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  • jwgilbreath

DSCSA —extension

Hello all!

I decided to put this blog here sort of as a place holder. This is just a reminder that the FDA has decided to extend the enforcment discretion date of DSCSA from November 27, 2023 to November 27, 2024. While this allows some "breathing room," this does NOT mean you should stop looking at the law and becoming compliant. The sooner you are compliant the better!


Jay G

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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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