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
Feb 112 min read
Updates to Regulations Affected By Controlled Substance Act—Opioid Use Disorder (OUD)
Hello all! Shifting gears from DSCSA! So, the final rules have officially been implemented surrounding OUD treatment. For context...it...
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jwgilbreath
Jan 142 min read
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
Nov 20, 20231 min read
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 read
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
Oct 8, 20232 min read
Hello all!—keep a watch on this! Fioricet
As many of you may be aware, DEA is considering removing Fioricet from the DEA exemption list. As of October 8, 2023, it is still listed...
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jwgilbreath
Aug 31, 20232 min read
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 27, 20231 min read
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 23, 20233 min read
DEA Visits
Hello all! I can tell you that the DEA has been active in the last month or so. There have been 4 hospitals and 1 retail site that I...
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jwgilbreath
Aug 20, 20231 min read
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
Jun 10, 20236 min read
Theft and Loss—Controlled Substances
Hello all! It's been a while since I posted. I've been very busy at work plus traveling a lot. Let's focus on something more simple and...
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jwgilbreath
Jun 1, 20231 min read
PPPMag
Exciting news! PPPMag has stated they want to publish an article I wrote about regulatory readiness. Hopefully you will see it sometime...
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jwgilbreath
May 11, 20231 min read
What is a regulation?
According to Merriam-Webster's dictionary, a regulation (in the context of this blog and page in general) refers to: a. an authoritative...
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