On April 1, 2025, Eli Lilly & Co. sent a letter to the Georgia Board of Nursing urging them to take certain actions to address nurse practitioners (NPs) who continue to prescribe compounded versions of tirzepatide—the active ingredient in Mounjaro® and Zepbound®—following its removal from the FDA’s drug shortage list.
What Does the Letter Say?
Eli Lilly claims that a recent Texas federal court ruling restores its statutory exclusivity over tirzepatide and prohibits other entities from producing or distributing compounded versions of the drug. The letter states that FDA enforcement is forthcoming and specifically alleges that “some telehealth providers and associated nurse practitioners have continued to mass prescribe and mass produce unapproved, untested compounded tirzepatide, putting patients in Georgia at risk.” The stated goal of the letter is to prompt the Board to act in the name of “patient safety,” but the practical impact could be increased scrutiny and enforcement risk for NPs across Georgia.
Eli Lilly Asks the Georgia BON to:
- Notify NPs of the court’s decision and the FDA’s anticipated enforcement efforts.
- Issue guidance to Georgia NPs taking the position that compounded tirzepatide—including versions with added ingredients like B-6 or B-12 or altered dosages—is unlawful.
- Collaborate with regulatory agencies, including the Georgia Board of Pharmacy, Georgia Composite Medical Board, and FDA, in investigating prescribing practices involving tirzepatide.
Key Points Raised in the Letter:
- FDA Shortage List Update: Tirzepatide has been removed from the FDA’s drug shortage list, which limits the circumstances under which it may be lawfully compounded.
- Safety Allegations: Lilly claims that compounded tirzepatide is untested, potentially unsafe, and associated with contamination risks such as bacteria and endotoxins.
- Legal Exposure: The letter implies that NPs engaged in mass prescribing of compounded tirzepatide—particularly through telehealth or without individualized clinical justification—could face legal and ethical consequences.
Why This Matters to Nurse Practitioners:
This letter is not just a pharmaceutical manufacturer asserting its rights—it is a call for regulatory agencies to investigate and potentially discipline Georgia NPs for prescribing behavior that, until recently, may have been lawful and commonplace.
Prescribing compounded tirzepatide—especially in bulk or with non-standard formulations—could now place NPs at risk for:
- Georgia Board of Nursing complaints
- Accusations of unprofessional conduct
- Federal or state regulatory investigations
- Civil liability for patient harm or off-label use
Protect Yourself: What You Should Do Now
- Review Your Prescribing Practices – Ensure you are not prescribing compounded tirzepatide unless justified by a specific patient need under applicable FDA and Georgia rules.
- Avoid Mass Prescribing or Standardized Formulations – Prescriptions must be in compliance with state and federal laws.
- Stay Informed – The legal and regulatory environment is shifting quickly. Stay informed by subscribing to my newsletter as well as alerts from your licensing boards.
Need Legal Help?
Our firm represents nurse practitioners and all healthcare providers in regulatory matters, investigations, and licensing defense matters before the Georgia Board of Nursing and other state licensing agencies. Contact us today for a confidential consultation.
ask@hahnahwilliams.com | https://hahnahwilliams.com
This newsletter is for informational purposes only and does not constitute legal advice. If you are facing a potential investigation or complaint, we recommend seeking legal counsel immediately.