USP Announces Proposed Standard for Supply-Chain Integrity

Amy Ritter

Amy Ritter is Scientific Editor, BioPharm International and Pharmaceutical Technology. Amy Ritter joined the editorial staff of BioPharm International and Pharmaceutical Technology in 2011. She received her BA in Biology from Boston University, and holds a PhD in Neurobiology from SUNY at Stony Brook. Before joining Advanstar’s Pharm Sciences group, she worked in the preclinical pharmacology group at Merck Research Labs, and is the author of numerous peer-reviewed scientific publications.

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Amy Ritter, PhD

Amy Ritter was Scientific Editor, BioPharm International.

The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.

The US Pharmacopeia (USP) announced in a press release a draft standard contained in the proposed USP General Chapter <1083> Good Distribution PracticesSupply Chain Integrity. The draft standard contains best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.

The proposed standard contains a section on importation that includes best practices for supply-chain risk management, development of effective supplier partnerships, and building a supply-chain quality system. Another section covers counterfeiting, including a definition of counterfeiting and best practices to combat counterfeit drugs and medicines. Included in the best-practices section are discussions of anticounterfeiting strategies such as the use of tamper-resistant packaging technologies and barcoding, as well as guidance for combating illegal Internet pharmacies. Finally, the guidance contains a section on diversion and theft.

In USP’s press release, Dr. Praveen Tyle, chief science officer of USP, says, “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.”

USP is seeking feedback on the draft standard, which will be posted in the Pharmacopeial Forum 38 (2), March–April 2012. The draft chapter and public comments will be the focus of the USP Supply Chain Integrity Workshop to be held on May 22–23, 2012, in Rockville, Maryland. The workshop will provide further opportunity to discuss the proposed standard and to decide if further information should be added.