On November 27, 2013, President Obama signed into law the Drug Quality Security Act (DQSA) which is being implemented over the course of 10 years. Once the DQSA is fully in place, it will provide the consumer protection against unknowingly obtaining and using counterfeit prescription drugs, as well as creating an efficient approach to recalling a product in the unfortunate situation that one needs to be removed from the supply chain. Understanding what a large undertaking this is for the pharmaceutical supply chain industry, deadlines and benchmarks have been identified and are already being met with January 1st, 2015 being the first milestone followed by several others ending in November 2023.
The first notable deadline relevant to FCM and pharmaceutical manufacturers, took place in January 2015 in which the requirement to send trading partners an electronic transaction report was implemented. The industry recognized that most manufacturers were not ready, and delayed the implementation date to May 2015. FCM was ready in January, already sending transaction reports which included the product information, the transaction statement and the transaction history in one electronic document. This same ahead-of-schedule mentality is continuing on with the next several deadlines.
November 27, 2017 is the next deadline which will directly affect FCM’s daily operations. This step in implementing the DQSA will require FCM to place a serial number onto each saleable Rx unit. This unique identifier, specific only to that unit, will provide business partners, pharmacies and customers the ability to trace each specific unit back to its manufactured origin with greater ease. This traceability will now be able to be done quickly, with complete transparency of when/where the product changed hands; beginning with manufacturing and ending with the consumer. This November ’17 deadline is also important because manufacturers like FCM will no longer be allowed to ship Rx products without serial numbers. As demonstrated with the 2015 deadline, FCM customers and business partners can rest assured that FCM’s team is well ahead of schedule in meeting this deadline. FCM has created a talented task force of key departmental leaders which has been working vigorously to maintain an internally mandated timeline that is well ahead of the federally required schedule.
By November 2023, full aggregation of the saleable Rx products will need to be in place. This pedigree will create a traceable picture for each unit as it traveled through the supply chain. Traceability from the pallet, to the case, to the bundle and finally to unit level will be possible with the electronic sharing of these pedigrees – all which begin with the manufacturer, such as FCM.
As one can imagine; these federal requirements aren’t easy, or cheap to implement, but once in place, they will help to instill confidence and comfort into the customer by knowing that the prescription drug which they are taking for themselves, or administering to a loved one, is legitimate and was indeed manufactured in a FDA regulated facility…and that, in our eyes, is well worth the cost.
If you’d like to learn more about AMD, or any of the other services Ferndale Contract Manufacturing provides, please call 877-548-0122 or fill out a contact form on our website.