USP is proposing a revision to General Chapter <1> regarding injections labeling of ferrules and cap overseals. The revision would limit printing on ferrules and caps to only those cautionary statements related to imminent threats of life-threatening situations. The proposal will appear in the January/February 2010 Pharmacopeial Forum; a preview of the revision can be found on USP’s Web site.
Cortegra Group Inc. (Fairfield, NJ) installs a Vijuk MV Large Format Folder in its Evansville, IN, facility. This purchase is in response to FDA's requirement for larger font sizes and additional prescribing information on packaging inserts to manage the risk of medical product use and reduce medication errors.
Has the scarcity of unit-of-use packaging hindered the distribution of medication guides? Could its prevalence increase if FDA develops a standardized document for written prescription information?
Securikett Ulrich & Horn GmbH (Austria) offers brand protection via complex labeling solutions aimed to fight counterfeiting. In June, Securikett won First Prize in the “Security” category at the international FINAT awards for its Sumitomo Void label, a tamper-evident seal for plastic bottles with high-ranking authentication features. The label was designed to protect Japan-based Sumitomo’s agricultural medicines in plastic bottles against tampering, refill, and counterfeiting in Turkey.
First Priority, a manufacturer of generic veterinary pharmaceutical products, implemented Global Vision's automated inspection solutions in an effort to reduce costs without compromising efficiencies and quality of their products.
First Priority previously spent significant amounts of time and manpower manually proofreading all labels, inserts, and secondary packaging. In addition, proofreaders had difficulty determining proper font sizes, transposition of characters, and foreign language spelling errors. Finally, they experienced inspector fatigue.
In 2004, Nosco launched a supply-chain initiative dubbed "Nosco On_Demand Solutions." The program set out to find ways to help manufacturers significantly compress supply-chain cycle time, reduce inventory, reduce obsolescence, improve service levels, and save money with digital offset package production. Turning to digital label production, Nosco has since converted thousands of SKUs to the digital process. These include labels with variable bar codes, RFID tags, and brand protection features.
Marchesini Group now offers international pharmaceutical companies packaging-line solutions for item-level serialization. Because of the growing interest in Data Matrix for encoding lot, expiry date, production factory data, etc., Marchesini offers a new labeling sytem that can also apply the space-saving codes.
By David Vaczek
FDA requirements for drug product labeling have created demand for larger inserts and expanded labels. Among recent guidance, the Med Guide requirement for prescription antidepressants was extended to include NSAIDs. As of 2007, packagers have added panels to bottle and pouch labels to accommodate warnings required on OTC pain-relief medications.