Maine § 13800-C. - Opioid medication product registration fee

§ 13800-C.. Opioid medication product registration fee

This section governs opioid medication product registration fees. As used in this section, "unit of an opioid medication" means the lowest identifiable quantity of the opioid medication that is dispensed.   [PL 2019, c. 536, §4 (NEW).]

1.  Registration fee.  Except as provided in subsection 2, a manufacturer that sells, delivers or distributes an opioid medication in this State shall pay an annual registration fee of $250,000 to the board on December 31st of each year.

2.  Exception.  A manufacturer that does not sell, deliver or distribute 2,000,000 or more units of an opioid medication within this State in the year in which a registration fee 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 manufacturer did not sell, deliver or distribute 2,000,000 or more units of an opioid medication within this State in the year in which the manufacturer seeks to claim the exception. 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.

3.  Calculation of units of an opioid medication sold, delivered or distributed.  When calculating the number of units of an opioid medication sold, delivered or distributed by a manufacturer under subsection 2, units of an opioid medication may be excluded when prescribed for the purpose of medication-assisted treatment of substance use disorder. The board periodically shall provide to the Department of Health and Human Services a list of medications exempted under this subsection.

4.  Registration fee review and report.