In this Pharmacy Insight webinar, Faegre Drinker attorneys Jay Warmuth and Jonathan A. Keller will present alongside Marty Allain, CEO & Co-Founder, Real Solutions Group to provide an overview of and address common pitfalls regarding state licensing considerations for virtual manufacturers, reverse drug distributors and MTM non-dispensing pharmacies.
Virtual drug manufacturer licensing continues to be a moving target for new drug application (NDA) holders who contract out both the manufacturing and distribution of their drug products. The licensure requirements for these entities and the terminology used to describe these business activities vary state-by-state, which often lead to issues when seeking multi-state licensure. We will discuss several of these issues and provide real world examples of how to comply with various state licensure requirements.
Reverse distribution is an important and often overlooked component of the drug supply chain system. Some states specifically define and license reverse distributors, but many other states either include reverse distributors under the umbrella of wholesale distributors or simply do not address such entities. Where there are regulations, they are often vague or inconclusive and require outreach to regulators at the applicable governing body for clarification. We will provide an overview of the reverse drug distributor licensing landscape and examples of various pitfalls to avoid.
The concept of a MTM non-dispensing pharmacy is relatively new and presents certain challenges for both pharmacies and pharmacists. We will provide a discussion on what services a MTM non-dispensing pharmacy typically provides, how such services fit within the scope of the “practice of pharmacy” for both pharmacies and pharmacists, and key licensing considerations.
12:00 – 1:00 p.m. ET
Have a scheduling conflict? Register for the live event, and we’ll send you the on-demand recording shortly after the broadcast date. Content available to view on demand through May 5, 2023. Please note, continuing education credit is not available for on-demand viewing.
Continuing Education Credit
Visit the event website for information on available continuing education credit.
Contact Natalie Brzoza or call +1 312 356 5146.