16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Busulfan Injection is packaged as a sterile solution in 10 mL single-dose clear glass vials.
Busulfan Injection is available as follows:
| Unit of Sale | Concentration |
|---|---|
| NDC 0409-1112-01 Carton containing 8 Single-dose vials | 60 mg/10 mL (6 mg/mL) |
16.2 Storage and Handling
Unopened vials of Busulfan Injection must be stored under refrigerated conditions between 2°C to 8°C (36°F to 46°F). Discard unused portion.
Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time.
Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time.
Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures1.