The World Health Organization reports that in more than 50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit.
In many cases, the drugs do not have their intended ingredients in them. Patients who unknowingly obtain and use the counterfeit drugs are not getting the medical treatment they need and many unsuspecting patients are dying from the counterfeit medicines.
A federal track and trace bill was recently signed into law. The law, known in Congress as the Drug Quality and Security Act means pharmaceutical companies will have to adopt a track and trace system for their medicines.
Individual packs of drugs will need serial numbers within four years of the bill becoming law, which is November 27, 2017. In 10 years, medicine will need to be traceable as it makes its way from the manufacturer to a pharmacy. Countries in other parts of the world have already implemented similar regulations.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our track and trace team will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.
