The Drug Supply Chain Security Act is a new law that is being implemented by the FDA. It outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain.
Needless to say, this is a complex law and brings significant change to the way most pharmacies will track and trace their products. Some traceability requirements are already in place, and others will begin to be enforced now, as we pass the November 1 deadline.
Our expertise is focused on complex regulatory environments – tracking changes and how they impact the people, products and industries involved. Compliance and policy are integral pieces of any business strategy, and structure is a necessity for you to adapt to new needs, and that’s where we come in. The InfiniTrak team crafts creative and practical solutions that address every last detail and bring you assurance that we are thinking about both the law and technology that supports the latest regulatory requirements.
Reverse Engineering for Your End of the Supply Chain
The result of our careful reverse engineering is a dynamic and practical software solution that affords our clients significant benefits beyond its primary role – full compliance with DSCSA.
- Quick and efficient ability to track and trace
- Assured product integrity through InfiniTrak’s simple, intuitive architecture that comes with our guarantee of training support if needed
The FDA has posted resources for small business owners to explain the essential components of DSCSA. Visit fda.gov for more information.
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