USP has released for comment a new draft general chapter <1083> titled “Good Distribution Practices – Supply Chain Integrity” that will be expand its series of information chapters addressing various aspects of the pharmaceutical supply chain.
The formal proposal will be published in March/April issue of Pharmacopeial Forum. Comments are due by May 31.
An advance copy of the draft was posted in late December on USP’s website to provide stakeholders adequate time to review and comment prior to a workshop USP will hold on supply chain integrity in late May at its Rockville, Maryland headquarters.
“The goal of good distribution practices,” the draft states, “is to encourage sound business practices that help deter interference and manipulation by bad actors and also to provide effective means to detect adulterated drug components and drug products to prevent them from entering the supply chain.”
In scope in the proposed informational chapter are APIs, drug products, devices and excipients. It contains scope, background and definitions sections, and three detailed sections covering: ● counterfeit drugs and medical devices ● best practices to combat counterfeit drugs and medical devices, and ● diversion and theft.
In late October, USP published for comment in “Pharmacopeial Forum,” PF 37 (6), available on its website, a draft of a general chapter <1197> on “good distribution practices for bulk pharmaceutical excipients” (IPQ “The News in Depth January 19, 2012). Comments were due by January 31.
Last fall, the standard-setting organization released for comment a wholesale revision of its chapter <1079> on “good storage and distribution practices for drug products” (IPQ “The News in Depth” Sept. 27, 2011 ).