On November 27, 2013, the United States Food and Drug Administration (FDA), began implementing the system to track and trace pharmaceuticals. This was part of the Drug Quality and Security Act (DQSA) and was designed to create a national program for all pharmaceutical companies to be able to monitor, track and track medications under consistent rules rather than state by state regulations.
This law originally planned to have all pharmaceutical packing produced with specific serial numbers over the four years following the signing of the law, and then also require the use of electronic codes on the packages by 2023.
The Benefits
While many laws that impose additional regulations on industries are challenged by the industry, the DQSA was actually endorsed by several leading associations and groups in the United States pharmaceutical sector.
These organizations included the Institute of Medicine, Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Healthcare Distribution Management Association, all supporting the idea of the ability to nationally track and trace pharmaceuticals.
With the program in place, it will greatly reduce the risk of counterfeit drugs or fake prescription medication begins introduced into the United States market. It will also ensure that medication packages can be identified as authentic and also tracked throughout the distribution and supply chain from packaging to end consumer purchase.
This is also a benefit to companies shipping pharmaceuticals outside of the United States. While the US track and trace system will not be integrated with European and other similar systems, it does provide a level of security that would not be present if the system were not in place. There are some US based companies that have the option to complete international serialization, something that may be of great importance to companies exporting their products.
Packaging Requirements
As of July 1, 2015, all dispensers of pharmaceutical products must be able to provide low-level information on the history of all pharmaceuticals produced. In addition, pharmacies and stores or chains selling pharmaceuticals have to ensure all products are correctly labeled and documented to be able to accept the shipment.
Through the use of electronic codes on the packaging, this system of being able to track and trace pharmaceuticals will become even easier. Currently large chain types of pharmaceutical outlets are currently using many electronic scanners for inventory control, making monitoring and inventory control even easier.
Working with a packaging company that specializes in pharmaceutical packaging is a must. These companies are in full compliance with the regulations, and they will ensure that your product is serialized and completely compliant with track and trace requirements.
