Dispensing Compounded Drugs from a 503B Outsourcing Facility and the Prohibition on Wholesaling Under Section 503B (On-Demand Webinar)
Date: 04/23/25
Closed captions are available.
Overview: This 60-minute webinar discusses FDA’s draft Guidance for Industry: Prohibition on Wholesaling under Section 503B of the Federal Food Drug and Cosmetic Act to illustrate how this draft guidance not only affects outsourcing facilities but offers potential market opportunities for state-licensed pharmacies. Speakers outline business models contemplated by the draft guidance as well as those models that are currently prohibited based on the draft guidance. The webinar provides examples to discuss how pharmacies can leverage this often overlooked statutory carve out to increase patient access to quality compounded drug products and increase pharmacy efficiencies.
Learning Objectives:
- Define the statutory prohibition on wholesaling under the Federal Food Drug and Cosmetic Act for outsourcing facilities.
- Describe various state interpretations of the federal statute.
- Explain opportunities for pharmacy and outsourcing facilities to work together to increase patient access.
Speaker Information:
Lee Rosebush, Partner, Baker Hostetler
Marc Wagner, Associate, Baker Hostetler
Credit Information:
CLE: The maximum number of credits available for ON DEMAND is 1.0 for a 60-minute state and 1.2 for a 50-minute state. Please note that the availability of credits may vary from state to state. This self-study course will be available for purchase for approximately one year after the recording date, but state rules on duration of eligibility for CLE-credits differ, so please check with your state before purchasing self-study offerings.
CPE: CPE credits are not available for on-demand.
For additional information, please visit the AHLA Continuing Education page.