The Compounded Weight Loss Medication Ban: Tirzepatide and Semaglutide

A new policy restricting access to compounded weight loss medications containing semaglutide is expected to take effect soon. This comes at a time when companies like Eli Lilly and Novo Nordisk are making efforts to improve affordability for their brand-name treatments, Zepbound and Wegovy. You may be considering how these changes could impact your options for weight management.

For individuals living with chronic weight challenges or conditions like polycystic ovarian syndrome, affordable compounded medications have played a significant role in making treatment accessible. Some people have seen meaningful results from these drugs, often at a much lower cost than brand-name alternatives. With the upcoming changes, you might be evaluating new ways to manage your health and maintain progress.

FDA Restrictions on Compounded Weight Loss Drugs

Due to recent decisions by the Food and Drug Administration, you may soon find it much harder to access compounded or custom-made versions of popular weight loss medications. In March, a ban on compounded drugs with the active ingredient tirzepatide came into force. An equivalent restriction for semaglutide compounds is scheduled for April 22.

These stricter rules followed a court decision affecting compounding pharmacies, and another related case is still under review. Since compounded medications aren’t FDA-approved, the agency cannot guarantee their safety or effectiveness, even though they have sometimes been allowed during drug shortages.

A few key points to know:

  • Compounded weight loss drugs: Created by pharmacies, typically in response to shortages or cost issues
  • New regulations: Directly impact your ability to purchase these alternatives
  • Affected medications: Medications containing tirzepatide and semaglutide as active ingredients
CompanyRole in Alternative Access
EdenProvided alternatives during shortages
MochiProvided alternatives during shortages
RoProvided alternatives during shortages
Hims & HersProvided alternatives during shortages

Previously, the FDA permitted telehealth firms and compounding pharmacies to make these drugs available due to a national shortage. When the shortage was officially declared over in December 2024, the FDA moved to restrict compounded versions again. The underlying reason for the overwhelming demand is that these drugs are currently among the most effective weight loss treatments available. For more details on the FDA’s actions and their impact, see this coverage on compounded medications and the weight loss drug market, click here

Cost and Access Challenges for Weight Loss Medications

Major pharmaceutical companies, such as Novo Nordisk and Eli Lilly, have responded to pricing concerns by introducing lower monthly costs for weight loss drugs. Eli Lilly offers Zepbound at $499 per month for specific vial sizes when you order with an initial prescription and continue refilling within a 45-day window. If you miss this window, expect to pay $599 or $699 per month depending on the vial size. To benefit from these reduced prices, you need to use LillyDirect and have a qualifying prescription for obesity or obstructive sleep apnea.

Similarly, Novo Nordisk enables eligible cash-paying customers to obtain Wegovy for $499 every month at certain local pharmacies. Both of these options aim to make weight loss medications more accessible, but not all individuals are able to take advantage of the price reductions due to insurance restrictions or other eligibility requirements.

If your insurance does not cover these prescriptions, you may still face significant financial barriers even with the discounted programs. For many, the monthly out-of-pocket expense remains a major concern.

Table: Price Options for Brand Name Weight Loss Medications

MedicationDiscounted PriceRefill RequirementsHow to Access
Zepbound$499 per monthInitial + refills within 45 daysLillyDirect website
Wegovy$499 per monthOngoing/eligible customersLocal pharmacies

Key Considerations:

  • Insurance may not always cover these drugs, leading to substantial costs for ongoing use.
  • Losing access to medication can make it challenging to maintain weight loss, even with continued diet and exercise.
  • Many patients assert the need for broad options in weight loss treatments to support varied individual needs.

While Kerry Spindler shares her own weight loss journey with patients and agrees that these medications have made significant strides for multiple health and wellness generes, she also believes in sticking to the branded medications that have had clinical trials. She also suggests the guidance of a medical professional over a telehealth visit or even a med-spa where blood work and medical history is available for the best outcomes.

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