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...

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...

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!! Remember we are about to enter into the “stabilization period” established by the FDA for DSCSA compliance. This is November...

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

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...

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 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...

Hello all! Something a little new to discuss....I am not completely versed in these regs but thought they were interesting. Sort of a...

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...

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,...

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...