Home Study Webinar: Preparing for FDA’s Compounding MOU
Food and Drug Administration’s (FDA’s) Memorandum of Understanding (MOU) on compounded human drug products can help reduce the risk of injury to patients by improving oversight of compounding pharmacies.
Related to Section 503A of the Federal Food, Drug, and Cosmetic Act, the MOU acts as an agreement between the state boards of pharmacy and FDA to collect information about the distribution of inordinate amounts of compounded human drugs, as well as complaints about compounders. The MOU better positions regulators to address patient safety and improve communication between FDA and boards.
At the end of this webinar, participants will be able to:
- Summarize the evolution of FDA’s data collection requirements under the MOU.
- Define “inordinate amounts” of compounded human drug products.
- Explain when boards must to report inordinate amounts to FDA as required by the MOU.
- Describe the National Association of Boards of Pharmacy (NABP) Information Sharing Network.
- Discuss how the NABP Information Sharing Network can streamline the data sharing process and help boards meet data reporting obligations.
Jack “Jay” Campbell IV, JD, RPh
Jay Campbell, executive director of the North Carolina Board of Pharmacy, is serving as chairperson of the NABP Executive Committee. In addition, Mr Campbell has served on many of the Association’s committees and task forces, including the Committee on Law Enforcement/Legislation, the Committee on Resolutions, and the Task Force to Review and Recommend Revisions to the Controlled Substances Act. Mr Campbell teaches pharmacy law and ethics classes at three North Carolina universities. Mr Campbell earned his bachelor of science degree in pharmacy from the University of North Carolina at Chapel Hill and his juris doctor degree from Vanderbilt University School of Law.
Melissa Madigan, JD, PharmD
Melissa Madigan is associate executive director, professional affairs for NABP. Melissa started with NABP in 1995 as professional affairs manager after graduating from DePaul University College of Law. Prior to that, she practiced pharmacy in a variety of settings, including University of Illinois Hospital, Loyola University Hospital’s Cancer Center, and Dominick’s Stores. Melissa graduated from the University of Illinois at Chicago College of Pharmacy and spent five years as a pharmacy law instructor at Midwestern University Chicago College of Pharmacy. She is also Past President of the American Society for Pharmacy Law.
The complimentary home study webinar is eligible for Accreditation Council for Pharmacy Education (ACPE)-accredited continuing pharmacy education (CPE) credit. More details regarding the presentations, CPE activity credits, and browser requirements can be found in the CPE Activity Information Guide.