Is Compounded Tirzepatide Safe? 6 Things to Know About Mounjaro and Zepbound Knock-Offs

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Compounding pharmacies play an important role in helping people access their medications. For instance, they can be helpful if a person needs a different dosage form than what's commercially available. They're also useful when it comes to helping people navigate drug shortages.

Sometimes, the FDA allows pharmacies to compound a medication that's in short supply. But when demand is high, it's also possible for unsafe compounded and counterfeit products to end up in people's hands. This has been the case for tirzepatide, the active ingredient in Mounjaro and Zepbound.

But is it ever safe to use compounded tirzepatide? Below, we'll discuss six things to keep in mind if you're considering this alternative to Mounjaro or Zepbound.

1. Compounded tirzepatide is not the same as Mounjaro or Zepbound

Both Mounjaro and Zepbound are FDA-approved medications. In order to be approved, a medication has to go through rigorous tests and reviews. This helps the FDA ensure that it's safe and effective for certain health conditions and populations. During this process, the FDA also inspects where and how the medication is manufactured.

On the other hand, compounded medications aren't required to go through the FDA's approval process. They're custom-made by combining pharmaceutical-grade active ingredients with various inactive ingredients. This can be helpful in some cases, such as when you need to avoid a substance due to allergies. But there are also risks involved.

Beyond FDA approval, there are other key differences between commercially available and compounded tirzepatide:

• Ingredients: All of the active and inactive ingredients are listed in Mounjaro's and Zepbound's labeling. This is standardized, and you can expect it to be the same for every injection. Pharmacies compounding tirzepatide follow a recipe to make the medication. Compounded versions can vary when it comes to the types and amounts of inactive ingredients used.

• Medication delivery: Most people receive Mounjaro or Zepbound as single-use injection pens. Vials of the medications are also made by Eli Lilly (the manufacturer), but they aren't as commonly prescribed. Compounded tirzepatide injections are typically dispensed as vials. Some compounded tirzepatide products come in oral forms, such as tablets. There haven't been clinical studies showing that these forms are safe or effective, or what a typical dosage may be.

• Storage: Mounjaro and Zepbound have standard storage requirements. Compounded tirzepatide's recommended storage instructions depend on how the product is made. And these recommendations may differ between compounding pharmacies.

It's a good idea to speak with your prescriber about the risks and benefits of using compounded tirzepatide. Depending on your health history and their experience prescribing compounded medications, they may prefer that you stick with Mounjaro or Zepbound if available.

Good to know: When medications are in shortage, the FDA may allow them to be compounded under certain circumstances. These medications should no longer be widely compounded once the shortage is resolved. As of August 2024, no doses of Mounjaro and Zepbound are in shortage.

2. If someone is selling tirzepatide without a prescription, it's not legitimate

Tirzepatide is a prescription-only medication. This includes Mounjaro, Zepbound, and compounded tirzepatide. To obtain it, a licensed healthcare professional will need to send a prescription for it to a pharmacy.

Avoid purchasing tirzepatide from someone who claims you can get it without a prescription. In many cases, it's sold as "research-grade" tirzepatide. This isn't approved, authorized, or regulated by the FDA. And this form of tirzepatide isn't intended for human use.

3. Pharmacies may be using unauthorized forms of tirzepatide

When a pharmacy compounds a medication, it must get the active ingredient from an FDA-registered supplier. This helps ensure the authenticity of the active ingredient included in a compounded medication.

Eli Lilly has stated that it doesn't supply bulk tirzepatide to facilities other than those that it owns and operates. But the FDA does list several registered suppliers on its website. However, it's possible that some pharmacies may be obtaining their bulk tirzepatide from an unregistered supplier. And if they're doing this, there's a greater risk of quality and safety issues.

4. Only certain pharmacies can compound injectable medications

Even if pharmacies are sourcing legitimate tirzepatide, there are extra steps needed before they can legally compound it. When a pharmacy compounds injectable medications, it needs to be done in a sterile environment. This helps lower the risk of contamination.

