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Both Eli Lilly and Novo Nordisk have recently taken legal action against companies selling compounded versions of drugs, often alleging trademark infringement. Novo Nordisk has filed 21 lawsuits since last summer. This June, Eli Lilly launched six lawsuits, followed by another 10 the drug company launched last fall. In one suit filed against a company selling compounded GLP-1s online, it alleged that presenting compounded drugs as having the same active ingredients as its products is “not only deceptive — it’s also dangerous.”

“Telehealth providers and compounding pharmacies that are offering or selling unapproved compounded products claiming to contain ‘semaglutide’ are likely obtaining their ingredients from entities other than Novo Nordisk,” Novo Nordisk spokesperson Jamie Bennett told WIRED. cautioned“The unapproved compounded ‘semaglutide’ medicines do not have the same assurances of safety, quality, and effectiveness as Novo Nordisk’s FDA-approved semaglutide medicines, and patients should not use the compounded medicine if an approved medicine is available.”

“There are huge safety implications,” says Ryder. In 2012, a compounding pharmacy caused a fungal infection meningitis outbreak The incident killed at least 64 people, making it one of the worst drug-contamination disasters in the United States. The supervisory pharmacist who oversaw the manufacture of the drug was sentenced to prison, and the incident led to tightening of monitoring and licensing requirements for compounders.

Some major compounding pharmacies that make GLP-1 drugs have run into trouble over their practices. Hollandale Pharmacy, a popular supplier — two of my four vials came in its sleek blue packaging — has run into trouble Trouble with regulators for past violations, which included concerns over record keeping and the condition of the facility. Warning letters received from the FDA, although it was last closed in May 2022, meaning the FDA found it had addressed the pending issues. (Hollandale declined requests for comment.)

However, the FDA has also found some problems with pharmaceutical companies. In 2023, FDA inspectors have also found some problems with pharmaceutical companies. found Bacterial contamination at a Novo Nordisk production plant in North Carolina. “Leadership addressed this immediately, and the site received FDA approval for full production for market in August 2023,” says Novo Nordisk’s Bennett.

Compounding advocates say that, although these drugs are not FDA-approved, they are still subject to rigorous quality control, in part because of changes in regulations since 2012. For example, Carroll says Hims did its “due diligence” when choosing its pharmacies and is satisfied with the quality of the drugs. “We’ve seen a very good response from our customers,” he says. “No unpleasant side effects that we didn’t expect.” According to Carroll, Hims hasn’t had to report any adverse effects to the FDA.

What will happen next?

As researchers continue to discover new potential use cases for GLP-1 drugs, and public interest and demand remain high, these drugs could remain on the FDA’s official shortage list for months or years to come. If a shortage occurs, one type of compounding pharmacy (called a 503a) must stop production immediately, while 503b pharmacies, which typically produce at a larger scale, there will be 60 daysEnding the shortage will require some significant changes in this burgeoning cottage industry. None of the telehealth companies that sent compounded semaglutide to WIRED mentioned what might happen in this scenario during the intake process.

Many people taking compounded medications may be surprised if they are told they will have to switch to branded medications within a few months — and pay a higher price.

However, even when the shortage is officially over, at least some telehealth companies don’t plan to back off from compounding. “We believe the demand for the drug will continue to grow even more, so it could make the shortage list even longer,” says Hims’ Pat Carroll. “We’re confident there’s a path to supply these compounded drugs, even if it comes off the shortage list.”

Even skeptics suspect this isn’t going to end anytime soon. With demand so high, Ryder suspects pharmaceutical companies will need to ramp up production to serve “basically 40 percent of the U.S. population” before the shortage ends. Until then, Ryder suspects this telehealth boom will continue unabated.

For now, the vials of compounded semaglutide that Wired ordered sit untouched in the back of the fridge.