FDA’s Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments

FDA hosted a public meeting on May 21, 2019, 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to discuss access to office stock from outsourcing facilities considering the policies proposed in the revised draft guidance Current Good Manufacturing Practice Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.

The meeting sought to explore how the revised draft guidance, if finalized as written, would impact outsourcing facilities producing drugs requested for office stock, filling smaller orders of these products, and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 Proposed policies in the revised draft guidance for discussion included those related to stability studies, beyond use dating, and release testing.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.

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
Silver Spring, MD 20993-0002

Agenda and Webcast Information

Agenda

Webcast Recording

• Part 1
• Part 2
• Part 3

Presentations

FDA Presentations

• Overview
• CGMP Guidance for Outsourcing Facilities – Revised Draft Guidance

External Stakeholder Presentations

• American Academy of Ophthalmology
• American Society of Cataract and Refractive Surgery
• American Society of Retina Specialists Comments
• Outsourcing Facility Association

Submitting Comments

In addition to providing input at the public meeting, stakeholders are invited to submit comments through the public docket at www.regulations.gov. The public docket will close on June 21, 2019.

Questions

Contact [email protected] if you have questions about the public meeting.