SF 4584

as introduced - 93rd Legislature (2023 - 2024) Posted on 03/15/2024 09:23am

A bill for an act
relating to health; modifying requirements for the medication repository program;
amending Minnesota Statutes 2023 Supplement, section 151.555, subdivisions 1,
4, 5, 6, 7, 8, 9, 11, 12.

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

Section 1.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 1, is amended
to read:

Subdivision 1.

Definitions.

(a) For the purposes of this section, the terms defined in this
subdivision have the meanings given.

(b) "Central repository" means a wholesale distributor that meets the requirements under
subdivision 3 and enters into a contract with the Board of Pharmacy in accordance with this
section.

(c) "Distribute" means to deliver, other than by administering or dispensing.

(d) "Donor" means:

(1) deleted text begin a health care facility as defined in this subdivision deleted text end new text begin an individual at least 18 years of
age, provided that the drug or medical supply that is donated was obtained legally and meets
the requirements of this section for donation new text end ; new text begin or
new text end

(2) deleted text begin a skilled nursing facility licensed under chapter deleted text end deleted text begin 144A deleted text end deleted text begin ; deleted text end new text begin any entity legally authorized
to possess medicine with a license or permit in good standing in the state in which it is
located, without further restrictions, including but not limited to a health care facility, skilled
nursing facility, assisted living facility, pharmacy, wholesaler, and drug manufacturer.
new text end

deleted text begin (3) an assisted living facility licensed under chapter deleted text end deleted text begin 144G deleted text end deleted text begin ;
deleted text end

deleted text begin (4) a pharmacy licensed under section 151.19, and located either in the state or outside
the state;
deleted text end

deleted text begin (5) a drug wholesaler licensed under section 151.47;
deleted text end

deleted text begin (6) a drug manufacturer licensed under section 151.252; or
deleted text end

deleted text begin (7) an individual at least 18 years of age, provided that the drug or medical supply that
is donated was obtained legally and meets the requirements of this section for donation.
deleted text end

(e) "Drug" means any prescription drug that has been approved for medical use in the
United States, is listed in the United States Pharmacopoeia or National Formulary, and
meets the criteria established under this section for donation; or any over-the-counter
medication that meets the criteria established under this section for donation. This definition
includes cancer drugs and antirejection drugs, but does not include controlled substances,
as defined in section 152.01, subdivision 4, or a prescription drug that can only be dispensed
to a patient registered with the drug's manufacturer in accordance with federal Food and
Drug Administration requirements.

(f) "Health care facility" means:

(1) a physician's office or health care clinic where licensed practitioners provide health
care to patients;

(2) a hospital licensed under section 144.50;

(3) a pharmacy licensed under section 151.19 and located in Minnesota; or

(4) a nonprofit community clinic, including a federally qualified health center; a rural
health clinic; public health clinic; or other community clinic that provides health care utilizing
a sliding fee scale to patients who are low-income, uninsured, or underinsured.

(g) "Local repository" means a health care facility that elects to accept donated drugs
and medical supplies and meets the requirements of subdivision 4.

(h) "Medical supplies" or "supplies" means any prescription or nonprescription medical
supplies needed to administer a drug.

(i) "Original, sealed, unopened, tamper-evident packaging" means packaging that is
sealed, unopened, and tamper-evident, including a manufacturer's original unit dose or
unit-of-use container, a repackager's original unit dose or unit-of-use container, or unit-dose
packaging prepared by a licensed pharmacy according to the standards of Minnesota Rules,
part 6800.3750.

(j) "Practitioner" has the meaning given in section 151.01, subdivision 23, except that
it does not include a veterinarian.

Sec. 2.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 4, is amended
to read:

Subd. 4.

Local repository requirements.

(a) To be eligible for participation in the
medication repository program, a health care facility must agree to comply with all applicable
federal and state laws, rules, and regulations pertaining to the medication repository program,
drug storage, and dispensing. The facility must also agree to maintain in good standing any
required state license or registration that may apply to the facility.

(b) A local repository may elect to participate in the program by submitting the following
information to the central repository on a form developed by the board and made available
on the board's website:

(1) the name, street address, and telephone number of the health care facility and any
state-issued license or registration number issued to the facility, including the issuing state
agency;

(2) the name and telephone number of a responsible pharmacist or practitioner who is
employed by or under contract with the health care facility; and

(3) a statement signed and dated by the responsible pharmacist or practitioner indicating
that the health care facility meets the eligibility requirements under this section and agrees
to comply with this section.

