Back to the drawing board for USP <1083>, Good Distribution Practices
At the Global Cold Chain Forum (Boston, Oct. 5-9), Mary Foster, PharmD, chair of the Packaging and Distribution Expert Committee at US Pharmacopeia (Bethesda, MD) gave an update on the organization’s plans for revising USP <1083>–the gist of which is, USP is reducing its involvement in distribution practices per se. The Expert Committee will continue work on materials of construction for packaging (presumably including the tertiary packaging which constitutes temperature-controlled shipping), and it will continue to develop at least one part of <1083> pertaining to quality systems in distribution management. But subchapters on other topics may be reduced or eliminated.
Source: Pharmaceutical Commerce