Hello all!
I'm attending the HDA traceability Seminar. Very interesting information. A couple FDA representatives are at the Seminar. They spoke on DSCSA including the November 27, 2024 enforcement discretion matter. So, FDA is branding this as a "Stabilization Period."
What does this mean? Well, you may not have findings for the next year and a few months, BUT this does not stop the responsibility requirements. First off, you need to move forward without delay on your plans. Remember that even NOW you must have many things in place such as your SOP related to DSCSA. Make sure you are following it. You should be investigating suspect products. Only purchase items from trading partners you have verified, etc. I recommend reading some of my previous post on DSCSA to get a more broad picture of requirements.
If you planned to hold off on a third-party solution with this delay, don't! Move forward! Get everything in order. Be ready for the drop dead enforcement date.
Thanks all!
Jay G.
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