(a) This subchapter limits the amount of annual statewide
production by licensees to the estimated demand as calculated under
this subchapter but shall not be construed as adopting a standard
of care for treatment involving the product. The intent of this subchapter
reflects legislative intent to serve a narrow population of patients
living with intractable epilepsy, as defined under Occupations Code,
Chapter 169. The subchapter includes a provision allowing the department
to increase the established production limit. This provision shall
be executed if ever necessary to prevent the subchapter from ever
being the cause of a patient legally prescribed the product under
Occupations Code, Chapter 169, from being unable to access his or
her full prescription from a licensee.
(b) On the first of every September or in accordance
with subsection (i) of this section, the Department of State Health
Services shall provide a report to the department with:
(1) a current estimate of people living with intractable
epilepsy, as defined by Occupations Code, Chapter 169, in Texas; and
(2) the most current scientifically accepted dosage
of product used to treat an average individual living with intractable
epilepsy for one (1) year.
(c) Any information reported under subsection (b) of
this section:
(1) may be extrapolated from the number of beneficiaries
receiving state public assistance treating individuals with intractable
epilepsy;
(2) is strictly for the purpose of estimating a limit
on production under this chapter; and
(3) shall not be construed as the Department of State
Health Services adopting a standard of care for treating intractable
epilepsy.
(d) Upon receipt of the report required under subsection
(b), the department shall determine the maximum amount of product
allowed to be produced statewide, which shall be limited to:
(1) an amount required to treat one third of the population
described in subsection (b)(1) of this section with each individual
receiving the dosage determined by subsection (b)(2) of this section,
if prior to September 1, 2018; or
(2) the amount of product demand from the previous
twelve (12) month period grown by a percent equal to the growth over
the same previous twelve (12) month period in the population described
by subsection (b)(1), if after September 1, 2018.
(e) The department shall determine a maximum amount
of cannabis sativa plants needed to produce the amount of product
described in subsection (d) and subsection (j) of this section, if
applicable.
(f) Except as provided in subsection (j), each licensee
shall not annually produce more than an amount of product described
by subsection (d) divided by the number of licensees.
(g) In any fiscal year, licensees shall not have more
live cannabis sativa plants than an amount authorized by the department
in subsection (e) in this section divided by the number of licensees.
(h) Licensees may report a forecasted shortage of product
once in any quarter of the fiscal year to the department, which shall
forward the report to the Department of State Health Services.
(i) The Department of State Health Services may resend
a revised report under subsection (b) at any time upon receipt of
reliable information that conflicts with the most recently released
report under subsection (b).
(j) The department may increase the amount allowed
under subsection (d) upon notice from the Department of State Health
Services under subsection (i). An increase under this subsection is
limited to meeting the forecasted demand for product in Texas for
the remainder of the current twelve (12) month period ending on the
last day of August.
(k) After the department makes a determination under
subsection (j), each licensee may increase their maximum production
allowed under subsection (f) of this section by the amount of the
increase divided by the number of licensees or as otherwise determined
by the department.
(l) On March 1, 2018, the Department of State Health
Services shall release updated population and dosage amounts required
under subsection (b) that will determine the maximum amount of product
allowed statewide under subsection (d)(1) of this subsection until
September 1, 2018.
(m) Subsection (l) expires on September 1, 2018.
|