The Role of a Tirzepatide Compounding Pharmacy

March 28, 2024
A tirzepatide compounding pharmacy

When it comes to managing your health, having access to specialized medications such as tirzepatide is crucial. Obesity is a chronic disease that increases your risk of heart disease, type 2 diabetes mellitus, high blood pressure, metabolic syndrome, and many other conditions.

The glucagon-like peptide-1 (GLP-1) receptor agonists have changed the treatment landscape for obesity and type 2 diabetes, and tirzepatide leads the pack in terms of average weight loss. However, obtaining tirzepatide can be challenging. An unexpected and enormous worldwide demand for tirzepatide has resulted in a medication shortage that traditional pharmacies cannot overcome. This is where tirzepatide compounding pharmacies come into play.

Whether you are searching for “compounding pharmacy tirzepatide” or “tirzepatide compounding pharmacy online,” your search is likely to lead to a lot of questions.

Understanding tirzepatide and its benefits

Tirzepatide is a medication prescribed to treat type 2 diabetes and obesity. It works by combining the action of two hormones your body naturally makes:  glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By boosting the levels of these two hormones, tirzepatide regulates your blood sugar and promotes weight loss.

Tirzepatide can improve body composition, blood sugar, and cardiovascular health.1,2,3

  • Improves body composition: suppresses appetite, increases satiety, decreases food cravings, and slows food digestion and stomach emptying.
  • Regulates blood sugar: increases insulin release from the pancreas, decreases glucagon release, and increases insulin sensitivity.
  • Improves cardiovascular health: decreases blood pressure, reduces LDL (bad) cholesterol, increases HDL (good) cholesterol, reduces triglycerides and protects heart function and blood vessel structure.

Because tirzepatide targets both GLP-1 and GIP receptors, it can help people meet their weight-loss goals even if they have not had success with other weight-loss medications.

A tirzepatide compounding pharmacy preparing compounded tirzepatide

The role of compounding pharmacies in tirzepatide therapy

Traditional compounding pharmacies specialize in creating customized medications tailored to meet an individual patient’s needs, whether it means changing a medication’s strength, dosage form, or the excipients typically found in the manufactured medication form.  

Compounding pharmacists mix and combine ingredients to produce medications personalized to meet each patient’s needs. They make customized medications that are not mass-produced and available at the traditional pharmacy.

How are compounding pharmacies regulated?

The 1938 U.S. Food, Drug, and Cosmetic Act (FDCA) regulates drugs distributed over state lines. The law requires that all new drugs receive FDA approval and prohibits the use of an adulterated or misbranded drug. The FDA does not use the FDCA provisions to regulate the practice of compounding drugs. Instead, it left compound pharmacy regulation to the states.

Their rationale was that to do so would shut down the practice of compounding medications because it was not medically practical or economically feasible to have each compounded medication individually tested for safety and efficacy to meet “new drug” requirements.

The FDCA provisions were updated due to concerns that establishments with retail pharmacy licenses were manufacturing and distributing unapproved new drugs for human use outside the bounds of traditional pharmacy practice. The updated law (FDAMA) requires that compounding must be done by a licensed pharmacist or physician in response to a valid prescription for an identified individual patient or produced in limited quantities in anticipation of receiving these prescriptions. The FDA focuses its concern on compounding pharmacies that produce large quantities of medication and leaves the regulation of traditional compounding to state authorities.4

Compounding pharmacies can be classified into two general categories:

  • 503A compounding pharmacies: Produce compounded medications for an identified individual patient based on the receipt of a valid prescription.
  • 503B compounding pharmacies: These pharmacies, commonly called outsourcing facilities, are defined as facilities at one geographic location that produce sterile drugs, follow current good manufacturing practices (CGMP), label prescriptions with adequate directions for use, and meet drug approval requirements. These pharmacies may also produce compounded medications in the same facility but must follow CGMP for these drugs as well.

