Compounding Diabetic Drugs for Weight Loss
-What are they?
Trulicity (Dulaglutide)-Bydureon (Exenatide)-Ozempic/Rybelsus (Semaglutide)-Victoza/Saxenda/Wegovy (Liraglutide) are Glucagon Like Peptide (GLP-1) Agonists are drugs used to help patients with diabetes to lower their blood sugar. Mounjaro (Tirzepatide) is a GLP-1 and Glucose-Dependent Insuilinotropic Polypeptide Agonist (GIP) also used to help treat patients with diabetes. They are injected daily or weekly subcutaneously. Rybelsus is taken orally.
Liraglutide and Dulaglutide have received an indicated use by the FDA for use in weight loss. This is because trials from patients taking these medications have shown weight loss in patients taking them. It is common for drug companies to rebrand a drug for use for another condition. This was the same with Viagra for erectile dysfunction after the drug trials for pulmonary hypertension.
-Why are people talking about them?
Many celebrities have been talking about using these medications (specifically Ozempic and Mounjaro) for weight loss. Typically these medications are not covered for weight loss by most insurance companies. They typically cost $1000 or more per month for cash paying patients. The increase in use for weight loss has created a shortage in the market, making it hard to find the medication. Many insurances are requiring a diagnosis code and/or previous use of metformin before covering them.
-What about compounding?
Compounding is the making of a specific drug for a patient. A commercially available drug can not be compounded unless there is a medical necessity (ie allergy to inactive ingredient, dye, etc). We can use commercially available products (like tablets to make a liquid) or raw powder to make the dosage form needed. This is for very specific cases and should not be used for the general public since the level testing and procedures are not the same as FDA inspected facilities. There is a higher risk taking a compounded medication.
-Can compounding pharmacies buy these raw powders?
These medications are protected under drug patents for the time being. No company selling Active Pharmaceutical Ingredients (API) for compounding can sell it. This means we can not buy these drugs for compounding. The major companies that sell these chemicals are PCCA, Medicare, and Fagron (they do not sell these powders). Some smaller companies are selling research grade ingredients or different salts of the drugs. Theses sodium salts are not listed in the FDA organge book and cannot be used legally in compounding (in my opinion).
-I’ve seen compounding pharmacies advertising these compounds!
These compounding pharmacies may be buying the powder from peptide companies. These peptide companies specifically say these products are for research purposes only. It is not intended for animal or human use. The quality controls are not the same as they would be for buying APIs. They may be adding things like Vitamin B-12 or BPC-157 to them so that it is not identical to the commercial product. BPC-157 does not have safety or efficacy studies performed and was recently banned by the Wold Anti-Doping Agency. Combining B-12, BPC-157, or other ingredients may interact with the drug. Unless several tests are performed to verify stability and efficacy, there is no way to know if it lowers the efficacy of the medication.
-What are the risks of using these compounded products?
The main issue is going to be safety. These products are produced in a licensed FDA facility. The quality controls for manufacturing are not regulated by their FDA. The purity standards are not the same as they are for human use. There are no FDA approved facilities making these medications in powder form (as far as I know). BPC-157 has no safety studies performed on the risk of adverse events or long term use. I doubt patients are made aware if this information. Efficacy could be lower if combined with other chemicals. Providers prescribing these medications and pharmacies making them can be held liable if a patient is injured.
-How can you find out if your medication is safe?
Ask your pharmacy for a Certificate of Analysis (CoA) of the chemicals they are using. Anytime we buy API, we get a CoA that we have for reference. It shows when/who/how the chemical was tested and the quality level. It also says where it came from. This will tell you where the pharmacy got the chemical. If the company does not sell APIs to pharmacies, it is not legal in most states to be used in compounding. Missouri law specifically says the APIs must be bought from distributors licensed in Missouri. I would wager the CoA for these chemicals would specifically say for research purposes only. Even if the CoA is valid, it may be for a chemical that is not FDA approved (like semaglutide sodium salt).
Drug companies have a patent on medications for many years. These peptides can be easily made in labs and sold. Eli Lilly and other manufactures don’t outsource their research into these drugs. There’s no legitimate way it would be available on the market for compounding. There is a strong demand in the market and some doctors/pharmacies are taking advantage of patients. Using these products can be dangerous and should be avoided in my professional judgment. If you have any questions, feel free to call me at the pharmacy. You should be aware of the chemicals you are injecting into your body.
Dr. Tyler Taylor