The FDA’s recent decision to remove tirzepatide from its shortage list has triggered a legal battle with significant implications for medical spas and compounders. In response to a lawsuit filed by the Outsourcing Facilities Association (OFA) and North American Custom Laboratories, a 503B outsourcing facility, the FDA filed a motion for voluntary remand to reassess its decision. The agency has also extended enforcement discretion for 503B facilities compounding tirzepatide, but only until November 21, 2024.
Why November 21 Matters
This deadline is critical. After November 21, the FDA’s reevaluation could lead to tighter restrictions on compounding tirzepatide, affecting both 503A and 503B compounders. Medical spas relying on compounded GLP-1 medications, such as tirzepatide and semaglutide, must prepare for potential supply chain and operation changes.
Key Risks and Uncertainties
- 503A Compounders in Limbo: Initially excluded from the FDA’s enforcement discretion, 503A compounders now face uncertainty. Although the FDA later clarified that it intends to apply consistent enforcement discretion to sterile compounders, the specifics remain unclear.
- Potential Restrictions Post-November 21: If the FDA decides against placing tirzepatide back on the shortage list, 503B facilities could lose the ability to compound the drug after a brief grace period. For 503A compounders, stricter rules would apply, limiting compounding to cases where prescribers document a significant medical need.
- Manufacturer Pushback: GLP-1 manufacturers are aggressively lobbying to curtail compounding. Semaglutide’s manufacturer, for example, has petitioned to add the drug to the FDA’s Difficult to Compound list, which could further restrict compounding options.
Legal and Financial Pressure
Smaller compounders, particularly 503A pharmacies, as well as medical spas, weight loss centers, and other types of businesses, are under increasing pressure from manufacturers. Cease-and-desist letters and litigation often target these entities, challenging the safety and legitimacy of compounded formulations. Many smaller companies, unable to afford costly legal battles, are forced to settle, setting precedents that could further limit compounding practices.
How Medical Spas Can Prepare
With the November 21 deadline looming, medical spas need to act now to mitigate risks and ensure compliance. Here’s what to focus on:
- Stay Informed: Monitor updates from the FDA regarding tirzepatide’s shortage status and any changes to enforcement policies.
- Work Closely with Compounders: Ensure your 503A or 503B partners are fully compliant and prepared for potential regulatory shifts.
- Document Patient Needs: For 503A compounding, ensure prescribers document significant medical differences to justify using compounded medications.
- Plan for Supply Chain Disruptions: Explore alternative products and suppliers to maintain your services in the event of tighter restrictions.
- Seek Legal Guidance: Consult with legal experts to navigate the evolving regulatory landscape and protect your business.
Preparing for a Post-November 21 World
The FDA’s decision could set a precedent for compounding GLP-1 drugs, impacting medical spas nationwide. By taking proactive steps now, you can ensure your business remains compliant and prepared for whatever changes come after November 21.
For legal guidance tailored to your medical spa or IV hydration business, Lengea Law focuses on this specialized area of the law. Contact us today to stay ahead of regulatory challenges and safeguard your operations.
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