Amica J. Nesbitt

Amica J. Nesbitt focuses her practice on representing life sciences clients—with a particular emphasis on compounding pharmacies—in regulatory, enforcement, and litigation matters. Amica helps guide clients through government investigations, inspections and audits, FDA Form 483’s, and FDA Warning Letters. This work often involves interfacing with regulatory bodies, including in the FDA, DEA, and state boards of pharmacy.

Amica also has experience defending clients, including academic medical centers, community hospitals, physicians, and physician practice groups in complex medical malpractice matters. Amica also has extensive experience drafting motions, arguing before judges, and preparing witnesses for testimony. Amica’s understanding of the clinical and technical aspects of defending various life science clients has uniquely prepared her to guide clients to resolve disputes expeditiously, whether that involves investigations and early resolution, vigorous defense of a case through trial, or an alternative dispute resolution.

Prior to joining the firm, Amica served as an associate at a global law firm and an associate at a healthcare and litigation law firm.

Outside the Firm

Amica enjoys traveling and spending time with her family.

• Represented a compounding pharmacy before a state board of pharmacy seeking to bring a fine and reportable discipline action against compounding pharmacy, which would have adversely affected their licensure in other states. Convinced the board to move to no fine and a non-disciplinary instrument that was not reportable.
• Successfully argued that a state board of pharmacy was exceeding its jurisdiction by seeking to enforce drug-related provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) against a compounding pharmacy. Won for compounding pharmacy at the administrative level and after the board nevertheless took adverse action against them, the state’s superior court ruled in the compounding pharmacy’s favor. This is the first ruling in the nation that has found a state board of pharmacy cannot enforce the FDCA through its disciplinary authority.
• Represented an outsourcing facility with respect to an FDA inspection, including handling all written submissions to FDA and representing facility in its most recent compliance conference with FDA. Outsourcing facility has maintained ongoing operations and worked efficiently and cooperatively with the FDA to ensure compliance with applicable standards.
• Provided regulatory counsel to a compounding pharmacy in its acquisition of the assets of a retail pharmacy, handling regulatory diligence, drafting of regulatory provisions of the purchase agreement, and the transfer of all licenses.

2021–2025, “Rising Star,” listed in Super Lawyers

Amica serves as a member of the Illinois State Bar Association and the Illinois Defense Counsel.

Admissions

• Illinois

Education

• University of Illinois Chicago School of Law, JD, cum laude
• Purdue University, BS