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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

Earlier this week APC received a letter from the FDA explaining the agency’s concerns regarding dosing and patient usage of compounded semaglutide and tirzepatide.

The letter brings up an issue (actually three related issues) that have come up in the FDA’s analysis of reported adverse events related to compounded GLP-1s. We’re not talking about pop-up fake pharmacies — these were dispensed by state-licensed pharmacies.

1. Prescribers of compounded GLP-1s started patients on doses that were approximately two to four times higher than the recommended starting doses.
2. Compounded semaglutide products were prescribed to be administered twice a week instead of once weekly.
3. Prescribers titrated the patients’ doses every one to two weeks instead of every four weeks.

Granted, the issues the FDA raised relate to prescribing errors, but obviously pharmacists have a critical role to play in counseling patients on dosing — especially in a day and age when some of those patients are getting guidance on their GLP-1 drugs from social media. As APC CEO Scott Brunner put it, “That’s just dangerous.”

“Pharmacists have an obligation when they see a dosing error in a prescription to contact the prescriber and alert them to the problem,” Brunner said. “And of course they can and should educate patients about proper dosing. Clearly that’s particularly important in these cases.”

In the next few weeks, APC will be issuing a guide to GLP-1 best practices that will provide more detailed information for compounding pharmacists. Until then, keep in mind those three issues the FDA outlined. Urge your patients to listen to your guidance, and even intervene with prescribers when possible.

As the final gatekeepers of patient health and safety, remember that it’s your duty to stand up and speak out.