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Global, common approach to pharmaceutical supply chain integrity the focus of workshop
Date:4/17/2012

Rockville, Md., April 17, 2012 The increasing globalization of the drug supply presents a host of public health challenges: theft and diversion of medicines, growth of illegal Internet pharmacies and insertion of adulterated medicines or ingredients into the supply chain. As pharmaceutical companies, regulatory authorities, lawmakers, healthcare practitioners and others continue to determine the best approaches to securing increasingly complex supply chains and protecting patients from potentially dangerous products, the U.S. Pharmacopeial Convention (USP) is convening a Supply Chain Integrity Workshop, May 22-23 in Rockville, Md., to consider key issues and solicit feedback on its newly proposed informational standard.

"The issues surrounding pharmaceutical supply chain integrity are not theoretical. On the contrary, they are very real, as evidenced by the discovery of counterfeit Avastin in various U.S. medical clinics in February and April," said Praveen Tyle, Ph.D., executive vice president and chief science officer for USP. "Legislative proposals circulating in Congress, continuing debate over product- versus lot-level tracking, gray markets growing in the face of drug shortages and other circumstances are converging, making it clear that the status quo is no longer adequate. Through this workshop, we hope to bring the different and sometimes disparate stakeholders together to find some common ground in addressing these difficult topics and to help determine a path forward on an overall approach to supply chain integrity."

Supply chain integrity involves minimizing risks that arise anywhere along the supply chain. As current approaches vary based on individual companies, and present guidelines consider specific aspects of this issue but not supply chain integrity as a whole, USP is encouraging comprehensive public standards through its proposed informational standard contained in the draft General Chapter <1083> Good Distribution Practi
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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