HF 3571

1st Engrossment - 90th Legislature (2017 - 2018) Posted on 03/29/2018 04:31pm

A bill for an act
relating to health; establishing standards for emergency prescription orders;
modifying requirements for distribution of certain home dialysis supplies; amending
Minnesota Statutes 2016, sections 151.15, by adding subdivisions; 151.19,
subdivision 1; 151.46.

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

Section 1.

Minnesota Statutes 2016, section 151.15, is amended by adding a subdivision
to read:

new text begin Subd. 5. new text end

new text begin Receipt of emergency prescription orders. new text end

new text begin A pharmacist, when that pharmacist
is not present within a licensed pharmacy, may accept a written, verbal, or electronic
prescription drug order from a practitioner only if:
new text end

new text begin (1) the prescription drug order is for an emergency situation where waiting for the
licensed pharmacy from which the prescription will be dispensed to open would likely cause
the patient to experience significant physical harm or discomfort;
new text end

new text begin (2) the pharmacy from which the prescription drug order will be dispensed is closed for
business;
new text end

new text begin (3) the pharmacist has been designated to be on call for the licensed pharmacy that will
fill the prescription drug order;
new text end

new text begin (4) in the case of an electronic prescription drug order, the order must be received through
secure and encrypted electronic means;
new text end

new text begin (5) the pharmacist takes reasonable precautions to ensure that the prescription drug order
will be handled in a manner consistent with federal and state statutes regarding the handling
of protected health information; and
new text end

new text begin (6) the pharmacy from which the prescription drug order will be dispensed has relevant
and appropriate policies and procedures in place and makes them available to the board
upon request.
new text end

Sec. 2.

Minnesota Statutes 2016, section 151.15, is amended by adding a subdivision to
read:

new text begin Subd. 6. new text end

new text begin Processing of emergency prescription orders. new text end

new text begin A pharmacist, when that
pharmacist is not present within a licensed pharmacy, may access a pharmacy prescription
processing system through secure and encrypted electronic means in order to process an
emergency prescription accepted pursuant to subdivision 5 only if:
new text end

new text begin (1) the pharmacy from which the prescription drug order will be dispensed is closed for
business;
new text end

new text begin (2) the pharmacist has been designated to be on call for the licensed pharmacy that will
fill the prescription drug order;
new text end

new text begin (3) the prescription drug order is for a patient of a long-term care facility or a county
correctional facility;
new text end

new text begin (4) the prescription drug order is processed pursuant to this chapter and rules adopted
under this chapter; and
new text end

new text begin (5) the pharmacy from which the prescription drug order will be dispensed has relevant
and appropriate policies and procedures in place and makes them available to the board
upon request.
new text end

Sec. 3.

Minnesota Statutes 2016, section 151.19, subdivision 1, is amended to read:

Subdivision 1.

Pharmacy licensure requirements.

(a) No person shall operate a
pharmacy without first obtaining a license from the board and paying any applicable fee
specified in section 151.065. The license shall be displayed in a conspicuous place in the
pharmacy for which it is issued and expires on June 30 following the date of issue. It is
unlawful for any person to operate a pharmacy unless the license has been issued to the
person by the board.

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

(c) No license shall be issued or renewed for a pharmacy located within the state unless
the applicant agrees to operate the pharmacy in a manner prescribed by federal and state
law and according to rules adopted by the board. No license shall be issued for a pharmacy
located outside of the state unless the applicant agrees to operate the pharmacy in a manner
prescribed by federal law and, when dispensing medications for residents of this state, the
laws of this state, and Minnesota Rules.

(d) No license shall be issued or renewed for a pharmacy 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 such licensure or registration.

(e) The board shall require a separate license for each pharmacy located within the state
and for each pharmacy located outside of the state at which any portion of the dispensing
process occurs for drugs dispensed to residents of this state.

(f) The board shall not issue an initial or renewed license for a pharmacy unless the
pharmacy passes an inspection conducted by an authorized representative of the board. In
the case of a pharmacy 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.

(g) The board shall not issue an initial or renewed license for a pharmacy located outside
of the state unless the applicant discloses and certifies:

(1) the location, names, and titles of all principal corporate officers and all pharmacists
who are involved in dispensing drugs to residents of this state;

(2) that it maintains its records of drugs dispensed to residents of this state so that the
records are readily retrievable from the records of other drugs dispensed;

(3) that it agrees to cooperate with, and provide information to, the board concerning
matters related to dispensing drugs to residents of this state;

(4) that, during its regular hours of operation, but no less than six days per week, for a
minimum of 40 hours per week, a toll-free telephone service is provided to facilitate
communication between patients in this state and a pharmacist at the pharmacy who has
access to the patients' records; the toll-free number must be disclosed on the label affixed
to each container of drugs dispensed to residents of this state; and

(5) that, upon request of a resident of a long-term care facility located in this state, the
resident's authorized representative, or a contract pharmacy or licensed health care facility
acting on behalf of the resident, the pharmacy will dispense medications prescribed for the
resident in unit-dose packaging or, alternatively, comply with section 151.415, subdivision
5.

new text begin (h) This subdivision does not apply to a manufacturer licensed under section 151.252,
subdivision 1, a wholesale drug distributor licensed under section 151.47, or a third-party
logistics provider, to the extent the manufacturer, wholesale drug distributor, or third-party
logistics provider is engaged in the distribution of dialysate or devices necessary to perform
home peritoneal dialysis on patients with end-stage renal disease, if:
new text end

new text begin (1) the manufacturer or its agent leases or owns the licensed manufacturing or wholesaling
facility from which the dialysate or devices will be delivered;
new text end

new text begin (2) the dialysate is comprised of dextrose or icodextrin and has been approved by the
United States Food and Drug Administration;
new text end

new text begin (3) the dialysate is stored and delivered in its original, sealed, and unopened
manufacturer's packaging;
new text end

new text begin (4) the dialysate or devices are delivered only upon:
new text end

new text begin (i) receipt of a physician's order by a Minnesota licensed pharmacy; and
new text end

new text begin (ii) the review and processing of the prescription by a pharmacist licensed by the state
in which the pharmacy is located, who is employed by or under contract to the pharmacy;
new text end

new text begin (5) prescriptions, policies, procedures, and records of delivery are maintained by the
manufacturer for a minimum of three years and are made available to the board upon request;
and
new text end

new text begin (6) the manufacturer or the manufacturer's agent delivers the dialysate or devices directly
to:
new text end

new text begin (i) a patient with end-stage renal disease for whom the prescription was written or the
patient's designee, for the patient's self-administration of the dialysis therapy; or
new text end

new text begin (ii) a health care provider or institution, for administration or delivery of the dialysis
therapy to a patient with end-stage renal disease for whom the prescription was written.
new text end

Sec. 4.

Minnesota Statutes 2016, section 151.46, is amended to read:

151.46 PROHIBITED DRUG PURCHASES OR RECEIPT.

It is unlawful for any person to knowingly purchase or receive a prescription drug from
a source other than a person or entity licensed under the laws of the state, except where
otherwise provided. Licensed wholesale drug distributors other than pharmacies shall not
dispense or distribute prescription drugs directly to patients new text begin except for licensed facilities
that dispense or distribute home peritoneal dialysis products directly to patients pursuant
to section 151.19, subdivision 1, paragraph (h) new text end . A person violating the provisions of this
section is guilty of a misdemeanor.