Operation of remote pickup sites from which patients may obtain drugs and devices dispensed by a managing pharmacy authorized, and rulemaking authorized.

A bill for an act

relating to health occupations; authorizing the operation of remote pickup sites

from which patients may obtain drugs and devices dispensed by a managing

pharmacy; authorizing rulemaking; amending Minnesota Statutes 2024, section

151.19, 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 2024, 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.
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A remote pickup site operating

in compliance with section 151.59 operates under the authority of the managing pharmacy's

license and is not required to hold a separate pharmacy license.
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(f) Prior to the issuance of an initial or renewed license for a pharmacy, the board may

require the pharmacy to pass 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
.

(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:

(1) the manufacturer or its agent leases or owns the licensed manufacturing or wholesaling

facility from which the dialysate or devices will be delivered;

(2) the dialysate is comprised of dextrose or icodextrin and has been approved by the

United States Food and Drug Administration;

(3) the dialysate is stored and delivered in its original, sealed, and unopened

manufacturer's packaging;

(4) the dialysate or devices are delivered only upon:

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

(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;

(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

(6) the manufacturer or the manufacturer's agent delivers the dialysate or devices directly

to:

(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

(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.

Sec. 2.

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[151.59] REMOTE PICKUP SITES TO OBTAIN LEGEND DRUGS AND

DEVICES.

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Subdivision 1.

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Definitions.

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(a) For purposes of this section, the following terms have

the meanings given.

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(b) "Grocery store" means a retail establishment that sells primarily meat, fish, seafood,

fruits, vegetables, dry groceries, and dairy products and may also sell household products,

sundries, and other products.

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(c) "Managing pharmacy" means a licensed pharmacy that controls and is responsible

for the operation of a remote pickup site.

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(d) "Remote pickup site" means a location other than the site of the managing pharmacy

at which a patient or a patient's designee may obtain legend drugs and devices dispensed

for the patient by a pharmacist at the managing pharmacy.

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Subd. 2.

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Designation of remote pickup site.

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(a) A managing pharmacy may designate

one or more grocery stores as remote pickup sites at which a patient or a patient's designee

may obtain legend drugs and devices dispensed for the patient by a pharmacist at the

managing pharmacy. A managing pharmacy must only transfer to a remote pickup site

legend drugs and devices dispensed to refill a patient's prescription. For legend drugs the

refill must be of the same strength, dosage, and administration frequency as that of the

patient's most recent prior prescription. A managing pharmacy must not transfer to a remote

pickup site a legend drug or device dispensed for a patient according to a new prescription

or according to a prescription for a different strength, dosage, or administration frequency

of the legend drug than the strength, dosage, or administration frequency in the patient's

most recent prior prescription.

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(b) A managing pharmacy and the pharmacist in charge are responsible for the operation

of the managing pharmacy's remote pickup sites. A managing pharmacy operating a remote

pickup site retains control over the legend drugs and devices held at the remote pickup site.

A remote pickup site must operate in compliance with this section.

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Subd. 3.

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Board approval.

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(a) To operate a remote pickup site, a managing pharmacy

must obtain approval from the board. A managing pharmacy seeking to operate a remote

pickup site must apply to the board in a form and manner specified by the board. An

application to operate a remote pickup site must include, at a minimum:

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(1) the name, address, and license number of the managing pharmacy;

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(2) the name, address, and license number of the managing pharmacy's pharmacist in

charge;

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(3) the name and address of the remote pickup site;

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(4) the policies, procedures, and security requirements for the remote pickup site; and

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(5) a sample of the log that patients and patients' designees must sign to acknowledge

receipt of legend drugs and devices at the remote pickup site and of any other forms to be

used at the remote pickup site.

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(b) The board must review the application and accompanying materials and may approve

the operation of a remote pickup site if the application demonstrates the site will operate in

compliance with this section and in a manner that ensures patient safety and the security of

the legend drugs and devices held at the site.

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(c) A managing pharmacy must notify the board within seven days after ceasing to

operate a remote pickup site.

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Subd. 4.

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Storage of legend drugs and devices.

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(a) Legend drugs and devices must be

placed in a locked cabinet, locked drawer, or secure kiosk immediately upon delivery to a

remote pickup site and must be stored in the locked cabinet, locked drawer, or secure kiosk

while at the remote pickup site.

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(b) Each legend drug or device in the locked cabinet, locked drawer, or secure kiosk

must be in a container inside an opaque bag that is stapled shut or otherwise sealed. The

opaque bag must not have any text on the outside of the bag other than the patient's name

and the name of a patient's designee if an individual other than the patient will pick up the

legend drug or device. A receipt must be placed inside the bag.

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Subd. 5.

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Access and pickup.

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(a) Staff at a remote pickup site must be designated by the

managing pharmacy's pharmacist in charge and must complete training as required by the

board in order to:

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(1) place legend drugs and devices in the remote pickup site's locked cabinet, locked

drawer, or secure kiosk;

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(2) remove legend drugs and devices from the locked cabinet or locked drawer to provide

to patients and patients' designees; and

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(3) inventory legend drugs and devices as required under subdivision 7.

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(b) Before removing a legend drug or device from a locked cabinet or locked drawer to

provide to a patient or patient's designee or allowing a patient or patient's designee to access

a secure kiosk, a staff person must verify the identity of the patient or patient's designee by

examining a valid state driver's license, valid state identification card, Tribal identification

card, or other government-issued identification card. Following verification of identity, the

patient or patient's designee must sign a paper or electronic log maintained at the remote

pickup site to verify receipt of the legend drug or device. When not being used to provide

a legend drug or device, the log must be maintained in a secure location.

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(c) A secure kiosk must require a patient or patient's designee to use a unique identifier

to access the patient's legend drug or device held in the kiosk. The secure kiosk must maintain

a record of the date and time the patient or the patient's designee removes a legend drug or

device from the kiosk.

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Subd. 6.

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Patient counseling.

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The pharmacist in charge for a remote pickup site must

establish a process:

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(1) to offer patient counseling, through electronic or written means or over the telephone,

to a patient or patient's designee picking up a legend drug or device at the remote pickup

site; and

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(2) to communicate to a patient or a patient's designee the steps to take to obtain a

replacement if the integrity of the legend drug or device is compromised before the patient

obtains the legend drug or device at the remote pickup site.

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Subd. 7.

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Records; compliance.

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(a) The pharmacist in charge of a remote pickup site

must maintain a record of all legend drugs and devices delivered to the remote pickup site.

At least once every seven days, a staff person at the remote pickup site who has been

designated by the pharmacist in charge and completed training as required by the board

must inventory the legend drugs and devices at the remote pickup site and must provide the

pharmacist in charge with a list of legend drugs and devices at the remote pickup site. The

remote pickup site must have a policy for the return to the managing pharmacy or disposal

of legend drugs and devices that are not picked up.

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(b) The pharmacist in charge must maintain a list of staff at the remote pickup site who

have received training and have access to legend drugs and devices at the remote pickup

site. The pharmacist in charge or a designee must:

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(1) at least annually, review with staff at a remote pickup site authorized to access

medications the remote pickup site's policies, procedures, and security requirements;

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(2) maintain documentation of this review; and

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(3) visit the remote pickup site at least every 30 days to ensure the remote pickup site

is operating in compliance with the site's policies, procedures, and security requirements.

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Subd. 8.

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Rulemaking.

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The board may adopt rules to implement this section.

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