In a recent regulatory shift, the FDA has ended the allowance for compounding pharmacies to produce copycat versions of popular GLP-1 receptor agonists such as semaglutide (Ozempic®, Wegovy®) and tirzepatide (Mounjaro®, Zepbound®). This change follows the FDA’s 2025 declaration that drug shortages for these medications have been resolved.
What has changed?
During previous shortages, compounded versions of GLP-1s became a widely used workaround, especially in weight management and diabetes care. Now that the supplies have stabilized, the FDA no longer considers compounded alternatives necessary or legal. Pharmacies must stop the production and distribution of compounded GLP-1 medications.
Many patients turned to clones or “off-brand” versions of GLP-1s found through online pharmacies, and weight loss spas. These came with risks, including inconsistent or inaccurate amounts of the active ingredients.
“I think we’ll see more patients coming into primary care who’ve been using compounded GLP-1s from med spas or online sources,” says Nebraska Medicine bariatric surgeon Cori McBride, MD. “If you believe a patient is on the right drug, start at a lower dose, regardless of what they were previously taking. Even if they report using 10 mg, the actual amount they received may have been inaccurate.”
Why this matters
GLP-1 medications have been life-changing for those with obesity and type 2 diabetes. Many patients who relied on these more affordable medications will now have to transition to FDA-approved formulas that may be more expensive or difficult to access due to insurance limitations. This regulatory update puts added pressure on health care providers to guide patients through alternative weight loss options.
Offer alternative treatment plans
When FDA-approved GLP-1s aren’t accessible, consider:
Non-GLP-1 pharmacologic options:
- Bupropion-naltrexone ER (Contrave ®)
- Phentermine-topiramate ER (Qsymia ®)
- Orlistat
- Lifestyle-based programs:
- Structured weight management programs.
- Registered dietitian support.
- Behavioral health referrals.
Medical nutrition therapy (MNT) for patients with diabetes or obesity-related complications.
Bariatric Surgery for long term durable results that is more cost effective than medication regimen.
When to diagnose and when to refer
Dr. McBride encourages providers who feel confident managing obesity in primary care to be strategic and proactive in both diagnosing and escalating care. She advises clinicians to:
Identify candidates based on BMI > 40 or lower BMI with obesity-related comorbidities.
- Screen for early diagnosis and provide thorough documentation.
Refer patients who don’t respond to lifestyle or pharmacological therapies.
“The loss of compounded GLP-1s is challenging, but it’s an opportunity for providers to step in and advocate for their patients and refer appropriately when the Bariatric Center is the best option,” says Dr. McBride. “By staying proactive and patient-centric, providers can help patients continue their weight-loss journey safely and effectively.”
Patients may feel frustrated, confused or anxious about losing access to medications that were working for them. It’s important to acknowledge these feelings and keep communication clear and compassionate. If providers need help, they should reach out to the Bariatric Center.
“The Bariatric Center is always happy to be a resource for anyone considering surgical options, especially if it’s clear compounded GLP-1s won’t be an option,” says Dr. McBride. “We offer e-consults and can support clinics that don’t have the tools or capacity to manage obesity cases on their own.”
To refer patients to the Bariatrics Center, call 402.559.9500 or email the completed intake form to BariatricsCenter@nebraskamed.com.