Before the pandemic, Diane Kinkade lost weight with diet and exercise.
asserted
Kinkade → lose → diet
But by 2026, she decided she needed to try something else.
asserted
she → decide → something
She had prediabetes and high blood pressure, in addition to being overweight, but her doctor declined to prescribe her a GLP-1 weight-loss medication, saying he thought the side effects outweighed the benefits.
asserted
effects → have → benefits
So she asked around and found a telehealth site that seemed more than happy to send her a prescription for a GLP-1 after a brief questionnaire.
asserted
that → ask → questionnaire
But the telehealth site didn’t send her a brand-name drug.
asserted
site → send → drug
It instead partnered with a compounding pharmacy to send her tirzepatide, the active ingredient in Eli Lilly’s popular drug Zepbound.
asserted
It → partner → drug
The compounded drug represented significant cost savings—$250 a month versus the $399 a month she would have paid through LillyDirect, the direct-to-consumer site that people often use when their insurance doesn’t cover the drug.
asserted
insurance → compound → drug
Kinkade, who is 72, says she wasn’t too worried about injecting herself with what the compounding pharmacy had sent, a combination of tirzepatide and vitamin B12.
asserted
pharmacy → say → tirzepatide
At first, she started to lose weight.
asserted
she → start → weight
But a few months into her injections, the telehealth site switched compounding pharmacies, and she had such bad side effects from the new medication (ordered with the same prescription) that she says she could barely function.
uncertain
she → switch → prescription
Brain fog, nausea, diarrhea, and exhaustion all plagued her.
asserted
fog → plague → her
“I could barely get up from the couch for a week,” she says.
uncertain
she → get → week
She tried reaching out to the telehealth site for help, but they just sent her canned, AI-type responses, she says.
asserted
she → try → responses
So she stopped taking the medication.
asserted
she → stop → medication
If Eli Lilly had its way, patients seeking tirzepatide would not be able to receive anything but Zepbound, which is approved by the U.S. Food and Drug Administration (FDA).
asserted
which → have → Administration
The company’s patent on the drug does not expire until 2036.
asserted
patent → expire → 2036
In a 2024 news release from Eli Lilly about litigation it had pursued against compounding pharmacies, the company says that it is “the only lawful supplier of FDA-approved tirzepatide medicines in the United States” and that “patients taking a product referred to only as ‘tirzepatide’ are not taking an FDA-approved product.”
asserted
patients → pursue → product
But because of a loophole—or a lack of enforcement, depending on who you ask—compounding pharmacies have still been sending patients compounded versions of tirzepatide.
asserted
pharmacies → depend → tirzepatide
An estimated 5 million people are using compounded GLP-1s in the U.S., according to a Gallup poll released in July; of the 11% of U.S. adults taking GLP-1 medications for weight loss, nearly one in five uses compounding pharmacies.
uncertain
five → estimate → pharmacies
Compounding pharmacies are set to boom even further because people may soon use them to get more peptides—short chains of amino acids that have become popular among influencers who tout their benefits (absent robust scientific evidence, in most cases) for a wide variety of ailments—than they previously could.
uncertain
they → compound → ailments
In July, an FDA committee decided that compounding pharmacies should be allowed to prepare six peptides for consumers; the FDA has not yet decided whether it will adopt the recommendations.
asserted
it → decide → recommendations
But compounding pharmacies are much less regulated than the drug manufacturers that make brand-name drugs.
asserted
that → compound → drugs
As more telehealth sites prescribe these medications and pitch them as a way to lose weight while saving money, some patient advocates argue that more people like Kinkade will fall through the cracks of a broken regulatory system.
asserted
people → prescribe → system
What are compounding pharmacies?
asserted
pharmacies → compound → ?
Many pharmacies can compound medications.
asserted
pharmacies → compound → medications
Compounding involves preparing a customized medication for a specific patient’s needs.
asserted
Compounding → involve → needs
“Compounding is absolutely essential,” says Dr. Anjali Deshmukh, a pediatrician and law professor at Seton Hall University.
asserted
Deshmukh → say → University
Deshmukh uses compounding pharmacies when, for example, she treats a 3-year-old with a serious disease who can’t swallow tablets and needs medication in a different form.
asserted
who → use → form
For much of U.S. history, pharmacists had to mix individual medicines themselves: in the 1930s, three-quarters of prescriptions required in-pharmacy compounding.
asserted
quarters → have → compounding
In this sense, compounding pharmacies have existed for as long as pharmacies have.
asserted
pharmacies → compound → sense
For decades, pharmacies that compound small amounts of medication have operated under what’s called Section 503A of the Federal Food, Drug, and Cosmetic Act.
asserted
what → compound → Act
Called 503As for short, they’re regulated by state boards of pharmacy.
asserted
they → call → pharmacy
Because they dispense small amounts of medications for individual patients, only with a doctor’s prescription, most 503As aren’t subject to certain FDA rules that apply to traditional larger drug manufacturers.
asserted
that → dispense → manufacturers
That includes what’s called “current good manufacturing practices,” which are regulatory standards that ensure drugmakers record and trace every batch of product they make and have their equipment tested regularly.
asserted
equipment → include → product
They must adhere to other regulations, however.
asserted
They → adhere → regulations
For instance, they must follow U.S. Pharmacopeia (USP) guidelines, which are set by a private non-profit that develops science-based standards for medicines, dietary supplements, and food ingredients.
asserted
that → follow → medicines
And they must source their active ingredients from FDA-registered suppliers, says Scott Brunner, the chief executive officer of the Alliance for Pharmacy Compounding, a trade group.
asserted
Brunner → source → Compounding
Struggles with regulation
This regulatory system has broken down before.
asserted
system → break → regulation
In 2012 a compounding pharmacy called the New England Compounding Center started mass-producing medications in a setting that had been flagged as unsanitary numerous times.
asserted
that → compound → unsanitary
It shipped thousands of vials of contaminated steroid injections to patients.
asserted
It → ship → patients
…and 92 more, not listed.
The Aporia
