217.5402 Manufacturer of investigational drug, biological product, or device may
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/ky/217-5402A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
make it available to a requesting patient eligible under KRS 217.5401 to
217.5408.
(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 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.