In an effort to enhance supply chain integrity with comprehensive public standards across the pharmaceutical industry, the U.S. Pharmacopeial Convention (USP) has proposed a set of recommended best practices to help ensure supply chain integrity. The proposed guidelines cover five main areas: Good Importation Practices, Counterfeit Drugs and Medical Devices, Best Practices to Combat Counterfeit Drug and Medical Devices, Diversion and Theft, and Natural Disasters.

The new proposed standard, which is not mandatory, is contained in the USP General Chapter <1083> Good Distribution Practices—Supply Chain Integrity. The proposal is intended to serve as a central guidance outlining the essential elements of an effective strategy and is available on the USP website: www.usp.org/USPNF/notices/generalChapter1083.html.
 
“There is incentive for all players in the pharmaceutical industry — large and small companies, regulators and standards-setting bodies — to 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.”
 
The proposed standard covers four main areas: Importation (detailing three primary initiatives to help prevent and detect potential risks), Counterfeit Drugs and Medical Devices (documenting types of counterfeit drugs, medical consequences, and distribution and extent of counterfeit drugs and devices), Best Practices to Combat Counterfeit Drug and Medical Devices, and Diversion and Theft (addressing factors that raise the risk of theft of drug products, drug components and medical devices).
 
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 Pharmacopeia–National Formulary (USP–NF).