SF 1227

1st Engrossment - 92nd Legislature (2021 - 2022) Posted on 07/30/2021 12:04pm

A bill for an act
relating to health care; establishing a separate licensure for medical gas distributors;
creating exemptions for certain opiate manufacturers from the opiate registration
fee; clarifying the opiate epidemic response advisory council's role in reporting to
the legislature and determining grant awards and amounts; specifying the term
limits for the initial advisory council members; reducing the license fee for
manufacturers and wholesalers of medical gases; amending Minnesota Statutes
2020, sections 16A.151, subdivision 2; 151.01, subdivision 29, by adding
subdivisions; 151.065, subdivisions 1, 3, 7; 151.066, subdivision 3; 256.042,
subdivision 4; 256.043, subdivision 4; proposing coding for new law in Minnesota
Statutes, chapter 151; repealing Minnesota Statutes 2020, section 151.19,
subdivision 3.

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

Section 1.

Minnesota Statutes 2020, section 16A.151, subdivision 2, is amended to read:

Subd. 2.

Exceptions.

(a) If a state official litigates or settles a matter on behalf of specific
injured persons or entities, this section does not prohibit distribution of money to the specific
injured persons or entities on whose behalf the litigation or settlement efforts were initiated.
If money recovered on behalf of injured persons or entities cannot reasonably be distributed
to those persons or entities because they cannot readily be located or identified or because
the cost of distributing the money would outweigh the benefit to the persons or entities, the
money must be paid into the general fund.

(b) Money recovered on behalf of a fund in the state treasury other than the general fund
may be deposited in that fund.

(c) This section does not prohibit a state official from distributing money to a person or
entity other than the state in litigation or potential litigation in which the state is a defendant
or potential defendant.

(d) State agencies may accept funds as directed by a federal court for any restitution or
monetary penalty under United States Code, title 18, section 3663(a)(3), or United States
Code, title 18, section 3663A(a)(3). Funds received must be deposited in a special revenue
account and are appropriated to the commissioner of the agency for the purpose as directed
by the federal court.

(e) Tobacco settlement revenues as defined in section 16A.98, subdivision 1, paragraph
(t), may be deposited as provided in section 16A.98, subdivision 12.

(f) Any money received by the state resulting from a settlement agreement or an assurance
of discontinuance entered into by the attorney general of the state, or a court order in litigation
brought by the attorney general of the state, on behalf of the state or a state agency, against
one or more opioid manufacturers or opioid wholesale drug distributors new text begin or consulting firms
working for an opioid manufacturer or opioid wholesale drug distributor new text end related to alleged
violations of consumer fraud laws in the marketing, sale, or distribution of opioids in this
state or other alleged illegal actions that contributed to the excessive use of opioids, must
be deposited in a separate account in the state treasury and the commissioner shall notify
the chairs and ranking minority members of the Finance Committee in the senate and the
Ways and Means Committee in the house of representatives that an account has been created.
new text begin Notwithstanding section 11A.20, all investment income and all investment losses attributable
to the investment of this account shall be credited to the account. new text end This paragraph does not
apply to attorney fees and costs awarded to the state or the Attorney General's Office, to
contract attorneys hired by the state or Attorney General's Office, or to other state agency
attorneys. If the licensing fees under section 151.065, subdivision 1, clause (16), and
subdivision 3, clause (14), are reduced and the registration fee under section 151.066,
subdivision 3, is repealed in accordance with section 256.043, subdivision 4, then the
commissioner shall transfer from the separate account created in this paragraph to the opiate
epidemic response fund under section 256.043 an amount that ensures that $20,940,000
each fiscal year is available for distribution in accordance with section 256.043, deleted text begin subdivisions
2 and deleted text end new text begin subdivision new text end 3.

new text begin (g) Notwithstanding paragraph (f), if money is received from a settlement agreement or
an assurance of discontinuance entered into by the attorney general of the state or a court
order in litigation brought by the attorney general of the state on behalf of the state or a state
agency against a consulting firm working for an opioid manufacturer or opioid wholesale
drug distributor and deposited into the separate account created under paragraph (f), the
commissioner shall annually transfer from the separate account to the opiate epidemic
response fund under section 256.043 an amount equal to the estimated amount submitted
to the commissioner by the Board of Pharmacy in accordance with section 151.066,
subdivision 3, paragraph (b). The amount transferred shall be included in the amount available
for distribution in accordance with section 256.043, subdivision 3. This transfer shall occur
each year until the registration fee under section 151.066, subdivision 3, is repealed in
accordance with section 256.043, subdivision 4, or the money deposited in the account in
accordance with this paragraph has been transferred, whichever occurs first.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 2.

