Dispensing Compounded Drugs from a 503B Outsourcing Facility and the Prohibition on Wholesaling Under Section 503B

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Date: 04/23/25
Time: 2:00-3:00 PM ET

* Please Note: registration closes at 11:59 PM ET the day before the live event. No further registrations will be accepted once registration has been closed *

Live closed captions are available.

Overview: This webinar discusses FDA’s draft Guidance for Industry: Prohibition on Wholesaling under Section 503B of the Federal Food Drug and Cosmetic Act to illustrate how this draft guidance not only affects outsourcing facilities but offers potential market opportunities for state-licensed pharmacies. Speakers outline business models contemplated by the draft guidance as well as those models that are currently prohibited based on the draft guidance.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 

Continuing Education:

CLE: IMPORTANT CHANGE REGARDING CLE CREDIT: We are now working with ABA CLE for our accreditation needs. To earn credits during a live webinar, attendees must be logged into the webinar for at least 75 minutes (of a 90-minute webinar) or 55 minutes (of a 60-minute webinar). Then, they will receive a personalized CLE affidavit from mcle-ahla@americanbar.org. Watch for this email within 7-10 business days. If you do not receive it, please check your spam or junk folders as these emails often end up there. Please note you will fill out one affidavit for the full event. Once you complete the affidavit, you will be able to download your certificate(s) of attendance, and certificates will be emailed to you from mcle-ahla@americanbar.org.

CPE: AHLA is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Nashville, TN 37219-2417. Website: www.nasba.org. For further information, please visit our Continuing Education Page.

AHLA is seeking CPE credits for live webinars. The maximum number of credits available is 1.80.


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