Overview

In 2024, MN Statute Sec. 151.741 Insulin Manufacturer Registration Fee was enacted - requiring manufacturers of insulin products to pay an annual registration fee of $100,000 if they do not meet the eligibility criteria for an exemption. Payments of this fee are deposited in the Insulin Safety Net Program account.

Subd. 2. Assessment of registration fee.

(a) The board shall assess each [insulin] manufacturer an annual registration fee of $100,000, except as provided in paragraph (b). The board shall notify each manufacturer of this requirement beginning November 1, 2024, and each November 1 thereafter.

(b) A manufacturer may request an exemption from the annual registration fee. The board shall exempt a manufacturer from the annual registration fee if the manufacturer can demonstrate to the board, in the form and manner specified by the board, that gross revenue from sales of prescription insulin produced by that manufacturer and sold or delivered within or into Minnesota was less than five percent of the total gross revenue from sales of prescription insulin produced by all manufacturers and sold or delivered within or into Minnesota in the previous calendar year.

Each year, insulin manufacturers must either submit an exemption waiver request or pay the $100k registration fee. Click here to download the exemption certification waiver.

Timetable of current and upcoming registration fee assessments: