How to Stay Legally Compliant When Offering Weight Loss Programs

By Dr. Jonathan Kaplan, CEO of Dr. Well
As more clinics begin to incorporate GLP-1 medications and other compounded therapies into their wellness programs, it’s critical to understand the legal, financial, and regulatory landscape that surrounds these treatments. While the clinical benefits of medications like semaglutide and tirzepatide are widely recognized, the infrastructure used to deliver them—pharmacies, payment systems, marketing, and provider protocols—requires careful attention to remain compliant.

Failure to understand the compliance requirements can lead to major consequences: advertising bans, payment processor shutdowns, malpractice exposure, or even federal prosecution. Fortunately, there are clear ways to mitigate risk, protect your practice, and still offer patients safe, effective access to weight loss care.

• A. Improper Marketing and Advertising: Many providers mistakenly advertise prescription medications using platforms like Google or Meta without the proper certifications. If a clinic is not LegitScript-certified, it cannot legally advertise drug names like semaglutide, tirzepatide, or testosterone—even when using generic names. Ads are likely to be pulled, accounts suspended, and domains flagged.
  Key Tip: Either pursue LegitScript certification independently (a costly and time-consuming process) or partner with a certified platform that can run ads legally on your behalf and direct patients through compliant pathways.
• B. Using the Wrong Payment Processor: GLP-1 medications fall under high-risk merchant codes (specifically, merchant code 5122). Most standard payment processors like Stripe, Square, or PayPal do not support these types of transactions. If your platform detects a patient dispute or chargeback related to a medication purchase, your entire account—including all unrelated services—could be suspended.
  Even EMR-integrated processors are often not high-risk compliant. To accept payment legally for pharmaceuticals, you must use a processor designated for high-risk services. While these can come with higher fees, bulk purchasing platforms may offer access to lower negotiated rates that preserve margin and ensure compliance.
• C. Sourcing Research-Grade or Illegitimate Medications: Providers who purchase and administer research-grade or unregulated medications—especially those labeled “not for human use”—face serious legal consequences. Even if patients are informed and sign consent forms, the FDA can and has pursued criminal charges in such cases. It is illegal to bypass FDA-approved medications by offering cheaper research-grade versions that are not compounded by a licensed 503A or 503B pharmacy.
  The risk is not theoretical—providers have been charged and prosecuted for distributing unapproved compounded semaglutide and similar medications, with penalties including prison time and six-figure fines.

Only Source From Licensed 503A or 503B Pharmacies

The pharmacy you use must be licensed to operate in the state where your patient is located. Always avoid suppliers offering powdered medications for reconstitution at home or those labeling vials as “research only” or “for physician use only.” These are clear red flags.

In addition, ensure that prescriptions meet the FDA’s requirement for commercially unavailable alternative formulations. For example:

• Methylcobalamin (B12): Added to GLP-1 medications to counteract nutrient depletion caused by delayed gastric emptying—a documented side effect.
• Glycine: Added to reduce lean body mass loss during weight loss, offering additional clinical value.

These are legitimate, medically justifiable combinations not commercially available in a single form, and therefore qualify under FDA compounding guidelines.

Use Asynchronous Telehealth Legally Across State Lines

• Providers can use asynchronous consultations (digital intake forms reviewed later by a clinician) in all 50 states, but each state has specific requirements.
• In 31 states, asynchronous consultations alone are sufficient to prescribe and dispense medications.
• In 19 states, including newly added Maine, a virtual or in-person follow-up is required after the intake form is reviewed.
• To legally serve patients in multiple states, providers must also hold licensure in the state where the patient is located. Systems that automatically route patients to licensed providers or restrict form access based on geography can help maintain compliance at scale.

Avoid Manual Workflows That Lead to Compliance Gaps

• Manual tracking of dosing schedules, refill approvals, or shipping state-by-state can lead to errors.
• Use systems that automate dosage progression tracking, auto-generate prescriptions, and route to state-licensed pharmacies.
• Automation improves compliance, safety, and practice efficiency.

Handle Payments Through High-Risk-Compliant Systems

• Use payment processors designed for healthcare-related pharmaceuticals.
• Ensure PCI compliance, merchant code 5122 capability, and transparent fee structures.
• Platforms offering network-wide negotiated rates can reduce transaction costs while maintaining compliance.

• Consent Forms: Ensure patients electronically sign medication-specific consent forms at multiple points in the process (e.g., intake, checkout).
• Malpractice Insurance: Confirm with your carrier that compounded medications are covered, or secure supplemental coverage.
• Digital Patient Experiences: Compete with direct-to-consumer platforms by offering frictionless enrollment, mobile access, and responsive provider relationships.

Weight and wellness programs, when structured correctly, offer strong recurring revenue potential. With automated workflows, many providers report net margins exceeding 65%–75% even after factoring in pharmacy costs and platform fees. Patients expect convenience—but they also want credibility and accountability. Providers who operate legally, transparently, and efficiently will not only avoid penalties—they’ll grow sustainably and deliver better care.

Offering weight and wellness programs is a clinical and financial opportunity—but only if done right. Every provider must take personal responsibility for sourcing medications legally, adhering to telehealth rules, protecting patient information, and billing through compliant systems.
The infrastructure and tools you choose will determine whether your weight and wellness program is scalable, safe, and sustainable—or whether it exposes your practice to avoidable risk.

Want to see how DrWell’s solutions could work for your clinic? Book a Demo

Dr. Jonathan Kaplan is a board-certified plastic surgeon and the founder of DrWell, a platform that empowers healthcare providers with the tools to offer legal, automated, and patient-friendly access to weight loss and wellness programs.