The Drug Supply Chain Security Act (DSCSA) is a game changer for the pharmaceutical industry. Created to reverse the spiraling trends in counterfeiting and product diversion that ultimately put the consumer at risk, the act is applauded for its intent. At the same time, some pharmaceutical manufacturers and their third-party contract partners are struggling to meet the November 2017 mandated deadline for the serialization component of the DSCSA.
Companies in the U.S. pharma supply chain report that significant issues – including high costs, limited manpower and an inaccurate projection of the amount of time required (1) – are threatening their ability to meet the serialization mandate. With less than a year until that deadline, the challenges that serialization poses, particularly to packaging organizations, are enormous, so it is apparent that not all third-party packaging partners will be ready to serialize when the mandate goes into effect.
If you or your third-party partner is not serialization-ready next November, is there a reasonable solution? A practical – and unique – approach is to utilize the services of an international serialization hub.
At Ropack Pharma Solutions, we created such a hub, a practical option that addresses all of the issues currently impeding the race to the serialization deadline.
The International Serialization Hub
Here is how the hub operates. Just as you always have, you can continue to handle your packaging in-house or utilize the services of your trusted contract partner. The serialization function is then outsourced to our international serialization facility in Montreal where we have stand-alone serialization stations to accept your packaged pharmaceutical product. We are able to serialize any packaged pharmaceutical product.
An additional complexity, often overlooked, is the fact that using third-party distributors requires shipper and supplier aggregation. At Ropack, we are able to serialize beyond the unit of sale directly to the palette – a requirement of distribution networks.
An international serialization hub can be a temporary option when companies are not prepared for serialization by the mandated deadline. Or, in many cases, the hub’s benefits make it an efficient ongoing option, bringing pharmas who package in-house – or their contract partners – a reduction in capital expenditures, personnel and coordination that the complex process of serialization requires.
The clock is ticking. Stakes are high. For some, an international serialization hub is the solution.
(1) March 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frquentz