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26 Mar 2014

Rx-360 Summary of FDA's Guidance on Allowable Fill Volume Excesses in Vials

FDA recently published a draft Guidance for Industry, Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products. Comments are due to FDA by 12 June 2014. 


This guidance applies to parenteral drug product provided in vials and is not applicable to drug product provided in pre-filled syringes and intravenous infusion bags. Both original NDAs, BLAs, ANDAs and their supplements are included within the scope of this draft guidance. 


FDA is concerned about “inappropriate excess volume and labeled vial fill sizes” may contribute to microbial contamination of drug product and possible medication errors.   

In this guidance, FDA notes that existing regulations require that sponsors/applicants comply with the “excess volume” recommendations in the USP <1151> for drugs in ampules and vials, intended for injection. If the applicant chooses to deviate from the USP requirements, they must provide justification.


To view or download the FDA Guidance, click here
To view or download the Rx-360 Summary of the FDA Guidance, click here

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