06/01/2025                                                                            
                                    
                                                                            
                                            Crackdown or Creativity? 
How Pharmacies Are Navigating New GLP-1 Restrictions.
The FDA’s move to tighten regulations around compounded GLP-1s like semaglutide and tirzepatide was meant to slow the booming market for cheaper alternatives to Ozempic, Wegovy, Mounjaro, and Zepbound.
But instead of closing the door, many compounding pharmacies and telehealth companies are finding compliant ways to adapt and continue serving patients:
🧪 Adjusting doses slightly below or above standard formulations
💉 Switching to alternative delivery methods (sublingual drops, pills, etc.)
💊 Adding vitamins like B3, B6, or B12 for patients who can’t tolerate branded versions
📉 Offering custom protocols for those with side effects like nausea. 
Under Section 503A of the FDCA, these changes must make a clinically significant difference for the individual patient—and not be mass-produced.
⚖️ Legal and regulatory pressure is mounting. Novo Nordisk and Eli Lilly have filed over 100 lawsuits. 
The FDA has ended the official shortage, meaning bulk copies are no longer allowed. But patient demand remains strong, and for many, the compounded versions are still the only affordable option.
📈 At RxConnexion, we work with pharmacies and clinics navigating these evolving rules—with compliant protocols, telehealth tools, and pharmacy-to-patient fulfillment that meet today’s market and regulatory expectations.
Want to learn how your pharmacy can offer GLP-1 treatments the right way?
DM us or visit www.RxConnexion.com to explore white-labeled telehealth and compliant compounding partnerships.
Schedule a call today