View EO 12866 Meeting 0910-AI31

Title: Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

Agency/Subagency: 0910-HHS/FDA

Stage of Rulemaking: Proposed Rule Stage

Meeting Date/Time: 09/19/2023 03:30 PM

Requestor: American Pharmacists Association Requestor's Name: Michael Baxter Requestor's Client: Compounding Core Group

Documents:

List of Documents
OMB Call Summary APhA Compounding Core Group

Attendees:

List of Attendees		Participation
•	Dr. Natalie Young - APhA Compounding Core Group Chair	Teleconference
•	Dr. Matt Martin - APhA Compounding Core Group Chair-Elect	Teleconference
•	Dr. Ilisa Bernstein - American Pharmacists Association	Teleconference
•	Michael Baxter - American Pharmacists Association	Teleconference
•	Julie Wise - OMB	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Megan Anderson - FDA	Teleconference
•	Sara Rothman - FDA	Teleconference
•	Kathleen Anderson - FDA	Teleconference
•	Aaron Young - FDA	Teleconference
•	Emily Galloway - FDA	Teleconference
•	Gabrielle Cosel - FDA	Teleconference
•	Jean McCue - FDA	Teleconference
•	Nikki Kofsky - FDA	Teleconference
•	Nnaemeka Chukwudebe - FDA	Teleconference