Written and medically reviewed by Dorcas Morak, Pharm.D
Medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) have made weight loss and diabetes management more accessible for many. These drugs have been game-changers, helping patients manage blood sugar levels, control appetite, and achieve meaningful weight loss. However, their popularity has come with high demand, occasional shortages, and steep costs, prompting some to consider compounded versions of these medications. Before you buy the compounded ones, here is what you should know.
What are Semaglutide and Tirzepatide?
Semaglutide and tirzepatide are medications designed to help manage diabetes and obesity. Both work by mimicking hormones in the body that regulate blood sugar levels and appetite:
- Semaglutide (sold under brand names like Ozempic and Wegovy) is a GLP-1 receptor agonist, that increases insulin production, reduces appetite, and slows digestion.
- Tirzepatide (sold as (Mounjaro and Zepbound)) acts on both GLP-1 and GIP receptors, making it a dual-action drug that enhances blood sugar control and promotes weight loss.
These FDA-approved medications have been extensively tested for safety and efficacy, making them popular options for individuals with Type 2 diabetes or obesity.
What are Compounded Medications, and Why are they Used?
Compounding is a process where a pharmacist customizes medications to meet a patient’s specific needs. This might involve altering a drug’s dosage, form (e.g., converting a tablet into a liquid), or ingredients to accommodate allergies or preferences. Compounded medications can fill critical gaps, particularly during drug shortages or when patients require unique formulations.
However, compounded drugs are not FDA-approved. Unlike commercial medicines, they don't undergo the rigorous testing and quality control processes required for FDA approval. For semaglutide and tirzepatide, this lack of oversight may raise safety concerns.
Can I Buy Compounded Semaglutide and Tirzepatide?
Semaglutide
Compounding pharmacies are allowed to make semaglutide because it's on the FDA's drug shortage list:
- FDA Authorization: The FDA's 503B program allows compounding pharmacies to make non-generic drugs that are in shortage.
- Filling a Need: Compounding pharmacies can help fill the gap when there's a shortage of conventionally manufactured drugs.
- Patient Demand: Compounded semaglutide is cheaper and more accessible than the brand-name version, which can cost $1,000 or more per month. Although compounded versions may seem appealing, it is important to weigh these benefits against the potential risks, such as inconsistent quality and safety concerns.
Tirzepatide
On December 19, 2024, the FDA announced that it has re-evaluated its previous determination from October 2, 2024, regarding the tirzepatide injection shortage. Following a comprehensive analysis of all available information, the agency has determined that the shortage of tirzepatide injection has been resolved.
In light of this updated status, the FDA also provided guidance to avoid unnecessary disruption to patient care. Despite the resolution of the shortage, the FDA does not plan to take enforcement action against compounders for certain violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) under specific conditions related to tirzepatide injection compounding and distribution:
- State-licensed pharmacies (under Section 503A of the FD&C Act): Compounding, distributing, or dispensing tirzepatide injection products within 60 calendar days of this announcement, up to February 18, 2025.
- Outsourcing facilities (under Section 503B of the FD&C Act): Compounding, distributing, or dispensing tirzepatide injection products within 90 calendar days of this announcement, up to March 19, 2025.
The FDA emphasized that this leniency does not exempt compounders from compliance with other statutory or regulatory requirements. The agency retains the authority to take enforcement actions if products are found to be of substandard quality or pose safety risks to patients.
This decision underscores the FDA's commitment to balancing patient needs with regulatory oversight to ensure access to safe and effective treatments.
Are Compounded Medications Always Unsafe?
Not necessarily. Compounded medications can be safe when prepared by reputable, accredited pharmacies. However, the lack of FDA approval introduces additional risks.
Why are Compounded Semaglutide and Tirzepatide Potentially Risky?
While it may be tempting to turn to compounded versions of these medications during shortages, it’s important to consider the following:
- Lack of FDA Oversight: Compounded drugs are not regulated by the FDA, meaning there’s less assurance of safety, quality, or effectiveness. Without strict testing, the final product may not work as intended or could cause harm.
