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.
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read by an AI voiceResearchers 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.
- The Yale secret shopper studyChetty and colleagues at Yale School of Medicine, “Online Prescribing of GLP-1 Receptor Agonists,” JAMA 2026;336(5):428-431, published online July 6, 2026 for the issue of Aug. 4; PubMed lists a coauthor, Joseph S. Ross, as a deputy editor of JAMA. The journal’s full text could not be opened, so these figures come from reports. A simulated patient profile built to qualify was tried on 49 websites from August to December 2025. Healio reports that 45 of 49 (91.8%) prescribed, 26.5% required a video visit and 6.1% a phone call, and 75.6% of prescribing sites charged and shipped without asking for confirmation. Epocrates reports that 18.4% asked about a primary care clinician. A June presentation, as HCPLive reported it, gave 39 of 45 prescriptions (86.7%) as compounded, supplements with 27 of 45 (60.0%), about 67% of sellers requiring no interaction with a clinician, and three clinicians prescribing to the profile, called Patient Sim, on two or more websites. Reports of the paper put the supplement share at 60.0% of prescribed compounded products (Pharmacy Times) and 60% of products that arrived (Epocrates).
- The shortage decisions, the compounding rules and the appealThe FDA determined on Oct. 2, 2024 that the tirzepatide injection shortage was resolved, confirmed it on reevaluation on Dec. 19, 2024, and determined on Feb. 21, 2025 that the semaglutide injection shortage was resolved. It first said it would not act against state-licensed (503A) pharmacies until Feb. 18, 2025 for tirzepatide and April 22, 2025 for semaglutide, or against outsourcing facilities (503B) until March 19, 2025 and May 22, 2025. It later tied the 503A periods to the district court’s rulings and announced their end on March 10, 2025 and April 28, 2025. After a shortage, a 503A pharmacy may compound essentially a copy only in limited cases, such as a change a prescriber determines makes a significant difference for an identified patient. On Aug. 27, 2026 the Fifth Circuit, in an unpublished opinion in Outsourcing Facilities Association v. FDA, No. 25-10600, affirmed judgment for the FDA and Eli Lilly on tirzepatide. In a companion opinion, No. 25-10758, stamped filed the same day, the same panel affirmed judgment for the FDA and Novo Nordisk on semaglutide.
- The FDA’s count of adverse event reportsThe FDA’s page on unapproved GLP-1 drugs used for weight loss, marked current as of Oct. 1, 2026, says that as of May 31, 2026 the agency had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. It says it is not always possible to determine whether an adverse event directly resulted from use of the drug, and that adverse events from compounded versions are likely underreported because federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit them. It describes reports of adverse events, some requiring hospitalization, that may be related to dosing errors with compounded injectable semaglutide. It states that compounded drugs are not FDA approved and that the agency does not review them for safety, effectiveness or quality before they are marketed. These are spontaneous reports, not measured rates of harm.Source: FDA
- The FDA’s letters and announcementsOn Sept. 9, 2025 the FDA sent a warning letter to Hims & Hers Health, Inc., doing business as Hers. It cited two website claims for compounded semaglutide, “Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy” and “Clinically proven ingredients”, called them false or misleading, said the products were therefore misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act, and asked for a response within 15 working days. The letter makes no finding about the drug’s safety or quality. On Feb. 6, 2026 the FDA announced its intent to restrict GLP-1 active pharmaceutical ingredients intended for non-approved compounded drugs mass-marketed by companies including Hims & Hers. On March 3, 2026 it announced 30 warning letters to telehealth companies over compounded GLP-1 marketing and said it had sent thousands of letters about misleading ads in the previous six months, more than in the entire preceding decade. Reuters reported on June 16, 2026 that the agency had issued 25 more warning letters to telehealth companies over compounded GLP-1 marketing, posted on its website that day.
- Hims & Hers and Novo NordiskHims & Hers launched a compounded semaglutide pill that, the Associated Press reported, it planned to sell at $49 for the first month and $99 a month after, against Novo Nordisk’s price of $149 a month for the Wegovy pill. The day after the FDA’s Feb. 6, 2026 announcement, Hims said on X that since launching the pill it had had constructive conversations across the industry and would stop offering it. On Feb. 9 Novo Nordisk said it had sued Hims & Hers for infringing US Patent 8,129,343, and asserted that compounded semaglutide products may contain dangerous impurities or incorrect amounts of active ingredients. On March 9, 2026 Novo Nordisk said it was dismissing the suit while reserving the right to refile. Hims & Hers said the same day that it would no longer advertise compounded GLP-1 offerings, and that it plans to offer access to compounded GLP-1s if a provider determines that a compounded product is clinically necessary. On March 26 it said Novo Nordisk’s Wegovy and Ozempic were available on its platform.
- Additives, and what is known about themA Mochi Health blog post on GLP-1 additives, first published Nov. 21, 2025 and updated Sept. 18, 2026, says additives support energy production, protect lean muscle, reduce nausea, improve fat metabolism and stabilize mood, and that compounded medications are prescribed based on medical necessity and individualized assessment. In a secret shopper study of 75 weight-loss clinics and medical spas in West Virginia and Oklahoma from August to October 2025 (DiStefano and colleagues, University of Colorado; JAMA Health Forum, July 17, 2026), 42 (56.0%) reported offering compounded GLP-1 drugs combined with B vitamins, and 4 of 21 supplying facilities assessed (19.0%) were not licensed for sterile compounding. Five authors employed by Eli Lilly reported in Expert Opinion on Drug Safety (April 30, 2026) a previously unidentified impurity in compounded tirzepatide and B12 products, formed by a reaction between tirzepatide and certain B12 analogs. They state that its clinical effects are unknown.
- What patients say they payA KFF poll of 1,350 adults, fielded Oct. 27 to Nov. 2, 2025 and published Nov. 14, 2025, found that 18% had ever taken a GLP-1 drug and 12% were taking one. Among users, 56% said the drugs were difficult to afford, 27% had insurance but paid the full cost themselves, and 17% got them from an online provider or website. Eli Lilly said on March 16, 2026 that with its savings card the Zepbound KwikPen starts at $299 a month for the 2.5 mg dose, which it describes as a starting dose and not an approved maintenance dose. The card is available to patients with a valid on-label prescription, including those without insurance, and does not apply to single-dose vials or the single-dose pen.
- What the records and the websites showHendrix and colleagues at the American Board of Family Medicine and Stanford (Pharmacoepidemiology and Drug Safety, October 2025) studied primary care records of 153,044 patients with documented semaglutide or tirzepatide use from Jan. 1, 2021 to Dec. 31, 2024. Compounded use was documented for 8.2%, which the authors say appeared lower than surveys reporting that about 23% of users received the drugs from compounders. Chetty and colleagues (JAMA Health Forum, Jan. 3, 2025) reviewed 79 websites selling compounded GLP-1 drugs, found in Google Shopping sponsored results from July to September 2024. The median first-month price, including discounts, was $231 for compounded semaglutide and $330 for compounded tirzepatide; 29 sites (36.7%) stated or implied the drugs were FDA approved; and the paper dates the shortages that allowed compounding to 2022.