Is Compounded Zepbound (Tirzepatide) Safe?

Title: Is Compounded Zepbound (Tirzepatide) safe?

I had the most wonderful conversation with a lovely pharmacist from a local compounding pharmacy today. You see, I have been researching compounded Zepbound (Tirzepatide) to see if I can make this a more affordable option for patient's who are currently paying out of pocket at the pharmacy.

According to GoodRx a 4 week supply of Zepbound (Tirzepatide) costs around $1,100 per box in Maine (source). That is mind blowing to me. While the Lifestyle Medicine Maine Weight Loss and Wellness Program addresses the root of chronic weight gain through sustainable changes in dietary pattern, Zepbound (Tirzepatide) is a fantastic adjunct for those of us who meet the FDA indications and wish to pursue medication support.

So the question of the day is, what are the risks of compounded Zepbound (Tirzepatide) and is there a safe option?

When it comes to compounding, there are two different types of compounding pharmacies:

• 503A pharmacies provides prescription medication directly to you as the patient. These are traditional compounding pharmacies that make small amounts of custom medications. 503A pharmacies offer high-quality, safe, compounded oral medications -- meaning medications that we take by mouth.

  • Picture the 'mom and pop' pharmacy that knows you with the pharmacist that makes your medication in house.

• 503B pharmacies provide medication directly to medical providers. These facilities typically manufacture medications in large batches.

  • Picture a large warehouse with everyone wearing personal protective equipment (PPE) that produces large quantities of generic medications.

When it comes to injectable medications -- we need to focus on 503B pharmacies. In order for an injectable medication to be considered safe, it need to be manufactured in a pharmacy where there are strict sterility measures that consistently meet FDA regulations.

The main difference comes down to sterility. Zepbound (Tirzepatide) is an injectable medication. That means that they can only be manufactured by a 503B pharmacy because sterility is a significant concern.

To put this into perspective, in 2019 a pharmacist named Glenn Chin from New England Compounding Pharmacy in Massachusetts was convicted and sentenced to 8 years in prison after he compounded medications contaminated with fungus (FDA). According to the FDA, "in 2012, 753 patients in 20 states were diagnosed with a fungal infection after receiving injections... 64 patients in nine states died" (FDA). Big pause... They died.

So, when it comes to choosing a compounding pharmacy, we want a 503B that is licensed as a sterile compounder through the FDA. But it's not enough to just be registered and inspected... Each facility is inspected annually and during the course of inspection, the FDA can issue a Form 483. This form is issued "when investigators observe any significant objectionable conditions" (FDA). And of course, these facilities have the opportunity to address and fix any concerns. Many of these cases appear to still be 'open'.

Out of 83 503B pharmacies registered on the FDA website, only two of them passed inspection without a Form 483 (as of 09/23/2024): BPI Labs and MedisourceRx (FDA).

I really appreciate that we can view any/all concerns on the FDA's website: https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities

Here at Lifestyle Medicine Maine I am committed to providing safe and reliable care to Maine State Residents. That's why I will only work with compounding pharmacies that have a strong track record of safety. As of September 2024, we have been unable to identify a 403B compounding pharmacy that meets our standards for safety for injectable Tirzepatide. When it comes to injectable medications, it's just too risky at the moment. We will continue to keep our finger on the pulse and will let you know if anything changes.

If you are interested in learning more about this topic, here is a helpful NPR article: NPR article link.

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