September 29, 2023 Responding to stakeholder concerns, the U.S. Food and Drug Administration (FDA) announced that it will establish a one-year stabilization period for theDrug Supply Chain Security Act (DSCSA)traceability requirements to ensure continuity of the supply chain and product availability ...
Effective November 27, 2023, the Drug Supply Chain Security Act (DSCSA) is a federal law that outlines requirements that must be followed by all entities involved in the pharmaceutical supply chain to enhance unit level tracing of prescription drugs throughout the supply chain – making it easier...
For pharmaceutical industry veterans, November 2023 marks the end of a decade-long journey to“achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.”This milestone will come with little...
Pharmaceutical manufacturing, distribution, dispensers, and packaging industries must meet the following requirements: Interoperable exchange: Trading partners must exchange transaction information in a secure and electronic manner with the DSCSA product identifier on all individual packages. Interoperable verificat...
There’s still time to implement solutions before November 2023, but not much. How much time is needed depends on what strides have already been taken toward preparation. When considering the breadth of manufacturers impacted by the DSCSA requirements and the limited resources available to implement...
In October 2023, the FDA announced another delay, introducing a phased approach to DSCSA compliance. Manufacturers now have until May 2025 to meet requirements, wholesale distributors until August 2025, and mid-to-large dispensers until November 2025. Small dispensers, defined as those with 25 or ...
In preparation for the November 27, 2023, interoperability deadline, pharmacies should have a working understanding of the DSCSA requirements and implement the required polices, practices, and procedures. In short, pharmacies should be ready to receive and/or exchange transaction information, including ...
But in reality, TH will be something less than this in most cases. Despite the TH definition, the DSCSA wholesale distributor requirements eliminate some of the data elements from the TH that the dispenser would receive for certain types of distributions. ...
. As he said, it’s an elephant-sized undertaking with a lot of moving parts that need coordination and consensus. The EPCIS COE is “the spoon” that’s helping the pharmaceutical industry digest the requirements, address the challenges, and get everyone compliant by November 27, 2023....
Each item must be treated as a unique, serialized entity that can be tracked individually. This condition is necessary to meet not only the 2017 deadlines, but also many of the requirements that you can see on the timeline between 2017 and 2023 (for the ultimate goal of full, unit-level ...