(a) A manufacturer of an investigational drug, biological product, or device may make available the manufacturer’s investigational drug, biological product, or device to eligible patients in accordance with this chapter if the patient provides to the manufacturer the informed consent required under § 490.052.
(b) This chapter does not require a manufacturer to make available an investigational drug, biological product, or device to an eligible patient.

(c) If a manufacturer makes available an investigational drug, biological product, or device to an eligible patient under this subchapter, the manufacturer must provide the investigational drug, biological product, or device to the eligible patient without receiving compensation.