Millions of people are taking compounded weight loss drugs. Now they're about to disappear.

Compounding pharmacies will have to stop producing copycats of tirzepatide, the active ingredient in the blockbuster weight loss drugs Mounjaro and Zepbound, in a matter of days. That’s because a federal judge has ruled that compounding pharmacies can’t keep making copies of the drug now that it’s no longer in shortage.

The order could spell trouble for Americans taking more affordable, compounded tirzepatide, many of whom get the medication from telehealth providers such as Ro, Mochi and Eden. Tirzepatide is approved by the Food and Drug Administration (FDA) for treating type 2 diabetes and obesity, akin to other GLP-1 medications such as semaglutide. The days of cheaper versions of both popular medications may be numbered. The FDA is giving makers of compounded semaglutide, the active ingredient in Ozempic and Wegovy, until April 22 to stop making the drug.

Meanwhile, customers taking these medications are receiving confusing messages from their providers. Some are being told their prescriptions won’t be affected. Others are being told nothing at all. So what is going on? We tried to find out.

What's happening?

On Mar. 5, a judge denied a request from the Outsourcing Facilities Association (OFA), an industry group for compounding pharmacies, to block the FDA’s attempt to stop the production of compounded tirzepatide. Generally, making copies of brand-name drugs is not legal until their patents expire. But there are exceptions: Compounding pharmacies can fill the gap when a drug is in shortage.

The FDA declared the tirzepatide shortage over in October, a move that theoretically should’ve made most compounded versions illegal. Instead, their legal status has been in limbo since the OFA sued the FDA, claiming that the end of the shortage was declared prematurely. But a federal judge isn’t buying it. Compounding pharmacies now have until March 19 to stop making tirzepatide, according to the FDA’s latest guidance.

A parallel legal battle is playing out over compounded semaglutide — the active ingredient in Ozempic and Wegovy — but the court case remains ongoing. Smaller compounding pharmacies will have to stop making compounded semaglutide on April 22. Larger compounding facilities that mass-produce the drugs have until May 22.

No more compounding of ‘commercially available doses’

Compounding pharmacies do two things: They create copies of medications that are in shortage, and they make bespoke versions of medications for individual patients who need special doses or formulations that aren’t commercially available, Scott Brunner, CEO of the Alliance for Pharmacy Compounding (APC) explains. Those are critically important functions when shortages of drugs like antibiotics arise or when a patient can’t take a standard form of a medication.

But the FDA’s order clearly means compounders can’t make copies based on now-resolved shortages. Still, companies prescribing compounded GLP-1s now seem to be trying to justify the prescriptions based on compounding’s second purpose: a need for customized versions of the drugs. If a patient requires a dose of an FDA-approved medication that’s not mass-produced, compounders can legally make it, regardless of shortages. The same is true when, for example, a patient is allergic to an ingredient in an FDA-approved drug and needs a version of it made without that component.

In an interview with Yahoo Life, a spokesperson for the telehealth company Hims & Hers says the new order would not apply to its “non-commercially available compounded doses” of its semaglutide, meaning customized versions of the medications. And in messages sent to a client on Mar. 10 and shared on Reddit, Hers said, “As you are on a personalized dose, this announcement [of the end of the semaglutide shortage] does not directly impact your subscription, and your affiliated pharmacy will be sending your next prescription refill as scheduled.” Users of other telehealth platforms received similar messages.

But by March 12, some Hers users were receiving a different message: Their subscriptions will be canceled, with a refund, in May because they have been taking a commercially available dose. That was fairly panic-inducing for the customer who shared the communication she’d received from Hers on Reddit. She captioned the screenshot she shared: “What am I going to do?!?!” Meanwhile, some compounded GLP-1 users are trying to prepare by stockpiling, taking advantage of providers’ offers to prescribe six months' worth of refills. A subset of those people are trying to wean themselves off of tirzepatide even though GLP-1s are intended for long-term use.

