Envisioning a year journey leading to the complete serialization of the U. The most recent β and arguably most significant β happened in August , when the Agency announced that it was delaying by one year enforcement of key DSCSA requirements. The Agency has made it clear that the stabilization period is not a delay of the requirements : It expects companies to have implemented the mandated systems and work to ensure they are operating correctly, smoothly, etc. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.
It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country. By providing comprehensive FDA guidance, the act facilitates the accurate tracing of products from the point of production to distribution to dispensation and beyond. The U. As we said above, the law has been rolled out in phases since it was passed nearly 10 years ago.
Even though enforcement was delayed until November , the FDA expects all supply chain stakeholders to keep preparing. 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 to being ready for November 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 drug 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. They must also notify the FDA and other interested parties when they find such drugs. Licensing: Wholesalers must report their licensing status and contact information to the FDA. Third-party logistics providers must obtain a state or federal license. Your compliance depends on making sure you can meet your responsibilities.
