37 Tex. Admin. Code § 12.61 - Production Limits
(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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.