U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0248
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 Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2014-D-0248.

Back to Top