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In a plot twist worthy of a medical drama, the Food and Drug Administration announced late Friday that pharmacists can keep playing mad scientists with compounded versions of tirzepatide—yes, the very ingredient in the glamorous, yet overpriced, weight loss drugs Mounjaro and Zepbound—as they reevaluate whether it should remain on the “oops, we’re all out” list. Because nothing screams “trust us” quite like an agency that can’t decide what’s in short supply and when.
This shocking announcement is a major win for compounding pharmacists, who were understandably furious at the FDA’s prior proclamation on October 2 that they’d miraculously solved the tirzepatide shortage—while the only thing anyone else could find in their medicine cabinets was dust.
The plot thickens with the ongoing Bermuda Triangle of health trends: tirzepatide and its accomplice semaglutide (the key ingredient in those trendy weight-loss darlings Ozempic and Wegovy) have sparked an explosive demand for compounding pharmacies to create their own versions of these sought-after drugs. Patients, tired of their bank accounts feeling lighter than their bodies, complain the compounded alternatives come at a fraction of the price. Who knew that science could double as a coupon-clipping opportunity?
So, under FDA regulations, when there’s a shortage (or an illusion of one), compounding pharmacies can whip up “essentially a copy” of the brand-name drugs. Yet, the big drug companies have their tails in a twist over the legitimacy of this practice, claiming, “That’s not how our carefully cultivated business model works!”
Back in October, when the FDA shook things up by declaring the shortage resolved, pharmacists had to hit pause on filling those sweet, sweet tirzepatide prescriptions. They were given 60 days to work through existing orders like a bad sitcom plot—one where the punchline is just wondering if anyone ever really gets what they need.
Of course, the Outsourcing Facilities Association, an occupational union for compounding pharmacists, promptly responded to the FDA’s mixed signals by filing a lawsuit on October 7, claiming: “Uh, excuse us, but this drug is still as scarce as a unicorn in a desert!”
Cue the dramatic FDA filing on Friday, responding to the lawsuit with the grace of a lifeguard in a kiddie pool. They suggested that for now, they won’t go after pharmacists for making those rogue compounded versions while they sort through this hilarious mess of contradictory declarations.
Speaking of patients, let’s meet Simone Williams, 50, of Spartanburg, South Carolina. Simone was understandably “deeply upset” about the FDA’s earlier restriction on tirzepatide, as she had turned to compounded versions after her savings card for the pricier Mounjaro expired. Because, as we all know, $1,060 a month is just a small price to pay for wellness in America—if you happen to be an oligarch.
Now, thanks to recent developments, she’ll just need to “play switcheroo” with compounded semaglutide instead, which is still as elusive as a well-behaved toddler at a birthday party. But, hey, at least the FDA’s latest update is “good news,” if one can ignore the lingering paranoia that the FDA might revoke its own lifesaver announcement at a moment’s notice.
Is tirzepatide really in shortage?
For nearly two years, tirzepatide was the main character on the FDA’s drug shortage list, initially debuting as the diabetes treatment Mounjaro, then later ascending to weight-loss stardom as Zepbound. With all that instant fame, it’s no wonder the shortages quickly spiraled into a full-blown soap opera. When Lilly finally declared their triumph over shortages last year, you could practically hear the collective gasp of patients everywhere wondering if they’d be left to improvise their health solutions.
In a bid to silence the chorus of complaints, Lilly has since rolled out plans to build more manufacturing facilities than a villain in a Bond film. They’re just trying to cash in on those alluring GLP-1 dollars, while patients continue to wonder if their medications will come from the moon or just the local compounding pharmacy down the street.
Despite the fervent claims from drugmakers that tirzepatide is no longer scarce, Michael Ganio, a pharmacy practice expert, mentioned the ongoing confusion means it might just take a few weeks for the drug supply to balance out. Translation: “We’ll get this figured out right after we finish counting how many licks it takes to get to the center of a Tootsie Pop.”
Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic, pointed out that this isn’t really about the drugs’ scarcity; it’s more about how many zeroes can be added to the balance sheet. “It’s about money,” he said, nudging those dollars like they’re a strategic pawn in a chess match. Compounding pharmacies are keen on continuing to sell while the big pharmaceutical companies insist there’s nothing to see here, folks.
Lilly’s spokesperson weighed in, attempting to squash the fears of all patients with logical assurances that everything is endearingly available and that untested, low-quality knockoffs can’t possibly compare. We’re paraphrasing a tad, of course—there’s a chance they didn’t mean “just roll the dice with the compounding versions” in such friendly terms.
Meanwhile, both the FDA and patients are combining their extensive dance of confusion about whether medication prices or availability is legal to regulate together. A spokesperson said, “We’re all frustrated here! But hey, our hands are tied like a magician’s assistant!”
‘Peace of mind’
For the moment, amid all the corporate drama and confusing announcements, compounding pharmacists and eager patients are raising a toast to the unexpected continuation of their little experiment with tirzepatide. The Outlandish Facilities Association (which sounds suspiciously like a clickbait title) declared itself “relieved” that its members can keep practicing their mad science without fear of state-driven intervention—for now, at least.
And Elizabeth Kenly, 59, of Graham, North Carolina, can breathe a little easier knowing she won’t have to search for a Plan B anytime soon, thanks to the compounding pharmacists who’ve helped her shed 30 pounds. “My lifeline is now confirmed!” she must have thought, in the midst of wishing the mega pharma world would notice regular people need these therapies too. Alas, back to the drawing board for the drug companies—maybe this time, they can pick the right patients to exploit.
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