In its next cycle, the Packaging, Storage, and Distribution Expert Committee of the United States Pharmacopeia (USP) will be addressing some of the challenges the pharmaceutical industry is facing in terms of supply-chain management, testing for extractables and leachables, and testing of glass, plastic, and metal container closure systems. The 2010–2015 committee will be led by chair Mary Foster, Pharm.D., vice president of quality for Catalent Pharma Solutions. “There are no written standards yet by FDA or USP in areas such as anti-counterfeiting, technologies for track and trace, supply chain security and risk mitigation practices, as well as for extractables and leachables testing. This USP Expert Committee will take on the challenge of [issuing] collaborative global decisions for new chapters that will provide guidance in these areas,” she explains. “Companies not already working in these areas will have to be prepared to make critical changes to their processes to ensur