Back to: FDA Compounding Quality Center of Excellence Annual Conference 2025
About:
Understand FDA’s draft guidance on the wholesaling prohibition under section 503B, including FDA’s proposed interpretation of key terms and the application of the provision. using examples involving sales, transfers, third-parties and dispensing.
Presenter:
Dominic Markwordt
Regulatory Counsel
U.S. Food and Drug Administration
Dominic Markwordt, J.D. is a Regulatory Counsel in the Center for Drug Evaluation and Research’s Office of Compounding Quality and Compliance. He works to help develop and implement human drug compounding policies on a variety of topics to protect the American public from unsafe, ineffective and low-quality drug products.