Carol Mooney

Director, Strategic Marketing, Biologics

August 06, 2013

Prepare Now for the USP Ch Revision to Labeling on Caps and Seals

The revision to the United States Pharmacopeia (USP) General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals standard becomes official on December 1, 2013. The revision will limit printing to only cautionary statements on the top surface of the ferrule or cap overseal of a vial containing an injectable drug product sold within the United States. Seals with the embossed “Flip-Off” or printed with other non-cautionary labeling will not be compliant with this new standard.

If your injectable drug product is sold in the United States and includes a message, logo or embossed statement on the vial’s cap or seal, it’s time to make a change. Contact your West Account Services Representative or Account Manager today to ensure that your supply chain is not interrupted. You will need to request a new item and update your specification as necessary.

To assist customers as they prepare for the industry’s revised standard, West has created an online resource center. The resource center provides a variety of information, including recommendations for compliant seals, Frequently Asked Questions and an item transition request form.