Compounding pharmacies can personalize the tirzepatide dosage and have the flexibility to combine tirzepatide with other medications or vitamins. For example, a compounding pharmacy may combine tirzepatide with vitamin B12 to reduce nausea, a common side effect when taking tirzepatide and other GLP-1 agonists. Invigor Medical partners with a compounding pharmacy to create tirzepatide formulations that meet each patient’s unique requirements.

How does a tirzepatide compounding pharmacy work

A tirzepatide compounding pharmacy operates differently from traditional retail pharmacies. Instead of dispensing pre-packaged medications, compounding pharmacies prepare medications on-site, following specific formulations and guidelines. When producing compounded tirzepatide, compounding pharmacies source the active pharmaceutical ingredient and create the medication according to the prescribed dosage and strength.

The process begins with a prescription from a healthcare provider outlining the required tirzepatide formulation. The compounding pharmacy’s team measures and mixes the ingredients, ensuring precise and accurate dosing. Once the tirzepatide formulation is prepared, it undergoes rigorous quality control checks.

Benefits of using a tirzepatide compounding pharmacy

A compounding pharmacy can provide personalized medication solutions by tailoring prescriptions to individual patient needs based on their healthcare provider’s prescription.

However, the biggest benefits of a tirzepatide compounding pharmacy have to do with cost and access.

Cost

The Eli Lilly Company produces tirzepatide under the brand name Zepbound. Novo Nordisk produces another GLP-1 agonist, semaglutide, under the brand name Wegovy. Both medications are FDA-approved to treat obesity. Both medications are on the FDA Drug Shortage List, and both are very expensive. Wegovy and Zepbound are each protected by approximately 20 patents, with many patents offering price protection to 2040 and beyond.5

The list price for Zepbound is $1,060 per month, and for Wegovy, it is $1,349 per month. Both companies offer savings programs to reduce consumers’ out-of-pocket costs, whether or not they have insurance.

A recent study found that semaglutide, sold as Ozempic to treat type 2 diabetes, can be manufactured for less than $5 per month. Three companies (Novo Nordisk, Eli Lilly, and Sanofi) control more than 90% of the insulin market and produce the GLP-1 agonists that are used to treat type 2 diabetes and obesity.6  

The estimated annual medical cost of obesity in the U.S. was nearly $173 billion in 2019, according to the Centers for Disease Control (CDC). Adults with obesity had annual medical costs that were $1,861 higher than medical costs for people with a healthy weight.

Researchers at Johns Hopkins University in Baltimore used a computer simulation to determine how much people could save over a lifetime if their body weight transitioned from obese to overweight to a healthy weight. At age 20, moving from obese to overweight saves more than $17,000 in direct medical costs and lost productivity. If you can reach a healthy weight at this age and maintain it over a lifetime, the cost savings exceed $28,000. At age 40, the savings are $18,000 and $31,000, respectively.

The researchers found that cost savings peak at age 50 for moving from obesity to overweight. After age 50, the highest cost savings occur after moving from obesity to overweight.7

Access

About half of all U.S. adults have asked about prescription weight loss medication. About 93 million people meet the eligibility criteria for taking a GLP-1 receptor agonist (body mass index (BMI) of 30 or higher, or 27 or higher with a weight-related medical condition).5  

Ozempic, Mounjaro, and Wegovy are all on the FDA shortages list at various dosages. The CEO of Novo Nordisk told CNN that it would take years for the company to catch up with demand. The Eli Lilly Company built another plant to manufacture tirzepatide. The plant runs 24 hours a day, 7 days a week, but synthesizing tirzepatide takes months, according to the company.

Pharmacy

Factors to consider when choosing a tirzepatide compounding pharmacy

While tirzepatide compounding pharmacies can improve tirzepatide cost and access, the high demand and ability to make a profit mean that some online companies are selling unsafe medications, often without requiring a prescription.

