Supply chain businesses nationwide are rushing to implement operational changes in order to meet upcoming FDA Drug Supply Chain Security Act deadlines. This process has been a struggle for many due to the complexity of this legislation. Different business types must follow different portions of the rule in regards to reporting, registering and much more. The Food and Drug Administration released a new draft to answer some of the most frequently asked questions from third party logistics and wholesale distribution operations. This report is an update to a previously published 2014 draft. It is the intention of the FDA that these drafts are viewed together. This Q&A supplemental provides clarification based on the most frequently asked questions and comments received after the publication of the Annual Reporting draft guidance.

It is critical to clearly understand how these changes will affect your operation as any error in reporting or filing can result in significant penalties. Take advantage of these detailed tools provided by the FDA to ensure your operation is prepared before reported deadline dates. For more information on technologies to aid in pharmaceutical regulatory compliance contact Datex experts today at or 800.933.2839 ext. 243.


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