Section 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, 2018.37 Tex. Admin. Code § 12.61
Adopted by Texas Register, Volume 42, Number 10, March 10, 2017, TexReg 1148, eff. 3/15/2017