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BlogsAsk The Experts ForumWhat Is the Status of the California E-pedigree Program for Pharmaceuticals?
What Is the Status of the California E-pedigree Program for Pharmaceuticals?
The program is scheduled to begin in 2015. However, I have not heard anything about it so far this year. Why not?
On Nov. 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. The law states: "Beginning on the date of enactment of the Drug Supply Chain Security Act, no State or political subdivision of a State may establish or continue in effect any requirements for tracing products through the distribution system... which are inconsistent with, more stringent than, or in addition to, any requirements applicable under section 503(e) (as amended by such Act) or this subchapter (or regulations issued thereunder)…" Essentially, federal drug-traceability standards preempt any state regulations, rendering the California law moot. The federal standards won't come into effect for another few years, so the pharmaceutical companies have successfully put off having to meet serialization requirements for a while longer.
—Mark Roberti, Founder and Editor, RFID Journal
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