The Food and Drug Administration (FDA) allows licensed compounding pharmacies to manufacture replicas of specific drugs that are currently in short supply, including the diabetes and weight loss medications semaglutide and tirzepatide, which are the active ingredients in two notable FDA-approved treatments.
“I conducted my research and located what I believed to be a reputable compounding pharmacy through a telehealth company,” revealed a patient who preferred to be identified as Lena.
Having turned to compounded tirzepatide only after her insurance ceased coverage for the FDA-approved Zepbound, Lena’s primary care physician had confirmed that the new class of weight loss medications could potentially benefit her health journey.
“Over the course of two years, I engaged in various diets and programs trying to lose weight on my own,” Lena recounted.
Hoping to address her metabolic challenges and achieve weight loss, Lena decided to explore the potential effects of medication alongside her continued diet and exercise regimen, which ultimately led to noticeable weight loss. She also shared encouraging news about improved results in her blood work.
There’s significant misinformation that conflates licensed compounding pharmacies with illegal online drug sellers and counterfeit drug manufacturers.
Tenille Davis, Chief Advocacy Officer of the Alliance for Pharmacy Compounding
However, a recent communication from the telehealth company that had been supplying her compounded medication informed Lena that they would no longer be able to fill her prescriptions for tirzepatide past December 2, 2024.
In October, despite many patients still encountering issues with acquiring medication, the FDA declared the shortage of tirzepatide to be “resolved.”
“Compounding pharmacies can only recreate these medications if there is a current shortage,” explained Tenille Davis. “Once the status was changed to resolved, 503a traditional compounding pharmacies were no longer permitted to create these copies of tirzepatide injections.”
Despite FDA policies permitting compounded drugs to assist patients during shortages, Davis pointed out ongoing challenges in the landscape.
“There’s a troubling overlap between legitimate compounding from state-licensed pharmacies and unlawful online sellers of counterfeit medications.”
Moreover, recent research published in JAMA, the Journal of the American Medical Association, has raised alarms, revealing that semaglutide—the key ingredient in FDA-approved Ozempic and Wegovy—was being illegally marketed without prescriptions by rogue online pharmacies, resulting in the distribution of unregistered and falsified products.
“This issue is prevalent, especially as I have worked in both wellness and urgent care environments,” asserted Dr. Tyler McAtee, MD. “I’ve witnessed patients arriving with drugs obtained from overseas or out of state, often unbeknownst to their source.”
In light of this situation, I chose to minimize my risk and anxiety and get the Zepbound directly from the pharmacy instead.
Lena, weight loss patient
Dr. McAtee, who has recently established the Ranch Wellness Center in Orange County, has been prescribing compounded tirzepatide to assist with weight management while implementing regular check-ins with clients, utilizing a strategy he refers to as microdosing and adjusting dosages for some patients.
“My primary focus was on managing cardiovascular disease and achieving weight loss to mitigate associated risks,” said patient Vic Gondotra. “I’m aiming for ways to maintain my weight with the least possible reliance on medications.”
Dr. McAtee indicated that he intends to reduce Gondotra’s dosage moving forward.
“The goal is to utilize these medications as a supportive boost,” he clarified. “This approach encourages the body to function more optimally.”
However, specialists in obesity medicine, such as Dr. Amanda Velazquez, Director at Cedars Sinai Center for Weight Management and Metabolic Health, emphasize the significance of scientific research related to this contemporary class of weight loss drugs.
“These medications aid in reprogramming how the body manages weight, but their effectiveness relies on maintaining an active presence in the body,” explained Dr. Velazquez, MD. “They influence not only appetite but also digestive processes. These treatments are fundamentally altering our biological mechanisms that may not be functioning effectively.”
Dr. Velazquez also expressed concern regarding the composition of compounded drug formulations and the practice of cycling patients on and off these medications.
“Clinically, there are valid concerns about this approach and its potential repercussions,” Dr. Velazquez noted. “What happens if you disrupt your body’s natural set point for its typical weight, and by striving to lower it, does the weight rebound to a higher level?”
Confusion differentiating branded drugs from compounded alternatives, coupled with patient access issues, leads many individuals to pursue cheaper, more accessible options.
Compounded formulations often carry costs that are less than half those of their branded counterparts. While these are not generic drugs, med spas and compounding entities offering generic versions of branded medications have been met with legal actions from drug manufacturers like Novo Nordisk and Eli Lilly.
Licensed compound pharmacists express concern over ensuring patient access to safe pharmaceutical products.
