FDA issues Guidance for Industry on "Allowable Excess Volume and Labelled Vial Fill Size in Injectable Drug and Biological Products"
USFDA recently issues its final guidance for industry on Allowable Excess Volume and labelled Vial Fill Size in Injectable Drug and Biological Products". The guideline was finalized for 24 June 2015. It replaces the draft of the same name that was published on March 14, 2014. 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 addresses withdrawable volume and labeled vial fill size for injectable drug products that are packaged in vials and ampules, including products that require reconstitution. Other packaging types (such as prefilled syringes and intravenous infusion bags) or noninjectable products are not mentioned. Injectable vial misuse, including unsafe handling and injection techniques, has led to vial contamination and an increased risk of blood borne illness transmission between patients. FDA has been concerned about these issues and is publishing this guidance to clarify its regulatory requirements and recommendations.