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Prepared By: Simone Armour & James McGovern, Esq.

The Market Surge and Regulatory Pressures

The GLP-1 receptor agonist market is booming. By 2035, it is expected to reach $157.5 billion. This surge in demand places immense pressure on independent pharmacies that operate in an increasingly competitive and tightly regulated space. For some, compounded GLP-1 medications—particularly Tirzepatide and Semaglutide—have provided a profitable niche in the market. However, these medications remain a cash-pay business, and regulatory scrutiny is mounting.

The U.S. Food and Drug Administration (FDA) recently removed Tirzepatide from the drug shortage list on December 19, 2024, tightening oversight and eliminating an emergency justification for compounding. Until then, 503A and 503B pharmacies had been permitted to compound the medication, but now restrictions are setting in. 503A pharmacies were required to stop by February 18, 2025, and 503B outsourcing facilities have until March 19, 2025. While some compounding remains permissible, it is heavily regulated—pharmacies must tread carefully to avoid enforcement action.

Compounded Medications and the Legal Battle

A pivotal federal court ruling has further complicated matters. In response to an October 2024 lawsuit, a U.S. judge denied an injunction that would have allowed compounding pharmacies to continue producing copies of Eli Lilly’s weight-loss and diabetes drugs, Zepbound and Mounjaro. The ruling upheld the FDA’s determination that compounded Tirzepatide is no longer justified, reinforcing regulatory constraints.

Eli Lilly has gone a step further, petitioning the FDA to designate Tirzepatide as “demonstrably difficult to compound.” If successful, this move would effectively prohibit all compounding of Tirzepatide, regardless of patient need.

The lawsuit, led by the Outsourcing Facility Association, argued that the FDA had relied solely on Eli Lilly’s statements to determine the shortage status. The plaintiffs contended that patients still struggle with access and that the agency had acted prematurely. Nevertheless, the judge’s decision upheld the FDA’s ruling, paving the way for more aggressive enforcement.

The Consequences for Pharmacies and Licensed Professionals

For independent compounding pharmacies, the ramifications are immediate. Increased FDA and state board audits are likely, requiring proof of clinical necessity and appropriate dispensing protocols. Pharmacies operating outside the updated regulatory framework risk swift action from enforcement agencies.

Licensed healthcare professionals such as physicians, nurse practitioners, and pharmacists who prescribe or dispense compounded GLP-1 medications must be aware of the risks. State medical, nursing, and pharmacy boards will scrutinize professionals who continue prescribing compounded Tirzepatide after the FDA’s restrictions take full effect. Failure to comply with updated laws could lead to professional sanctions, including loss of licensure.

The Broader Impact

This issue extends beyond pharmacy operations—it affects licensed healthcare professionals, patient access, healthcare costs, and regulatory precedent. The legal battles unfolding today could determine the future of compounded medications in an era of increasing pharmaceutical oversight. With large drug manufacturers exerting influence over regulatory bodies, independent pharmacies, licensed prescribers, and advocacy groups face an uphill battle.

Citations

US Judge Bars Copies of Lilly Weight-Loss Drug | Reuters

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This document is intended to provide general information regarding regulatory changes made by the FDA. It does not constitute legal advice. For specific guidance, please consult a Graff & McGovern attorney at 614-228-5800.