Compounded Weight-Loss Drugs Boom as Regulators Struggle to Keep Pace
An estimated 5 million Americans now use compounded GLP-1 medications, drawn by lower prices and looser oversight. Patient advocates warn the regulatory gap leaves people like 72-year-old Diane Kinkade exposed to side effects and little recourse.
Millions of Americans seeking weight-loss medication are turning to compounding pharmacies, drawn by prices far below brand-name drugs and a regulatory system that critics say leaves patients exposed. An estimated 5 million people in the U.S. are using compounded GLP-1s, according to a Gallup poll released in July, and nearly one in five of the 11% of U.S. adults taking GLP-1 medications for weight loss obtains them through compounding pharmacies.
The trend is driven by cost and access. Diane Kinkade, a 72-year-old with prediabetes, high blood pressure, and excess weight, was declined a GLP-1 prescription by her doctor, who felt the side effects outweighed the benefits. She found a telehealth site that sent her a prescription after a brief questionnaire — not for a brand-name drug, but for compounded tirzepatide, the active ingredient in Eli Lilly's Zepbound, mixed with vitamin B12. The compounded version cost $250 a month, compared with $399 through LillyDirect, the company's direct-to-consumer site often used when insurance does not cover the drug.
Kinkade initially lost weight. But a few months into treatment, the telehealth site switched compounding pharmacies, and the same prescription produced severe side effects: brain fog, nausea, diarrhea, and exhaustion. «I could barely get up from the couch for a week,» she said. When she sought help, she said the site sent canned, automated responses. She stopped taking the medication.
Eli Lilly has argued that patients seeking tirzepatide should receive only Zepbound, which holds FDA approval and whose patent does not expire until 2036. In a 2024 news release about litigation against compounding pharmacies, the company said it is «the only lawful supplier of FDA-approved tirzepatide medicines in the United States» and warned that patients taking a product labeled only as «tirzepatide» are not receiving an FDA-approved product. Compounding pharmacies have continued to dispense compounded versions nonetheless.
The practice is poised to expand. In July, an FDA committee decided compounding pharmacies should be allowed to prepare six peptides for consumers, though the agency has not yet adopted the recommendation. Peptides — short chains of amino acids — have gained popularity among influencers who promote them for a range of ailments, often without robust scientific evidence.
Compounding itself is a long-established and essential part of pharmacy. It involves preparing a customized medication for a specific patient's needs. Dr. Anjali Deshmukh, a pediatrician and law professor at Seton Hall University, said she relies on compounding pharmacies when treating a 3-year-old who cannot swallow tablets and needs medication in a different form. «Compounding is absolutely essential,» she said. In the 1930s, three-quarters of U.S. prescriptions required in-pharmacy compounding.
For decades, pharmacies that compound small amounts of medication have operated under Section 503A of the Federal Food, Drug, and Cosmetic Act. Known as 503As, they are regulated by state boards of pharmacy. Because they dispense small amounts for individual patients with a doctor's prescription, most are exempt from certain FDA rules that apply to large drug manufacturers, including current good manufacturing practices, which require drugmakers to record and trace every batch and test equipment regularly. They must still follow U.S. Pharmacopeia guidelines and source active ingredients from FDA-registered suppliers, according to Scott Brunner, chief executive of the Alliance for Pharmacy Compounding.
That system has failed before. In 2012, the New England Compounding Center mass-produced medications in a setting flagged repeatedly as unsanitary and shipped thousands of vials of contaminated steroid injections. Dozens of people died, and investigators found severe safety lapses in the pharmacy's production of sterile drugs. Its owner was later convicted of racketeering and other offenses by a federal jury. Congress responded in 2013 with new legislation.
As telehealth sites prescribe compounded medications and market them as a cheaper path to weight loss, patient advocates argue that more people like Kinkade will fall through the cracks of a regulatory system that has not kept pace with the scale of demand.
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