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Minnesota Legislature

Office of the Revisor of Statutes

SF 223

as introduced - 91st Legislature (2019 - 2020) Posted on 01/17/2019 02:21pm

KEY: stricken = removed, old language.
underscored = added, new language.

Current Version - as introduced

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A bill for an act
relating to health; establishing a prescription drug repository program;proposing
coding for new law in Minnesota Statutes, chapter 151.

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

Section 1.

new text begin [151.555] PRESCRIPTION DRUG REPOSITORY PROGRAM.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

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

new text begin (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.
new text end

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

new text begin (d) "Donor" means:
new text end

new text begin (1) a health care facility as defined in this subdivision;
new text end

new text begin (2) a skilled nursing facility licensed under chapter 144A;
new text end

new text begin (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;
new text end

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

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

new text begin (6) a drug manufacturer licensed under section 151.252.
new text end

new text begin (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. 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.
new text end

new text begin (f) "Health care facility" means:
new text end

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

new text begin (2) a hospital licensed under section 144.50;
new text end

new text begin (3) a pharmacy licensed under section 151.19 and located in Minnesota; or
new text end

new text begin (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.
new text end

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

new text begin (h) "Medical supplies" or "supplies" means any prescription and nonprescription medical
supply needed to administer a prescription drug.
new text end

new text begin (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.
new text end

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

new text begin Subd. 2. new text end

new text begin Establishment. new text end

new text begin By January 1, 2019, the Board of Pharmacy shall establish a
drug 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. The
board shall contract with a central repository that meets the requirements of subdivision 3
to implement and administer the prescription drug repository program.
new text end

new text begin Subd. 3. new text end

new text begin Central repository requirements. new text end

new text begin (a) The board shall 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 drug repository program. The board shall follow
all applicable state procurement procedures in the selection process.
new text end

new text begin (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.
new text end

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

new text begin Subd. 4. new text end

new text begin Local repository requirements. new text end

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

new text begin (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 Web site:
new text end

new text begin (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;
new text end

new text begin (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
new text end

new text begin (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.
new text end

new text begin (c) Participation in the drug repository program is voluntary. A local repository may
withdraw from participation in the drug 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 Web site. 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.
new text end

new text begin Subd. 5. new text end

new text begin Individual eligibility and application requirements. new text end

new text begin (a) To be eligible for
the drug 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:
new text end

new text begin (1) is a resident of Minnesota;
new text end

new text begin (2) is uninsured, has no prescription drug coverage, or is underinsured;
new text end

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

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

new 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.
new text end

new text begin (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.
new text end

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

new text begin Subd. 6. new text end

new text begin Standards and procedures for accepting donations of drugs and supplies. new text end

new text begin (a)
A donor may donate prescription 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.
new text end

new text begin (b) A prescription drug is eligible for donation under the drug repository program if the
following requirements are met:
new text end

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

new text begin (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;
new text end

new text begin (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;
new text end

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

new text begin (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
new text end

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

new text begin (c) A medical supply is eligible for donation under the drug repository program if the
following requirements are met:
new text end

new text begin (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;
new text end

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

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

new text begin (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.
new text end

new text begin (d) The board shall develop the drug repository donor form and make it available on the
board's Web site. The form must state that to the best of the donor's knowledge the donated
drug or supply has been properly stored and that the drug or supply has never been opened,
used, tampered with, adulterated, or misbranded.
new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin Subd. 7. new text end

new text begin Standards and procedures for inspecting and storing donated prescription
drugs and supplies.
new text end

new text begin (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, 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.
new text end

new text begin (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. 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).
new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin (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 five years. For each drug or supply
destroyed, the record shall include the following information:
new text end

new text begin (1) the date of destruction;
new text end

new text begin (2) the name, strength, and quantity of the drug destroyed; and
new text end

new text begin (3) the name of the person or firm that destroyed the drug.
new text end

new text begin Subd. 8. new text end

new text begin Dispensing requirements. new text end

new text begin (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 prescription drugs in compliance with applicable federal
and state laws and regulations for dispensing prescription drugs, including all requirements
relating to packaging, labeling, record keeping, drug utilization review, and patient
counseling.
new text end

new text begin (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.
new text end

new text begin (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 Web site. The form must include the following information:
new text end

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

new text begin (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
new text end

new text begin (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 drug 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.
new text end

new text begin Subd. 9. new text end

new text begin Handling fees. new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin Subd. 10. new text end

new text begin Distribution of donated drugs and supplies. new text end

new text begin (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.
new text end

new text begin (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.
new text end

new text begin Subd. 11. new text end

new text begin Forms and record-keeping requirements. new text end

new text begin (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 Web site:
new text end

new text begin (1) intake application form described under subdivision 5;
new text end

new text begin (2) local repository participation form described under subdivision 4;
new text end

new text begin (3) local repository withdrawal form described under subdivision 4;
new text end

new text begin (4) drug repository donor form described under subdivision 6;
new text end

new text begin (5) record of destruction form described under subdivision 7; and
new text end

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

new text begin (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 five years.
Records required as part of this program must be maintained pursuant to all applicable
practice acts.
new text end

new text begin (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.
new text end

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

new text begin Subd. 12. new text end

new text begin Liability. new text end

new text begin (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:
new text end

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

new text begin (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.
new text end

new text begin (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.
new text end