Big Buttons

• 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 will be holding a virtual meeting of its Pharmacy Compounding Advisory Committee, open to the public, on Wednesday, June 9, 2021, from 10:00 am to 5:05 pm EDT.

Agenda: “The committee will discuss the following four bulk drug substances nominated for inclusion on the 503A Bulks List: Choline chloride, oxitriptan (also known as 5-hydroxytryptophan or 5-HTP), melatonin, and methylcobalamin.” It will also discuss adding neomycin sulfate to the Withdrawn or Removed List.

You can find more information on the announcement page, and you can submit comments on the meeting (by June 8, 2021) — follow the instructions on Regulations.gov.

APC will be developing input for the committee on at least two of the nominated substances. If you have suggestions, please direct them to scott@a4pc.org.