With the overwhelming number of events and things happening in the US Rx Supply Chain, many manufacturers to Rx dispensers are asking this question.
There are many who will mention the requirements for barcodes being well established, statutorily required and still unfolding that they feel means there is a decision to be made between the approaches. Our belief is that manufacturers should not let the expected long term use of barcodes prevent the avenues of the significant number of benefits that are increasing all the way to the point of dispense. …
We know there is a lot of information to process and wanted to share our notes from the review of the larger organizational comments submitted.
With the passing of the important deadline of submitting comments for the FDA Guidance (Enhanced Drug Distribution Security at the Package Level Under DSCSA), we hope all stakeholders will take time to carefully review all the informational packed comments. With 29 comments submitted so far (not including any added later through mail or other delayed posting) interest in the topic is growing and you can sense the importance of industry, regulatory and agency alignment.
Comments…
We encourage any US Rx stakeholders to join to hear the latest on FDA’s plans for the important DSCSA 2023 that is just 26 months away!
Based on the recent significant number of comments on the FDA related draft guidance on enhanced DSCSA and the variety of opinions on the progress and direction towards interoperability, there is a clear need for more stakeholders to understand, engage and participate in the road to November 27, 2023.
As was pointed out in many of the comments, DSCSA requires a significant level of collaboration to understand the requirements of each sector and ensure…
We are excited to share our new & improved website that includes an updated services menu and news page for the latest on all things DSCSA and pharmaceutical supply chain.
Check out our new page at www.tencountconsulting.com !
We would like to thank Aleberry for their creative and website design efforts!
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The US pharmaceutical supply chain is undergoing increasing innovation and disruption including the DSCSA (Drug Supply Chain Security Act). DSCSA is a law passed in 2013 to serialize and enable tracking features for most prescription drugs. …
