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
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
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
Oct 8, 20232 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
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
Jun 22, 20231 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, 20236 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...
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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 24, 20236 min
Destruction of controlled substance documentation—- DEA form 41
Hello all! From time to time I've had questions regarding documentation of drugs that are destroyed by a registrant...ex. If you have a...
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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 17, 20233 min
Regulatory Body Visit (#2)
Hello All! Let's continue the discussion of how to be ready for a regulatory body visiting your sites. The regulatory body will expect...
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jwgilbreath
May 13, 20232 min
Regulatory Body Visit (#1)
As many of you have experienced the slight twinge in your stomach when someone presents to the pharmacy and says..."I'm from the Board of...
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jwgilbreath
May 11, 20231 min
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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