New Exemptions..DSCSA-October 2024
Hello all… As you may have already heard, the FDA has announced more exemptions for authorized trading partners. For this post I will...
top of page
Search
jwgilbreath
Jun 144 min read
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...
14 views0 comments
jwgilbreath
May 171 min read
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. ...
14 views0 comments
jwgilbreath
Feb 291 min read
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...
8 views0 comments
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...
9 views0 comments
jwgilbreath
Dec 5, 20231 min read
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...
15 views0 comments
jwgilbreath
Nov 29, 20232 min read
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). ...
24 views0 comments
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...
29 views0 comments
jwgilbreath
Sep 26, 20231 min read
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...
14 views0 comments
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...
18 views0 comments
jwgilbreath
Aug 30, 20231 min read
DSCSA—November 27, 2024
Hello all! I'm attending the HDA traceability Seminar. Very interesting information. A couple FDA representatives are at the Seminar. ...
27 views0 comments
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...
46 views0 comments
jwgilbreath
Jun 22, 20231 min read
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...
44 views0 comments
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...
27 views0 comments
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...
4 views0 comments
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...
9 views0 comments
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...
16 views0 comments
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...
36 views0 comments
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...
4 views0 comments
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...
12 views0 comments
bottom of page