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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.
On December 1, 2013, revisions to USP Ch. <1> Injections, Labeling on Ferrules and Cap Overseals will go into effect for all drug products sold in the United States, including veterinary products. Now is the time to ensure that your product packaging is compliant.
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).
On December 1, 2013, the United States Pharmacopeia (USP) General Chapter <1> Injections<em>, </em>Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) revised standard will become effective. The revised chapter affects all injectable drug products, human and veterinary, intended for sale in the United States.
West has been busy behind the scenes building our offerings in the West Knowledge Center. The Knowledge Center launched just over a year ago, and since then we’ve more than doubled our content based on customer requests and real-time data and analytics.
The traditional way to package injectable drugs is to place them in a stoppered vial. The stopper is typically held in place with an aluminum ferrule that is called a seal. The vial seal is crimped onto the vial and not only serves to keep the stopper secured to the vial and the <a href="/blog/2018/february/minimize-microbial-contamination-with-flip-off-seals">vial contents sterile<sup>i</sup></a> but also protects the injection site on the stopper and provides a means of demonstrating lack of tampering.
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