HF 3924

as introduced - 92nd Legislature (2021 - 2022) Posted on 04/07/2022 01:07pm

A bill for an act
relating to health; requiring the Board of Pharmacy to provide the central repository
under contract to administer the medication repository program with any legislative
funding provided for the purpose; making conforming changes related to donations
of over-the-counter medications; appropriating money; amending Minnesota
Statutes 2020, section 151.555, as amended.

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

Section 1.

Minnesota Statutes 2020, section 151.555, as amended by Laws 2021, chapter
30, article 5, sections 2 to 5, is amended to read:

151.555 deleted text begin PRESCRIPTION DRUG deleted text end new text begin MEDICATION new text end REPOSITORY PROGRAM.

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) a health care facility as defined in this subdivision;

(2) a skilled nursing facility licensed under chapter 144A;

(3) an assisted living facility licensed under chapter 144G;

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

(5) a drug wholesaler licensed under section 151.47;

(6) a drug manufacturer licensed under section 151.252; or

(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.

(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 deleted text begin and deleted text end new text begin or new text end nonprescription
medical supplies needed to administer a deleted text begin prescription deleted text end 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.

Subd. 2.

Establishment new text begin ; contract and oversight new text end .

new text begin (a) new text end By January 1, 2020, the Board of
Pharmacy shall establish a deleted text begin drug deleted text end new text begin medication new text end repository program, through which donors may
donate a drug or medical supply for use by an individual who meets the eligibility criteria
specified under subdivision 5.

new text begin (b) new text end The board shall contract with a central repository that meets the requirements of
subdivision 3 to implement and administer the deleted text begin prescription drug deleted text end new text begin medication new text end repository
program. new text begin The contract must:
new text end

new text begin (1) require the board to transfer to the central repository any money appropriated by the
legislature for the purpose of operating the medication repository program and require the
central repository to spend any money transferred only for purposes specified in the contract;
new text end

new text begin (2) require the central repository to report the following performance measures to the
board:
new text end

new text begin (i) the number of individuals served and the types of medications these individuals
received;
new text end

new text begin (ii) the number of clinics, pharmacies, and long-term care facilities with which the central
repository partnered;
new text end

new text begin (iii) the number and cost of medications accepted for inventory, disposed of, and
dispensed to individuals in need; and
new text end

new text begin (iv) locations within the state to which medications are shipped or delivered; and
new text end

new text begin (3) require the board to annually audit the expenditure by the central repository of any
funds appropriated by the legislature and transferred by the board to ensure that this funding
is used only for purposes specified in the contract.
new text end

Subd. 3.

Central repository requirements.

(a) The board may publish a request for
proposal for participants who meet the requirements of this subdivision and are interested
in acting as the central repository for the deleted text begin drug deleted text end new text begin medication new text end repository program. If the board
publishes a request for proposal, it shall follow all applicable state procurement procedures
in the selection process. The board may also work directly with the University of Minnesota
to establish a central repository.

(b) To be eligible to act as the central repository, the participant must be a wholesale
drug distributor located in Minnesota, licensed pursuant to section 151.47, and in compliance
with all applicable federal and state statutes, rules, and regulations.

(c) The central repository shall be subject to inspection by the board pursuant to section
151.06, subdivision 1.

(d) The central repository shall comply with all applicable federal and state laws, rules,
and regulations pertaining to the deleted text begin drug deleted text end new text begin medication new text end repository program, drug storage, and
dispensing. The facility must maintain in good standing any state license or registration that
applies to the facility.

Subd. 4.

Local repository requirements.

(a) To be eligible for participation in the deleted text begin drug deleted text end new text begin
medication new text end repository program, a health care facility must agree to comply with all applicable
federal and state laws, rules, and regulations pertaining to the deleted text begin drug deleted text end new text begin medication new text end 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 deleted text begin drug deleted text end new text begin medication new text end repository program is voluntary. A local
repository may withdraw from participation in the deleted text begin drug deleted text end new text begin medication new text end 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. 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.

Subd. 5.

Individual eligibility and application requirements.

(a) To be eligible for
the deleted text begin drug deleted text end new text begin medication new text end repository program, an individual must submit to a local repository an
intake application form that is signed by the individual and attests that the individual:

(1) is a resident of Minnesota;

(2) is uninsured and is not enrolled in the medical assistance program under chapter
256B or the MinnesotaCare program under chapter 256L, 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.

(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.

(c) The local repository shall send a copy of the intake application form to the central
repository by regular mail, facsimile, or secured e-mail within ten days from the date the
application is approved by the local repository.

