Injectable Drug Allowable Excess Guidance

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Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] In late June, FDA released a final guidance on “Allowable Excess Volume and Labelled Vial Fill Size in Injectable Drug and Biological Products.” The guidance covers drugs in ampules or vials that are intended for injection, and does not cover prefilled syringes or intravenous infusion bags. The agency notes in the guidance that 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.” Inappropriate excess volume and labeled vial fill sizes, it maintains, are two factors that may contribute to unsafe handling and injection practices by consumers and health care providers. It points out that even when appropriately labeled, single-dose vials that contain significantly more drug than is required for a single dose may result in the misuse of the leftover drug product. The guidance clarifies the agency’s position on vial overfilling and makes recommendations on vial fill levels based on the product type and intended use. The draft was released in March 2014, and no comments were submitted to the agency.
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