A manufacturer of an investigational drug, biological product or device may make available the investigational drug, biological product or device to an eligible patient.
1. Compensation. A manufacturer may provide an investigational drug, biological product or device to an eligible patient with or without receiving compensation.
2. Costs. A manufacturer may require an eligible patient to pay the costs of manufacturing the dosage of an investigational drug, a biological product or a device dispensed to that eligible patient.