Although the universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply chain integrity to the public. While several states are actively pursuing similar legislation, California’s pending requirements are the most demanding since they track product to the smallest saleable unit level. Enforcement of the ePedigree legislation, combined with the accelerated pace of regulatory involvement worldwide in serialization and track-and-trace means that it is now vital for the industry to accelerate its efforts to put compliance measures in place.
Read More →Serialization: Optimizing Planning and Implementation
Increased globalization in the supply chain for prescription drugs has also increased the distribution of counterfeit drugs. To combat this problem in the U.S., the FDA has outlined requirements to make every unit of saleable prescription drug products traceable. Meeting the requirements for these regulations requires a long-term strategy and preparation. Recro Gainesville, understanding the changing manufacturing landscape, began this process years in advance. Product serialization enables manufacturers and distributors to protect consumers from potentially harmful counterfeit and stolen drug products by improving supply chain tracking, visibility and management.
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