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 17
- 1 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 29
- 1 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
- Feb 11
- 2 min
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 14
- 2 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, 2023
- 1 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, 2023
- 2 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, 2023
- 1 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, 2023
- 3 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
- Oct 8, 2023
- 2 min
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
- Sep 26, 2023
- 1 min
DSCSA —where are you now?
Hello all!! With the FDA information about stabilization period for DSCSA in mind.... Are you pushing forward with your plans to be fully...
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jwgilbreath
- Aug 31, 2023
- 2 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, 2023
- 1 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, 2023
- 1 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 25, 2023
- 2 min
Pharmaceutical and Sharps Waste
Hello all! Something a little new to discuss....I am not completely versed in these regs but thought they were interesting. Sort of a...
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jwgilbreath
- Aug 23, 2023
- 3 min
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, 2023
- 1 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
- Jun 22, 2023
- 1 min
DEA form 106 —timeliness changes
Hello all! Big news! It has finally happened! DEA has placed a time frame on when DEA form 106s must be sent in! Also, forms must be...
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jwgilbreath
- Jun 10, 2023
- 6 min
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...
26 views0 comments
jwgilbreath
- Jun 1, 2023
- 1 min
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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