There’s been a noticeable increase in versions of popular medications like Ozempic and Mounjaro, with some experts pointing to what they call “restriction negligence.” This, they argue, has allowed potentially harmful and unapproved drugs to make their way into the hands of consumers.
When the Food and Drug Administration (FDA) categorizes a drug as being in shortage, compounding pharmacies can step in to sell their own versions, ensuring patients still have access to these medications.
This scenario occurred with weight loss drugs like tilzepatide and semaglutide, which faced shortages due to high demand. Companies like Hims & Hers and Ro have since jumped into the GLP-1 market, offering their own variations of Wegovy and Zepbound.
These compounded medications use the same active pharmaceutical ingredients as their branded counterparts but are formulated a bit differently, especially for patients who might struggle to swallow pills. However, because these drugs are crafted in a highly individualized way, they haven’t received FDA approval.
Despite the FDA removing these medications from its shortage list, stakeholders continue to express concern as these compounded drugs remain on the market, prompting lawmakers in Congress to seek answers from federal regulators.
There are two primary types of compounding pharmacies: 503a and 503b. The former focuses on personalized prescriptions, while the latter also accommodates bulk orders for larger clients like hospitals.
During the shortage, telehealth companies relied heavily on 503B pharmacies, but now online retailers are turning to 503A ones to maintain their competitive edge, according to industry insiders.
After the shortage was lifted, Novo Nordisk, the manufacturer of Semaglutide, joined forces with HIMS & HERS to provide a lower-cost version of Wegovy. However, the partnership dissolved when Novo Nordisk accused Hims & Hers of continuing to sell compounded versions of the medication under the misleading banner of personalization.
Experts note that this situation falls into a regulatory “gray area.” One former FDA official, Peter Pitts, voiced concern that these operations might resemble illegal pharmaceutical practices rather than legitimate compounding.
“The idea that you can personalize medications for millions of people just doesn’t hold up,” Pitts remarked. “It’s more of a faux brand extension than anything else.”
A bipartisan group of House members sent a letter in July, urging FDA Commissioner Marty McCurry to address the flow of illegal anti-obesity medications.
While the letter did not specifically target compounded drugs, it pointed out the potential confusion between those and illegally sourced medications.
“We recognize the distinction between legally compounded drugs from certified pharmacies and counterfeit or illegally sourced drugs,” the lawmakers stated. They also noted that unapproved anti-obesity medications are still widely available online.
Sen. Marsha Blackburn (R-Tenn.) reached out to the Federal Trade Commission in July, seeking action regarding online advertisements for compounded GLP-1 medications, echoing concerns raised by a bipartisan group of state attorneys general.
In her correspondence, she warned that amid increasing demand for these drugs, criminals might be jeopardizing public safety by selling counterfeit or misleadingly marketed GLP-1 products.
A spokesperson for Ro asserted that the company “does not sell or promote compounded GLP-1s.”
In the meantime, research uncovered six lesser-known companies providing compounded GLP-1 medications online.
Hims & Hers, likely the most recognized among these, countered Pitts’ description of their operations.
“It’s incorrect to say we combine personalized medications for millions. We strictly adhere to regulations and only provide complex treatments deemed necessary by licensed healthcare professionals,” they said. “This is about creating a patient-centric system where healthcare providers have tailored solutions.”
The Federal Trade Commission opted not to comment, as its investigation is confidential. The FDA has yet to respond to inquiries.
Despite this, Pitts expressed skepticism regarding the lack of intervention from federal regulators. “How long will the FDA continue to overlook this issue and allow it to persist?” he questioned.
The ongoing sale of compounded GLP-1 medications occupies a gray regulatory area, but Pitts contends that it contradicts the essence of the regulations themselves.
He referenced the “5% rule,” noting that online sellers assert they have exceeded this limit by “10,000 times” due to practices which allow out-of-state compounded medications to operate beyond the threshold.
Recent surveys indicate that consumers are wary of the origins of compounded drugs.
Opinion polling conducted by Fabrizio Ward indicated that 64% of those surveyed doubt the legality of drug compounding outside permitted circumstances.
When queried about their confidence in the safety and FDA approval of online pharmacies, voters were divided: 46% expressed confidence, while 41% did not. Additionally, a significant majority—78%—voiced concerns over whether compounded medications like Wegovy and Zepbound might stem from dubious overseas sources.
With GLP-1 products still in high demand, questions linger regarding the sourcing of active pharmaceutical ingredients by compounding pharmacies. Telehealth providers claim these ingredients come from FDA-regulated facilities.
“There’s a significant distinction between items produced in FDA-approved places and those made along an FDA-compliant production line,” Pitts noted. “The FDA hasn’t inspected lines for illegal production, which simply isn’t happening. It’s a disingenuous narrative.”
