FDA DECISION DELAYED UNTIL 12/19/24 AT THE LATEST
From the Joint Report filed today in the Northern District of Texas:
"Joint Report: The parties believe that this case should continue to be stayed pursuant to the October 11, 2024 Order, and they intend, absent alternative direction from the Court, to file a further joint status report by the earlier of December 19, 2024, or within seven days of FDA’s decision on remand."
WHAT THIS MEANS: So, as of now, the new D-Day would be 12/19/24 assuming that the FDA issues their decision concurrently with the new deadline for the parties to file a joint status report. However, the FDA could still issue their decision sooner and I presume it would have the same effect as the 10/2/24 shortage decision.
In a nutshell, it means that compounding is safe...for now.
Edit: Adding screenshot from the Joint Report:
2nd edit to make 1 commenter happy: 12/19/24 is not a deadline for a decision. It is a deadline for a joint status report. The parties to the action could very well agree to a further stay of the case if the FDA reevaluation is still not complete. If it is complete, the decision by the FDA will presumably be issued on or before 12/19/24. I suppose I have enough faith in you all that would have been clear.