Finding information about the Drug Supply Chain Security Act (DSCSA) and how to meet the requirements is difficult. You need to sift through a lot of information and much of what you find will be out-of-date, biased, or wrong.
As the serialization deadline in the US approaches, finding accurate and timely information is proving to be more and more difficult. For this reason, we asked our Regulatory Strategist and expert, Dirk Rodgers, to compile a complete list of resources that comprise the most authoritative information you need to understand and meet the requirements.
The resource guide includes all the following information:
The Food and Drug Administration (FDA): Full text of the law, FDA guidance, webinars, Q&A documents and FDA planning documents.
The Healthcare Distribution Alliance (HDA): The HDA has done more than any other organization in producing documents that can be used to understand the law and how it changes the way manufacturers must interact with wholesale distributors. Documents include barcode guidance, clear explanations of all DSCSA data exchange scenarios, guidance for using EDI to meet the lot-based DSCSA requirements, solutions to the 2019 saleable returns problem, solutions to the master data exchange problem raised by the DSCSA, and much more.
GS1 Healthcare: Includes essential and hard to find foundational documents for GS1 standards that the industry has chosen to use to meet the DSCSA. These are not presented in a DSCSA context but they provide an understanding of the technology behind the interoperable exchange of data within a supply chain like ours that uses GS1 standards.
GS1 US: Includes the key reference for meeting the DSCSA when using GS1 standards as compiled by members of the U.S. pharma supply chain.
U.S. wholesale distributors, Cardinal Health, and AmerisourceBergen: Includes their DSCSA websites and various documents from these companies explaining what they are expecting from their suppliers to help everyone meet the regulation on time.
RxTrace: Includes dozens of essays that break down and explain DSCSA concepts and technologies needed to meet the requirements.
Compliments of Systech: Download this free resource now and use it to learn what you need to do to meet ALL the DSCSA requirements through 2023.
You won’t find a more comprehensive list anywhere else.