| (a) The purpose of this subchapter is to establish
the requirements for a patient with a severe chronic disease to access
and use an investigational drug, biological product, or device, consistent
with Texas Health and Safety Code Chapter 490 and the rules in this
subchapter.
(b) Texas Health and Safety Code Chapter 490 and the
rules in this subchapter do not require a manufacturer to make available
an investigational drug, biological product, or device to an eligible
patient but a manufacturer choosing to do so must not receive compensation.
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