1.1 	A bill for an act
1.2 	relating to health care; modifying the prescription drug repository program;
1.3 	amending Minnesota Statutes 2020, section 151.555, subdivisions 1, 7, 11, by 
1.4 	adding a subdivision.
1.5 	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

1.6 	Section 1. Minnesota Statutes 2020, section 151.555, subdivision 1, is amended to read:
1.7 		Subdivision 1.Definitions. (a) For the purposes of this section, the terms defined in this 
1.8 	subdivision have the meanings given.
1.9 	(b) "Central repository" means a wholesale distributor that meets the requirements under 
1.10 	subdivision 3 and enters into a contract with the Board of Pharmacy in accordance with this 
1.11 	section.
1.12 	(c) "Distribute" means to deliver, other than by administering or dispensing.
1.13 	(d) "Donor" means:
1.14 	(1) a health care facility as defined in this subdivision;
1.15 	(2) a skilled nursing facility licensed under chapter 144A;
1.16 	(3) an assisted living facility registered under chapter 144D where there is centralized 
1.17 	storage of drugs and 24-hour on-site licensed nursing coverage provided seven days a week;
1.18 	(4) a pharmacy licensed under section 151.19, and located either in the state or outside 
1.19 	the state;
1.20 	(5) a drug wholesaler licensed under section 151.47;
1.21 	(6) a drug manufacturer licensed under section 151.252; or
2.1 	(7) an individual at least 18 years of age, provided that the drug or medical supply that 
2.2 	is donated was obtained legally and meets the requirements of this section for donation.
2.3 	(e) "Drug" means any prescription drug that has been approved for medical use in the 
2.4 	United States, is listed in the United States Pharmacopoeia or National Formulary, and 
2.5 	meets the criteria established under this section for donation; or any over-the-counter 
2.6 	medication that meets the criteria established under this section for donation. This definition 
2.7 	includes cancer drugs and antirejection drugs, but does not include controlled substances, 
2.8 	as defined in section 152.01, subdivision 4, or a prescription drug that can only be dispensed 
2.9 	to a patient registered with the drug's manufacturer in accordance with federal Food and 
2.10 	Drug Administration requirements.
2.11 	(f) "Health care facility" means:
2.12 	(1) a physician's office or health care clinic where licensed practitioners provide health 
2.13 	care to patients;
2.14 	(2) a hospital licensed under section 144.50;
2.15 	(3) a pharmacy licensed under section 151.19 and located in Minnesota; or
2.16 	(4) a nonprofit community clinic, including a federally qualified health center; a rural 
2.17 	health clinic; public health clinic; or other community clinic that provides health care utilizing 
2.18 	a sliding fee scale to patients who are low-income, uninsured, or underinsured.
2.19 	(g) "Local repository" means a health care facility that elects to accept donated drugs 
2.20 	and medical supplies and meets the requirements of subdivision 4.
2.21 	(h) "Medical supplies" or "supplies" means any prescription and nonprescription medical 
2.22 	supplies needed to administer a prescription drug.
2.23 	(i) "Original, sealed, unopened, tamper-evident packaging" means packaging that is 
2.24 	sealed, unopened, and tamper-evident, including a manufacturer's original unit dose or 
2.25 	unit-of-use container, a repackager's original unit dose or unit-of-use container, or unit-dose 
2.26 	packaging prepared by a licensed pharmacy according to the standards of Minnesota Rules, 
2.27 	part 6800.3750.
2.28 	(j) "Practitioner" has the meaning given in section 151.01, subdivision 23, except that 
2.29 	it does not include a veterinarian.