Compounding pharmacies are regulated by state Boards of Pharmacy. Some states require these pharmacies to obtain certain licenses or certifications in order to operate. But compounding regulations and the degree of oversight required can vary from state to state. There are also outsourcing facilities, which are compounding pharmacies that are registered with the FDA. Outsourcing facilities are inspected by the FDA and must meet more stringent requirements.

Some pharmacies may obtain accreditation that is specific to compounded medications. Accreditation is optional, but it shows that a pharmacy has met a specific set of quality and safety standards for compounding.

The quality of the medication that you receive can depend on the compounding pharmacy that fills your prescription. For an added layer of reassurance, there are ways to find out if a pharmacy or pharmacist is certified or accredited to perform sterile compounding. But keep in mind that not all states require these extra certifications.

• The National Association of Boards of Pharmacy (NABP): You can submit an online form to NABP with the pharmacy's name and location. NABP will respond to you with details regarding whether it has accredited the pharmacy for compounding and if it's in good standing.

• Pharmacy Compounding Accreditation Board (PCAB): You can search for compounding pharmacies that are accredited by PCAB using its online tool. Be sure to select "PCAB Compounding Pharmacy" from the drop-down menu where it says "Select Your Program." You can then filter the results by your location.

• Board of Pharmacy Specialists (BPS): Many pharmacists who regularly perform sterile compounding are board-certified to do so. Using BPS' online tool, you can search for pharmacists who are certified in your state. Just make sure to select the "Compounded Sterile Preparations Pharmacy" from the list of specialties.

Good to know: Healthcare professionals that frequently prescribe compounded medications are often familiar with compounding pharmacies in their area. Consider asking your prescriber for recommendations on a pharmacy that they trust.

5. Counterfeit tirzepatide is out there, and it poses safety risks

The existence of counterfeits is another issue when it comes to purchasing a tirzepatide product that's not Mounjaro or Zepbound. These fake products, which are often sold online, can pose more risks than tirzepatide made by a compounding pharmacy.

Some safety issues that can happen with counterfeit tirzepatide include:

• The product may contain too high or too low of a dose of tirzepatide.

• The product may not contain any medication at all.

• The product may contain another medication, such as insulin.

• The product could be contaminated with germs, such as bacteria or fungi.

• The medication you receive could be expired.

• The device you use to inject yourself could malfunction and hurt you.

There are steps you can take to verify if you've received legitimate Mounjaro or Zepbound. A good place to start is to check your product against images from the manufacturer. Other steps you can take include:

• Check the box that the medication comes in. Look for the brand name, concentration (written as mg/mL), and a National Drug Code (NDC) number. You can verify whether an NDC is real at the FDA's NDC directory website.

• Check the labels on your pens or vials. These should also have the brand name, concentration, and an NDC on them. The NDC may be slightly different from what's on the box. But you should still be able to verify it on the FDA's database.

• If you're using Mounjaro or Zepbound pens, check for a purple injector button that doesn't extend. The pen shouldn't require you to dial up a dose or attach a pen needle before you use it.

If you're ever in doubt as to whether your product is legitimate, you can verify it with the manufacturer using their barcode scanner or by contacting them by phone at 1-800-545-5979.

6. Cheaper doesn't mean better

Compounded tirzepatide is often marketed as a lower-cost alternative to Mounjaro or Zepbound. But as discussed above, there are risks and unknowns involved with using it. In some cases, a lower price tag could mean that lower-quality ingredients were used while producing it.

What's more, tirzepatide should no longer be widely compounded once the shortage has resolved. And the FDA doesn't consider cost a reason for someone to receive a compounded medication when the FDA-approved product is available.

If medication costs are preventing you from accessing your medication, speak with your prescriber. There are lower-cost, FDA-approved alternatives available for both Mounjaro and Zepbound.

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