Navigating Telehealth and Compounded Medications: Addressing Safety and Regulatory Challenges
Imagine receiving a prescription for a custom-made medication from a telehealth provider you’ve never met in person—one that bypasses the traditional pharmacy system, lacks FDA oversight, and could put your health at risk.
With the rapid rise of telehealth, compounded medications have entered a legal gray area, creating concerns about patient safety, drug efficacy, and regulatory enforcement. While telehealth has expanded access to care, it has also made it easier for unscrupulous actors to exploit regulatory gaps, leading to fraudulent prescribing, substandard medications, and potential harm to patients.
Companies like Hims & Hers and Sesame offer compounded medications, such as semaglutide, to address weight loss. Hims & Hers provides compounded GLP-1 injections containing semaglutide, the active ingredient in FDA-approved drugs like Ozempic and Wegovy. However, these compounded versions are not FDA-approved, raising concerns about their safety and efficacy.
Similarly, Sesame has launched "Success by Sesame," a weight loss program offering compounded semaglutide to eligible patients. While this initiative aims to make weight loss treatments more accessible, it also highlights the need for careful consideration of the regulatory and safety challenges associated with compounded medications in telehealth.
These developments underscore the importance of ensuring that compounded medications prescribed via telehealth adhere to established safety and regulatory standards to protect patient health.
This article explores the key regulatory challenges, real-world case studies, and what pharmacists and providers must do to stay compliant.
Understanding the Risks of Compounded Medications in Telehealth
But first…what is a compounded medication?
Compounded medications are custom-made drugs prescribed when commercially available options do not meet a patient's needs. Unlike FDA-approved medications, these drugs are not subject to the same rigorous testing for safety and efficacy.
The concern many have is that some telehealth providers are prescribing compounded medications without proper oversight, medical necessity, or quality assurance, often across state lines where enforcement is weak.
Key concerns include:
Are telehealth providers conducting proper patient evaluations?
Are the compounded drugs coming from licensed and accredited pharmacies?
Are patients unknowingly being prescribed ineffective or unsafe treatments?
Case Studies: Real-World Consequences of Unregulated Prescribing
1. Legal Challenges in Telehealth Prescribing
Several legal cases have highlighted the complexities and risks associated with prescribing compounded medications via telehealth. In one notable instance, a compounding pharmacy owner was convicted for their role in a telehealth scheme that involved both private and public payors. This case underscores the legal repercussions of engaging in fraudulent telehealth practices related to compounded medications.
Additionally, the Department of Justice has expanded its enforcement efforts in the telehealth sector, particularly concerning the prescribing of controlled substances without proper patient evaluation. This increased scrutiny aims to address potential abuses in telehealth prescribing practices, including those involving compounded medications.
In January 2025, a Louisiana grand jury indicted Dr. Margaret Carpenter, a New York-based telehealth physician, for prescribing abortion medication to a Louisiana resident. While New York has laws protecting out-of-state telehealth providers, Louisiana's actions highlight the legal complexities of interstate telehealth prescribing. While not directly to compound medications, it shines a light on the muddy waters of cross-state prescribing, even when medications are fully regulated.
These cases emphasize the importance of adhering to regulatory standards and ensuring that telehealth practices involving compounded medications are conducted ethically and legally.
Key takeaway: Telehealth providers prescribing compounded medications across state lines must understand and comply with differing state regulations to avoid legal action.
2. Regulatory Actions on Weight-Loss Medications
In February 2025, the UK's General Pharmaceutical Council (GPhC) implemented stricter rules for online pharmacies selling weight-loss injections like Wegovy and Mounjaro.
Why? Some telehealth providers were prescribing these medications based solely on online questionnaires, without proper medical evaluations. The new rules require video consultations and clinical record verification before prescribing these drugs.
Key takeaway: Providers must ensure legitimate doctor-patient relationships and thorough medical assessments before prescribing compounded medications, especially those with significant health implications.
3. Telemedicine Fraud in Compounded Medications
In January 2021, a New Jersey doctor was sentenced to 33 months in prison for his role in a $24 million telemedicine scheme involving compounded drugs. The physician admitted to signing pre-printed prescription forms without evaluating patients, leading to fraudulent prescriptions and unsafe medication use.
Key takeaway: Overprescribing compounded drugs through telehealth without proper oversight can lead to fraud charges, patient harm, and regulatory crackdowns.
Regulatory Landscape: What Providers and Pharmacists Need to Know
1. The Ryan Haight Act and Telehealth Prescribing
The Ryan Haight Online Pharmacy Consumer Protection Act requires an in-person evaluation before prescribing controlled substances, with some exceptions for telehealth. However, some providers exploit loopholes, prescribing high-risk compounded drugs without proper oversight.
2. FDA Oversight of Compounded Medications
The FDA does not approve compounded drugs, which means their safety, efficacy, and quality vary significantly. The FDA only regulates outsourcing facilities (503B compounding pharmacies), while traditional 503A pharmacies fall under state laws—leaving room for potential risks.
Risk: Telehealth platforms working with non-compliant 503A pharmacies could face legal action if those pharmacies violate state or federal regulations.
3. State Laws and Interstate Pharmacy Regulations
Each state has different laws governing compounding and telehealth prescribing. Some telehealth companies partner with pharmacies in states with looser regulations to bypass stricter rules elsewhere, raising concerns about:
Drug safety
Lack of professional accountability
Enforcement gaps in cross-state prescribing
Red Flags: What Pharmacists and Providers Should Watch For
High-volume, one-size-fits-all prescribing – If a telehealth provider prescribes compounded medications to most patients without clear medical necessity, that’s a warning sign.
Lack of transparency about pharmacy accreditation – Ensure pharmacies meet USP <795> and <797> standards for non-sterile and sterile compounding.
Cross-state prescribing risks—If a pharmacy fills prescriptions for multiple states but lacks the necessary licensure, it could be violating state laws.
Aggressive online marketing of compounded drugs – Beware of telehealth companies that promote compounded drugs as “miracle solutions” for weight loss, hormone replacement, or pain management.
How to Ensure Compliance and Protect Patients
Operating out of compliance or in a “gray area” is a costly practice. CTeL is a trusted resource to help your practice and organization maintain compliance while delivering the highest level of care. In addition to regular compliance checks, we recommend providers:
Verify the legitimacy of compounding pharmacies – Only work with state-licensed, FDA-compliant facilities.
Ensure proper telehealth evaluations – Avoid prescriptions based solely on online forms; conduct thorough patient assessments.
Stay informed on evolving regulations – Follow updates from CTeL and the DEA, FDA, and state medical boards to ensure compliance. Reference CTeL’s 50 State reports on prescribing laws for additional oversights (included in CTeL membership)
Advocate for responsible telehealth practices – Push for clearer national standards to close regulatory loopholes.
Balancing Innovation with Patient Safety
Telehealth has transformed healthcare accessibility, but when it comes to compounded medications, regulatory gaps pose serious risks. Policymakers, pharmacists, and healthcare providers must work together to ensure compounded prescribing via telehealth remains safe, ethical, and legally compliant.
Without stronger oversight, the very technology designed to expand healthcare access could become a vehicle for harm.