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Drug Quality and Security Act Unifies State Pedigree Laws

By November 26, 2013February 21st, 2019Company News

On November 18, 2013, the U.S. Senate passed the Drug Quality and Security Act (H.R. 3204), setting forth a series of new compliance requirements for the pharmaceutical manufacturers, distributors, and dispensers. Expected to be signed by President Obama in the near future, H.R. 3204 will preempt the state level pedigree requirements, notably the California Pedigree Law.

Intended to prevent counterfeit or contaminated drugs from entering the U.S. drug supply chain and to allow faster recall of suspected products, the Act requires product trace, product verification, unit level serialization, and other safeguard drug supply chain measures. Under this Act, the pharmaceutical manufacturers and distributors selling to the U.S. are mandated to meet the product trace and product verification requirements by January 1, 2015, as well as the unit level serialization in 4 years.  Read more about the act here at