USP Invites Comments on Good Storage and Shipping Practices Chapter

United States Pharmacopeial Convention (USP) invites public comments on a new revision of USP General Chapter <1079> Good Storage and Shipping Practices. This general information chapter provides guidance on the proper storage and transportation of drug products from manufacturer to end user. As USP notes, the transportation of drug products through the supply chain is complex, involving different modes of transportation between holding facilities and the potential for different controls and procedures in different storage facilities and areas. “The proposed revision of the entire chapter is intended to reflect the globalization of activities surrounding the storage and transportation of drug products. As we have moved from a regional to a global supply chain, it has become more important to adhere to labeled temperature requirements. In addition, the importance of cold chain storage has increased with the increase in biotechnology-derived drugs requiring refrigerated storage,” USP indicates in the introduction to the proposed changes. The document can be accessed in the online Pharmacopeial Forum by searching for “1079 Good Storage and Shipping Practices.” Comments may be submitted via this site or by sending an e-mail to Desmond Hunt at DGH@usp.org, and must be received by September 30, 2011.