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Proposed standard offers best practices to help ensure pharmaceutical supply chain integrity
Date:1/4/2012

ality, and purity of medicines and their ingredients, published in the United States PharmacopeiaNational Formulary (USPNF). USP's official standards named in the adulteration and misbranding sections of the Federal food and drug laws are legally enforceable by the FDA, and are also used around the world in a variety of ways. In addition to including quality specifications for individual medicines and ingredients, USPNF encompasses general chapters that either contain tests or other information that apply to multiple medicines or ingredients (often enforceable), or provide guidance on a various topics affecting medicines quality (informational). The latter are not legally enforceable but are often widely used domestically and internationally.

USP envisions the general chapter will be of use to all organizations and individuals involved in the global supply chain, including manufacturers; transportation companies involved in automobile, truck, rail, sea and air services; third-party logistics providers, freight forwarders and consolidators; brokers, importers and exporters; packaging and repackaging operations; wholesalers and distributors; retail, mail-order, hospital, nursing home and other pharmacies; and mail distributors including the U.S. Postal Service and other expedited shipping services. The proposed chapter is available on the USP website at http://www.usp.org/USPNF/notices/generalChapter1083.html. The formal proposal will be published in Pharmacopeial Forum 38(2), MarchApril 2012. This is the vehicle (which is freely and publicly available online) through which USP accepts public comment on its standards.

The draft general chapter and comments submitted to USP will be a central topic of a Supply Chain Integrity Workshop that USP is convening May 22-23, 2012, in Rockville, Md. This will be a further opportunity to provide input, including whether additional informatio
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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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