RxTrace readers are already well aware that multiple new laws around the world will require prescription drug manufacturers to put a new 2D barcode on their products in the next few years. But what if your drug package is too small to fit the new mandated 2D barcode and human readable information on the label? Let’s take a look at what the regulations say in the E.U., Brazil and the United States. From that, we can come up with some strategies. Continue reading Is Your Drug Too Small For The Mandated 2D Barcode?→
With the approach of pharma serialization deadlines all around the world, this is the season for label redesign. The addition of new unique identifiers in 2D barcodes and human readable forms—often without removing existing linear barcodes—requires knowledge of the pharma labeling regulations in the target markets as well as artwork skills (see “DSCSA: Label Artwork Heartaches”). The problem is, serialization doesn’t apply to just one product, it applies to all prescription drugs marketed in the target market. That threatens to cause Continue reading Sponsored: The Season For Label Redesign→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.