Kentucky Statutes 217.5402 – Manufacturer of investigational drug, biological product, or device may make it available to a requesting patient eligible under KRS 217.5401 to 217.5408
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(1) A manufacturer of an investigational drug, biological product, or device may make the investigational drug, biological product, or device available to an eligible patient who has requested it pursuant to KRS § 217.5401 to KRS § 217.5408.
(2) The manufacturer may:
(a) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or
(b) Require an eligible patient to pay the costs of or the costs associated with the manufacture of the investigational drug, biological product, or device.
(3) A manufacturer shall not be required to make an investigational drug, biological product, or device available to an eligible patient.
Effective: June 29, 2017
History: Created 2017 Ky. Acts ch. 65, sec. 2, effective June 29, 2017.
Formerly codified as KRS § 217.5403.
(2) The manufacturer may:
Terms Used In Kentucky Statutes 217.5402
- Device: means any instrument or contrivance other than a firearm which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life other than man and other bacteria, virus, or other microorganisms on or in living man or other living animals. See Kentucky Statutes 217.544
(a) Provide an investigational drug, biological product, or device to an eligible patient without receiving compensation; or
(b) Require an eligible patient to pay the costs of or the costs associated with the manufacture of the investigational drug, biological product, or device.
(3) A manufacturer shall not be required to make an investigational drug, biological product, or device available to an eligible patient.
Effective: June 29, 2017
History: Created 2017 Ky. Acts ch. 65, sec. 2, effective June 29, 2017.
Formerly codified as KRS § 217.5403.