Global Communications

二月 18, 2013

West Introduces Online Resource Center for USP Chapter 1

West has announced a new online resource center to assist pharmaceutical and biopharmaceutical manufacturers as they prepare for the industry’s revised standard regarding labeling for cap overseals and ferrules on injection vials, United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010).

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.”