Fake and Compounded Tirzepatide Products: What You Need to Know

Learn how to stay safe from fake and compounded tirzepatide products. In today’s digital age, it is easier than ever to access medications online. However, this convenience comes with significant risks, particularly when it comes to medications like tirzepatide and semaglutide, two medications used to treat type 2 diabetes and that promote weight loss. Unfortunately, the proliferation of fake and compounded products poses serious health risks. In this blog post, we will explore what tirzepatide is used for, the FDA’s stance on compounded medications, and how you can protect yourself from counterfeit and unsafe compounded tirzepatide products. To learn more about protecting yourself from fake or compounded semaglutide products read my blog “The Best Tips to Identify a Fake Semaglutide Injection.”

What is Tirzepatide Used For?

Tirzepatide is an innovative medication known under brand name Mounjaro^® for managing type 2 diabetes and, more recently, Zepbound^® for weight management. It mimics the effects of two hormones, GLP-1 and GIP, which regulate blood sugar and appetite. This dual action supports both blood sugar control and weight loss, making it valuable for those with obesity and diabetes. However, its growing popularity has also led to concerns about counterfeit and compounded versions being marketed by illegal entities.

FDA’s Recommendations Against Using Compounded Products

The FDA strongly recommends against using compounded versions of medications like tirzepatide, when a FDA-approved version is available. Compounded drugs are custom-made by pharmacists to meet specific patient needs, but they are not subjected to the same rigorous testing and approval processes as FDA-approved medications. This lack of oversight can lead to variations in potency, purity, and quality, which can result in ineffective treatment or serious side effects. The FDA has issued multiple warnings about the dangers of using compounded medications, especially when approved, safe, and effective alternatives are available. Most recently, warnings related to compounded semaglutide¹ were dosing errors 10x the recommended dose due to administration errors and prescribing errors from multi-dose vials.

What You Need to Know About Fake and Compounded Tirzepatide Products

Recognizing the Risks

Fake and compounded tirzepatide products can pose numerous health risks. Counterfeit medications often contain incorrect dosages, harmful ingredients, or no active ingredients at all. Compounded versions, while intended to be tailored to patient needs, can suffer from contamination, incorrect dosages, and variability in their formulation if not purchased from licensed pharmacies. Both types of products can lead to adverse health outcomes, including ineffective diabetes or weight management, severe allergic reactions, or toxic side effects.

A recent study² found that of the fraudulent pharmacies supplying compounded semaglutide:

• some were found to have endotoxins indicating possible contamination.
• The actual semaglutide content was far lower than advertised, ranging from 7% to 14% purity compared to the claimed 99%.
• The measured amount of semaglutide in the products was up to 39% higher than what was labeled, posing a risk of overdose.

How to Verify Your FDA-Approved Medication

To protect yourself from fake tirzepatide products, follow these steps to verify the authenticity and safety of your Mounjaro^® or Zepbound^® medication:

Purchase from a Reputable Source: Only buy medications from licensed pharmacies or authorized online retailers. Avoid purchasing from unofficial websites or third-party sellers.

• To verify the medication is authentic Mounjaro^® (tirzepatide) or Zepbound^® (tirzepatide) use Lilly’s website – Check the Authenticity of Your Medicine
• Verify the pharmacy on their state’s board of pharmacy website. For example, if the pharmacy location is in Georgia, I would use the Georgia Board of Pharmacy site HERE. Keep in mind you are verifying a facility or business.

Inspect Packaging and Labeling: Authentic medications will have clear, professional packaging and labeling. Look for misspellings, incorrect logos, or unusual packaging, which can be signs of counterfeit products.

• The minimum requirements for a drug container label include:
  • Drug Name: Clearly display the generic name of the drug and, if applicable, the brand name.
  • Strength: Indicate the strength or concentration of the medication.
  • Dosage Form: Specify the form in which the medication is provided (e.g., tablets, capsules, liquid).
  • Route of Administration: Describe how the medication should be administered (e.g., oral, injection).
  • Manufacturer’s Name and Address: Include the name and address of the drug manufacturer, packer, or distributor.
  • Lot or Batch Number: Display the lot or batch number for traceability in case of recalls or quality issues.
  • Expiration Date: Clearly state the expiration date of the medication.
  • National Drug Code (NDC): Include the NDC, a unique identifier for the medication, facilitating tracking and reporting.
  • Storage Instructions: Provide guidance on how the medication should be stored to maintain its stability.
  • Warning Statements: Include any necessary warnings or cautionary statements regarding potential risks or side effects.
  • Use Instructions: If applicable, provide specific instructions for using the product, especially for devices or products with unique administration requirements.

