This past year has been a rollercoaster ride for Telehealth platforms, defined by federal interventions, regulatory crackdowns and legal friction.
Industry leaders, like Him & Hers and Ro, are reporting record revenues. The high reports are fueled largely by surged demand for GLP-1 weight loss medications. The rise of compounded semaglutide and tirzepatide, commercialized under the brands Ozempic, Wegovy and Zepbound, have ignited a turbulent legal battle over trademarks.
Now, federal regulators are signaling a shift towards more rigorous oversight. Recent actions have tightened their grip on marketing and prescribing on direct to consumer prescribing platforms.
The Rule Maintaining Telehealth Business Models Remains Temporary
The U.S. Department of Health and Human Services (DHS) and Drug Enforcement Administration (DEA) extended COVID-era flexibility allowing online prescribing of controlled substances without initial in-person visits. This fourth federal extension and is set to expire December 31, 2026.
Federal law generally prohibits doctors from prescribing controlled substances (Schedule II–V) without at least one in-person medical evaluation of the patient. To date, a significant portion of the modern Telehealth industry is operating under a temporary regulatory grace period.
Without continued federal extension or a permanent framework, Telehealth practitioners face a legal barrier. They would not be able to prescribe ADHD stimulants, anxiety benzodiazepines for anxiety, and opioid use disorder treatments without in-person evaluations.
The DEA is currently reviewing public comments for a permanent solution, titled the “Special Registration for Telemedicine.” If launched, Telehealth companies and doctors would have to register to virtually prescribe Schedule II-V controlled substances. They would be subject to reporting requirements.
FDA Is Cracking Down On Compound GLP-1s On Telehealth Platforms
Back in March, the U.S. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary described a “new era” of oversight for Telehealth companies.
“It’s a new era. We are paying close attention to misleading claims being made by Telehealth and pharma companies across all media platforms—and taking swift action,” Makary said in a statement on a recent press release. “Compounded drugs can be important for overcoming shortages or meeting unique patient needs — but compounders should not try to compound drugs in a way that circumvents FDA’s approval process.”
The FDA released their second group of warning letters since launching in September to 30 Telehealth companies for misleading marketing related to compounded GLP-1s. The government agency called out companies for making misleading claims about compounded GLP-1 medications.
“Over the past six months, the agency has sent thousands of letters warning pharmaceutical and Telehealth firms to remove misleading ads, more than had been sent over the entire preceding decade,” the release read.
The FDA especially mentioned those containing semaglutide or tirzepatide. Regulators gave companies 15 days to correct violations.
According to the agency, companies who were making these copies of popular drugs received warnings for implying that compounded GLP-1 medications are identical to or as safe as FDA-approved versions. Additionally, some Telehealth firms advertised compounded drugs using brand names or trademarks without proper disclaimers. They obscured both the manufacturer’s identity and the quality of the compounded product.
New Rules Impact GLP-1 Medications Sold Online
In the released statement, the agency reiterated that compounded drugs are not FDA-approved.
“Compounded drugs are not FDA-approved. This means the agency does not review their safety, effectiveness or quality before they are marketed,” the statement read. “Compounded drugs are also not the same as generic drugs, which are FDA-approved.”
The federal government oversees manufactured pharmaceuticals through standardized federal reviews. In contrast, the state board of pharmacies oversee compounded drugs. The rules and reviews can vary by state.
Pharmacies mix in compounded drugs without regulatory pre-market evaluation for safety or efficacy, per the FDA. The agency has warned that consumers purchasing compounded products online don’t always know the identify of the pharmacy or quality of product. While compounders contain the active ingredient, they also include additives to promote stable formulation and differentiation from the pharmaceutical grade version.
A global shortage of GLP-1s created an unusual legal opening that allowed compounding pharmacies to scale up production. During the height of the shortage, drugs, like semaglutide and tirzepatide, were placed on the FDA’s official shortage list. This meant they were no longer considered “commercially available.” Under federal law, that designation permits compounding pharmacies to produce and sell their own versions in larger quantities than normally allowed.
What Caused Regulations To Shift?
The situation changed in 2025 when major manufacturers, like Eli Lilly and Novo Nordisk, stabilized their supply chains and met market demand. Once the FDA determined the shortage had been resolved, those drugs were removed from the shortage list. This effective closed the temporary legal pathway that had enabled widespread compounding.
In standard practice, compounding is tightly regulated and typically reserved for individualized patient needs. This includes modifying a drug for someone with an allergy or dosage requirement. It is not intended to support mass production of copies of FDA-approved medications.
With the shortage designation lifted, pharmacies lost the legal basis to continue large-scale compounding of these GLP-1 drugs. As a result, regulators have begun reinforcing existing restrictions, and many compounders now face pressure to scale back or cease production altogether. This ultimately reshapes access and pricing dynamics for patients who had relied on these alternatives.
Pharmaceutical Manufactures Are Requesting Legal Intervention
While regaining control of the compounded GLP-1 market has been a slated focus of the FDA, manufactures have also joined in on the high-stakes clash for control. Pharmaceutical companies have filed several high profile lawsuits this year against compounding
In Feburary, Novo Nordisk sued Hims & Hers after the company announced plans to sell an oral Wegovy pill. The manufacturer argued the pill infringed on their patents. A month later, the tides shifted as both companies publicly settled their feud, announcing a partnership. Him and Hers stopped selling compounded GLP-1s and become an official distributor of brand name Wegovy and Ozempic.
Eli Lilly has filed numerous lawsuits against telehealth firms Mochi Health, Fella Health, and Henry Meds. These cases are still ongoing.
Legal experts say these lawsuits could set critical precedents for how far compounding pharmacies and digital health platforms can go in replicating branded drugs. The outcomes may also influence future FDA enforcement strategies and reshape how patients access lower-cost alternatives in a post-shortage market.
