The FDA has officially declared an end to the shortage of semaglutide, the active ingredient in the popular medications Ozempic and Wegovy. This announcement signals a significant shift in how compounding pharmacies, medical spas, and other businesses can offer these medications. Compliance will be key moving forward. If your business has been providing compounded semaglutide, it’s essential to understand the legal and regulatory implications of this update.
FDA’s Position on Compounded Semaglutide
During the shortage, many compounding pharmacies stepped in to provide semaglutide formulations to meet patient demand. However, with the shortage now resolved, the FDA is reinforcing its regulatory authority over compounded versions. The agency has made it clear that:
- Compounded semaglutide was only permissible under shortage exemptions. Now that the FDA considers the shortage resolved, those exemptions no longer apply.
- Some compounded versions contain unapproved salts. The FDA has warned that certain formulations contain semaglutide sodium or acetate, which have not been reviewed for safety or effectiveness.
- Regulatory deadlines apply. 503A compounding pharmacies and providers must cease compounding, dispensing, and distributing semaglutide by April 22, 2025. For 503B outsourcing facilities, the deadline is May 22, 2025.
What This Means for Your Practice
Medical spas that have been offering compounded semaglutide need to take immediate action to ensure compliance. Here’s what you should consider:
- Transitioning to FDA-Approved Medications
Medspas should now source semaglutide exclusively from FDA-approved manufacturers. Providers offering compounded versions past the deadline could face enforcement actions, including warnings, fines, civil suits, or even more severe penalties.
- Reviewing Agreements with Compounding Pharmacies
If your medspa has partnered with a compounding pharmacy to supply semaglutide, review those agreements and ensure that operations align with current FDA regulations. Continuing to source compounded semaglutide after the cutoff dates may expose your practice to liability.
- Communicating Changes to Patients
Patients who have been receiving compounded semaglutide will need to be transitioned to FDA-approved medications. Clear communication will be essential, including discussing pricing differences and potential supply issues.
- Understanding State Law Considerations
In addition to federal regulations, state laws vary regarding compounding and medical spa practices. Some state medical and pharmacy boards may impose additional restrictions. Ensuring that your medspa is compliant with both federal and state law is critical.
Potential Legal Risks for Non-Compliance
Failing to adhere to the FDA’s updated policies can expose your business to: regulatory enforcement actions from the FDA or state pharmacy boards, potential malpractice claims from patients receiving non-compliant medications, or contract disputes if your medspa is engaged in agreements with compounding pharmacies that no longer align with regulatory requirements.
Next Steps for Medspas
- Conduct an immediate review of your semaglutide supply chain and discontinue compounded versions before the deadline.
- Educate your staff on compliance risks and FDA policies to ensure they understand the transition.
- Consult legal counsel to ensure that your business practices remain compliant with both federal and state laws.
- Communicate with patients to manage expectations regarding pricing and access to FDA-approved alternatives.
Conclusion
With the FDA tightening regulations around compounded semaglutide and tirzepatide, your practice must act swiftly to ensure compliance. If you have questions about how these changes affect your practice, our law firm is here to help. We specialize in healthcare and medspa regulations and can guide you through this transition smoothly and legally.
Contact Lengea for legal guidance on how to proceed given these changes.