Arizona Laws 36-1332. Individualized investigational treatment; availability
A. A manufacturer operating within an eligible facility and pursuant to all applicable federalwide assurance regulations may make available to an eligible patient an individualized investigational treatment. An eligible patient’s physician may request an individualized investigational drug, biological product or device from an eligible facility or manufacturer operating within the eligible facility. This article does not require that a manufacturer make available an individualized investigational drug, biological product or device to an eligible patient.
Terms Used In Arizona Laws 36-1332
- Eligible facility: means a health care institution that operates under a federalwide assurance for the protection of human subjects pursuant to Title 45 of the Code of Federal Regulations, Part 46 and that is subject to the federal federalwide assurance regulations, policies and guidelines, including renewals or updates. See Arizona Laws 36-1331
- Eligible patient: means a patient who meets all of the following conditions:
(a) Has a life-threatening disease or condition or a severely debilitating illness, attested to by the patient's physician. See Arizona Laws 36-1331
B. An eligible facility or manufacturer operating within an eligible facility may do both 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 individualized investigational drug, biological product or device.