Drug Quality and Security Act (DQSA) Implementation Timeline
For 2014/2015 Reference Guide
By Laura Olson
as of November 10, 2014
DSCSA vs DQSA
The Drug Quality and Security Act (DQSA) was signed into law On November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA) outlines Steps to build “an interoperable system to identify and trace certain Prescription drugs as they are distributed in the United States”.
2014
11/27/14: FDA issues guidance for interoperable exchange of transaction information/history/statement in electronic or paper form 3PLs required to report annually pursuant to schedule determined by the FDA
2015
1/1/15: Supply chain partners are required to do business only with “authorized trading partners” Develop a system for wholesale drug distributor reporting & public database with licensing information
11/27/15: Process for waivers and exceptions Grandfathering product Establishing standards for licensing of wholesale drug distributors and third party logistics providers (3PLs)
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm382022.htm
From FDA.gov website
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