FDA CERSI Lecture on Outsourcing Facilities and Bulk Drug Substances: University of Maryland Research Projects by Dr. Ashlee Mattingly
September 16, 2021
- September 16, 2021
University of Maryland CERSI
Thursday, September 16, 2021
Ashley Mattingly, PharmD
University of Maryland School of Pharmacy
University of Maryland
About the Presentation
The University of Maryland School of Pharmacy is currently conducting 2 research projects. The first is focused on obtaining clarifying information from nominators about the bulk drug substances that they nominated for addition to a list of bulk drug substances that may be used in compounding. The second is to understand how drugs compounded with bulk drug substances have been used historically, and how they are used currently in clinical practice. This presentation reviewed each of these projects. For more information regarding compounding please visit https://www.fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding.
About the Presenter
Dr. Ashlee Mattingly received her Doctor of Pharmacy degree from the University of Kentucky College of Pharmacy in 2011. After graduation, she worked as a pharmacist at Kindred Hospital, a long-term acute care hospital, in Louisville, Kentucky. In 2013, she joined Community Hospital South in Indianapolis, In., as a clinical pharmacist. She transitioned into academia at the University of Maryland School of Pharmacy, where she focuses on sterile and non-sterile compounding and serves as the director for the School’s PharmTechX Program, an advanced pharmacy technician training program. Her research includes the advancement in delivery of patient care through the use of pharmacy technicians, including the potential opportunities and the positive impact this can have on patient outcomes and overall pharmacy technician satisfaction. She is also interested in the regulations surrounding sterile and non-sterile compounding and developing processes that balance public safety with the efficient production of compounded pharmaceutical products. She has two research grants with the FDA evaluating the use of bulk drug substances in compounding as outlined in the Drug Quality and Security Act passed in 2013.
Play recording (46 mins)
Please contact Rebekah Zinn at Rebekah.Zinn@fda.hhs.gov.