When Chris Spears couldn’t get the obesity medication his doctor prescribed, he turned to Facebook. There, he saw a flood of ads for online telehealth services offering alternatives to brand-name drugs. Curious, he tried one of the medications.
“The medication worked brilliantly — absolutely phenomenal,” Spears said. “But the experience was clunky.”
That experience gave Spears, a former tech consultant in Decatur, Georgia, a business idea.He launched OrderlyMeds, a telehealth company that connects patients to healthcare providers who prescribe weight loss medications. The prescriptions are filled by pharmacy partners. Today, Spears says the company serves around 40,000 patients a month.
The drugs being offered are not generic versions of name-brand medications like Wegovy or Zepbound. Instead, they are “compounded” drugs — copies made by specialized pharmacies allowed by the U.S. Food and Drug Administration (FDA) when brand-name medications are in short supply. For months, such shortages created a booming market for compounded drugs and telehealth services offering them at lower costs.
That market is now shifting. The FDA announced this year that Novo Nordisk and Eli Lilly — the makers of Wegovy and Zepbound — can once again meet demand. As a result, the temporary permission that allowed compounders to produce these drugs has expired. Many have stopped making them.
With shortages officially over, the era of mass compounding obesity medications may be coming to a close. Some telehealth companies have started working directly with drugmakers to sell their medications to patients without insurance. But others, including OrderlyMeds, are taking a different approach.
Spears says his company is leasing a new facility in Tampa and hiring 100 people to begin producing its own compounded versions of semaglutide and tirzepatide — the active ingredients in Wegovy and Zepbound. To stay within legal boundaries, Spears says OrderlyMeds will modify its products by adding supplements, such as vitamin B-12, tailored to patients’ individual needs. This, he argues, makes the products unique, not copies.
Traditional compounding is meant to customize medicine based on a doctor’s prescription for an individual patient. But the line between a personalized treatment and an illegal copy of a commercially available drug isn’t always clear.
“The line is not very well defined,” said Ameet Sarpatwari, an assistant professor at Harvard Medical School who specializes in pharmaceutical policy. “That’s why we’re seeing certain companies who are willing to stay and test the waters.”
FDA guidelines suggest that even minor changes to a medication, like altering its strength or adding a small ingredient, do not make it significantly different from the original. The law forbids not just exact copies, but “essentially” similar versions — a term used to prevent companies from bypassing restrictions by making small, cosmetic changes.
When asked about companies adding vitamins, like B-12, to the compounds, a spokesperson from the Department of Health and Human Services, which oversees the FDA, referred NPR to the agency’s existing guidance but declined to comment on the legality of specific examples.
For now, companies like OrderlyMeds are operating in a gray zone — between the end of a supply shortage and the beginning of stricter enforcement. Whether their approach holds up under regulatory scrutiny remains to be seen.
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