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FDA clarifies recommendations for injectable drug products packaged in vials and ampules.
FDA has released guidance that clarifies the agency’s current thinking on allowable excess volume and labeled vial-fill size in injectable drug and biological products. The draft guidance document states FDA’s requirements and recommendations in regards to allowable excess volume in vials. The guidance also explains when justification is needed for a proposed excess volume in these injectable drug products.
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) point out the importance of appropriate packaging sizes for injectable drug products in the guidance. The agencies recommend that labeled vial fill sizes be appropriate for the intended use and dosing of the drug product.
Fill and packaging issues for injectable drug products that are packaged in vials and ampules, including products that require reconstitution, are addressed in the guidance. Injectable drug products in other packaging types (e.g., prefilled syringe package systems and intravenous infusion bags) or noninjectable products are not covered in the guidance because there may be unique considerations for these packaging configurations. FDA states that the guidance applies to new drug applications, abbreviated new drug applications, biologics license applications, and new packaging supplements to these existing applications submitted to CDER and CBER.