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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 27, 20233 min read
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 read
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 19, 20234 min read
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 read
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 14, 20232 min read
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 13, 20232 min read
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 read
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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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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