HF 4098

as introduced - 93rd Legislature (2023 - 2024) Posted on 02/22/2024 02:56pm

A bill for an act
relating to health; amending opiate product manufacturer reporting requirements;
amending opiate product registration fee determination process; amending
Minnesota Statutes 2022, section 151.066, subdivisions 1, 2, 3.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

Minnesota Statutes 2022, section 151.066, subdivision 1, is amended to read:

Subdivision 1.

Definitions.

(a) For purposes of this section, the following terms have
the meanings given to them in this subdivision.

(b) "Manufacturer" means a manufacturer licensed under section 151.252 deleted text begin that is engaged
in the manufacturing of an opiate deleted text end new text begin , excluding those exclusively licensed to manufacture
medical gas new text end .

(c) "Opiate" means any opiate-containing controlled substance listed in section 152.02,
subdivisions 3 to 5, that is distributed, delivered, sold, or dispensed into or within this state.

(d) new text begin "Third-party logistics provider" means a third-party logistics provider licensed under
section 151.471.
new text end

new text begin (e) new text end "Wholesaler" means a wholesale drug distributor licensed under section 151.47 deleted text begin that
is engaged in the wholesale drug distribution of an opiate deleted text end new text begin , excluding those exclusively
licensed to distribute medical gas new text end .

Sec. 2.

Minnesota Statutes 2022, section 151.066, subdivision 2, is amended to read:

Subd. 2.

Reporting requirements.

(a) By March 1 of each year, beginning March 1,
2020, each manufacturer and each wholesaler must report to the board every sale, delivery,
or other distribution within or into this state of any opiate that is made to any practitioner,
pharmacy, hospital, veterinary hospital, or other person who is permitted by section 151.37
to possess controlled substances for administration or dispensing to patients that occurred
during the previous calendar year. Reporting must be in the automation of reports and
consolidated orders system format unless otherwise specified by the board. new text begin If no reportable
distributions occurred for a given year, notification must be provided to the board in a
manner specified by the board. new text end If a manufacturer or wholesaler fails to provide information
required under this paragraph on a timely basis, the board may assess an administrative
penalty of $500 per day. This penalty shall not be considered a form of disciplinary action.

(b) By March 1 of each year, beginning March 1, 2020, each owner of a pharmacy with
at least one location within this state must report to the board any intracompany delivery
or distribution into this state, of any opiate, to the extent that those deliveries and distributions
are not reported to the board by a licensed wholesaler owned by, under contract to, or
otherwise operating on behalf of the owner of the pharmacy. Reporting must be in the
manner and format specified by the board for deliveries and distributions that occurred
during the previous calendar year. The report must include the name of the manufacturer
or wholesaler from which the owner of the pharmacy ultimately purchased the opiate, and
the amount and date that the purchase occurred.

new text begin (c) By March 1 of each year, beginning March 1, 2024, each third-party logistics provider
must report to the board any delivery or distribution into this state of any opiate, to the
extent that those deliveries and distributions are not reported to the board by a licensed
wholesaler or manufacturer. Reporting must be in the manner and format specified by the
board for deliveries and distributions that occurred during the previous calendar year.
new text end

Sec. 3.

Minnesota Statutes 2022, section 151.066, subdivision 3, is amended to read:

Subd. 3.

Determination of an opiate product registration fee.

(a) The board shall
annually assess an opiate product registration fee on any manufacturer of an opiate deleted text begin that deleted text end new text begin
whose opiate product is new text end annually deleted text begin sells, delivers, or distributes an opiate deleted text end new text begin sold, delivered, or
distributed new text end within or into the state new text begin in a quantity of new text end 2,000,000 or more units as reported to
the board under subdivision 2.

(b) For purposes of assessing the annual registration fee under this section and
determining the number of opiate units a manufacturer sold, delivered, or distributed within
or into the state, the board shall not consider any opiate that is used for substance use disorder
treatment with medications for opioid use disorder.

(c) The annual registration fee for each manufacturer meeting the requirement under
paragraph (a) is $250,000.

(d) In conjunction with the data reported under this section, and notwithstanding section
152.126, subdivision 6, the board may use the data reported under section 152.126,
subdivision 4, to determine which manufacturers meet the requirement under paragraph (a)
and are required to pay the registration fees under this subdivision.

(e) By April 1 of each year, beginning April 1, 2020, the board shall notify a manufacturer
that the manufacturer meets the requirement in paragraph (a) and is required to pay the
annual registration fee in accordance with section 151.252, subdivision 1, paragraph (b).

(f) A manufacturer may dispute the board's determination that the manufacturer must
pay the registration fee no later than 30 days after the date of notification. However, the
manufacturer must still remit the fee as required by section 151.252, subdivision 1, paragraph
(b). The dispute must be filed with the board in the manner and using the forms specified
by the board. A manufacturer must submit, with the required forms, data satisfactory to the
board that demonstrates that the assessment of the registration fee was incorrect. The board
must make a decision concerning a dispute no later than 60 days after receiving the required
dispute forms. If the board determines that the manufacturer has satisfactorily demonstrated
that the fee was incorrectly assessed, the board must refund the amount paid in error.

(g) For purposes of this subdivision, a unit means the individual dosage form of the
particular drug product that is prescribed to the patient. One unit equals one tablet, capsule,
patch, syringe, milliliter, or gram.

new text begin (h) For the purposes of this subdivision, an opiate's units will be assigned to the
manufacturer holding the New Drug Application (NDA) or Abbreviated New Drug
Application (ANDA), as listed by the United States Food and Drug Administration.
new text end