“Telephone providers and compounding pharmacies that claim to supply or sell unapproved products that claim to contain ‘semaglutide’ source their ingredients from organizations other than Novo Nordisk,” a Novo Nordisk spokesperson said. Nordisk’s Jamie Bennett told WIRED. “As the FDA has warned, the unapproved semaglutide drug does not have the same safety profile, quality and efficacy as Novo Nordisk’s FDA-approved semaglutide drug, and patients should not use combination drugs if there is an approved drug available.”

“There are major safety implications,” Ryder says. The chief pharmacist who oversaw the drug’s manufacture was sentenced to prison, and the incident led to increased oversight and licensing requirements for the drug. chemical.

Some of the compounding drugs that produce GLP-1 drugs have run into problems for their mechanisms. Hallandale Pharmacy, a well-known retailer—two of my four bottles are packaged in its blue-green packaging—has run into trouble with cosmetics regulators in the past, which included concerns about maintain records and standards of the facility. It has received warning letters from the FDA, although the last one was closed in May 2022, which means that the FDA found that it addressed unexpected issues. (Hallandale declined requests for comment.)

However, the FDA has found problems with pharmaceutical companies. In 2023, FDA inspectors found bacterial contamination at a Novo Nordisk manufacturing plant in North Carolina. “The lead was handled immediately, and the site received FDA approval for full market release in August 2023,” said Novo Nordisk’s Bennett.

Complementary advocates say that, although the drugs are not FDA-approved, they are still subject to strict quality control, in part because of regulatory changes after 2012. Carroll, for example, says Hims is has done “due diligence” when choosing its pharmacy and that it is satisfied with the quality of the medicines. He says: “We have seen a very good response from our customers. “There were no adverse side effects that we weren’t expecting.” According to Carroll, Hims does not have to report any side effects to the FDA.

What’s Next?

As researchers continue to find new uses for GLP-1 drugs, and public interest and demand remain high, these drugs may be on the FDA’s regulatory shortage list for months or years. coming. If the shortage ends, one type of chemical compound (called 503a) will be required to stop production immediately, while 503b pharmacies, which usually produce in larger quantities, will will have 60 days. Eliminating the shortage will require major initiatives within this growing toilet industry. None of the telehealth companies that sent the compounded semaglutide to WIRED commented on what might happen in this situation during the dosing process.

Many people who take compounded drugs may be surprised to be told that they have to switch to brand-name drugs—and pay much higher prices—within a few months.

However, even if the shortage ends legally, at least some telehealth companies do not plan to leave the merger. “We believe that there will be an increasing demand for medicines, so that could lengthen the list of shortages,” says Hims’ Pat Caroll. “We are confident that there is a way, even if it is from the shortage list, to provide this combination medicine.”

Even the most skeptics doubt that it will end soon. With demand so high, Ryder suspects pharmaceutical companies will need to ramp up production to serve “basically 40 percent of the US population” before the shortage ends. Until then, Ryder suspects the telehealth boom will continue unabated.

Currently, the vials of semaglutide WIRED compound ordered are sitting in the back of the refrigerator untouched.