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  • jwgilbreath

DSCSA Stabilization Period

Hello all!! Remember we are about to enter into the “stabilization period” established by the FDA for DSCSA compliance. This is November 20, 2023...that means on November 27, 2023 (I.e., one week and counting!) the stabilization period begins. This is 1 year time frame allowance.

What does this mean to you? As you remember one of my previous posts I discussed the period. You MUST move forward. Test your systems! Make sure you will fully be able to handle electronic interoperability! Don't stop! If you haven't talked with a third party company now is the time to get that moving. In fact, some third party companies may be offering specials/incentives during this stabilization period. Reach out and talk to them.

You cannot blow this off. Do your best!

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DSCSA Mid Point

Hello All! We are coming up to the midpoint of the FDAs stabilization period allowed for the industry to prepare for DSCSA compliance. Are you still moving forward? Testing your processes? At the 20

DSCSA—CDER NextGen Portal. Follow up

Hello all! So, as a follow up regarding the CDER NextGen Portal: As I stated in an earlier post, the portal is used as a communication tool especially if the FDA sends you a letter, email, etc request

Verification Systems —DSCSA

I know it's been a while since my last post...the holidays plus traveling a lot for work! So, the FDA did puboish new guidance in December related to "Verification Systems." Here is the link (you may


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