Be Wary of Unusually Low Prices: If a deal seems too good to be true, it probably is. Extremely low prices can be an indicator of counterfeit or substandard products.

Consult Your Healthcare Provider: Before starting any new medication, including tirzepatide, consult with your healthcare provider. They can provide guidance on where to purchase safe and legitimate medications. Ensure that you receive a prescription from a licensed provider for the medication. If the company does not provide a prescription, it is likely operating illegally.

Report Suspicious Products: If you suspect that you have received a fake or compounded Tirzepatide product, report it to the FDA and your healthcare provider immediately.

How to Verify Your Compounded Medication

#1 TIP–Purchase from a Reputable Source: Only buy medications from licensed pharmacies or authorized online retailers. Avoid purchasing from unofficial websites or third-party sellers.

• To verify a compounded product, make sure they are state licensed pharmacy. See how below:
  • Are they listed on the Board of Pharmacy Digital Pharmacy list?
  • Use the Alliance for Compounding Pharmacy, though you may not find some of the online retailers. This is helpful to find local compounding pharmacies.
  • If the facility states they are an Outsourcing Facility, this can be verified HERE through the FDA’s website.
  • Verify at LegitScript’s verification website
    • Another tip: Look for this logo on the companies website, still verify online as well.

Inspect Packaging and Labeling: Unfortunately, since compounded medications are not regulated by the FDA, there can be significant variations in packaging and labeling. Some products may even lack information on medication strength or concentration, which is concerning from a pharmacist’s perspective.

• To navigate these issues, here are my top tips:
  • Make sure the vial is clearly labeled with the medication name and concentration of medication in (mg/mL).
  • Ensure you understand the dosing whether in units, milligram (mg) or in milliliter (mL).
    • see below an example of how dosing can vary in regard to mg, mL, and units
    • this is for educational purposes only
    • dose should always be confirmed with healthcare provider
  • Does the vial have a label with instructions? If not, request a label or document with clear instructions on how to administer the medication and what potential side effects you should be aware of.
  • Do not administer the medication unless you fully understand what you are administering and at what dose. If the dose seems way off from typical dosing for the FDA-approved version, I would question it.

Other Tips:

• Use Proper Measuring Tools: If your medication is dosed in units you will need an insulin syringe, if in mL then a regular syringe with the closest volume.
• Ask Questions: Don’t hesitate to ask your pharmacist or provider to explain the dosing and demonstrate how to measure the correct dose.
• Self Check: Double check dose before administering. Once you inject the medication, there is no way to reverse it. If you realize you made a mistake after, call POISON CONTROL at 1-800-222-1222 to determine what your next steps should be.

Consult Your Healthcare Provider: Before starting any new medication, including tirzepatide, consult with your healthcare provider. They can provide guidance on where to purchase safe and legitimate medications. Ensure that you receive a prescription from a licensed provider for the medication. If the company does not provide a prescription, it is likely operating illegally.

Conclusion

The rise of fake and compounded tirzepatide products is a serious issue that requires vigilance and awareness. By understanding the risks associated with these products and following the recommended steps to verify your medication, you can protect your health and ensure effective treatment. Always prioritize safety by sourcing your medications from reputable providers and consulting with healthcare professionals.

Stay informed and stay safe Friends! I would love to hear about any scares you have encountered with your compounded medication. Comment below or send me a message!

1. U.S. Food and Drug Administration. FDA alerts health care providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products. Available at: https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded. Accessed August 3, 2024. ↩︎
2. Ashraf, A. R., Mackey, T. K., Schmidt, J., Kulcsár, G., Vida, R. G., Li, J., & Fittler, A. (2024). Safety and Risk Assessment of No-Prescription Online Semaglutide Purchases. JAMA Network Open, 7(8), e2428280. ↩︎

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