The Food and Drug Administration allows for licensed compounding pharmacies to make copies of certain drugs in short supply, and that has included semaglutide and tirzepatide, the main ingredients in two different FDA-approved diabetes and weight loss drugs.
“I did my research, and found what I believed to be a reputable compounding pharmacy through a tele-health company,” said a patient who asked to be called Lena.
She turned to compounded tirzepatide only after her insurance stopped covering the FDA-approved Zepbound. Her primary care doctor had agreed the new class of weight loss drugs might work for her.
“I did a series of different kinds of diets and things trying to work on myself to lose weight over the course of two years,” said Lena.
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She wanted to see if going on the medication could help her lose weight and control her metabolic issues. After continuing her diet and exercise regimen, she started to shed those stubborn pounds. She said her blood work also showed positive change.
What’s happening is a lot of conflation of legitimate compounding, state licensed compounding pharmacies to illegal online drug sellers and counterfeit drug manufacturers.
Tenille Davis, Alliance for Pharmacy Compounding
But she recently received a letter from the telehealth company she turned to for her compounded medication, saying it could no longer fill tirzepatide past Dec. 2, 2024.
In October, the FDA declared the drug shortage of tirzepatide “resolved” even though many patients still report having issues filling the medication.
“Compounding pharmacies are only allowed to make these copies when the status is currently in shortage,” said Tenille Davis, Chief Advocacy Officer of the Alliance for Pharmacy Compounding. “So once it was changed to resolved, 503a traditional compounding pharmacies were no longer allowed to make these copies of tirzepatide injections.”
Davis said while FDA policy clearly allows for compounded drugs to help patients during drug shortages, she points to problems.
“What’s happening is a lot of conflation of legitimate compounding, state licensed compounding pharmacies to illegal online drug sellers and counterfeit drug manufacturers.”
In fact recently published research in JAMA, the Journal of the American Medical Association, tracked the safety of semaglutide — the main ingredient in FDA-approved Ozempic and Wegovy— and found it was being ”sold without a prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products.”
“It’s a real problem. I’ve seen it because I’ve worked not only in the wellness side but also in urgent care,” said Dr. Tyler McAtee, MD. “I’ve seen it where patients are coming in because they’ve gotten stuff overseas or out of state where they really don’t know who the supplier was.”
I decided to reduce the risk, reduce my anxiety right now while all this is happening and just go get the Zepbound direct from the pharmacy.
Lena, weight loss patient
Dr. McAtee, who recently opened the Ranch Wellness Center in Orange County, has been prescribing compounded tirzepatide for weight management with regular check-ins for patients, using what he calls microdosing and cycling some of his clients on and off the compounded formulations.
“My primary motivation was dealing with cardiovascular disease and getting my weight down so that I reduce the risk,” said patient Vic Gondotra. “I’m focused on seeing if I could maintain this weight with the least amount of drugs possible.”
Dr. McAtee said he is ready to lower Gondotra’s dose.
“The idea is to kind of use it as a boost,” he said. “Use it as a way to kind of teach your body how to function more optimally.”
But experts in the field like Dr. Amanda Velazquez, Director of Obesity Medicine at Cedars Sinai Center for Weight Management and Metabolic Health, point to the scientific research on this new class of weight loss drugs.
“When these medications are working to help the body reprogram how it’s managing the weight, it is only effective while the medication is still active in the body,” explained Dr. Velazquez, MD. “The medication is helping not just to reduce appetite and slow the gut. It is not a form of retraining an individual. These medicines are really changing our biology because the biology is not working correctly.”
Dr. Velazquez is also concerned about what is actually in compounded forms of the drugs as well as cycling patients on and off of them.
“Clinically speaking, there are concerns for doing that because of what it could that lead to,” Dr. Velazquez explained. “Are you disrupting your set point to where your body wants to be for its typical weight, and therefore by trying to drive it lower? Will it rebound and go back and then potentially be even higher than when you started?”
Confusion between branded products and compounding as well as issues of access is leading many patients to seek cheaper, more available options.
Compounded formulations can cost less than half the price of the branded drugs. These are not generic options, and med spas and compounders promising generic versions of the branded drugs have been sued by drug makers NovoNordisk and Eli Lily.
But licensed compounding pharmacists point to concern about patient access to safe products.
“What tirzepatide coming off shortage has taught us is that we need to be better prepared for when semaglutide comes off of shortage,” said Davis. “We don’t want our patients to go without medication, so (compounding) pharmacists can do things like get prescriptions for the FDA approved product now and put it on hold.”
But after worrying about filling her needle correctly, questioning what is in the compounded drug she is injecting, and ultimately retaining access to the medication, Lena found a coupon on drug maker Eli Lily’s website.
“I decided to reduce the risk, reduce my anxiety right now while all this is happening and just go get the Zepbound direct from the pharmacy.”
With that discount from Eli Lily, it will cost Lena about $500 a month, which is about $200 more than filling the compounded drug. Without insurance, the brand name weight loss drugs can cost more than a thousand dollars a month.
Lena also hopes sharing her experience will help reduce the stigma surrounding these weight loss drugs and ultimately lead insurance to recognize the proactive health benefits of covering them.
Meanwhile, both Eli Lily and NovoNordisk recently asked the FDA to ban compounded copies of their drugs, saying they are too complex to safely produce. While the FDA considers this, it is also now reviewing whether tirzepatide is still in short supply.
Dr. Velasquez, who has received modest payment from NovoNordisk as a consultant, encourages all weight loss patients to talk with their doctors about other FDA-approved medicines for weight loss if this new class of drugs is not available to them.
To check whether a compounding pharmacy operates a licensed facility here in California or in other states, the Alliance for Pharmacy Compounding has created a search engine.
Lawyers for the Alliance for Pharmacy Compounding recently sent this letter to the FDA opposing Eli Lilly’s nomination of tirzepatide to the agency’s list of “Drug Products that Present Demonstrable Difficulties for Compounding.”
The California Board of Pharmacy also allows consumers to search the status of a particular sterile compounding pharmacy in this state.
