South Carolina Code 44-137-20. Availability to eligible patients of investigational drug, biological product, or device; compensation; costs
Current as of: 2023 | Check for updates
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(A) A manufacturer of an investigational drug, biological product, or device may make available to an eligible patient, and an eligible patient may request, the manufacturer’s investigational drug, biological product, or device. Nothing in this article shall be construed to require a manufacturer of an investigational drug, biological product, or device to make such investigational drug, biological product, or device available to an eligible patient.
(B) A manufacturer of an investigational drug, biological product, or device may provide the investigational drug, biological product, or device to an eligible patient without receiving compensation or may require the eligible patient to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product, or device.
Terms Used In South Carolina Code 44-137-20
- Eligible patient: means an individual who:
(a) has a terminal illness, attested to by a treating physician;
(b) has, in consultation with a treating physician, considered and exhausted all other treatment options currently approved by the United States Food and Drug Administration;
(c) has received a recommendation from the treating physician for use of an investigational drug, biological product, or device for treatment of the terminal illness;
(d) has given informed consent in writing to use the investigational drug, biological product, or device for treatment of the terminal illness or, if the individual is a minor or is otherwise incapable of providing informed consent, the parent or legal guardian has given informed consent in writing to use the investigational drug, biological product, or device; and
(e) has documentation from the treating physician that the individual meets all of the criteria for this definition, including an attestation from the treating physician that the treating physician was consulted in the creation of the written, informed consent required under this chapter. See South Carolina Code 44-137-10