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Proposed standard offers best practices to help ensure pharmaceutical supply chain integrity

Rockville, Md., January 4, 2012 As the pharmaceutical industry continues to globalize, the challenges of securing complex supply chains and protecting patients from counterfeit medicines, as well as the consequences of lapses in security or proper handling, have mounted. In an effort to encourage comprehensive public standards across the pharmaceutical industry, the U.S. Pharmacopeial Convention (USP) is proposing a set of recommended best practices that will 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. USP is seeking broad feedback on these recommendations on supply chain integrity, which are posted at

Supply chain integrity involves minimizing risks that arise anywhere along the supply chain, from sourcing pharmaceutical raw materials to their manufacture and distribution. The new standard being proposed is not mandatory, and is contained in the proposed USP General Chapter <1083> Good Distribution PracticesSupply Chain Integrity. The proposal is intended to serve as a central guidance document outlining the essential elements of an effective strategy. While individual pharmaceutical companies have their own approaches to addressing this issue, the size and sophistication of companies and their suppliers vary widely, as do their quality systems and risk management approaches. Broad consensus around issues such as track-and-trace technology does not exist, and smaller companies that may be relied upon for sourcing pharmaceutical ingredients may or may not have security approaches comparable to their larger counterparts.

"There is incentive for all players in the pharmaceutical industrylarge and small companies, regulators and standards-setting bodiesto come to some agreement on hot-button issues such as track and trace technology and, at the larger level, to codify what constitutes a solid, universal approach to global supply chain integrity," said Praveen Tyle, Ph.D., chief science officer for USP. "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. While some pockets of information are available via FDA guidances, trade organizations and other sources, an overall approach is lacking. USP can move forward something more concrete than a technical report, as part of a mechanism that can be regularly updated to best meet the needs of all."

The proposed standard covers four main areas:

  • ImportationDetails three primary initiatives importers should undertake to help prevent and detect potential risks: supply chain risk management, development of effective supplier partnerships and building a supply chain quality system.
  • Counterfeit Drugs and Medical DevicesDocuments types of counterfeit drugs, medical consequences, and distribution and extent of counterfeit drugs and devices.
  • Best Practices to Combat Counterfeit Drug and Medical DevicesCovers topics including packaging technologies (tamper-evident designs, authentication technologies and serialization); drug pedigrees; machine-readable data carriers (2D bar codes and RFID tags); repackaging guidance, information retention and security; international standards; and best anti-counterfeiting practices.
  • Diversion and TheftAddresses factors that raise the risk of theft of drug products, drug components and medical devices; security systems, devices and procedures that should be implemented to reduce risk; and critical information to be gathered following discovery of a theft.

USP is a nonprofit public health organization that develops standards for the identity, strength, quality, 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 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 information needs to be included in the chapter. More information about the workshop is available at

Contact: Francine Pierson
US Pharmacopeia

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