In order to allow for more accurate tracking of pharmaceuticals and medical devices, the Food and Drug Administration is now mandating the use of barcode tracking software.
Packaging World reported that this move stems from a 2007 congressional mandate. In addition, the the Food and Drug Administration Safety and Innovation Act was signed into law last year to add greater oversight and compliance specifically for implantable devices but more broadly for the medical device industry.
The barcode or other unique device identification (UDI) code used, according to Packaging World, will have to include the following information:
• The precise version or model of the device and its manufacturer
• An expiration date, a serial number of a lot or batch number
• The specific date the product was created
"The device identifier would be a reference number that allows a healthcare provider or the FDA to find data concerning the device in a new FDA database, the Global Unique Device Identification Database, or GUDID," the news source said.
International barcode tracking software guidelines enacted
The United States is not the only country mandating the increased use of barcode software for its pharmaceutical industry. Live mint, a news source associated with The Wall Street Journal, reported that India's highest court is set to rule on a new mandate by the nation's commerce department that would require all drug makers to use a barcode generator for their products. According to top officials, the move is meant to curb the flow of counterfeit drugs coming from India and to add more reliability and openness to its pharmaceutical industry.
"During our consultations with the government, we had said that technology has to be integrated at every level so it does not interfere with operations," said D.G. Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), an industry lobby group that represents local drug makers, according to live mint. He added, "The industry, especially small-scale players, will require time to comply with the government requirements, order new equipment and validate them. Besides, importing countries have their own requirements. The packaging and [labeling] will also have to be changed accordingly. These factors need to be considered before the government rushes into implementing track and trace."
These data collection tools have already been in place since January 2011 for larger cases and cartons, live mint reported. The Commerce Ministry wants to have barcodes and other more advanced tracking instruments in place for secondary level packaging, which includes tablet strips and syrup bottles, by this month.