Medication repository program procedures modifications

A bill for an act

relating to health; modifying medication repository program procedures; amending

Minnesota Statutes 2024, section 151.555, subdivision 7.

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

Section 1.

Minnesota Statutes 2024, 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. 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
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accepted
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donated drugs and supplies that are not dispensed

under subdivision 8
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, are subject to a recall under paragraph (e), or are not suitable for

donation
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or are subject to a recall under paragraph (e)
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shall be maintained by the repository

for at least two years.
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For each drug or supply destroyed,
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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.

No other record of destruction is required.