“The experience with tirzepatide emerging from shortage has revealed that we need to enhance our preparedness for when semaglutide runs out,” Davis advised. “Our objective is to ensure that patients do not lack access to their medications, which is why compounding pharmacists can secure prescriptions for FDA-approved products in advance and hold them.”
Amid fears about the integrity of her compounded medication and anxiety regarding the content of the injections she was using, Lena eventually discovered a discount option on the Eli Lilly website.
“In the interest of reducing risks and managing my anxiety during this turbulent period, I opted to procure the Zepbound directly from a pharmacy.”
Thanks to the Eli Lilly coupon, Lena’s monthly cost will be approximately $500, which is about $200 more than the compounded drug. In the absence of insurance coverage, branded weight loss medications may exceed one thousand dollars per month.
Lena aspires to share her journey to diminish the stigma surrounding these weight loss medications and encourage insurance companies to acknowledge their preventive health benefits for coverage.
In the meantime, both Eli Lilly and Novo Nordisk have recently appealed to the FDA to prohibit the compounding of their medications, arguing that their complexity makes them inappropriate for safe production. As the FDA considers this request, it is also in the process of reviewing whether tirzepatide continues to be in short supply.
Dr. Velazquez, who has received compensation from Novo Nordisk for her consultancy, urges all patients seeking weight loss solutions to engage in discussions with their healthcare providers about alternative FDA-approved medications if the new class is unavailable.
For patients in California and beyond seeking to verify the legitimacy of a compounding pharmacy, the Alliance for Pharmacy Compounding has established a search engine to check licensed facilities.
Moreover, legal representatives for the Alliance for Pharmacy Compounding have forwarded a formal letter to the FDA voicing their opposition to Eli Lilly’s recommendation to classify tirzepatide among “Drug Products that Present Demonstrable Difficulties for Compounding.”
The California Board of Pharmacy permits consumers to verify the status of specific sterile compounding pharmacies within the state.
What challenges did Lena face regarding the availability of her compounded tirzepatide medication?
**Interview with Lena: A Patient’s Journey in the Compounding Pharmacy Landscape**
**Editor:** Today, we are joined by Lena, a patient who sought compounded medications for her weight loss journey. Lena, thank you for speaking with us.
**Lena:** Thank you for having me.
**Editor:** You turned to compounded tirzepatide after your insurance stopped covering the FDA-approved Zepbound. Could you tell us about your decision-making process?
**Lena:** Absolutely. After struggling with my weight for two years through various diets and programs, it became clear I needed more support. My primary care physician mentioned that this new class of medications could potentially help, so I decided to look for compounded options through a telehealth service I found reputable.
**Editor:** You mentioned seeing positive results while on the compounded medication. Can you elaborate on that?
**Lena:** Yes, I started to notice significant weight loss along with improvements in my blood work. The combination of the medication, a focused diet, and regular exercise was making a real difference for me.
**Editor:** However, you faced challenges with your compounded prescriptions recently. Can you explain what happened?
**Lena:** Sure. I was notified by the telehealth company that they wouldn’t be able to fill my prescriptions for tirzepatide after December 2, 2024. It was frustrating because the FDA had declared the shortage resolved, which limited the compounding pharmacies’ ability to produce my medication.
**Editor:** That’s quite a shift. There are many misconceptions regarding compounding pharmacies and counterfeit drugs. What has your experience been with this?
**Lena:** It’s confusing. When I initially sought out a compounded medication, I did so because it seemed like a practical solution. But, I’ve learned there are significant risks associating with rogue online sellers and the quality of their products. This is why I eventually opted to get Zepbound directly from the pharmacy to mitigate my risks.
**Editor:** And what was your experience with the pricing of the branded medication compared to the compounded version?
**Lena:** The compounded tirzepatide was roughly $300 monthly, while the Zepbound, even with a discount coupon from Eli Lilly, is about $500 monthly—quite a jump! It’s crucial for patients like me to weigh options carefully considering the costs and the quality of medications.
**Editor:** Dr. Tenille Davis mentioned the complexities within the compounding pharmacy landscape. How do you feel about the availability of these medications now?
**Lena:** I think it’s essential for patients to have access to safe and effective medications while ensuring we aren’t compromising on quality. But the changes in regulations do make it challenging.
**Editor:** what advice would you give to others who may be considering compounded medications?
**Lena:** Do your research, and consult with your healthcare provider about all available options. Seek out licensed pharmacies, and always prioritize safety over convenience.
**Editor:** Wise words, Lena. Thank you for sharing your experiences and insights with us. We hope that you continue to make progress on your health journey.
**Lena:** Thank you for having me!
