DSCSA—Small Dispensers
Hello all, On June 12, 2024, the FDA announced DSCSA exemptions for certain types of dispensers (i.e., “small dispensers”) until November...
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jwgilbreath
May 171 min
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. ...
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jwgilbreath
Feb 291 min
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...
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jwgilbreath
Jan 142 min
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...
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jwgilbreath
Dec 5, 20231 min
FDA CDER NextGen Portal Update
Hello all! I have been communicating with one of the FDA help lines for made clarity related to the CDER NextGen portal. The...
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jwgilbreath
Nov 29, 20232 min
FDA CDER Site for DSCSA
Hello all! So, FDA has added to their Centers for Drug Evaluation and Research (CDER) internet site (I.e., their "CDER NextGen" Portal). ...
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jwgilbreath
Nov 20, 20231 min
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...
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jwgilbreath
Oct 31, 20233 min
DSCSA and Ambulance Replenishment
Hello all! So one thing that has been asked of me is the following: How does DSCSA affect ambulance restocking/replenishment? Many of...
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jwgilbreath
Aug 31, 20232 min
DSCSA and Reconciliation
Hello all! I know I have been bombarding you with info regarding DSCSA last few days! I attended a Seminar that was solely discussing...
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jwgilbreath
Aug 30, 20231 min
DSCSA—November 27, 2024
Hello all! I'm attending the HDA traceability Seminar. Very interesting information. A couple FDA representatives are at the Seminar. ...
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jwgilbreath
Aug 27, 20231 min
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...
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jwgilbreath
Aug 20, 20231 min
More DSCSA
Sorry everybody.... I've been very tied up at work lately so have not been focusing on the blog. Decided to jump on and post a very,...
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jwgilbreath
May 27, 20233 min
DSCSA — Suspect and Illegitimate Products
Welcome back to the blog! Let's discuss one of the core reasons why DSCSA was formulated ...suspect and illegitimate products. FDA has...
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jwgilbreath
May 20, 20234 min
DSCSA—Path to November 27, 2023
Hello all! Previously, I gave an overview of DSCSA current state. Well changes are coming that will impact dispensers! Most of the...
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jwgilbreath
May 14, 20232 min
DSCSA compliance now vs. after Nov 27, 2023 —Trading Partners and T3 info.
So, let's briefly discuss a few matters related to how your site should be in compliance with DSCSA now. Changes for the future will be...
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jwgilbreath
May 11, 20231 min
DSCSA…what’s the purpose?
So, some of you may wonder why the Drugs Supply Chain Security Act (DSCSA) was passed through legislation. Nationally it was recognized...
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