
I’m currently on compound tirzepatide and before I got on it, I did a bit of a deep dive to find out if it was safe. Like so many others, my insurance will not cover name-brand GLP-1 medications, and I really wanted to try this therapy to get to a healthier weight. I found a telehealth that would prescribe me the compounds and after doing some research, I felt good about the compounded medications I was receiving. This is some of the information that helped me come to my decision.
Compounding Laws and Regulations
The American Pharmacists Association (APhA) offers comprehensive insights into the practice of compounding. According to the APhA, “Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs. A patient may not be able to tolerate the commercially available drug, the exact preparation needed may not be commercially available, or a patient may require a drug that is currently in shortage or discontinued.”
The APhA explains that compounding is regulated by state boards of pharmacy and pharmacists involved in compounding must adhere to applicable standards and regulations for the types of preparations they make. The FDA oversees the integrity and safety of the drugs used in compounded preparations. The Drug Enforcement Administration (DEA) has oversight for any controlled substances used in the preparation of compounded medications. Furthermore, the United States Pharmacopeial (USP) Convention defines the chemical purity of drugs and issues practice standards.
So compounding pharmacies and compounded medications are legal and regulated by both state and national authorities.
Shortages
One of the reasons why compounded medications are gaining popularity is due to drug shortages. The FDA’s drug shortages list indicates that the first three starting doses of Wegovy (semaglutide) have limited availability, with the duration of the shortage yet to be determined. Similarly, Zepbound, a tirzepatide injection, has the 7.5, 10, and 15 mg doses in limited availability. These shortages make it challenging for patients to access necessary medications, prompting many to turn to compounded alternatives.
Price Gouging
The issue of price gouging by pharmaceutical companies is another significant factor. Novo Nordisk, for example, charges $1,349 a month for Wegovy in the United States, while the same drug costs $92 in the UK, $186 in Denmark, and $265 in Canada. Eli Lilly charges $1,023 for Mounjaro in the US, compared to $319 in Japan and $444 in the Netherlands. According to CNBC, only about 27% of health insurances cover GLP-1s for weight loss, and this number is decreasing.
Big Pharma Statements
Big pharma companies have voiced their concerns regarding compounded medications. Novo Nordisk stated, “We will continue to pursue legal action against those who provide potentially unsafe and ineffective compounded ‘semaglutide’ products and knowingly deceive patients who are seeking treatment, thereby eroding public trust in the safety of FDA-approved medicines.”
Eli Lilly echoed similar sentiments: “Patient safety is Lilly’s highest priority. Lilly is deeply concerned that products fraudulently claimed by compounding pharmacies or counterfeiters to be FDA-approved tirzepatide, Mounjaro®, or Zepbound® may expose patients to serious health risks. Neither the FDA nor any global regulatory agency has reviewed these products for safety, quality, or efficacy, and unsafe products should not be on the market. Lilly has discovered products claiming to be compounded tirzepatide medicines that contain bacteria, high impurity levels, different chemical structures, and different colors than Mounjaro® or Zepbound®. In at least one instance, the product was nothing more than sugar alcohol.”
Compounding Pharmacy Statement
The Alliance for Pharmacy Compounding responded to these concerns, stating: “Legitimate compounded drugs are prescribed by a physician for a specific patient when an FDA-approved drug is not appropriate for or available to that patient. They are prepared and dispensed by state-licensed compounding pharmacies using documented pure active pharmaceutical ingredients that come from FDA-registered facilities. Lilly rightly notes that compounded drugs are not FDA-approved. But that fact does not mean compounded drugs are unsafe – any more than it means that FDA-approved drugs are always safe.”
Watch Out For These
It’s crucial to distinguish between reputable sources of compounded medications and those that are not. Med spas and random online sellers are often not regulated compound pharmacies. Anything labeled “research grade” should not be used. However, reputable telehealth services or physician’s clinics that send prescriptions to state-regulated compound pharmacies, which require a prescription, are generally trustworthy.
My Findings
Based on my research and experience, I believe compounded semaglutide and tirzepatide can be safe and effective alternatives to commercially available drugs, provided they are obtained from reputable, regulated sources. They offer a more affordable and available solution for many patients, especially those facing drug shortages or price gouging by big pharmaceutical companies. While big pharma companies like Novo Nordisk and Eli Lilly raise valid concerns about the potential risks of compounded medications, these risks can be mitigated by ensuring that patients obtain their medications from licensed and regulated compound pharmacies.
Ultimately, it is up to the pharmaceutical industry to adjust their prices and address availability issues. Until then, compounded medications remain a viable and necessary option for many patients.