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The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
FDA has issued guidance clarifying the Center for Drug Evaluation and Research’s and the Center of Biologics Evaluation and Research’s recommendations for allowable excess volume and labeled vial fill size in injectable drugs and biologics. The guidance describes when justification is required for proposed excess volume, the importance of appropriate fill volumes, and appropriate labeled vial fill sizes and dosing.
The guidance focuses on withdrawable volume and labeled vial fill size for injectables packaged in vials and ampules but does not address prefilled syringes, intravenous infusion bags, or noninjectables. FDA states that the recommendations apply to new drug applications, abbreviated new drug applications, biologics license applications, and supplements or other changes to these applications for new packaging or changes that affect fill volume.