Public Meeting: Drugs Compounded for Office Stock by Outsourcing Facilities

Public Meeting: Drugs Compounded for Office Stock by Outsourcing Facilities

Date and Time Tuesday, May 21, 2019 9:00 a.m. to 5:00 p.m. EST Location FDA White Oak Campus 10903 New Hampshire Avenue Building 31 Conference Center The Great Room (Rm. 1503, Sections B-C) Silver Spring, MD 20993-0002 FDA will host a public meeting to provide health care professionals, outsourcing facilities, and other stakeholders with an opportunity to discuss access to office stock from outsourcing facilities considering the policies proposed in the revised draft guidance Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. The meeting will explore how the revised draft guidance, if finalized as written, would impact outsourcing facilities producing drugs requested for office stock, filling smaller orders of these products, and providing products with beyond-use-dating that meets prescribers’ requests, among other topics. Proposed policies in the revised draft guidance for discussion include those related to stability studies, beyond use dating, and release testing. A set of proposed discussion topics and additional background for this meeting are found in the Federal Register Notice. Registration: Persons interested in attending this public meeting must register online by May 7, 2019. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. More information regarding the meeting, including registration instructions, will be posted at: Public Meeting on Drugs Compounded for Office Stock for Outsourcing Facilities.

For more information, please visit FDA's Human Drug Compounding web site.