(c) Participation in the medication repository program is voluntary. A local repository
may withdraw from participation in the medication repository program at any time by
providing written notice to the central repository on a form developed by the board and
made available on the board's website. deleted text begin The central repository shall provide the board with
a copy of the withdrawal notice within ten business days from the date of receipt of the
withdrawal notice.
deleted text end

Sec. 3.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 5, is amended
to read:

Subd. 5.

Individual eligibility and application requirements.

(a) deleted text begin To be eligible for
the medication repository program deleted text end new text begin At the time of or before receiving donated drugs or
supplies as a new eligible patient new text end , an individual must submit to a local repository an new text begin electronic
or physical new text end intake application form that is signed by the individual and attests that the
individual:

(1) is a resident of Minnesota;

(2) is uninsured deleted text begin and is not enrolled in the medical assistance program under chapter
deleted text end deleted text begin 256B deleted text end deleted text begin or the MinnesotaCare program under chapter deleted text end deleted text begin 256L deleted text end , has no prescription drug coverage,
or is underinsured;

(3) acknowledges that the drugs or medical supplies to be received through the program
may have been donated; and

(4) consents to a waiver of the child-resistant packaging requirements of the federal
Poison Prevention Packaging Act.

deleted text begin (b) Upon determining that an individual is eligible for the program, the local repository
shall furnish the individual with an identification card. The card shall be valid for one year
from the date of issuance and may be used at any local repository. A new identification card
may be issued upon expiration once the individual submits a new application form.
deleted text end

deleted text begin (c) deleted text end new text begin (b) new text end The local repository shall send a copy of the intake application form to the central
repository by regular mail, facsimile, or secured email within ten days from the date the
application is approved by the local repository.

deleted text begin (d) deleted text end new text begin (c) new text end The board shall develop and make available on the board's website an application
form deleted text begin and the format for the identification card deleted text end .

Sec. 4.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 6, is amended
to read:

Subd. 6.

Standards and procedures for accepting donations of drugs and supplies.

(a)
new text begin Notwithstanding any other law or rule, new text end a donor may donate drugs or medical supplies to
the central repository or a local repository if the drug or supply meets the requirements of
this section as determined by a pharmacist or practitioner who is employed by or under
contract with the central repository or a local repository.

(b) A drug is eligible for donation under the medication repository program if the
following requirements are met:

deleted text begin (1) the donation is accompanied by a medication repository donor form described under
paragraph (d) that is signed by an individual who is authorized by the donor to attest to the
donor's knowledge in accordance with paragraph (d);
deleted text end

deleted text begin (2) deleted text end new text begin (1) new text end the drug's expiration date is at least six months after the date the drug was donated.
If a donated drug bears an expiration date that is less than six months from the donation
date, the drug may be accepted and distributed if the drug is in high demand and can be
dispensed for use by a patient before the drug's expiration date;

deleted text begin (3) deleted text end new text begin (2) new text end the drug is in its original, sealed, unopened, tamper-evident packaging that includes
the expiration date. Single-unit-dose drugs may be accepted if the single-unit-dose packaging
is unopened;

deleted text begin (4) deleted text end new text begin (3) new text end the drug or the packaging does not have any physical signs of tampering,
misbranding, deterioration, compromised integrity, or adulteration;

deleted text begin (5) deleted text end new text begin (4) new text end the drug does not require storage temperatures other than normal room temperature
as specified by the manufacturer or United States Pharmacopoeia, unless the drug is being
donated directly by its manufacturer, a wholesale drug distributor, or a pharmacy located
in Minnesota; and

deleted text begin (6) deleted text end new text begin (5) new text end the drug is not a controlled substance.

(c) A medical supply is eligible for donation under the medication repository program
if the following requirements are met:

(1) the supply has no physical signs of tampering, misbranding, or alteration and there
is no reason to believe it has been adulterated, tampered with, or misbranded;

(2) the supply is in its original, unopened, sealed packaging; new text begin and
new text end

deleted text begin (3) the donation is accompanied by a medication repository donor form described under
paragraph (d) that is signed by an individual who is authorized by the donor to attest to the
donor's knowledge in accordance with paragraph (d); and
deleted text end

deleted text begin (4) deleted text end new text begin (3) new text end if the supply bears an expiration date, the date is at least six months later than
the date the supply was donated. If the donated supply bears an expiration date that is less
than six months from the date the supply was donated, the supply may be accepted and
distributed if the supply is in high demand and can be dispensed for use by a patient before
the supply's expiration date.

