Compounding GLP-1 Medications Amid FDA Shortages

The rise of compounded medications in medical weight loss has gained considerable attention, particularly with the success of drugs like semaglutide and tirzepatide in promoting weight loss and enhancing metabolic health. Reputable compounding pharmacies  have played a crucial role in providing access to these medications during shortages. However, recent updates to the FDA’s drug shortage list have impacted their ability to compound these essential drugs. In this post, we’ll explore how compounding pharmacies have navigated the FDA’s drug shortage rules, the implications of tirzepatide’s removal from the shortage list, and the varied responses from different types of compounding pharmacies.

Compounded Medications and the FDA Drug Shortage Rule

Compounding pharmacies specialize in creating personalized medications tailored to individual patient needs by mixing or modifying active ingredients. This is especially beneficial when commercially available medications do not suit a patient’s specific requirements, such as allergies or dosage preferences. In the context of weight loss, compounding may involve incorporating vitamins or nutrients to alleviate side effects, like adding vitamin B12 to combat fatigue.

Typically, compounding pharmacies cannot produce commercially available drugs. However, the FDA allows exceptions during drug shortages. When a medication is listed as in short supply, both 503(A) and 503(B) compounding pharmacies can manufacture it, ensuring patients have access to necessary treatments. While 503(B) pharmacies provide medications for clinicians to dispense, 503(A) pharmacies create drugs tailored for individual prescriptions.

Recent Developments: Tirzepatide and Shortage Status

On October 2, 2024, tirzepatide, a groundbreaking medication for diabetes and obesity, was removed from the FDA’s drug shortage list. Consequently, 503(B) outsourcing facilities now have a 60-day grace period to discontinue their compounded versions of the drug. After this period, 503(B) pharmacies may only compound tirzepatide under specific FDA guidelines.

This change has caused confusion among compounding pharmacies. Some 503(A) pharmacies, which serve individual patients, have ceased distributing tirzepatide to adhere strictly to FDA regulations. In contrast, others are investigating alternative pathways to continue compounding the drug if they can demonstrate a significant medical benefit beyond what the commercial version provides.

Defining Significant Medical Benefits

The FDA permits some compounding of commercially available medications when a “significant medical difference” exists between the compounded product and the approved drug. This difference must be based on more than just cost. For instance, adding specific vitamins or amino acids not present in the commercial formulation can yield a compounded medication with unique advantages. In the case of weight loss drugs like tirzepatide or semaglutide, compounding pharmacies have considered incorporating:

• Vitamin B12: To alleviate fatigue often experienced by patients on GLP-1 medications, particularly those on low-calorie diets, helping to support energy levels and overall metabolic function.
• Glycine: To help preserve muscle mass during weight loss. Rapid weight loss can lead to muscle loss, and glycine may offer protective benefits, aiding patients in reaching their weight loss goals while maintaining lean body mass.

The Future of Compounded Weight Loss Medications

With tirzepatide no longer classified as in short supply, the landscape for compounded medications is evolving. While 503(B) outsourcing facilities phase out their compounded versions, 503(A) pharmacies must evaluate whether their formulations meet the FDA’s criteria for significant medical benefit.

The future availability of compounded tirzepatide will largely depend on the FDA’s interpretation of what constitutes a significant medical benefit. Compounding pharmacies will need to ensure their formulations offer patient-specific advantages not found in commercially produced products, such as mitigating side effects through nutrient supplementation or customizing dosages for patients with unique health conditions.

Navigating Changes in Compounding

The recent updates to the FDA’s drug shortage list, especially regarding tirzepatide, present challenges for compounding pharmacies. While 503(B) facilities are phasing out their compounded versions, some 503(A) pharmacies are exploring options to continue offering these medications based on medical necessity.

At Unique Weight Loss and Family Practice, we are dedicated to providing top-notch care and the latest information on medical weight loss options, including applicable compounded formulations, semaglutide as well as other weight loss medications.  We still have compounded tirzepatide available!