HF 1440

as introduced - 90th Legislature (2017 - 2018) Posted on 03/08/2018 05:35pm

A bill for an act
relating to health; establishing an opiate stewardship program; appropriating money;
requiring a report; amending Minnesota Statutes 2016, sections 151.065, subdivision
3; 151.252, subdivision 1; proposing coding for new law in Minnesota Statutes,
chapter 151.

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

Section 1.

Minnesota Statutes 2016, section 151.065, subdivision 3, is amended to read:

Subd. 3.

Annual renewal fees.

Annual licensure and registration renewal fees are as
follows:

(1) pharmacist, $145;

(2) pharmacy technician, $37.50;

(3) pharmacy, $225;

(4) drug wholesaler, legend drugs only, $235;

(5) drug wholesaler, legend and nonlegend drugs, $235;

(6) drug wholesaler, nonlegend drugs, veterinary legend drugs, or both, $210;

(7) drug wholesaler, medical gases, $185;

(8) drug wholesaler, also licensed as a pharmacy in Minnesota, $150;

(9) drug manufacturer, legend drugs only, $235;

(10) drug manufacturer, legend and nonlegend drugs, $235;

(11) drug manufacturer, nonlegend, veterinary legend drugs, or both, $210;

(12) drug manufacturer, medical gases, $185;

(13) drug manufacturer, also licensed as a pharmacy in Minnesota, $150;

new text begin (14) drug manufacturer, stewardship fee, one cent per morphine equivalent milligram
of opiates sold in the state, calculated as specified in section 151.252, subdivision 1,
paragraph (h);
new text end

deleted text begin (14) deleted text end new text begin (15) new text end medical gas distributor, $110;

deleted text begin (15) deleted text end new text begin (16) new text end controlled substance researcher, $75; and

deleted text begin (16) deleted text end new text begin (17) new text end pharmacy professional corporation, $75.

Sec. 2.

Minnesota Statutes 2016, section 151.252, subdivision 1, is amended to read:

Subdivision 1.

Requirements.

(a) No person shall act as a drug manufacturer without
first obtaining a license from the board and paying any applicable fee specified in section
151.065.

(b) Application for a drug manufacturer license under this section shall be made in a
manner specified by the board.

(c) No license shall be issued or renewed for a drug manufacturer unless the applicant
agrees to operate in a manner prescribed by federal and state law and according to Minnesota
Rules.

(d) No license shall be issued or renewed for a drug manufacturer that is required to be
registered pursuant to United States Code, title 21, section 360, unless the applicant supplies
the board with proof of registration. The board may establish by rule the standards for
licensure of drug manufacturers that are not required to be registered under United States
Code, title 21, section 360.

(e) No license shall be issued or renewed for a drug manufacturer that is required to be
licensed or registered by the state in which it is physically located unless the applicant
supplies the board with proof of licensure or registration. The board may establish, by rule,
standards for the licensure of a drug manufacturer that is not required to be licensed or
registered by the state in which it is physically located.

(f) The board shall require a separate license for each facility located within the state at
which drug manufacturing occurs and for each facility located outside of the state at which
drugs that are shipped into the state are manufactured.

(g) The board shall not issue an initial or renewed license for a drug manufacturing
facility unless the facility passes an inspection conducted by an authorized representative
of the board. In the case of a drug manufacturing facility located outside of the state, the
board may require the applicant to pay the cost of the inspection, in addition to the license
fee in section 151.065, unless the applicant furnishes the board with a report, issued by the
appropriate regulatory agency of the state in which the facility is located or by the United
States Food and Drug Administration, of an inspection that has occurred within the 24
months immediately preceding receipt of the license application by the board. The board
may deny licensure unless the applicant submits documentation satisfactory to the board
that any deficiencies noted in an inspection report have been corrected.

new text begin (h) The board shall not issue a renewed license for a drug manufacturer unless the
manufacturer annually pays the stewardship fee required by section 151.065, subdivision
3, and calculated as specified in this paragraph. Annually by March 1, a manufacturer must
report the quantity of each opiate listed in section 152.02, subdivision 3, paragraphs (b) and
(c), that the manufacturer sold into the state in the previous calendar year. The board shall
use the information in the report to calculate the stewardship fee for each manufacturer.
The stewardship fee shall be equal to one cent per morphine milligram equivalent of opiates
listed in section 152.02, subdivision 3, paragraphs (b) and (c). The board shall use a morphine
equivalent chart published by the Centers for Disease Control and Prevention or another
reputable source to calculate morphine equivalents. If there is no commonly accepted
morphine equivalent for an opiate in a manufacturer's report, the board shall determine an
appropriate conversion based on its knowledge and expertise and shall notify the
manufacturer of the conversion value and method.
new text end

