SF 1773

as introduced - 90th Legislature (2017 - 2018) Posted on 03/07/2017 09:15am

A bill for an act
relating to health; exempting certain facilities that deliver home renal products
from pharmacy licensure requirements; amending Minnesota Statutes 2016, sections
151.19, subdivision 1, by adding a subdivision; 151.46.

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

Section 1.

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) deleted text begin The board shall not issue deleted text end new text begin Before issuing new text end an initial or renewed license for a pharmacy
deleted text begin unless deleted text end new text begin , the board may require new text end the pharmacy deleted text begin passes deleted text end new text begin to pass new text end 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.

Sec. 2.

Minnesota Statutes 2016, section 151.19, is amended by adding a subdivision to
read:

new text begin Subd. 1a. new text end

new text begin Home renal products. new text end

new text begin A facility licensed as a manufacturer under section
151.252, subdivision 1, or as a wholesaler or third party logistics provider under section
151.47 that delivers dialysate necessary to perform home renal dialysis to a patient in this
state is exempt from subdivision 1 if:
new text end

new text begin (1) the manufacturer of the dialysate is licensed by the board as a manufacturer and the
manufacturer or its agent leases or owns the licensed manufacturing or wholesaling facility
from which the dialysate will be delivered;
new text end

new text begin (2) the dialysate 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 is delivered only upon receipt of a prescription drug order issued by a
licensed practitioner;
new text end

new text begin (5) the dialysate is delivered by the manufacturer or licensed manufacturer's agent, except
that the manufacturer may use a common carrier to deliver the dialysate;
new text end

new text begin (6) prescriptions and record 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 (7) the manufacturer or its agent delivers the dialysate directly to the patient for whom
the dialysate was prescribed, or to a designee of the patient, for self-administration of dialysis
therapy.
new text end

Sec. 3.

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 renal products directly to patients pursuant to section 151.19,
subdivision 1a new text end . A person violating the provisions of this section is guilty of a misdemeanor.