- Inconsistent Dosages: Commercial medications are manufactured with precise dosages, ensuring each dose is as prescribed. In compounded versions, dosages can vary, making it difficult to know whether you're receiving the right amount of the active ingredient.
- Quality Control Issues: Compounding pharmacies may not adhere to the same quality standards as pharmaceutical manufacturers. This increases the risk of contamination, impurities, or errors in production—particularly concerning injectable medications.
- Unregulated Ingredients: Some compounded versions use unapproved ingredients like semaglutide salts (e.g., semaglutide acetate) instead of the FDA-approved semaglutide base. These alternatives haven’t been thoroughly studied for safety or effectiveness.
What are the Warning Signs of Poor-Quality Compounded Drugs?
Warning signs include inconsistent appearance, lack of clear labeling, or side effects like redness or irritation at injection sites.
Legal and Ethical Considerations
The legality of compounded versions is a gray area. For instance:
- Eli Lilly, the maker of tirzepatide, has taken legal action against compounding pharmacies selling unapproved versions of their drug.
- Similarly, compounded semaglutide often includes additives like vitamin B12 or other untested substances, which may increase the potential for adverse effects. Using compounded versions also raises ethical concerns, as some pharmacies may take advantage of patient desperation during shortages or price hikes.
How can I Tell if a Pharmacy is Reputable?
Look for accreditation from the Pharmacy Compounding Accreditation Board (PCAB) and ensure the pharmacy adheres to strict quality standards.
Potential Benefits of Compounded Medications
In some circumstances, compounded medications may offer specific advantages:
- Affordability: Compounded versions are often less expensive than brand-name drugs.
- Availability: They may be accessible during shortages of FDA-approved medications.
- Customization: Compounded formulations can be tailored to meet individual patient needs, such as specific dosages or allergy-friendly ingredients.
However, these potential benefits must be carefully weighed against safety and quality concerns.
Are there Safer Alternatives if Cost or Shortages are a Concern?
If you’re considering compounded medications due to high costs or limited availability, there are safer options to explore:
- Check Insurance Coverage: Many insurance plans cover FDA-approved versions of semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound)), often with copay assistance programs.
- Use Discount Tools: The RxLess® Assurance Plan can help you find discounts and compare prices for FDA-approved medications. By using RxLess coupons, you can significantly reduce the out-of-pocket cost of these prescriptions if you don’t have insurance.
- Choose Zepbound Vial: The cost of a one-month supply of Zepbound Vial is 60% cheaper than the pen injector through the RxLess® app.
- Discuss Alternatives with Your Doctor: Your healthcare provider may suggest other approved treatments or adjust your regimen to make it more affordable. Always consult your doctor before considering compounded options.
- Explore Patient Assistance Programs: Many pharmaceutical companies offer financial assistance programs for eligible patients.
What Should you do if Considering Compounded Medications?
If you’re still considering a compounded version of semaglutide or tirzepatide, here are some steps to take:
- Consult Your Doctor First: Discuss the risks and benefits with your healthcare provider. They can help you weigh your options and make an informed decision.
- Choose Accredited Pharmacies: If you decide to use a compounded medication, ensure the pharmacy is accredited by the Pharmacy Compounding Accreditation Board (PCAB). Accreditation ensures specific safety and quality standards are met.
- Report Any Adverse Effects: If you experience side effects from a compounded medication, immediately report them to your doctor and the FDA's MedWatch program.
Conclusion
While compounded versions of semaglutide and tirzepatide may seem like an attractive option during shortages or periods of high costs, they come with potential risks. Lack of FDA oversight, inconsistent dosages, and unregulated ingredients can raise safety concerns. Instead, consider safer alternatives such as exploring insurance coverage, using discount tools, or consulting your doctor for affordable options. By staying informed and cautious, you can make the best choice for your health and safety.
