USP best practices proposal to safeguard drug supply chain

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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