Potential Governing Body Emerges For DSCSA Tracing Of US-Marketed Drug Packages
The idea of establishing a non-profit governance group to coordinate the package-level tracing of pharmaceuticals through the US distribution chain that DSCSA requires drew widespread support at a May 1 PDSA meeting in Washington, DC. PDSA wants to get the group up and running by October.
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Despite some previous uncertainty about sufficient funding commitments from members, the coalition of manufacturers, wholesalers and distributors is operational, with a meeting planned for early next year. It will oversee data governance systems for implementing the US supply chain safety law, a key element of the law's third phase set to go into effect November 2023.
But there’s a wrinkle: Many prospective participants cannot budget for the tiered fees until 2020.
Although compounding of certain shortage drugs is allowed during the public health emergency, remdesivir is off limits due to its complexity. Providers should only use the FDA-approved version of the drug, Gilead’s Veklury, the agency says.