When repackaging drugs from a stock container into smaller quantities, which information must be included on the repackaged unit label?

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When repackaging into smaller units, labeling must provide complete identity and traceability to ensure safe dispensing and easy recalls if needed. The repackaged unit label should show the drug name, the strength, and the dosage form so clinicians know exactly what was dispensed. It must also include the manufacturer’s name (or repackager’s name) to identify the source, the lot number to track the specific batch, the expiration date to prevent using expired product, and the quantity per repackaged unit so the exact amount in each package is clear. All of these elements together support accurate dosing, traceability, and safety across the supply chain.

Options missing any of these essential items—such as omitting the dosage form, the manufacturer's or repackager’s name, or the quantity per repackaged unit—don’t provide a complete, compliant label and could hinder proper identification, dosing, or recall actions.