(d) The board shall develop and make available on the board's website an application
form and the format for the identification card.

Subd. 6.

Standards and procedures for accepting donations of drugs and supplies.

(a)
A donor may donate deleted text begin prescription deleted text end 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 deleted text begin prescription deleted text end drug is eligible for donation under the deleted text begin drug deleted text end new text begin medication new text end repository
program if the following requirements are met:

(1) the donation is accompanied by a deleted text begin drug deleted text end new text begin medication new text end 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);

(2) 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;

(3) 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;

(4) the drug or the packaging does not have any physical signs of tampering, misbranding,
deterioration, compromised integrity, or adulteration;

(5) 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

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

(c) A medical supply is eligible for donation under the deleted text begin drug deleted text end new text begin medication new text end 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;

(3) the donation is accompanied by a deleted text begin drug deleted text end new text begin medication new text end 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

(4) 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 deleted text begin drug deleted text end new text begin medication new text end repository donor form and make it
available on the board's website. 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.

(e) 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 to accept donations. A drop box must not be used to deliver
or accept donations.

(f) The central repository and local repository shall inventory all drugs and supplies
donated to the repository. 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.

Subd. 7.

Standards and procedures for inspecting and storing donated deleted text begin prescription deleted text end
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
deleted text begin prescription deleted text end 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. The pharmacist or practitioner who inspects the drugs or supplies shall sign an
inspection record stating that the requirements for donation have been met. 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 deleted text begin prescription deleted text end 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 deleted text begin prescription deleted text end 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.

Subd. 8.

Dispensing requirements.

(a) Donated 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 deleted text begin prescription deleted text end drugs in compliance with applicable federal
and state laws and regulations for dispensing deleted text begin prescription deleted text end 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 a drug or supply is dispensed or administered to an individual, the individual
must sign a drug repository recipient form acknowledging that the individual understands
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:

(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 deleted text begin drug deleted text end new text begin medication new text end 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.

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 drug
repository program shall not receive reimbursement under the medical assistance program
or the MinnesotaCare program for that dispensed or administered drug or supply.

Subd. 10.

Distribution of donated drugs and supplies.

(a) The central repository and
local repositories may distribute drugs and supplies donated under the drug repository
program to other participating repositories for use pursuant to this program.

(b) A local repository that elects not to dispense donated drugs or supplies must transfer
all donated drugs and supplies to the central repository. A copy of the donor form that was
completed by the original donor under subdivision 6 must be provided to the central
repository at the time of transfer.

Subd. 11.

Forms and record-keeping requirements.

(a) The following forms developed
for the administration of this program shall be utilized by the participants of the program
and 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) deleted text begin drug deleted text end new text begin medication new text end repository donor form described under subdivision 6;

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

(6) deleted text begin drug deleted text end new text begin medication new text end repository recipient form described under subdivision 8.

(b) All records, including drug inventory, inspection, and disposal of donated deleted text begin prescription deleted text end
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 deleted text begin drug deleted text end new text begin medication new text end 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.

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, or a donor of a drug or medical supply 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 pharmacist or practitioner 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.

Subd. 13.

Drug returned for credit.

Nothing in this section allows a long-term care
facility to donate a drug to a central or local repository when federal or state law requires
the drug to be returned to the pharmacy that initially dispensed it, so that the pharmacy can
credit the payer for the amount of the drug returned.

Subd. 14.

Cooperation.

The central repository, as approved by the Board of Pharmacy,
may enter into an agreement with another state that has an established drug repository or
drug donation program if the other state's program includes regulations to ensure the purity,
integrity, and safety of the drugs and supplies donated, to permit the central repository to
offer to another state program inventory that is not needed by a Minnesota resident and to
accept inventory from another state program to be distributed to local repositories and
dispensed to Minnesota residents in accordance with this program.

new text begin Subd. 15. new text end

new text begin Funding. new text end

new text begin The central repository may seek grants and other funds from nonprofit
charitable organizations, the federal government, and other sources to fund the ongoing
operations of the medication repository program.
new text end

Sec. 2. new text begin APPROPRIATION.
new text end

new text begin $....... in fiscal year 2023 is appropriated from the general fund to the Board of Pharmacy
for transfer to the central repository to be used to administer the medication repository
program as required under the terms of the contract between the central repository and the
Board of Pharmacy. Base funding for this activity is $....... in fiscal year 2024 and $....... in
fiscal year 2025.
new text end