§1300.73. Individualized investigational drugs; facility and manufacturer abilities
A. A manufacturer operating within an eligible facility and in accordance with all
applicable Federalwide Assurance for the Protection of Human Subjects laws and regulations
may make available an individualized investigative treatment and an eligible patient may
request an individualized investigational drug, biological product, or device from an eligible
facility or manufacturer operating within an eligible facility in accordance with this Part.
This Part shall not require a manufacturer to make available an individualized investigational
drug, biological product, or device to an eligible patient.
B. An eligible facility or manufacturer operating within an eligible facility may do
all of the following:
(1) Provide an individualized investigational drug, biological product, or device to
an eligible patient without receiving compensation.
(2) Require an eligible patient to pay the costs of, or the costs associated with, the
manufacture of the investigational drug, biological product, or device.
Acts 2024, No. 750, §1.