Date & Time of Session - 12/19125 - from 12:00 - 1:00PM

Overview
In the United States, drug manufacturers are able to obtain approval for medications using a variety of different approval pathways regulated by the Food & Drug Administration (FDA). The traditional 505(b)(1) drug approval pathway requires rigorous clinical testing to prove that a new, innovative medication is both safe and effective for patient use.  The generic 505(j) drug approval pathway allows manufacturers to bring generic medications to market based on bioequivalence studies. In addition to these drug approval pathways, there is an additional hybrid 505(b)(2) drug approval pathway that allows manufacturers to bring new formulations of previously approved medications to market without any data submission requirements. Because no data is required to be submitted for medications approved through the 505(b)(2) drug approval pathway, the FDA does not designate 505(b)(2) medications as therapeutically equivalent to the reference listed drug that they are derived from. This presentation will cover the unique financial and operational considerations that must be managed to appropriately use 505(b)(2) medications. 

Objectives
Upon completion of this activity, participants will be able to:
1. Define 505(b)(2) medications and explain how the 505(b)(2) approval pathway differs from the 505(b)(1) and 505(j) approval pathways
2. Review the financial and operational challenges in formulary management, procurement, and inventory control for 505(b)(2) drugs
3. Discuss best practices for evaluating and integrating 505(b)(2) products into pharmacy workflows

Target Audience
Pharmacists, residents, and students

Special Services
If you require special assistance to attend this event, please call Megan Russell at (304) 550-0896.

Speaker:
James T. Isaacs, PharmD, MSPS
PGY2 Health-System Pharmacy Administration & Leadership Resident
UK College of Pharmacy - Lexington, Kentucky