practice of combining, mixing, or altering ingredients of a drug to create a medication tailored to an individual patient’s needs. The practice ...