Compounded Wegovy and Zepbound, Copycat or Legitimate
What are compounding pharmacies?
Compounding pharmacies have been around for nearly 90 years. Most of the medications people obtained in the 1930’s were compounded by a pharmacist based on the doctor’s orders. Over the years, the process became standardized and FDA stepped in to oversee the quality and safety. Today’s compounding pharmacy is an advanced lab where numerous medications are being made. The main role of this type of pharmacy is to help customize medications. If a person can’t swallow a pill or tolerate the taste of a pill, this pharmacy can accommodate and change the negative aspect of the original pill. A crucial role for this type of pharmacy is that it can manufacture medications that are on the FDA shortage list. As of November 2024, Tirzepatide (Zepbound) is no longer on the shortage list. Semaglutide (Wegovy) is still considered on the shortage list for some of the doses.
How did we get here?
The FDA approved Ozempic for treatment of diabetes in 2017. Wegovy, used to treat obesity, was approved in 2021. It wasn’t until late 2021 that the social media machine caused an explosion in demand for this drug. Norvo Nordisk and eventually Eli Lilly didn’t anticipate the demand for these medications. Once the demand started to greatly out weigh supply, shortages occurred and compounding of these medications became a very lucrative business. Compounding played a crucial role in allowing the people to get this medication at affordable prices.
What is the controversy all about?
The main controversy is the question of efficacy and safety. Does the compounded version work as well as the official FDA approved version. More importantly, are there specific complications related to compounded versions. The official products used are a patented process and technically none of the compounding pharmacies are creating the same medication. Keep in mind, compounded and generic medications are NOT the same. Generic medications are allowed to be manufactured once the patent on the medication runs out. Generic medication based on the FDA approved formulation and ideally gets sold for a lower price, giving greater access to patients. As discussed earlier, compounded versions of patented medications are not the same as the medications produced by the official companies. The FDA issued a stern warning about the use of compounded weight loss medications and you can read this in the following article, https://bit.ly/40AFhZE. One of the earlier issues with compounded medications dealt with people injecting the wrong amount of medication. The official medications come in a single dose pen, not requiring you to measure out the dose and thus preventing you from getting too much medication. The compounded versions require you to measure out a specific dose and the difference between normal and dangerously high levels can be very subtle. You can read more about this in the following article, https://bit.ly/4hDZ1BH. Pharmacies known as “outsourcing facilities” are able to manufacture medications in a sterile environment and have to be registered with the FDA. These facilities are subjected to rigorous rules established by the FDA. Once these medications are created in the big laboratories, the product is sent to a smaller compounding pharmacy where individual doses of the medication are created for a patient. These smaller pharmacies, known as 503a, are not held to the same high standards as the large FDA registered pharmacies. The three layers of manufacturing include:
· Bulk material manufacturers of the raw ingredients that will be turned into a particular medication by the bigger manufacturer called 503b
· Outsourcing Facilities- can take the raw material and create the medication that is being requested such as Semaglutide and Tirzepatide
· Traditional compounding pharmacies- obtain the large amount of medication from the outsourcing facility and create individual doses of medication that are sold to the patient or to the provider who then sells it to the patient.
Bottom Line-
· The use of compounded weight loss medication is controversial due to a question of quality of the drug and dose of the active drug
· The Obesity Society, Obesity Action Coalition and Obesity Medicine Association have all made warning about the use of compounded weight loss medications.
· Once a medication is off the shortage list, compounding pharmacies are not allowed to create and sell this medication. Tirzepatide (Zepbound) is currently off the shortage list. Semaglutide (Wegovy) is still on the shortage list.
· Work with a doctor who’s office can help with preauthorization of these medications so that you have a better chance of your insurance covering them
So what should you do?
The most important thing you can do is to discuss your options with your doctor. Most doctors may not feel comfortable prescribing compounded medications. Work with a doctor whose office can help with preauthorization of these medications so that you have a better chance of your insurance covering them.
If the official medication is too expensive or is not available, you can discuss compounded medication with your healthcare provider. Keep in mind the FDA warnings. Most importantly, communicate closely with your doctor in case something doesn’t feel right, call them right away.
*** This article is meant strictly for educational purposes. This article does not make any recommendations regarding the use of compounded weight loss medications.
Medical Weight Loss Done Right ©
Dr. Leon Katz
Sources:
1) FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, https://bit.ly/4hDZ1BH
2) FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products, https://bit.ly/4hDZ1BH
