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SF 1920

as introduced - 92nd Legislature (2021 - 2022) Posted on 03/10/2021 03:37pm

KEY: stricken = removed, old language.
underscored = added, new language.

Current Version - as introduced

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A bill for an act
relating to health; clarifying requirements for the licensure of facilities that handle
medical gases; amending Minnesota Statutes 2020, section 151.01, subdivision
29, by adding subdivisions; 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 151.01, subdivision 29, is amended to read:


Subd. 29.

deleted text beginLegenddeleted text end Medical gas.

"deleted text beginLegenddeleted text end Medical gas" means deleted text begina 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 endnew 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. 2.

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. 3.

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. 4.

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. 5.

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 subdivision 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.
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) Before issuing an initial or renewed license for a medical gas manufacturing facility,
the board may require that the facility 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 that the applicant pay the cost of the inspection,
in addition to the license fee in section 151.065, unless the applicant provides the board 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 if 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 subdivision 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.
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) Before issuing an initial or renewed license for a medical gas wholesaling facility,
the board may require that the facility 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 that the applicant pay the cost of the inspection, in addition
to the license fee in section 151.065, unless the applicant provides the board 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 wholesaler
must not engage in the dispensing of medical gases without first obtaining a registration
from the board and paying the applicable fee 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 subdivision 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. A registration 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.
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) Before issuing an initial or renewed registration for a medical gas dispenser, the board
may require that the medical gas dispenser 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 that the applicant pay the cost of the inspection, in addition to
the applicable fee in section 151.065, unless the applicant provides the board 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
registration application by the board. The board may deny registration 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 licensed or
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. 6. new text beginREPEALER.
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: 21-03194

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.