FDA’s Pharmacy Compounding Advisory Committee has announced that it will hold two meetings (!) between now and year-end to consider recommending several bulk drug substances to the 503A Bulks List.
Two meetings in a row? Like the Mets in the World Series, it does happen once in a while. It’s nice to see, of course, but it catches everyone by surprise.
PCAC will meet on October 29 (from 8:00 am to 5:00 pm) to discuss:
PCAC will also discuss whether to recommend adding certain drug products containing hydroxyprogesterone caproate to the Withdrawn or Removed List. (You might recall this as Makena, a drug intended to prevent preterm birth. It was given accelerated approval, but after further studies suggested it had no benefit, the FDA withdrew that approval.)
The following PCAC meeting, set for December 4, will discuss recommending the following for inclusion the 503A bulks list:
If you follow these things (as APC always does), you might remember that Evexias et al., which includes APC PFM member-pharmacy Farmakeio, filed a lawsuit against the FDA regarding the (fairly arbitrary) September 2023 classification of four of the peptides mention above — ipamorelin, AOD-9604, thymosin alpha-1, and CJC-1295 — as Category 2 drugs and thus off limits for compounding.
Now — perhaps as a result of that Evexia lawsuit? — it seems willing to take another look via the PCAC process. Editorially, we’d add that the PCAC process is how they should have proceeded on several of these substances in the first place. Stay tuned.