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• CALL TO ACTION: Tell FDA to deny drugmakers’ request

  Drugmakers are urging FDA to prohibit compounded GLP-1s. FDA needs to hear from you and your patients NOW! read more →

• APC to FDA: Just say no to Lilly

  This week APC's lawyers sent a formal comment to the FDA about Eli Lilly’s request that tirzepatide be added to the Demonstrably Difficult to Compound list. read more →

• California BOP sends proposed compounding regs to comment period

  The California State Board of Pharmacy decided to move the modified proposed sterile compounding regulations forward to a 30-day comment period. read more →

• Checking in on the post-Chevron fallout

  What’s happened in the world of federal regulation since the end of Chevron? read more →

• Hi, Noom!

  Welcome to our newest Bronze-level Corporate Patron, Noom! read more →

• PFMs can get 2.5% credit card processing

  A new benefit for APC’s Pharmacy/Facility Members: They may be able to cut their credit card processing fees to just 2.5% – 2.8%. read more →

• Phoenix compounders, rise!

  The latest of APC’s new regional meetings — CompoundED UpDATE — is coming to the Phoenix area December 5. read more →

• APC election results: directors and bylaws

  See the results of APC's elections, including four new directors and several changes to our bylaws. 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PCAC will also discuss whether to recommend adding certain drug products containing hydroxyprogesterone caproate to the Withdrawn or Removed List.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.