USP publishes draft general chapter on supply chain integrity

The US Pharmacopeial Convention (USP) has published its proposed general chapter on good distribution practices to ensure pharmaceutical supply chain integrity, for comment in advance of its upcoming workshop on the topic in May.

The aim will be to develop best practices to combat counterfeit active pharmaceutical ingredients (APIs), excipients, drug products and medical devices that are imported into the USA (see also USP draws up guidelines on supply chain integrity).

The draft general chapter  (1083) provides "non-mandatory information"  to "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," according to USP.

It would serve as a revision of the current general chapter on good storage and shipping practices (1079), and is intended as a central guidance document outlining the essential elements of a strategy to maintain supply chain integrity.

The new document brings together information which is currently distributed across a range of documents, including USP's own publications, FDA guidance, trade organisation recommendations and other sources.

"USP has developed an initial proposal that we expect to evolve as industry, FDA and others weigh in," commented Praveen Tyle, USP's chief scientific officer.

"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," he added.

The chapter covers four main areas, namely: preventing and detecting risk for importation of raw materials and finished drugs; documenting types, distribution patterns and the extent of counterfeit medicines and medical devices, along with their medical consequences; developing best practices to combat counterfeits such as packaging technologies, drug pedigrees, data carriers, repackaging guidance and anti-counterfeit technologies; and addressing the issue of diversion and theft of drug products, drug components and medical devices.

The current proposed schedule is for the formal proposal to be published in Pharmacopeial Forum 38(2) journal for March/April 2012, according to USP.

The draft general chapter and comments will then be discussed in detail at the USP Workshop on Supply Chain Integrity, scheduled for May 22-23 at its headquarters in Rockville, Maryland.

The deadline for submitting comments and feedback on the proposal is May 31.