FDA Webview

Free FDA Notices

Guidance on Injectable Drug/Biologic Excess Volume


Federal Register Notice: FDA is making available a guidance for industry entitled Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products. It replaces the draft of the same name that was published 3/14/14. It clarifies FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products. To download this guidance, click here. To view this notice, click here.