Big Buttons

• FDA doubles down: Tirzepatide is off shortage

  ...but that doesn't mean the issue is completely settled. read more →

• A couple of state updates

  Good news from Alabama, but a problem in Massachusetts read more →

• Defending GLP-1 compounding

  The latest letters APC's been sending to oppose efforts to restrict compounding read more →

• Thumbs-up for FDA crackdown

  APC was thrilled when the FDA announced it was taking action against illegal online businesses claiming to sell “research-grade” compounds. read more →

• A PANS/PANDAS explainer

  For your patients: Information about a couple of underdiagnosed pediatric mental health conditions read more →

• What, a year?

  In the final board chair column of the year, here are our top 7 accomplishments in 2024. read more →

• “Simply not a rational approach to regulating an industry”

  This week APC offered its final (and pointed) suggestions to the California Board of Pharmacy on their proposed significant – and we would say unjustified – changes to their compounding regulations. read more →

• Get a cease and desist letter from Verrica?

  APC has heard reports from several pharmacies that have received them — here's what to know. read more →

More News

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: 

• Ibutamoren mesylate
• L-theanine
• Ipamorelin-related bulk drug substances (Ipamorelin acetate and Ipamorelin (free base))
• Kisspeptin-10

PCAC will also discuss whether to recommend adding certain drug products containing hydroxyprogesterone caproate to the Withdrawn or Removed List.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:

• AOD-9604-related bulk drug substances (AOD-9604 acetate and AOD-9604 (free base))
• Several CJC-1295-related bulk drug substances 
• Thymosin alpha-1-related bulk drug substances (e.g., thymosin alpha-1 acetate and thymosin alpha-1 (free base))

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.