Minnesota Statutes 2020, section 151.01, subdivision 29, is amended to read:

Subd. 29.

deleted text begin Legend deleted text end Medical gas.

" deleted text begin Legend deleted text end Medical gas" means deleted text begin a liquid or gaseous
substance used for medical purposes and that is required by federal law to be dispensed
only pursuant to the prescription of a licensed practitioner deleted text end new text begin any gas or liquid manufactured
or stored in a liquefied, nonliquefied, or cryogenic state that:
new text end

new text begin (1) has a chemical or physical action in or on the human body or animals or is used in
conjunction with medical gas equipment; and
new text end

new text begin (2) is intended to be used for the diagnosis, cure, mitigation, treatment, or prevention of
disease new text end .

Sec. 3.

Minnesota Statutes 2020, section 151.01, is amended by adding a subdivision to
read:

new text begin Subd. 29a. new text end

new text begin Medical gas manufacturer. new text end

new text begin "Medical gas manufacturer" means any person:
new text end

new text begin (1) originally manufacturing a medical gas by chemical reaction, physical separation,
compression of atmospheric air, purification, or other means;
new text end

new text begin (2) filling a medical gas into a dispensing container via gas to gas, liquid to gas, or liquid
to liquid processes;
new text end

new text begin (3) combining two or more medical gases into a container to form a medically appropriate
mixture; or
new text end

new text begin (4) filling a medical gas via liquid to liquid into a final use container at the point of use.
new text end

Sec. 4.

Minnesota Statutes 2020, section 151.01, is amended by adding a subdivision to
read:

new text begin Subd. 29b. new text end

new text begin Medical gas wholesaler. new text end

new text begin "Medical gas wholesaler" means any person who
sells a medical gas to another business or entity for the purpose of reselling or providing
that medical gas to the ultimate consumer or patient.
new text end

Sec. 5.

Minnesota Statutes 2020, section 151.01, is amended by adding a subdivision to
read:

new text begin Subd. 29c. new text end

new text begin Medical gas dispenser. new text end

new text begin "Medical gas dispenser" means any person, other
than a licensed practitioner or pharmacy, who sells or provides a medical gas directly to the
ultimate consumer or patient via a valid prescription.
new text end

Sec. 6.

Minnesota Statutes 2020, section 151.065, subdivision 1, is amended to read:

Subdivision 1.

Application fees.

Application fees for licensure and registration are as
follows:

(1) pharmacist licensed by examination, $175;

(2) pharmacist licensed by reciprocity, $275;

(3) pharmacy intern, $50;

(4) pharmacy technician, $50;

(5) pharmacy, $260;

(6) drug wholesaler, legend drugs only, $5,260;

(7) drug wholesaler, legend and nonlegend drugs, $5,260;

(8) drug wholesaler, nonlegend drugs, veterinary legend drugs, or both, $5,260;

(9) drug wholesaler, medical gases, deleted text begin $5,260 for the first facility and deleted text end $260 deleted text begin for each
additional facility deleted text end ;

(10) third-party logistics provider, $260;

(11) drug manufacturer, nonopiate legend drugs only, $5,260;

(12) drug manufacturer, nonopiate legend and nonlegend drugs, $5,260;

(13) drug manufacturer, nonlegend or veterinary legend drugs, $5,260;

(14) drug manufacturer, medical gases, deleted text begin $5,260 for the first facility and deleted text end $260 deleted text begin for each
additional facility deleted text end ;

(15) drug manufacturer, also licensed as a pharmacy in Minnesota, $5,260;

(16) drug manufacturer of opiate-containing controlled substances listed in section
152.02, subdivisions 3 to 5, $55,260;

(17) medical gas dispenser, $260;

(18) controlled substance researcher, $75; and

(19) pharmacy professional corporation, $150.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 7.

Minnesota Statutes 2020, 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, $175;

(2) pharmacy technician, $50;

(3) pharmacy, $260;

(4) drug wholesaler, legend drugs only, $5,260;

(5) drug wholesaler, legend and nonlegend drugs, $5,260;

(6) drug wholesaler, nonlegend drugs, veterinary legend drugs, or both, $5,260;

(7) drug wholesaler, medical gases, deleted text begin $5,260 for the first facility and deleted text end $260 deleted text begin for each
additional facility deleted text end ;

(8) third-party logistics provider, $260;

(9) drug manufacturer, nonopiate legend drugs only, $5,260;

(10) drug manufacturer, nonopiate legend and nonlegend drugs, $5,260;

(11) drug manufacturer, nonlegend, veterinary legend drugs, or both, $5,260;

(12) drug manufacturer, medical gases, deleted text begin $5,260 for the first facility and deleted text end $260 deleted text begin for each
additional facility deleted text end ;

(13) drug manufacturer, also licensed as a pharmacy in Minnesota, $5,260;

(14) drug manufacturer of opiate-containing controlled substances listed in section
152.02, subdivisions 3 to 5, $55,260;

(15) medical gas dispenser, $260;

(16) controlled substance researcher, $75; and

(17) pharmacy professional corporation, $100.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 8.

