The DSCSA timeline has established requirements and deadlines to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country. So, by November 27, , manufacturers, wholesale distributors, dispensers i. The DSCSA requirements can be divided into several categories that apply to manufacturers, repackagers, wholesale distributors, dispensers, and 3PLs.
Each is important, but four are particularly vital because they require these stakeholders to have specific systems in place to be fully compliant. Manufacturers and repackagers must put a unique product identifier PI , such as a bar code, on certain prescription drug packages. This must be able to be read electronically. Manufacturers, wholesale distributors, repackagers, and dispensers must establish systems and processes to verify PIs for certain prescription drugs packages.
All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must be ATPs and be able to electronically verify that their trading partners are ATPs. The definitions of ATP also include language about accepting or transferring direct ownership or possession of products. Create a checklist for each requirement and make sure you have the resources needed to meet those standards.
The FDA made it clear that the stabilization period is not an excuse for pharma stakeholders to take a break from preparing. During the stabilization period, companies need to assess their readiness and implement and test serialization and data-exchange solutions. Your solution must be capable of verifying product identifiers serialized data , aggregation, and electronic data exchange. It has links to our articles, webinars, white papers, and other resources that will help you better understand the DSCSA requirements.
If you have questions about the DSCSA timeline and your obligations or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts.
