USP draws up guidelines on supply chain integrity

The US Pharmacopeial Convention (USP) will issue a new set of guidelines for safeguarding the integrity of the medicines supply chain next spring, and hold a workshop shortly afterwards to gauge public reactions to the proposals.

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, according to a presentation given at the recent Xavier University Global Outsourcing Conference by Mary Foster, chair of USP's packaging, storage and distribution expert committee.

The proposals will cover a number of topics, including packaging technologies, drug pedigrees and repackaging, and are intended to ensure materials reach their intended destination unadulterated and with their quality intact. The intention is also to allow materials to be traced back to their original manufacturer, according to Foster.

The guidelines - due to be released ahead of a May 2012 workshop convened by USP - will be largely contained within a new General Chapter <1083> in the USP-NF, a compendium of public pharmacopeial standards, according to a Healthcare Packaging report.

Subheadings in that chapter include supply chain risk management, partnerships, cargo screening, best anti-counterfeiting practices, diversion and theft, illegal online pharmacies and natural disasters.

Packaging technologies covered in the chapter include tamper-evident designs, authentication technologies and serialisation, and it also looks at the application of data carriers such as 2D datamatrix codes and radiofrequency identification (RFID).