From Boom to Bust in Compounded GLP-1 Medicines

Electric LampIf you wonder why the Obesity Action Coalition, Obesity Medicine Association, and the Obesity Society all warn against using compounded versions of GLP-1 medicines for obesity, consider the boom and bust story of ACA Pharmacy in Nashville, Tennessee. After semaglutide went into shortage in 2022, it began doing a booming business with a compounded version of that GLP-1 agonist.

Then tirzepatide joined the FDA drug shortage list and by early 2023, compounded versions of these two GLP-1 agonists were generating a small fortune for ACA Pharmacy, dominating its business.

Then in July, the business went from boom to bust and closed.

Disciplinary Order from the Tennessee Board of Pharmacy

Ned Ashley is chief executive of ACA’s parent company, Rx Partners. He calls the decision to shut down this business “nuanced and multifaceted.”

But then there’s the disciplinary order issued by the Tennessee Board of Pharmacy on August 4 of last year. It called for the business to voluntarily surrender its license for sterile compounding. The order is vague about specific violations, but goes into detail about the retraining and other measures related to maintaining sterility and quality that would be necessary if the pharmacy ever wanted to resume its business in sterile compounding.

A Stressful Inspection and a Suicide

The Washington Post reports that the pharmacy went through a stressful inspection in late July:

“The sterile-compounding director had left the previous month, and employees struggled to answer the inspectors’ questions, according to one employee who was there. One pharmacy technician who didn’t work in compounding walked into the sterile area of the lab, prompting questions from inspectors about whether she had followed proper protocols, this person said.

“Brantley Wescott, Rx Partners’ chief operating officer, died by suicide three days later. Ashley said Wescott also oversaw ACA’s operations. He told police that Wescott had struggled with anxiety but he hadn’t known Wescott to be depressed. Ashley added that a recent pharmacy audit ‘was stressing [Wescott] out,’ according to a police report.”

“Nuanced and multifaceted” is one way to describe this situation. But a simpler description might be more apt. It was a terrible mess. And thus, the boom of a sketchy business in compounded GLP-1 medicines became a bust.

This is a cautionary tale for anyone who might be tempted to try dubious versions of these important medicines.

Click here and here for more from the Washington Post. For further perspective, click here.

Electric Lamp, painting by Natalia Goncharova / WikiArt

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January 16, 2024