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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

The recent withdrawal of Makena by the FDA has created complications for pharmacy compounders, particularly regarding the use of hydroxyprogesterone.

While hydroxyprogesterone has a USP monograph and is not on the list of drugs withdrawn for safety or efficacy at this time, it seems likely that it will be added to the list due to the reason for Makena’s removal from the market.

The FDA’s FAQs on the substance are correct from a strict reading of the law, but the issue lies in how compounding as a whole will be viewed if pharmacies continue to make a drug that the FDA panel has said doesn’t work and ultimately led to the removal of a similar drug from the market.

At present, it is unclear whether the FDA plans to officially put hydroxyprogesterone on the list of drugs withdrawn for safety or efficacy, and even if they did, it may not materially change the current situation.

Ongoing, it is essential that compounding pharmacies closely monitor any changes in the FDA’s list of drugs withdrawn for safety or efficacy and adjust their practices accordingly to ensure that they are providing the best possible care for their patients.