February 18, 2013
The revised USP General Chapter <1> Injections standard will go into effect on December 1, 2013. The standard applies to multiple packaging, storage and labeling requirements, as well as procedures and methods that provide specifications for individual drug products or substances. The revision will limit printing to cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product. A cautionary statement is defined as one intended to prevent an imminent life-threatening situation if the injectable drug is used inappropriately.
The West USP General Chapter <1> Online Resource Center is designed to provide drug manufacturers with key information, considerations and regulatory assistance to prepare for implementation of the revised standard.
“The revised standard represents a fundamental shift in the pharmaceutical and biopharmaceutical industry, and drug manufacturers need to begin preparing now for implementation,” said Carol Mooney, Global Market Segment Director. “West is working side-by-side with customers to provide high-quality insight and guidance through the transition and ensure uninterrupted product supply.”