Summary of FDA DSCSA 2023 Draft Guidance Comments

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Comments on the draft guidance range from some minor suggestions for clarification, significant suggestions to improve the guidance to recommendations for the FDA to withdrawal the draft guidance. We welcome your feedback or comments or links to any other summaries. It is impossible to summarize the suggestions in a short blog post and we strongly encourage reading the details to understand the points being raised and ones that might be of concern for your organization.

We apologize for the 18 comments that we did not summarize but tried to focus on mostly trade groups that were representing significant portions of sectors.

Please feel free to add to the document or send us any updates to consider.

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These notes are provided for free use without copyright and meant to summarize the comments in the documents to the best of our ability but are not a complete representation of the documents and are not intended to be legal or business advice.

Our hope is that the documents will help inform the reader in the importance of making time to read all the comments and engage with the industry!

https://drive.google.com/file/d/1b6btBD3zUyJIUQVeKrBcO9pgspkMtqRF/view?usp=sharing

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The original comment documents can be found here:

https://www.regulations.gov/docket/FDA-2020-D-2024

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