As a response to Europe's Directive 2011/62/EU regarding counterfeit medicines and their limitation, the US Pharmacopeia (USP) is developing guidelines to help ensure the safety of the supply chain and to prevent counterfeits. The USP is elaborating new General Chapter <1083> "Good Distribution Practices - Supply Chain Integrity". The new chapter will be published in the Pharmacopeial Forum - March-April edition - for comment. In terms of content, the chapter will focus on packaging technologies (tamper proof evidence) and on identification and serialisation technologies (2D Barcode or RFID). Furthermore, regulations should be developed for re-packaging and measures should be taken against illegal internet pharmacies. The USP considers counterfeiting as an integral issue which can only be solved when measures are taken considering medicines manufacturers, the supply chain, authorities and patients all together.
For this prupose, the USP is organising a workshop to discuss the comments received. For more information, please visit the USP website.
Dr Robert Eicher