(CONTAINS TEXT WITH VARYING EFFECTIVE DATES) (WHOLE SECTION TEXT EFFECTIVE UNTIL 1/01/27) (WHOLE SECTION TEXT REPEALED 1/01/27) This section governs insulin product registration fees. As used in this section, "unit of insulin" means the lowest identifiable quantity of insulin that is dispensed. [PL 2021, c. 303, §5 (NEW).] 1. Registration fee. Except as provided in subsection 2, a manufacturer that produces insulin that is sold, delivered or distributed in this State shall pay an annual registration fee of $75,000 to the board on December 31st of each year in addition to any license renewal fee required to be paid by the manufacturer under this chapter. [PL 2021, c. 303, §5 (NEW).] 2. Exception. A manufacturer that is a nonprofit organization or whose aggregate total of insulin sold, delivered or distributed in this State does not exceed 500,000 units of insulin in the year in which a registration fee under subsection 1 is due is not required to pay the registration fee. To qualify for the exception under this subsection, a manufacturer must demonstrate to the board, by January 31st of the year following the year in which the registration fee is due, in a manner determined by the board, that the aggregate total of insulin produced by the manufacturer that was sold, delivered or distributed within this State in the year in which the manufacturer seeks to claim the exception did not exceed 500,000 units. The board may adopt rules to implement this section. Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A. [PL 2023, c. 610, §4 (AMD).] This section is repealed January 1, 2027. [PL 2021, c. 303, §5 (NEW).]
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