FDA's UFI System For Pharmaceutical Track And Trace

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FDA's UFI System For Pharmaceutical Track And Trace

As a component of the FDA's Safety and Innovation Act (FDASIA) of 2012, the agency's Unique Facility Identification (UFI) system is coming nearer completion every day. This system is designed to help pharmaceutical manufacturers establish stronger track and trace standards, and will be a requirement for both domestic and foreign manufacturers. What does this mean for pharmaceutical manufacturers? This new system for tracking and regulation will require owners or operators of establishments engaged in the preparation, manufacturing, compounding, processing, or propagation of drugs in any state to register specific information with the Secretary of State. This information will include the name of owners or operators, physical location of the facility, point of contact email address, and the UFI (unique facility identifier) of each individual location/facility. According to the FDA, this applies to every individual who owns or operates the type of establishment described above in any foreign country, and who imports or offers for import any drug or medical device imported into the U.S. Based on the DUNS (Data Universal Numbering System) of Dun and Bradstreet, DUNS numbers will be available to all manufacturers free of charge. As the UFI goes into effect, it will be vital for pharmaceutical manufacturers to upgrade marking and/or labeling solutions in order to remain compliant with standards set forth by the FDA. At Markem-Imaje, we know that standards for manufacturers are ever-changing, particularly in the pharmaceutical industry. While implementing the UFI system may be stressful for manufacturers initially, it should be effective for improving pharmaceutical track and trace standards. Pharmaceutical manufacturers as well as those in food, beverage, personal care, electronics, and postal can rely on our continuous inkjet printers, thermal printing, and laser printing solutions for superior results. For unsurpassed industrial coding and marking systems, count on our wide array of solutions, trusted around the world.

January 10, 2014
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