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• 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 →

• Education (and CE) from USP

  For the fourth year in a row, USP will be holding a hybrid live/virtual workshop dedicated to improving the quality of compounding. read more →

• Compounding post-Chevron

  At least three issues affecting pharmacy compounding might be affected by the overturning of the decades-old “Chevron doctrine.” read more →

• 503B sourcing: our state-by-state analysis

  Do you work for one of APC’s PFMs? If you’re with a Pharmacy/Facility Member, you’ve got access to a new resource. read more →

• What we’ll be talking about at CCH

  When we get together on Capitol Hill to meet with legislators and their staffs, as much as we’d like to talk about a half-dozen issues (easily!), we’re going to be focusing on the three most important.  read more →

More News

As Chairman Grzib wrote in last week’s Compounding Connections, three state boards of pharmacy recently issued licensee communications that contained incorrect information about FDA guidance on shortage drug compounding by 503A pharmacies.

FDA guidance states that if a drug is listed as “currently in shortage”—that’s the exact language—it may be compounded. While the FDA website is confusing in that it does speak of availability of certain drugs, availability is not mentioned in the FDA guidance. “Currently in shortage” is the determinative language, and as of this writing, semaglutide remains in that category. (To assure compliance, we advise that licensees compounding semaglutide should refer to the FDA drug shortage list daily; a substance’s status on the list can change without notice.)

In this matter, APC’s concern is not so much about semaglutide compounding in particular. Rather our concern is that states may misread FDA guidance and apply that misreading to the compounding of other FDA-approved drugs in shortage in the future.

Last Thursday, at APC’s urging, FDA sent a letter to NABP, to be shared with state boards of pharmacy, clarifying the issue described above. The FDA letter also included a statement on compounding of semaglutide sodium.