Tirzepatide is a prescription medication. Like most medications, it has potential side effects, and taking tirzepatide comes with higher risks for some patients. When choosing a tirzepatide compounding pharmacy, only consider the ones that require a prescription. Also, be wary of pharmacies that offer to ship your medication overnight, sell it at significantly lower prices than their competitors, or state that the medication is for research purposes only.

Selecting the right tirzepatide compounding pharmacy is crucial for a successful treatment experience. Here are some factors to consider when making your choice:

  1. Accreditation and certification: Ensure that the compounding pharmacy is accredited and certified by recognized organizations.
  2. Experience and expertise: Look for a compounding pharmacy with experience in formulating tirzepatide and other complex medications.
  3. Customer reviews and testimonials: Read reviews and testimonials from previous customers to get an understanding of their experience with the compounding pharmacy.
  4. Communication and support: Choose a compounding pharmacy that is responsive, accessible, and willing to address any questions or concerns you may have.

The process of ordering tirzepatide from a compounding pharmacy

If you meet the BMI criteria for getting compounded tirzepatide online and do not have a medical condition that increases your risk when taking this medication, ordering tirzepatide is relatively straightforward.

To get started, request a tirzepatide treatment plan on the Invigor Medical wellness platform. Complete your medical information forms. After your forms are completed, you will meet with a licensed healthcare provider to determine whether you are a good candidate for tirzepatide or another weight loss medication. Invigor Medical partners with compounding pharmacies, which saves you time and research. Your prescription will be transmitted to the compounding pharmacy and then shipped to your home.

Does compounded tirzepatide require a prescription?

Yes, tirzepatide is a prescription-only weight-loss medication. It has side effects, and the medication is not appropriate for everyone. It is extremely important to discuss the risks and benefits of taking tirzepatide with your Invigor Medical healthcare provider.

Is compounded tirzepatide a generic?

No. Zepbound is protected by patents, and there are no legal generics for this medication. Compounding pharmacies can produce the active ingredient tirzepatide legally as long as the medication remains on the FDA shortage list.

Is compounded tirzepatide FDA-approved?

No, compounded medications are produced in response to an individual patient’s medication needs, as written on their prescription. They are not mass-produced.

Author: Leann Poston, M.D.
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Sources

  • Chavda VP, Ajabiya J, Teli D, Bojarska J, Apostolopoulos V. Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review. Molecules. 2022;27(13).
  • Frías JP, Davies MJ, Rosenstock J, Pérez Manghi FC, Fernández Landó L, Bergman BK, Liu B, Cui X, Brown K. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021;385(6):503-515.
  • Forzano I, Varzideh F, Avvisato R, Jankauskas SS, Mone P, Santulli G. Tirzepatide: A Systematic Update. Int J Mol Sci. 2022;23(23).
  • Nolan A. Congressional Research Service (April 2013). Federal Authority to Regulate the Compounding of Human Drugs. Retrieved March 27, 2024, from extension://oemmndcbldboiebfnladdacbdfmadadm/https://sgp.fas.org/crs/misc/R43038.pdf
  • Mozaffarian D. GLP-1 Agonists for Obesity—A New Recipe for Success? JAMA. 2024;331(12):1007–1008. doi:10.1001/jama.2024.2252
  • Barber, M. J., Gotham, D., Bygrave, H., & Cepuch, C. (2024). Estimated sustainable cost-based prices for diabetes medicines. JAMA Network Open, 7(3), e243474. https://doi.org/10.1001/jamanetworkopen.2024.3474
  • Fallah-Fini S, Adam A, Cheskin LJ, Bartsch SM, Lee BY. The Additional Costs and Health Effects of a Patient Having Overweight or Obesity: A Computational Model. Obesity (Silver Spring). 2017 Oct;25(10):1809-1815. doi: 10.1002/oby.21965. PMID: 28948718; PMCID: PMC5679120.
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