Hello all…   As you may have already heard, the FDA has announced more exemptions for authorized trading partners. For this post I will...

Hello all, On June 12, 2024, the FDA announced DSCSA exemptions for certain types of dispensers (i.e., “small dispensers”) until November...

Hello All! We are coming up to the midpoint of the FDAs stabilization period allowed for the industry to prepare for DSCSA compliance. ...

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...

Hello all! Shifting gears from DSCSA! So, the final rules have officially been implemented surrounding OUD treatment. For context...it...

Hello all! I have been communicating with one of the FDA help lines for made clarity related to the CDER NextGen portal. The...

Hello all! So, FDA has added to their Centers for Drug Evaluation and Research (CDER) internet site (I.e., their "CDER NextGen" Portal). ...

Hello all! So one thing that has been asked of me is the following: How does DSCSA affect ambulance restocking/replenishment? Many of...

Hello all!! With the FDA information about stabilization period for DSCSA in mind.... Are you pushing forward with your plans to be fully...

Hello all! I know I have been bombarding you with info regarding DSCSA last few days!  I attended a Seminar that was solely discussing...

Hello all! I'm attending the HDA traceability Seminar. Very interesting information. A couple FDA representatives are at the Seminar. ...

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...

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...

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...

Exciting news! PPPMag has stated they want to publish an article I wrote about regulatory readiness. Hopefully you will see it sometime...

Welcome back to the blog! Let's discuss one of the core reasons why DSCSA was formulated ...suspect and illegitimate products. FDA has...

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...

Hello all! Previously, I gave an overview of DSCSA current state. Well changes are coming that will impact dispensers! Most of the...

Hello All! Let's continue the discussion of how to be ready for a regulatory body visiting your sites. The regulatory body will expect...

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...