2.30 	EFFECTIVE DATE. This section is effective the day following final enactment.

3.1 	Sec. 2. Minnesota Statutes 2020, section 151.555, subdivision 7, is amended to read:
3.2 		Subd. 7.Standards and procedures for inspecting and storing donated prescription 
3.3 	drugs and supplies. (a) A pharmacist or authorized practitioner who is employed by or 
3.4 	under contract with the central repository or a local repository shall inspect all donated 
3.5 	prescription drugs and supplies before the drug or supply is dispensed to determine, to the 
3.6 	extent reasonably possible in the professional judgment of the pharmacist or practitioner, 
3.7 	that the drug or supply is not adulterated or misbranded, has not been tampered with, is safe 
3.8 	and suitable for dispensing, has not been subject to a recall, and meets the requirements for 
3.9 	donation. The pharmacist or practitioner who inspects the drugs or supplies shall sign an 
3.10 	inspection record stating that the requirements for donation have been met. If a local 
3.11 	repository receives drugs and supplies from the central repository, the local repository does 
3.12 	not need to reinspect the drugs and supplies.
3.13 	(b) The central repository and local repositories shall store donated drugs and supplies 
3.14 	in a secure storage area under environmental conditions appropriate for the drug or supply 
3.15 	being stored. Donated drugs and supplies may not be stored with nondonated inventory. ~~If~~ 
3.16 	~~donated drugs or supplies are not inspected immediately upon receipt, a repository must~~ 
3.17 	~~quarantine the donated drugs or supplies separately from all dispensing stock until the~~ 
3.18 	~~donated drugs or supplies have been inspected and (1) approved for dispensing under the~~ 
3.19 	~~program; (2) disposed of pursuant to paragraph (c); or (3) returned to the donor pursuant to~~ 
3.20 	~~paragraph (d).~~
3.21 	(c) The central repository and local repositories shall dispose of all prescription drugs 
3.22 	and medical supplies that are not suitable for donation in compliance with applicable federal 
3.23 	and state statutes, regulations, and rules concerning hazardous waste.
3.24 	(d) In the event that controlled substances or prescription drugs that can only be dispensed 
3.25 	to a patient registered with the drug's manufacturer are shipped or delivered to a central or 
3.26 	local repository for donation, the shipment delivery must be documented by the repository 
3.27 	and returned immediately to the donor or the donor's representative that provided the drugs.
3.28 	(e) Each repository must develop drug and medical supply recall policies and procedures. 
3.29 	If a repository receives a recall notification, the repository shall destroy all of the drug or 
3.30 	medical supply in its inventory that is the subject of the recall and complete a record of 
3.31 	destruction form in accordance with paragraph (f). If a drug or medical supply that is the 
3.32 	subject of a Class I or Class II recall has been dispensed, the repository shall immediately 
3.33 	notify the recipient of the recalled drug or medical supply. A drug that potentially is subject 
4.1 	to a recall need not be destroyed if its packaging bears a lot number and that lot of the drug 
4.2 	is not subject to the recall. If no lot number is on the drug's packaging, it must be destroyed.
4.3 	(f) A record of destruction of donated drugs and supplies that are not dispensed under 
4.4 	subdivision 8, are subject to a recall under paragraph (e), or are not suitable for donation 
4.5 	shall be maintained by the repository for at least ~~five~~ two years. For each drug or supply 
4.6 	destroyed, the record shall include the following information:
4.7 	(1) the date of destruction;
4.8 	(2) the name, strength, and quantity of the drug destroyed; and
4.9 	(3) the name of the person or firm that destroyed the drug.

4.10 	EFFECTIVE DATE. This section is effective the day following final enactment.

4.11 	Sec. 3. Minnesota Statutes 2020, section 151.555, subdivision 11, is amended to read:
4.12 		Subd. 11.Forms and record-keeping requirements. (a) The following forms developed 
4.13 	for the administration of this program shall be utilized by the participants of the program 
4.14 	and shall be available on the board's website:
4.15 	(1) intake application form described under subdivision 5;
4.16 	(2) local repository participation form described under subdivision 4;
4.17 	(3) local repository withdrawal form described under subdivision 4;
4.18 	(4) drug repository donor form described under subdivision 6;
4.19 	(5) record of destruction form described under subdivision 7; and
4.20 	(6) drug repository recipient form described under subdivision 8.
4.21 	(b) All records, including drug inventory, inspection, and disposal of donated prescription 
4.22 	drugs and medical supplies, must be maintained by a repository for a minimum of ~~five~~ two
4.23 	years. Records required as part of this program must be maintained pursuant to all applicable 
4.24 	practice acts.
4.25 	(c) Data collected by the drug repository program from all local repositories shall be 
4.26 	submitted quarterly or upon request to the central repository. Data collected may consist of 
4.27 	the information, records, and forms required to be collected under this section.
4.28 	(d) The central repository shall submit reports to the board as required by the contract 
4.29 	or upon request of the board.

4.30 	EFFECTIVE DATE. This section is effective the day following final enactment.

5.1 	Sec. 4. Minnesota Statutes 2020, section 151.555, is amended by adding a subdivision to 
5.2 	read:
5.3 		Subd. 14.Cooperation. The central repository, as approved by the Board of Pharmacy, 
5.4 	may enter into an agreement with another state that has an established drug repository or 
5.5 	drug donation program if the other state's program includes regulations to ensure the purity, 
5.6 	integrity, and safety of the drugs and supplies donated, to permit the central repository to 
5.7 	offer to another state program inventory that is not needed by a Minnesota resident and to 
5.8 	accept inventory from another state program to be distributed to local repositories and 
5.9 	dispensed to Minnesota residents in accordance with this program.

5.10 	EFFECTIVE DATE. This section is effective the day following final enactment.