At the University of Florida, our Pharmaceutical Regulation specialty track is extremely unique! In fact, we think it’s one-of-a-kind. Why? Because this specialty track really focuses on developing regulatory professionals to assume executive positions and who are ready to be change-makers. Is this you?

What is Pharmaceutical Regulation?

Pharmaceutical Regulation is an essential, global and diverse field that is tasked with ensuring safe, effective, and high-quality health care through regulatory compliance. Pharmaceutical Regulation may comprise drug research and development, clinical trials, market approvals, manufacturing, labeling, distribution, advertising and promotion, and safety surveillance.

Pharmaceutical Regulation Curriculum

The courses are designed to give students a firm grounding in the regulatory framework around the manufacture, distribution, dispensing and use of pharmaceutical products, and place pharmaceuticals in a larger context of health care. Students explore the roles of regulation, regulation responsibilities and delve into the complexities and challenges that face health care.The track curriculum provides a comprehensive education in in the regulatory framework of pharmaceutical-related topics.

Pharmaceutical Regulation addresses topics like:

  • Manufacturing & Distribution
  • Advertising, Promotion & Labeling
  • Dispensing & Use
  • Public Health Protection
  • Global Health & Security
  • Patient Privacy & Data Management
  • Ethics

UF’s Impact in Pharmaceutical Regulation, Nov. 5, 2019

UF study finds FDA strategy cuts fetal exposure to harmful immunosuppressive drug, but risks remain

Learn more about the study and how pharmaceutical regulation is applied outside the classroom.


Executive Summary: Strategic Plan for Regulatory Science

Learn more about this diverse field and UF’s impact in pharmaceutical regulation by reading this article on the FDA’s plan for regulatory science.

Meet the track Director

Dr. Tommy Smith

The Pharmaceutical Regulation specialty track is led by W. Thomas (Tommy) Smith, Pharm.D, J.D. He is a member of the American Bar Association (ABA), the American Society for Pharmacy Law, and the American Association of Colleges of Pharmacy (AACP), Smith has served as an author, speaker and leader in areas such as pharmacy law, cultural competency, health disparities, bioethics and disability law.

W. Thomas Smith


Master’s Curriculum

Topics include Federal Regulation of Drugs & Pharmacy, Pharmaceutical Fraud & Abuse, and Medicare & Medicaid.

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Graduate Certificate

Topics include Federal Regulation of Drugs & Pharmacy, Structure, Process, & Outcomes of Regulation, and Federal Regulation of controlled Substances.

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