The Drug Supply Chain Security Act (DSCSA) was enacted by Congress in November of 2013 and lays out steps for the development of systems to track and trace prescription drugs as they are shipped throughout the country. The DSCSA requires drug manufacturers, wholesalers, repackagers, and dispensers to develop interoperable systems for the exchange of commissioning, packaging, and shipping information. Implementation of the DSCSA regulations will help allow for the U.S. Food and Drug Administration and law enforcement to detect drugs that may be stolen, contaminated, or counterfeit.
Electronic Product Code Information Services (EPCIS) is a global GS1 Standard for creating and sharing event data regarding the physical movement and status of products throughout the supply chain. The current version of EPCIS is 1.2; however, Drummond Group offers testing for version 1.1 as well.
The Drummond Group tool is a web portal that allows entities in the drug supply chain and software vendors to assess their EPCIS messages for compliance with the DSCSA rule. The tool will analyze uploaded EPCIS documents and provide detailed feedback on their conformance with the GS1 Implementation Guideline for DSCSA.
A trustmark is a seal issued by GS1 that indicates successful completion of one or more of the GS1 test scenarios for EPCIS 1.2. A Trustmark is awarded for the set of test cases successfully completed. In order to be eligible, a company must pass validation by the Drummond tool for at least one GS1 test scenario.
You have unlimited attempts for each test case.
No, you may choose a subset of the available test cases, however you may only receive a GS1 trustmark for test cases that are successfully completed.
You may only upload .xml formatted documents at this time.
You can find the GS1 DSCSA Implementation Guideline here. https://www.gs1us.org/industries/healthcare/standards-in-use/dscsa/implementation-guideline
You can find a list of standards and helpful links here. DSCSA Links Page
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