drug quality and security act dqsa implementation timeline
DESCRIPTION
The FDA Drug Quality and Security Act (DQSA) was signed into law in November 2013 and takes effect January 2015. Title II of the Drug Quality and Security Act (DQSA), known as the Drug Supply Chain Security Act or DSCSA outlines steps to "build an interoperable system to identify and trace certain prescription drugs as they are distributed in the United States". Designed to help keep consumers safe from counterfeit, unapproved or dangerous products, the new DQSA law has a wide reach. DQSA affects businesses across the supply chain including pharmaceutical manufacturers, re-packagers, wholesale distributors, third party logistics providers (3PLs) and dispensers. The FDA DQSA regulation includes requirements for product identification, tracing and verification including a provision that all drug products are required to be encoded with a unique product identifier that must be at the smallest saleable unit. Drug products must be able to be verified at the package level standardized numerical identifier. The Drug Quality Safety Act (DQSA) also mandates conditions for the proper detection and response for handling suspect products that are identified as possibly being counterfeit, unapproved or dangerous. This includes quarantining suspect products. Because of the new provisions of product traceability as part of the Drug Quality Safety Act, pharmaceutical supply chain businesses need to be informed and cognizant of the timeline for implementing the new FDA Drug Quality and Safety Act. The purpose of this document is to provide a brief reference guide to the implementation timeline for late 2014 and 2015 so that pharmaceutical supply chain businesses can be aware, prepared and ready to meet the new Drug Quality and Safety Act standards. For the first time in history, third party logistics providers are identified and affected. As part of new DQSA regulations, third party logistics providers will no longer be able to operate under state licensing requirements that are “inconsistent with or less stringent” than federal licensing standards.TRANSCRIPT
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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