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November 2017 deadline for pharma packagers looms closer
It has been known for nearly four years that November 2017 was the deadline for US pharma manufacturers to include a unique serial code on each package of drugs going into commercial distribution; this originates with the Drug Supply Chain Security Act (DSCSA), passed in 2013. Many Big Pharma companies have long been ready; more recently the pressure has been on contract manufacturers (CMOs) and foreign companies new to the US market.
With barely six months to go to the deadline, Antares Vision (US HQ: Moorestown, NJ) has announced the Quick Compliance Program, offering a 10-week timeline from project start to DSCSA compliance. The program is based on preconfigured modules in concert with a standardized package of software, documentation and services, says the company, adding that all units, are preconfigured in Antares Vision’s Moorestown warehouse, and are ready-to-ship. Components include:
Featured hardware in the Antares Vision Quick Compliance Program includes:
“As we enter the stretch run toward November’s initial serialization deadline, pharmaceutical companies, contract manufacturers and contract packagers all know that it’s time to engage a track and trace partner if they haven’t already done so,” said Andrew Pietrangelo, president, Antares Vision North America. Antares Vision, headquartered in Italy, is a global player in pharma packaging equipment; the company says that it has already installed solutions on over 950 production lines in 180 plants around the world.
Having the units in stock is a key factor; there are anecdotal reports that timelines for obtaining equipment are now stretching out, and that the availability of engineering teams necessary to install and validate this equipment is getting tight. Antares Vision is joining other packaging-line vendors who have announced quick-start programs, including Optel Vision and SystechONE. In the recent past (i.e., before January), observers have noted that a full-blown DSCSA compliance program can take upwards of 18 months—factoring in the steps necessary to make serialized data available to trading partners in a validated, reliable manner. US wholesalers, the primary recipients of the serial data, are themselves working out details of managing these data to downstream trading partners. Even so, everyone is counting on FDA, which is behind in providing guidance on DSCSA compliance, allowing for enforcement discretion once the November deadline arrives; the prospect of shutting off drug access because serial codes are not available is daunting.