(d) The board shall develop the medication repository donor form and make it available
on the board's website. deleted text begin The form must state that to the best of the donor's knowledge the
donated drug or supply has been properly stored under appropriate temperature and humidity
conditions and that the drug or supply has never been opened, used, tampered with,
adulterated, or misbranded. deleted text end new text begin Prior to the first donation from a new donor, a central repository
or local repository shall verify and record the following information on the donor form:
new text end

new text begin (1) the donor's name, address, phone number, and license number, if applicable;
new text end

new text begin (2) that the donor will only make donations in accordance with the program;
new text end

new text begin (3) to the best of the donor's knowledge, only drugs or supplies that have been properly
stored under appropriate temperature and humidity conditions will be donated; and
new text end

new text begin (4) to the best of the donor's knowledge, only drugs or supplies that have never been
opened, used, tampered with, adulterated, or misbranded will be donated.
new text end

(e) new text begin Notwithstanding any other law or rule, a central repository or a local repository may
receive donated drugs from donors. new text end Donated drugs and supplies may be shipped or delivered
to the premises of the central repository or a local repository, and shall be inspected by a
pharmacist or an authorized practitioner who is employed by or under contract with the
repository and who has been designated by the repository deleted text begin to accept donations deleted text end new text begin prior to
dispensing new text end . A drop box must not be used to deliver or accept donations.

(f) The central repository and local repository shall new text begin maintain a written or electronic
new text end inventory new text begin of new text end all drugs and supplies donated to the repository new text begin upon acceptance of each drug
or supply new text end . For each drug, the inventory must include the drug's name, strength, quantity,
manufacturer, expiration date, and the date the drug was donated. For each medical supply,
the inventory must include a description of the supply, its manufacturer, the date the supply
was donated, and, if applicable, the supply's brand name and expiration date. new text begin The board
may waive the requirement under this paragraph if an entity is under common ownership
or control with a central repository or local repository and either the entity or the repository
maintains an inventory containing all the information required under this paragraph.
new text end

Sec. 5.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 7, is amended
to read:

Subd. 7.

Standards and procedures for inspecting and storing donated drugs and
supplies.

(a) A pharmacist or authorized practitioner who is employed by or under contract
with the central repository or a local repository shall inspect all donated drugs and supplies
before the drug or supply is dispensed to determine, to the extent reasonably possible in the
professional judgment of the pharmacist or practitioner, that the drug or supply is not
adulterated or misbranded, has not been tampered with, is safe and suitable for dispensing,
has not been subject to a recall, and meets the requirements for donation. deleted text begin The pharmacist
or practitioner who inspects the drugs or supplies shall sign an inspection record stating that
the requirements for donation have been met. deleted text end If a local repository receives drugs and supplies
from the central repository, the local repository does not need to reinspect the drugs and
supplies.

(b) The central repository and local repositories shall store donated drugs and supplies
in a secure storage area under environmental conditions appropriate for the drug or supply
being stored. Donated drugs and supplies may not be stored with nondonated inventory.

(c) The central repository and local repositories shall dispose of all drugs and medical
supplies that are not suitable for donation in compliance with applicable federal and state
statutes, regulations, and rules concerning hazardous waste.

(d) In the event that controlled substances or drugs that can only be dispensed to a patient
registered with the drug's manufacturer are shipped or delivered to a central or local repository
for donation, the shipment delivery must be documented by the repository and returned
immediately to the donor or the donor's representative that provided the drugs.

(e) Each repository must develop drug and medical supply recall policies and procedures.
If a repository receives a recall notification, the repository shall destroy all of the drug or
medical supply in its inventory that is the subject of the recall and complete a record of
destruction form in accordance with paragraph (f). If a drug or medical supply that is the
subject of a Class I or Class II recall has been dispensed, the repository shall immediately
notify the recipient of the recalled drug or medical supply. A drug that potentially is subject
to a recall need not be destroyed if its packaging bears a lot number and that lot of the drug
is not subject to the recall. If no lot number is on the drug's packaging, it must be destroyed.

(f) A record of destruction of donated drugs and supplies that are not dispensed under
subdivision 8, are subject to a recall under paragraph (e), or are not suitable for donation
shall be maintained by the repository for at least two years. For each drug or supply destroyed,
the record shall include the following information:

(1) the date of destruction;

(2) the name, strength, and quantity of the drug destroyed; and

(3) the name of the person or firm that destroyed the drug.

new text begin No other record of destruction is required.
new text end

Sec. 6.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 8, is amended
to read:

Subd. 8.

Dispensing requirements.

(a) Donated new text begin prescription new text end drugs and supplies may
be dispensed if the drugs or supplies are prescribed by a practitioner for use by an eligible
individual and are dispensed by a pharmacist or practitioner. A repository shall dispense
drugs and supplies to eligible individuals in the following priority order: (1) individuals
who are uninsured; (2) individuals with no prescription drug coverage; and (3) individuals
who are underinsured. A repository shall dispense donated drugs in compliance with
applicable federal and state laws and regulations for dispensing drugs, including all
requirements relating to packaging, labeling, record keeping, drug utilization review, and
patient counseling.