A potential loophole

Patients and experts alike are wondering if compounding purportedly personalized GLP-1 doses might make producing the medication legal beyond the FDA’s spring deadlines, says Brunner. But the FDA allows these kinds of bespoke doses only when they make a “clinical difference” for the patient. Brunner notes that many providers are already writing prescriptions for compounded semaglutide with B12 or B6 mixed in, because the vitamins may reduce side effects to GLP-1s.

Brunner says that prescribers may argue this is a custom formulation their patients need. Hims & Hers hinted that the company’s providers may utilize that approach. “We offer personalized care, which can include customized treatments and compounded medications when a provider deems it clinically necessary,” a company spokesperson said in a statement emailed to Yahoo Life. “Everybody is debating, ‘Does B12 really make a clinical difference?’” says Brunner. If so, that’s “absolutely allowed” by the FDA, and the agency is unlikely to interfere, he says.

But when huge numbers of patients — which, Brunner estimates, is on the order of millions — suddenly need these personalized formulations, it’s likely to catch the attention of litigious drugmakers. “It’s a legal risk to compounding pharmacies" that could face lawsuits from massive companies: Novo Nordisk and Eli Lily. So prescribing these purportedly “custom” compounded injections is “a practice that is worrisome, and it’s worrisome because it positions compounding in a way that it was not intended to be, and I believe, frankly, that it pokes the bear.” The bear here is large pharmaceutical companies. The poker is the cottage industry that has sprung up around compounded weight loss drugs. “Compounding is not intended to be competition for FDA-approved drugs,” Brunner says. “But if compounding looks to be competition, drug makers are going to use every weapon at their disposal to push back.”

Compounding pharmacies, he insists, don’t want to be competition and “are trying to alert patients to the fact that, if they’ve been taking a compounded copy of a [GLP-1] drug, that era is coming to an end.” It’s a hard reality for patients to accept. Online, some wonder what’s different now, months after the shortage was declared over. But at least one provider echoes Brunner’s warning that this time really is the end of most tirzepatide compounding and that the same fate awaits compounded semaglutide.

“I’m angry about it,” Lisa Hallock, a Hers compounded semaglutide customer, tells Yahoo Life. She is grateful to the company for providing unprecedentedly effective weight loss medication at a cost she can afford. But she doesn’t know what option she’ll have if she can’t take compounded semaglutide. She didn’t realize that some doses of compounded GLP-1s wouldn’t be available to her once the semaglutide shortage ended.

Hallock says it will strain her budget if she has to switch to brand-name semaglutide. “Even if I say, ‘OK, I’m going to pay $500 a month [for it],’ most people cannot do that,” she says. “I don’t think it’s fair, and I don’t think it’s right.” But, legally speaking, affordability is not a gap that compounding pharmacies are supposed to fill. It never was. “What is clear is that some telehealth platforms are absolutely utilizing price as a lever in this debate,” says Brunner. “That puts compounding into a situation it was never intended to be.”

So what’s a patient to do?

It’s all but inevitable that many people currently taking compounded GLP-1s soon won’t be able to get weight loss medications, Brunner says. It’s a stressful time, but Katie Rickel, a psychologist who counsels patients about weight loss, shared some tips for riding out the uncertainty:

1. Don’t panic. She notes that high-stress situations can cloud your thinking and lead to rash, potentially unsafe decisions. “Take a day or two to breathe, and then evaluate your next steps,” says Rickel.

2. Talk to your current prescriber. Rickel warns against the temptation of consulting “Dr. Google” or going on a “solo scavenger hunt” for compounded GLP-1 refills. Your prescriber will be able to point you in a better, safer direction. “You are likely not their only patient affected, and so they may have a solution for you as well,” Rickel says.

3. If it looks too good to be true, it probably is. “Especially when you are feeling desperate, it can be easy to fall for schemes, gimmicks and scams,” says Rickel, “and the weight loss industry, unfortunately, is filled with ‘quick fixes.’” So be careful that you don’t commit to buying or subscribing from any unreliable sources. Here, again, your prescriber or doctor can likely help.