Sec. 3.

new text begin [151.2521] OPIATE PRODUCT STEWARDSHIP.
new text end

new text begin Subdivision 1. new text end

new text begin Product stewardship. new text end

new text begin A manufacturer licensed under section 151.252
that sells opiates as defined in section 152.02, subdivision 3, paragraphs (b) and (c), shall
pay to the Board of Pharmacy an annual stewardship fee as specified in section 151.065.
new text end

new text begin Subd. 2. new text end

new text begin Appropriation. new text end

new text begin Charges collected by the Board of Pharmacy under section
151.065, subdivision 3, clause (14), must be deposited in the state treasury and credited to
a dedicated account in the special revenue fund. Money in the account is annually
appropriated to the commissioner of human services for the purposes in subdivision 3. This
appropriation is available until expended.
new text end

new text begin Subd. 3. new text end

new text begin Purposes. new text end

new text begin The commissioner of human services, in consultation with the
commissioner of health and the Opiate Product Stewardship Advisory Council established
in subdivision 4, must use the money appropriated under subdivision 2 to add or expand
care services for individuals who are addicted to opiates, subject to the following conditions:
(1) at least 50 percent of the money appropriated under subdivision 2 must be for competitive
grants to one or more nonprofit organizations engaged in expanding prescriber education,
public awareness, and overdose prevention program development and sustainability, to
include the public and emergency medical services providers regulated under chapter 144E;
and (2) at least 2.5 percent of the money appropriated under subdivision 2 must be for a
grant to the Board of Pharmacy to be used for the Minnesota prescription monitoring program
and for administration of the charge under section 151.252, subdivision 1, paragraph (h).
The commissioner of human services may use up to 5 percent of the money appropriated
under subdivision 3 for administration of this section. The commissioner of human services
must develop a grant process to provide funding to successful applicants the first quarter
after revenue is collected under section 151.252, subdivision 1, paragraph (h).
new text end

new text begin Subd. 4. new text end

new text begin Opiate Product Stewardship Advisory Council. new text end

new text begin (a) An Opiate Product
Stewardship Advisory Council is created. The council must consist, at a minimum, of the
following voting members, appointed by the commissioners of human services and health
except where otherwise specified:
new text end

new text begin (1) one representative of the Board of Pharmacy;
new text end

new text begin (2) one representative of the Minnesota chapter of the Academy of Emergency Physicians
who is a medical doctor;
new text end

new text begin (3) one representative of treatment facilities or sober living facilities;
new text end

new text begin (4) one representative of the Minnesota Hospital Association who is a medical doctor;
new text end

new text begin (5) one member of the Minnesota Society of Addiction Medicine who is a medical
doctor;
new text end

new text begin (6) one pain psychologist;
new text end

new text begin (7) one representative of the Steve Rummler Hope Network;
new text end

new text begin (8) one representative of the Minnesota Ambulance Association;
new text end

new text begin (9) one representative of Minnesota courts who is a judge or law enforcement officer;
new text end

new text begin (10) one Minnesota resident who has been impacted by opiates; and
new text end

new text begin (11) one representative from an Indian tribe.
new text end

new text begin (b) The council shall also include, at a minimum, the following nonvoting members:
new text end

new text begin (1) two members of the house of representatives, one from the majority party appointed
by the speaker of the house and one from the minority party appointed by the minority
leader; and
new text end

new text begin (2) two members of the senate, one from the majority party appointed by the senate
majority leader and one from the minority party appointed by the senate minority leader.
new text end

new text begin (c) The council shall be organized and administered under section 15.059.
new text end

new text begin (d) The commissioners of health and human services must convene the first meeting of
the council no later than October 1, 2017. The members shall elect a chair at the first meeting.
new text end

new text begin (e) The advisory council shall meet when convened by the chair, and must meet at least
quarterly.
new text end

new text begin (f) By February 1, 2018, and annually thereafter, the council shall submit a report to the
committees in the house of representatives and the senate with jurisdiction over health and
human services policy. The report shall include information on funds spent pursuant to
subdivision 3 in the previous year and outcomes resulting from the expenditures.
new text end