Minnesota Statutes 2020, section 151.065, subdivision 7, is amended to read:

Subd. 7.

Deposit of fees.

(a) The license fees collected under this section, with the
exception of the fees identified in paragraphs (b) and (c), shall be deposited in the state
government special revenue fund.

(b) $5,000 of each fee collected under subdivision 1, clauses (6) to deleted text begin (9) deleted text end new text begin (8) new text end , deleted text begin and deleted text end (11) to
new text begin (13), and new text end (15), and subdivision 3, clauses (4) to deleted text begin (7) deleted text end new text begin (6) new text end , deleted text begin and deleted text end (9) to new text begin (11), and new text end (13), and $55,000
of each fee collected under subdivision 1, clause (16), and subdivision 3, clause (14), shall
be deposited in the opiate epidemic response fund established in section 256.043.

(c) If the fees collected under subdivision 1, clause (16), or subdivision 3, clause (14),
are reduced under section 256.043, $5,000 of the reduced fee shall be deposited in the opiate
epidemic response fund in section 256.043.

Sec. 9.

Minnesota Statutes 2020, 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 that
annually sells, delivers, or distributes an opiate within or into the state 2,000,000 or more
units as reported to the board under subdivision 2.

(b) new text begin 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 medication assisted
therapy for substance use disorders. If there is money deposited into the separate account
as described in section 16A.151, subdivision 2, paragraph (g), the board shall submit to the
commissioner of management and budget an estimate of the difference in the annual fee
revenue collected under this section due to this exception.
new text end

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

deleted text begin (c) deleted text end new text begin (d) new text end 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.

deleted text begin (d) deleted text end new text begin (e) new text end 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).

deleted text begin (e) deleted text end new text begin (f) new text end 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.

deleted text begin (f) deleted text end new text begin (g) new text end 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 EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 10.

new text begin [151.191] LICENSING MEDICAL GAS FACILITIES; FEES;
PROHIBITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Medical gas manufacturers; requirements. new text end

new text begin (a) No person shall act as
a medical gas manufacturer without first obtaining a license from the board and paying any
applicable fee specified in section 151.065.
new text end

new text begin (b) Application for a medical gas manufacturer license under this section must be made
in a manner specified by the board.
new text end

new text begin (c) A license must not be issued or renewed for a medical gas manufacturer unless the
applicant agrees to operate in a manner prescribed by federal and state law and according
to Minnesota Rules.
new text end

new text begin (d) A license must not be issued or renewed for a medical gas 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
standards for the licensure of a medical gas manufacturer that is not required to be licensed
or registered by the state in which it is physically located.
new text end

new text begin (e) The board must require a separate license for each facility located within the state at
which medical gas manufacturing occurs and for each facility located outside of the state
at which medical gases that are shipped into the state are manufactured.
new text end

new text begin (f) Prior to the issuance of an initial or renewed license for a medical gas manufacturing
facility, the board may require the facility to pass an inspection conducted by an authorized
representative of the board. In the case of a medical gas 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, 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 end

new text begin (g) A duly licensed medical gas manufacturing facility may also wholesale or dispense
any medical gas that is manufactured by the licensed facility, or manufactured or wholesaled
by another properly licensed medical gas facility, without also obtaining a medical gas
wholesaler license or medical gas dispenser registration.
new text end

new text begin (h) The filling of a medical gas into a final use container, at the point of use and by liquid
to liquid transfer, is permitted as long as the facility used as the base of operations is duly
licensed as a medical gas manufacturer.
new text end

new text begin Subd. 2. new text end

new text begin Medical gas wholesalers; requirements. new text end

new text begin (a) No person shall act as a medical
gas wholesaler without first obtaining a license from the board and paying any applicable
fee specified in section 151.065.
new text end

new text begin (b) Application for a medical gas wholesaler license under this section must be made in
a manner specified by the board.
new text end

new text begin (c) A license must not be issued or renewed for a medical gas wholesaler unless the
applicant agrees to operate in a manner prescribed by federal and state law and according
to Minnesota Rules.
new text end

