From DCAT Value Chain Insights (VCI)
The US Food and Drug Administration (FDA) has issued final guidance, Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products to provide the pharmaceutical industry with the Center for Drug Evaluation and 17 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 20 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.
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. It does not address injectable drug products in other packaging types (e.g., prefilled syringe package systems and intravenous infusion bags) or noninjectable products, because there may be unique considerations for these packaging configurations. The recommendations in this guidance apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), as well as supplements or other changes to these applications for new packaging or other changes that may affect the fill volume.
The FDA said that it issued the guidance to address issues relating to injectable vial misuse, including unsafe handling and injection techniques, which have led to vial contamination and an increased risk of bloodborne illness transmission between patients. It said that inappropriate excess volume and labeled vial fill sizes are two factors that may contribute to unsafe handling and injection practices by consumers and health care providers. The FDA said it has been concerned about these issues and issued the guidance to clarify its regulatory requirements and recommendations.
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