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GUIDANCE DOCUMENT

Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products June 2015

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.