The US Senate passed the Drug Quality and Security Act on November 18th. The bill now heads to President Obama’s desk, where it is expected to be signed into law soon.
If signed into law, pharmaceutical companies will have to adopt a track-and-trace system for their medicines. Individual packs of drugs would need serial numbers within four years of the bill becoming law. In 10 years, medicine would need to be traceable as it makes its way from the manufacturer to a pharmacy.
The law would also create stricter license requirements for distributors and third parties who transport drugs. The FDA would also maintain a database of wholesalers that would be available to the public through its website.
Federal track and trace requirements would replace California’s ePedigree law, which means pharmaceutical companies would have more time to comply with the new regulations.
Pharmaceutical companies need to develop a strategy to conform to the Drug Quality and Security Act, which will likely become law in the next few weeks.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet the regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made.
Read More About USDM Life Sciences Unique Device Identification/Track and Trace Services
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