By Surya Padmanabhan and Monica P. Mallampalli, PhD

Key Takeaways:

• Compounded or counterfeit tirzepatide is not verified for safety, effectiveness, or quality, increasing the risk to patients since it is not FDA-approved.
• Some compounding pharmacies modify drugs in minor ways to continue to sell “unique” compounded medications.
• With tirzepatide’s recent approval to treat OSA in patients with obesity, sleep medicine providers must educate themselves and their patients on the risks and benefits of medications from compounding pharmacies.
• The FDA has declared an end to the tirzepatide shortage, which should force compounding pharmacies to stop selling copycat or compounded tirzepatide.

If you watched the Super Bowl, you may have seen American telehealth company Hims & Hers advertising its affordable glucagon-like peptide-1 (GLP-1) drugs for weight loss. However, the commercial did not disclose any side effects or safety information required for a US Food and Drug Administration (FDA)-approved drug. Compounded medications like this are marketed to the public but have not undergone the FDA’s rigorous approval process to determine whether the product is safe and effective and if its potential benefits outweigh the potential risks. We urge the sleep medicine community to be aware of the potential dangers that compounded formulations of tirzepatide pose for patients seeking treatment for obesity and obstructive sleep apnea (OSA).

Tirzepatide, which combines a long-acting glucose-dependent insulinotropic polypeptide (GIP) analog and a GLP-1 receptor agonist, selectively binds to and activates the GIP and GLP-1 receptors. So far, the FDA has only approved two tirzepatide products: Mounjaro and Zepbound. Mounjaro was first approved by the FDA in May 2022 to treat type 2 diabetes, and Zepbound was approved by the FDA in November 2023 for long-term weight loss in adults with both obesity and either diabetes or an increased risk for a cardiovascular condition. In December 2024, Zepbound received an additional indication for treating adults with OSA and obesity and is the first pharmaceutical treatment for OSA. 

Both Mounjaro and Zepbound, approved as pre-filled sterile single-dose pen injections, were added to the FDA drug shortage list within a few months of their initial approvals. The FDA made this determination after receiving numerous complaints from patients, providers, manufacturers, compounders, and other stakeholders that these drugs were unavailable on the market. According to the Food, Drug, and Cosmetic (FD&C) Act, a drug shortage is defined as a time when the demand or projected demand for a drug within the United States exceeds its supply. The FDA tracks these shortages at a national level and gathers information from manufacturers about their ability to meet demand. 

Interestingly, only sterile pre-filled injectables were placed on the FDA shortage list, not single-dose vial products. However, online and compounding pharmacies have been marketing and selling “copycat” versions of the injectables, vials, and, in some instances, tablet versions of tirzepatide. Oral forms and nasal forms of tirzepatide are counterfeit medications and have never been studied for safety and efficacy by their manufacturers, nor have they been approved by the FDA.

Traditionally licensed pharmacists in state-licensed compounding pharmacies and licensed physicians can compound medications under section 503A of the FD&C Act only if 

1. the commercially available prescription medication has to be modified or tailored to fit a patient’s unique needs (such as creating a liquidized form due to a patient’s gastrointestinal issues or modifying the drug due to their allergies)—but only in small amounts and not regularly; and 
2. the FDA-approved prescription medications are listed on the drug shortage list with no limitations on compounding copies of the drugs.

However, Section 503A explicitly states that neither licensed pharmacists nor physicians can make copies when the medications are commercially available. Outsourcing compounding facilities are specialized pharmacies that make drugs in large quantities, often for hospitals or health care providers. They are strictly governed for quality by the FDA under the 2013 Drug Quality and Security Act. These facilities cannot make copies of an FDA-approved medication unless the drug is on the FDA shortage list and are only allowed to mass produce the active ingredient as per Section 503B of the FD&C Act. These facilities are restricted from producing copies of the drugs when the shortage is resolved, though the FDA allows a grace period to fulfill existing in-house orders.