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• PCAC to discuss 503A bulks list substances

  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.  read more →

• Next APC regional meeting: Seattle

  The latest of APC’s new regional meetings — CompoundED UpDATE — is coming to the Seattle area October 3. read more →

• Don’t skip EduCon’s final (fantastic) session(s)

  The final session of this year’s EduCon is coming up in just a few weeks, and it’s a special double helping of legal goodness. read more →

• Welcome, new PFMs!

  We’ve added 31 Pharmacy-Facility Members since February! read more →

• Let’s talk about that Lilly announcement

  There’s been plenty of coverage of Eli Lilly’s announcement this week that it will sell vials of Zepbound directly to consumers at a discount. But the company seems to have left out a few important caveats. read more →

• Our response to the op-ed in The Hill

  The Hill published an editorial by Dr. Kenneth McCall titled “Fake, unsafe weight-loss drugs are a worsening public health dilemma” in which he makes unfounded claims about pharmacy compounding. Here’s the response from our CEO. read more →

• The shortage ends … then what? (Find out at CCH) 

  We’ve added a new session to the Compounders on Capitol Hill lineup. Don’t miss the discussion of what’s on many a compounder’s (and regulators’ … and reporters’...) mind. read more →

• A new bronze corporate patron

  A big welcome to Ro, APC’s newest tier-level corporate patron! 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PCAC will also discuss whether to recommend adding certain drug products containing hydroxyprogesterone caproate to the Withdrawn or Removed List.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.