USP Proposes Recommended Best Practices to Help Ensure Supply Chain Security, Seeks Broad Stakeholder Feedback

US Pharmacopeial Convention (USP) has published a proposed set of recommended best practices developed to help ensure that medicines can be traced back to their original manufacturer, are not adulterated or counterfeited, and are transported to their intended destination with their quality intact. This new standard proposed by USP is not mandatory and is intended to serve as a central guidance document outlining the essential elements of an effective strategy, as indicated in a USP press release. The proposed recommendations focus on four main areas: importation, counterfeit drugs and medical devices, best practices to combat counterfeit drug and medication devices, and diversion and theft. Praveen Tyle, PhD, chief science officer, USP, stated, “USP has developed an initial proposal that we expect to evolve as industry, FDA and others weigh in. Our role as an independent body provides an opportunity to convene all these parties and advance this critical issue.” The proposed chapter is available on the USP Web site. USP notes that the formal proposal will be published in the March-April 2012 issue of Pharmacopeial Forum and that public comments will be accepted via the Forum.