USP Quality Review

No. 51, Issued 10/95

Nature of the Problem

Consumers and health care practitioners should be concerned with the stability and integrity of drug products, especially after they leave the manufacturers' control. Reporters often express concerns through the USP Practitioners' Reporting Network^SM (USP PRN^SM) about the environmental stresses to which their medicines are exposed. Concern increases during the summer and winter months, when extremes of temperature and humidity are more likely to be encountered.