Regulatory Roundup: USP Releases Proposed Supply Chain Guidelines

Published on: 

USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.

The US Pharmacopeia has released proposed guidelines on ensuring the integrity of the pharmaceutical supply chain. The guidelines cover five main areas: good importation practices, counterfeit drugs and medical devices, best practices to combat counterfeit drug and medical devices, diversion and theft, and natural disasters. The guideline is open for public comment through May 31, 2012, and will appear in the Pharmacopeial Forum 38(2). A May 2012 USP workshop will address the comments received and the draft chapter.