new text begin (d) A license must not be issued or renewed for a medical gas wholesaler 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 standards
for the licensure of a medical gas wholesaler that is not required to be licensed or registered
by the state in which it is physically located.
new text end

new text begin (e) The board must require a separate license for each facility located within the state at
which medical gas wholesaling occurs and for each facility located outside of the state from
which medical gases that are shipped into the state are wholesaled.
new text end

new text begin (f) Prior to the issuance of an initial or renewed license for a medical gas wholesaling
facility, the board may require the facility to pass an inspection conducted by an authorized
representative of the board. In the case of a medical gas wholesaling 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, 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 end

new text begin (g) A duly licensed medical gas wholesaling facility may also dispense any medical gas
that is manufactured or wholesaled by another properly licensed medical gas facility.
new text end

new text begin Subd. 3. new text end

new text begin Medical gas dispensers; requirements. new text end

new text begin (a) A person or establishment not
licensed as a pharmacy, practitioner, medical gas manufacturer, or medical gas dispenser
must not engage in the dispensing of medical gases without first obtaining a registration
from the board and paying the applicable fee specified in section 151.065. The registration
must be displayed in a conspicuous place in the business for which it is issued and expires
on the date set by the board.
new text end

new text begin (b) Application for a medical gas dispenser registration under this section must be made
in a manner specified by the board.
new text end

new text begin (c) A registration must not be issued or renewed for a medical gas dispenser located
within the state unless the applicant agrees to operate in a manner prescribed by federal and
state law and according to the rules adopted by the board. A license must not be issued for
a medical gas dispenser located outside of the state unless the applicant agrees to operate
in a manner prescribed by federal law and, when dispensing medical gases for residents of
this state, the laws of this state and Minnesota Rules.
new text end

new text begin (d) A registration must not be issued or renewed for a medical gas dispenser 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 the licensure or registration. The board may
establish standards for the registration of a medical gas dispenser that is not required to be
licensed or registered by the state in which it is physically located.
new text end

new text begin (e) The board must require a separate registration for each medical gas dispenser located
within the state and for each facility located outside of the state from which medical gases
are dispensed to residents of this state.
new text end

new text begin (f) Prior to the issuance of an initial or renewed registration for a medical gas dispenser,
the board may require the medical gas dispenser to pass an inspection conducted by an
authorized representative of the board. In the case of a medical gas dispenser 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, 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 end

new text begin (g) A facility holding a medical gas dispenser registration must not engage in the
manufacturing or wholesaling of medical gases, except that a medical gas dispenser may
transfer medical gases from one of its duly registered facilities to other duly registered
medical gas manufacturing, wholesaling, or dispensing facilities owned or operated by that
same company, without requiring a medical gas wholesaler license.
new text end

Sec. 11.

Minnesota Statutes 2020, section 256.042, subdivision 4, is amended to read:

Subd. 4.

Grants.

(a) The commissioner of human services shall submit a report deleted text begin of the
grants proposed by the advisory council to be awarded for the upcoming fiscal year deleted text end to the
chairs and ranking minority members of the legislative committees with jurisdiction over
health and human services policy and finance, by March 1 of each year, beginning March
1, 2020 new text begin , describing the priorities and specific activities the advisory council intends to
address for the upcoming fiscal year based on the projected funds available for grant
distribution new text end .

(b) deleted text begin The commissioner of human services shall award grants from the opiate epidemic
response fund under section 256.043. deleted text end The grants shall be awarded to proposals selected by
the advisory council that address the priorities in subdivision 1, paragraph (a), clauses (1)
to (4), unless otherwise appropriated by the legislature. new text begin The advisory council shall determine
grant awards and funding amounts based on the funds appropriated to the commissioner
under section 256.043, subdivision 3, paragraph (e). The commissioner shall award the
grants from the opiate epidemic response fund and administer the grants in compliance with
section 16B.97. new text end No more than three percent of the grant amount may be used by a grantee
for administration.

Sec. 12.

Minnesota Statutes 2020, section 256.043, subdivision 4, is amended to read:

Subd. 4.

Settlement; sunset.

(a) If the state receives a total sum of $250,000,000 either
as a result of a settlement agreement or an assurance of discontinuance entered into by the
attorney general of the state, or resulting from a court order in litigation brought by the
attorney general of the state on behalf of the state or a state agency, against one or more
opioid manufacturers or opioid wholesale drug distributors new text begin or consulting firms working for
an opioid manufacturer or opioid wholesale drug distributor new text end related to alleged violations of
consumer fraud laws in the marketing, sale, or distribution of opioids in this state, or other
alleged illegal actions that contributed to the excessive use of opioids, or from the fees
collected under sections 151.065, subdivisions 1 and 3, and 151.066, that are deposited into
the opiate epidemic response fund established in this section, or from a combination of both,
the fees specified in section 151.065, subdivisions 1, clause (16), and 3, clause (14), shall
be reduced to $5,260, and the opiate registration fee in section 151.066, subdivision 3, shall
be repealed.

