This guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on 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 on March 14, 2014 (79 FR 14517). Specifically, the guidance clarifies the FDA regulatory requirements and recommendations pertaining to allowable excess volume in injectable vials and describes when justification is needed for a proposed excess volume in these injectable drug products. This guidance also discusses the importance of appropriate fill volumes for injectable drug products and recommends that labeled vial fill sizes be appropriate for the intended use and dosing of the drug product.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.