(b) Before dispensing or administering a drug or supply, the pharmacist or practitioner
shall visually inspect the drug or supply for adulteration, misbranding, tampering, and date
of expiration. Drugs or supplies that have expired or appear upon visual inspection to be
adulterated, misbranded, or tampered with in any way must not be dispensed or administered.

(c) Before deleted text begin a deleted text end new text begin the first new text end drug or supply is dispensed or administered to an individual, the
individual must sign deleted text begin a deleted text end new text begin an electronic or physical new text end drug repository recipient form acknowledging
that the individual understands deleted text begin the information stated on the form. The board shall develop
the form and make it available on the board's website. The form must include the following
information deleted text end :

(1) that the drug or supply being dispensed or administered has been donated and may
have been previously dispensed;

(2) that a visual inspection has been conducted by the pharmacist or practitioner to ensure
that the drug or supply has not expired, has not been adulterated or misbranded, and is in
its original, unopened packaging; and

(3) that the dispensing pharmacist, the dispensing or administering practitioner, the
central repository or local repository, the Board of Pharmacy, and any other participant of
the medication repository program cannot guarantee the safety of the drug or medical supply
being dispensed or administered and that the pharmacist or practitioner has determined that
the drug or supply is safe to dispense or administer based on the accuracy of the donor's
form submitted with the donated drug or medical supply and the visual inspection required
to be performed by the pharmacist or practitioner before dispensing or administering.

Sec. 7.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 9, is amended
to read:

Subd. 9.

Handling fees.

(a) The central or local repository may charge the individual
receiving a drug or supply a handling fee of no more than 250 percent of the medical
assistance program dispensing fee for each drug or medical supply dispensed or administered
by that repository.

(b) A repository that dispenses or administers a drug or medical supply through the
medication repository program shall not receive reimbursement under the medical assistance
program or the MinnesotaCare program for that dispensed or administered drug or supply.

new text begin (c) A supply or handling fee must not be charged to an individual enrolled in the medical
assistance or MinnesotaCare program.
new text end

Sec. 8.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 11, is amended
to read:

Subd. 11.

Forms and record-keeping requirements.

(a) The following forms developed
for the administration of this program deleted text begin shall be utilized by the participants of the program
and deleted text end shall be available on the board's website:

(1) intake application form described under subdivision 5;

(2) local repository participation form described under subdivision 4;

(3) local repository withdrawal form described under subdivision 4;

(4) medication repository donor form described under subdivision 6;

(5) record of destruction form described under subdivision 7; and

(6) medication repository recipient form described under subdivision 8.

new text begin Participants may use substantively similar electronic or physical forms.
new text end

(b) All records, including drug inventory deleted text begin , inspection, deleted text end and disposal of donated drugs and
medical supplies, must be maintained by a repository for a minimum of two years. Records
required as part of this program must be maintained pursuant to all applicable practice acts.

(c) Data collected by the medication repository program from all local repositories shall
be submitted quarterly or upon request to the central repository. Data collected may consist
of the information, records, and forms required to be collected under this section.

(d) The central repository shall submit reports to the board as required by the contract
or upon request of the board.

Sec. 9.

Minnesota Statutes 2023 Supplement, section 151.555, subdivision 12, is amended
to read:

Subd. 12.

Liability.

(a) The manufacturer of a drug or supply is not subject to criminal
or civil liability for injury, death, or loss to a person or to property for causes of action
described in clauses (1) and (2). A manufacturer is not liable for:

(1) the intentional or unintentional alteration of the drug or supply by a party not under
the control of the manufacturer; or

(2) the failure of a party not under the control of the manufacturer to transfer or
communicate product or consumer information or the expiration date of the donated drug
or supply.

(b) A health care facility participating in the program, a pharmacist dispensing a drug
or supply pursuant to the program, a practitioner dispensing or administering a drug or
supply pursuant to the program, deleted text begin or deleted text end a donor of a drug or medical supply new text begin , or a person or entity
that facilitates any of the above new text end is immune from civil liability for an act or omission that
causes injury to or the death of an individual to whom the drug or supply is dispensed and
no disciplinary action by a health-related licensing board shall be taken against a deleted text begin pharmacist
or practitioner deleted text end new text begin person or entity new text end so long as the drug or supply is donated, accepted, distributed,
and dispensed according to the requirements of this section. This immunity does not apply
if the act or omission involves reckless, wanton, or intentional misconduct, or malpractice
unrelated to the quality of the drug or medical supply.