SF 751

as introduced - 92nd Legislature (2021 - 2022) Posted on 05/21/2021 02:33pm

A bill for an act
relating to health care; modifying the prescription drug repository program;
amending Minnesota Statutes 2020, section 151.555, subdivisions 1, 7, 11, by
adding a subdivision.

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

Section 1.

Minnesota Statutes 2020, 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) a health care facility as defined in this subdivision;

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

(3) an assisted living facility registered under chapter 144D where there is centralized
storage of drugs and 24-hour on-site licensed nursing coverage provided seven days a week;

(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 new text begin ; or any over-the-counter
medication that meets the criteria established under this section for donation new text end . 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 and nonprescription medical
supplies needed to administer a prescription 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.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 2.

Minnesota Statutes 2020, section 151.555, subdivision 7, is amended to read:

Subd. 7.

Standards and procedures for inspecting and storing donated prescription
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
prescription 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. deleted text begin If
donated drugs or supplies are not inspected immediately upon receipt, a repository must
quarantine the donated drugs or supplies separately from all dispensing stock until the
donated drugs or supplies have been inspected and (1) approved for dispensing under the
program; (2) disposed of pursuant to paragraph (c); or (3) returned to the donor pursuant to
paragraph (d).
deleted text end

(c) The central repository and local repositories shall dispose of all prescription 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 prescription 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 deleted text begin five deleted text end new text begin two new text end 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 EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 3.

Minnesota Statutes 2020, 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 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) drug repository donor form described under subdivision 6;

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

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

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

(c) Data collected by the drug 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.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end

Sec. 4.

Minnesota Statutes 2020, section 151.555, is amended by adding a subdivision to
read:

new text begin Subd. 14. new text end

new text begin Cooperation. new text end

new text begin 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 end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective the day following final enactment.
new text end