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On December 1, 2013, the United States Pharmacopeia (USP) General Chapter <1> Injections, 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 Pharmaceutical Services, Inc.’s Carol Mooney, Global Market Segment Director, Pharma/Biotech, offers guidance to pharmaceutical manufacturers seeking to comply with the new standards.
How does the revised standard impact pharmaceutical packaging?
The revision places limits on what drug manufacturers can print or otherwise display on the top surface of cap overseals and ferrules (aluminum shells) used to secure injectable drug vials. This revised standard is specific to injectable human and veterinary drug products that are intended to be sold in the United States, so even manufacturers based in Europe or Asia Pacific must comply if the product is intended for sale in the U.S.
How will the revised chapter affect what can be printed on caps and/or seals?
Many pharmaceutical manufacturers currently print or display information on the surface of the plastic cap or seal. Printed information often includes the trade name of the product, company logos or the company name. West also embosses and prints our registered “Flip-Off” name on seals. The revised standard prohibits this type of information, and the USP has specifically cited these examples as messages that can no longer appear on the cap or seal.
In addition, the revised chapter restricts printing to cautionary statements, which are statements intended to prevent an imminent life-threatening situation and may include instructional statements that provide potency or other safety-related instructions if warranted. Cautionary labeling statements must be simple, concise and devoid of non-essential information. Only cautionary statements may appear on the top (circle) surface of the ferrule and/or cap overseal of a vial containing an injectable product. The statement should be printed in a contrasting color and be clearly visible under ordinary conditions of use. Other statements or features, including but not limited to, identifying numbers or letters, such as code numbers, lot numbers, company names, logos or product names, may appear on the side (skirt) surface of the ferrule but not on the top (circle) surface of the ferrule or cap overseal.
Click here for more information and watch for additional Frequently Asked Questions on USP Ch <1> coming soon!
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, 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.
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.
For injectable drug product package systems, seals are considered to be secondary package components. Though not in direct contact with drug products, they perform critical functions such as: Maintain an integral sterile seal by holding the stopper firmly in place, protect the injection site on the stopper and provide evidence of tampering (dependent on seal design).
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 <span style="text-decoration: underline;">only</span> 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.
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