(b) The commissioner of management and budget shall inform the Board of Pharmacy,
the governor, and the legislature when the amount specified in paragraph (a) has been
reached. The board shall apply the reduced license fee for the next licensure period.

(c) Notwithstanding paragraph (a), the reduction of the license fee in section 151.065,
subdivisions 1 and 3, and the repeal of the registration fee in section 151.066 shall not occur
before July 1, 2024.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 13. new text begin OPIATE EPIDEMIC RESPONSE ADVISORY COUNCIL; INITIAL
MEMBERSHIP TERMS.
new text end

new text begin Notwithstanding Minnesota Statutes, section 256.042, subdivision 2, paragraph (c), the
initial term for members of the opiate epidemic response advisory council established under
Minnesota Statutes, section 256.042, identified in Minnesota Statutes, section 256.042,
subdivision 2, paragraph (a), clauses (1), (3), (5), (7), (9), (11), (13), (15), and (17), ends
September 30, 2022. The initial term for members identified under Minnesota Statutes,
section 256.042, subdivision 2, paragraph (a), clauses (2), (4), (6), (8), (10), (12), (14), and
(16), ends September 30, 2023.
new text end

Sec. 14. new text begin OPIATE REGISTRATION FEE REDUCTION.
new text end

new text begin (a) For purposes of assessing the opiate registration fee under Minnesota Statutes, section
151.066, subdivision 3, that is required to be paid on June 1, 2021, in accordance with
Minnesota Statutes, section 151.252, subdivision 1, paragraph (b), the Board of Pharmacy
shall not consider any injectable opiate product distributed to a hospital or hospital pharmacy.
If there is money deposited into the separate account as described in Minnesota Statutes,
section 16A.151, subdivision 2, paragraph (g), the board shall submit to the commissioner
of management and budget an estimate of the difference in the annual opiate registration
fee revenue collected under Minnesota Statutes, section 151.066, due to the exception
described in this paragraph.
new text end

new text begin (b) Any estimated loss to the opiate registration fee revenue attributable to paragraph
(a) must be included in any transfer that occurs under Minnesota Statutes, section 16A.151,
subdivision 2, paragraph (g), in calendar year 2021.
new text end

new text begin (c) If a manufacturer has already paid the opiate registration fee due on June 1, 2021,
the Board of Pharmacy shall return the amount of the fee to the manufacturer if the
manufacturer would not have been required to pay the fee after the calculations described
in paragraph (a) were made.
new text end

Sec. 15. new text begin REPEALER.
new text end

new text begin Minnesota Statutes 2020, section 151.19, subdivision 3, new text end new text begin is repealed.
new text end

APPENDIX

Repealed Minnesota Statutes: S1227-1

151.19 REGISTRATION; FEES.

Subd. 3.

Sale of federally restricted medical gases.

(a) A person or establishment not licensed as a pharmacy or a practitioner must not engage in the retail sale or dispensing of federally restricted medical gases without first obtaining a registration from the board and paying the applicable fee specified in section 151.065. The registration must be displayed in a conspicuous place in the business for which it is issued and expires on the date set by the board. It is unlawful for a person to sell or dispense federally restricted medical gases unless a certificate has been issued to that person by the board.

(b) Application for a medical gas dispenser registration under this section must be made in a manner specified by the board.

(c) A registration must not be issued or renewed for a medical gas dispenser located within the state unless the applicant agrees to operate in a manner prescribed by federal and state law and according to the rules adopted by the board. A license must not be issued for a medical gas dispenser located outside of the state unless the applicant agrees to operate in a manner prescribed by federal law and, when dispensing medical gases for residents of this state, the laws of this state and Minnesota Rules.

(d) A registration must not be issued or renewed for a medical gas dispenser 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 the licensure or registration. The board may, by rule, establish standards for the registration of a medical gas dispenser that is not required to be licensed or registered by the state in which it is physically located.

(e) The board must require a separate registration for each medical gas dispenser located within the state and for each facility located outside of the state from which medical gases are dispensed to residents of this state.

(f) Prior to the issuance of an initial or renewed registration for a medical gas dispenser, the board may require the medical gas dispenser to pass an inspection conducted by an authorized representative of the board. In the case of a medical gas dispenser 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, 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.