USP best practices proposal to safeguard drug supply chain

February 15, 2012

Various drug pedigree technologies and standards are among the issues discussed in the U.S. Pharmacopeial Convention's new best practices proposal on supply chain integrity.

The USP developed the General Chapter document, Good Distribution Practices – Supply Chain Integrity, for discussion ahead of USP's Supply Chain Integrity Workshop in Rockville, Md., May 22-23. Among the measures discussed to prevent counterfeit and adulterated drugs, as well as theft of prescription medicines, are: establishment of drug pedigrees, packaging technologies, combating illegal internet pharmacies, and supply chain risk management.

The USP developed the Good Distribution Practices General Chapter as a discussion document, and not a regulation. "The industry gives us comments and feedback, so the current version will not stand up. It will look drastically different [after industry feedback]," said Desmond Hunt, senior scientific liaison for USP. Because counterfeiting, theft, and diversion of drugs are important industry issues, Hunt expects many comments.

Hunt believes that the USP will receive a lot of input on drug pedigree, both from the industry and FDA. "E-pedigree is not a settled issue, and the landscape of supply chain management changes every 4 to 5 months. I would love to get some consensus on track and trace," Hunt said.

The document discusses how various packaging technologies – including authentication technologies, serialization, and tamper-evident designs – can help prevent drug counterfeiting and diversion. "Although tamper-evident designs are relatively simple...they can be combined with a number of more sophisticated authentication technologies in an approach described as layering," according to a statement in the report. "One limitation of these approaches is that they protect the package, not the product," the report added.

To read the Good Distribution Practices document, visit:

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