This is a Physician in the Loop special topic.

Prescribed at checkout

A weight-loss prescription can now take a questionnaire and a card number. Patients deserve a clinician who knows them and a drug the FDA has checked.

Researchers at Yale invented a patient last year and went shopping for a weight-loss drug. Built to qualify, the profile was tried on 49 websites selling drugs like semaglutide and tirzepatide. Forty-five prescribed. Every site used a questionnaire. Three clinicians wrote prescriptions for that same patient, whom the team called Patient Sim, on two or more separate websites. Three in four of the prescribing sites charged the patient and shipped without asking for confirmation. The findings suggest, the authors said, that clinicians “are only present on these platforms in name, not in practice.”

That market was born in a shortage. Demand for these drugs outran the makers’ supply from 2022, and a shortage lets pharmacies sell copies of an approved drug. The FDA ruled both shortages over, tirzepatide’s in late 2024 and semaglutide’s in February 2025. Compounders sued. In August a federal appeals court upheld the tirzepatide decision and the semaglutide one. Even so, most of Patient Sim’s prescriptions were for a compounded drug. A drug that needs a prescription needs a clinician who knows the patient and a product the FDA has checked. The checkout page can skip both, and that puts patients at risk.

Compounded drugs are not FDA approved, and the agency does not review them for safety, effectiveness or quality before they are sold. On a page updated Oct. 1, the FDA counts 990 reports of adverse events linked to compounded semaglutide and more than 730 linked to compounded tirzepatide, as of the end of May. Some of its reports describe hospital stays that may be related to dosing errors with injectable compounded semaglutide. These are reports, not proven harms. The agency says the real number is probably higher. Federal law does not require state-licensed pharmacies, other than outsourcing facilities, to report them to the FDA.

Many copies now come with vitamins added. Mochi Health, which provides technology services to affiliated medical practices, says the additives support energy production, protect lean muscle, reduce nausea, improve fat metabolism and stabilize mood, and that compounded drugs “are prescribed based on medical necessity and individualized assessment.” That phrase echoes the legal test. Once a shortage is over, a pharmacy may not routinely copy an approved drug unless a prescriber documents a significant difference for an identified patient. On the Yale websites, most compounded prescriptions came with a supplement such as vitamin B12. Scientists employed by Eli Lilly, which makes Zepbound, tested samples of compounded tirzepatide with B12 obtained from various sources in the American market. They report that tirzepatide reacts with certain forms of the vitamin to form an impurity. Its clinical effects, they write, are unknown.

Fewer than one in five of the Yale websites asked whether the patient had a primary care clinician, and about two in three required neither a video visit nor a phone call. Among more than 150,000 primary care patients on these drugs between 2021 and 2024, compounded versions were documented for about 8 percent, while surveys suggest nearly a quarter of users get them that way. Many patients, the authors suggest, may be getting these drugs outside coordinated care. A doctor cannot watch for the side effects of a drug that is not in the chart.

Patients have a real answer, and so do the sellers. In a poll last fall, more than half of Americans who had taken these drugs said they were hard to afford, and about one in four had insurance but paid the full cost themselves. In 2024, websites selling compounded semaglutide charged a median of $231 for the first month. In February Hims & Hers stopped offering a compounded pill it had just launched, citing constructive conversations across the industry. It said it remained “committed to the millions of Americans who depend on us for access to safe, affordable, and personalized care.” That came a day after the FDA named it among companies mass-marketing copies. A doctor who has watched a patient priced out of treatment should not wave that away.

The price case is weaker than it was. Lilly says that, with its savings card, its Zepbound pen costs $299 a month at the lowest dose, which it calls “a starting dose and not an approved maintenance dose.” In March Novo Nordisk dropped a patent suit against Hims & Hers, and Hims agreed to offer branded Wegovy and Ozempic and to stop advertising compounded copies. It said it would still offer access to compounded versions, for what it expected to be a limited set of customers, when a provider determines one is clinically necessary. A 2025 FDA warning letter had already told the company that promoting its copy as having “the same active ingredient as Ozempic and Wegovy” was false or misleading. The letter concerned the advertising, not the drug’s quality. Access matters. It does not require a copy the FDA never reviewed, prescribed by a clinician the patient never meets.

Every clinician who sees adults with obesity or diabetes should ask at each visit whether the patient is injecting anything bought online, and record it in the medication list. State licensing boards, which oversee the clinicians named on these prescriptions, should say whether a questionnaire alone meets the standard of care for a weekly injection. The FDA, which sent thousands of letters about misleading drug ads in the six months to March, should also do as the Yale authors ask and collect data on how much is compounded and who prescribes it.

Patient Sim was never real, so nobody was hurt when three clinicians prescribed for it more than once. The FDA’s reports describe people who were real, and the agency believes it is missing some. The records suggest that many Americans may be injecting a copy their own doctor has never heard of. Their doctors can start finding out at the next visit.

This special topic was read by an AI voice. Its sources are linked at physicianintheloop.org.