Compounding and Distribution of GLP-1 Medications - Pharmacists Mutual Insurance Company

GLP-1 drugs seem to be on everyone’s mind and in the news pretty regularly.  Compounding pharmacies have played a crucial role in providing these medications to patients, while the manufactured drugs have remained in shortage for many months.  Pharmacists Mutual has seen claims against pharmacists and pharmacies for adverse reactions in patients and allegations in these claims include improper compounding techniques as well as potential copyright infringement issues.  If you are actively involved in compounding GLP-1 drugs or are looking to add these medications to your formulation list, consider the following points:

Federal law has established criteria for what active pharmaceutical ingredients (APIs) may be used in human medications.  To be eligible, an API must:

1. Be a component of and FDA approved drug product; or
2. Have an applicable USP or National Formulary monograph; or
3. Appear on a the 503A Bulks List published by the FDA.

In addition, it is against the law for pharmacies to compound drugs that are “essentially a copy” of an FDA-approved product.  There are some exceptions to this rule, one of which is if the medication is listed as “currently” in shortage on the FDA drug shortage webpage.  This rule protects both the patent holders of the drug but also allows for compounding pharmacies to provide critical medications to patients in the event the manufacturer is not able to produce the commercially available product.

Both semaglutide and tirzepatide have been in high demand and have spent a significant amount of time on the FDA drug shortage list.  These medications are instrumental in lowering blood sugar levels in diabetic patients, assisting with weight loss, and reducing the risk of many diseases associated with obesity, including heart attack and stroke.  Many patients would be without their medications with the current manufacturer shortages if compounding pharmacies were not willing to step in and help provide these products.

As pharmacy professionals, consider the following to mitigate errors and allegations:

1. Engage in compounding only if you are trained and understand the process of compounding AND have the proper facilities.
2. Procure your active ingredient from an FDA licensed facility and review the entire Certificate of Analysis for each drug.
3. Follow USP 797 or your state guidelines for batching, testing, recording keeping, and beyond use date (BUD) requirements. This includes having a robust recall process in place.
4. DO NOT use the trademark name in your advertising or labeling. Compounded drugs should be referred to by the active pharmaceutical ingredient name.  They should also not be referred to as the generic drug.
5. Refer to the FDA Drug Shortage list daily so that you may remain in compliance with compounding commercially available drugs regulations.
6. DO NOT bill insurance for the brand product when dispensing a compounded product. This could result in payment recoupment and accusations of fraudulent charges.
7. Consider a risk assessment in your own business prior to and regularly thereafter when providing new services.

Pharmacists are providing a service to patients who desperately need these medications, but it is not without risk.  These tips are provided to assist in reducing errors and claims associated with errors.

To learn more about other pharmacy issues and what you can do to protect yourself and your business, visit the Risk Management Center (RMC). The RMC is available at no cost to Pharmacists Mutual’s commercial insurance customers at www.phmic.com. Click “My Accounts” in the upper right corner to access or enroll.

© 2024 Pharmacists Mutual Insurance Company. 

This presentation is intended to provide general information only on certain risk management topics, and is not intended to provide any coverage determinations or coverage positions, nor is it to be construed as providing legal, medical, or professional advice of any form.