Recent Changes: Semaglutide, Deadlines, and Lawsuits. Last update: April 2nd, 2025

Both semaglutide and tirzepatide have been removed from the FDA shortage list. Compounded tirzepatide from Hallandale pharmacy is no longer available. Compounded GLP-1 medications are still available on a limited basis. Compounded medications are only indicated for patients when a prescribing practitioner determines that the compounded preparation produces a significant difference for their patient compared to the FDA-approved product. Compounded medications are not reviewed by the FDA for safety, efficacy, or quality.

We are excited to offer manufacturer direct GLP-1 weight loss medication. More info here.

Anticipated deadlines:

• May 22, 2025: Deadline for 503(b) pharmacies to distribute semaglutide. 503(b) pharmacies manufacture medications in large quantities for sale to health care providers who then prescribe to patients.

Compounding GLP-1 Medications and FDA Shortages

The use of compounded medications in medical weight loss has garnered significant attention recently, especially with the popularity of GLP-1 medications, which have shown promise in achieving weight loss and improving metabolic health. Compounding pharmacies have been instrumental in providing access to these medications during times of shortages, but recent changes in the FDA’s drug shortage list have affected their ability to continue compounding these drugs. In this blog post, we’ll discuss how compounding pharmacies have provided weight loss drugs under the FDA’s drug shortage rule, the implications of tirzepatide & semaglutide being removed from the drug shortage status, and how different types of compounding pharmacies are responding to these changes.

Compounded Medications and the FDA Drug Shortage Rule

Compounding pharmacies create customized medications tailored to individual patient needs by combining, altering, or adjusting active pharmaceutical ingredients. This is particularly useful in situations where a commercially available drug does not meet a patient’s specific requirements due to factors such as allergies, dosage variations, or ingredient sensitivities. In the context of weight loss, compounding can involve adding vitamins and other nutrients that help mitigate some of the medication’s side effects, such as custom dosing and vitamin B12 to combat fatigue.

Under normal circumstances, compounding pharmacies are restricted from compounding medications that are commercially available. However, the FDA provides an exception to this rule during times of drug shortages. When a drug is placed on the FDA’s shortage list, 503(A) and 503(B) compounding pharmacies can produce that medication, offering an essential service to patients who might otherwise be unable to access it. 503(B) pharmacies provide medications that can be dispensed by clinicians. 503(A) pharmacies provide medications that are tailored for a specific patient prescription.

Significant Medical Benefits: The Key to Continued Compounding

The FDA allows compounding of commercially available medications when there is a “significant medical difference” between the compounded product and the approved drug on the market. This significant difference must be justified by factors other than cost alone. For example, the addition of specific vitamins or amino acids that are not present in the commercially available product can create a compounded medication with unique benefits. In the context of GLP-1 medications, compounding pharmacies have explored including compounds such as:

• Customized dosing: For patients who need non standard dosing to balance side effects and weight loss.
• Vitamin B12: To counteract the fatigue often reported by patients on GLP-1 medications. B12 supplementation can be helpful, especially for those following a low-calorie diet, as it supports energy levels and overall metabolic function.
• Glycine: To support muscle mass retention during weight loss. Many patients on GLP-1 agonists experience rapid weight loss, which can lead to muscle mass loss. Adding glycine can promote a protective effect, helping to preserve lean body mass while patients achieve their weight loss goals.

What’s Next for Compounded Weight Loss Medications?

Compounding pharmacies must ensure that their formulations offer patient-specific benefits that are not available in commercially produced products if the lawsuit is ruled against the compounding pharmacy association. This may include addressing side effects through nutrient supplementation or providing custom dosages for patients with unique health concerns. Those who benefit from an atypical dose or additional additives such as glycine and vitamin B12 will likely still be able to receive compounded medication though pending litigation may change this situation.

Navigating Changes in the Compounding Landscape

The recent changes to the FDA’s drug shortage list have created a complex landscape for compounding pharmacies. Flow Wellness remains committed to providing the highest quality care and up-to-date information on medical weight loss options, including compounded formulations when applicable. If you have questions about compounded medications or want to explore your weight loss options, reach out to us for more information.