HF3917

Purpose

This bill updates how Minnesota handles donated drugs and medical supplies in the medication repository program. It aims to improve safety, storage, recall handling, and record-keeping when items are donated, stored, and possibly dispensed.

Main provisions

• Inspection before dispensing

  • A pharmacist or authorized practitioner must check donated drugs and supplies to ensure they are not adulterated, misbranded, tampered with, or unsafe for dispensing, and that they have not been subject to a recall.
  • If a local repository receives items from the central repository, the local repository does not need to reinspect them.

• Storage requirements

  • Donated items must be stored in a secure storage area with environmental conditions appropriate for each drug or supply.
  • Donated items cannot be stored together with non-donated inventory.

• Disposal and hazardous waste

  • Drugs and medical supplies that are not suitable for donation must be disposed of in compliance with federal and state rules on hazardous waste.

• Handling certain shipped items

  • If donated items include controlled substances or drugs that can only be dispensed to a patient registered with the drug manufacturer, the shipment must be documented and returned immediately to the donor or the donor’s representative.

• Recalls and destruction

  • Each repository must have drug and medical supply recall policies and procedures.
  • If a recall is issued, the repository must destroy all affected inventory and maintain a destruction record.
  • If a drug or supply on a recall has been dispensed, the repository must immediately notify the recipient.
  • If a recall item lacks a lot number, it must be destroyed; if it has a lot number and the lot is not recalled, it may not need to be destroyed.

• Record-keeping for destruction

  • Records of destruction for donated items not dispensed or subject to a recall must be kept for at least two years. Each destruction record must include: the destruction date, the drug’s name/strength/quantity, and the name of the person or firm that performed the destruction.

Significant changes to existing law

• Adds explicit requirements for destruction records related to recalls and for documenting destruction of donated items.
• Clarifies that when central repositories donate to local repositories, reinpection by the local repository is not required.
• Introduces lot-number-based rules for whether a recalled item must be destroyed.
• Requires separation of donated vs non-donated inventory and formal recall policies.

Practical impact

• Increases safety and traceability of donated drugs and supplies.
• Improves accountability around recalls and disposal.
• Clarifies handling of controlled substances and items requiring manufacturer registration.

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Relevant Terms - central repository - local repository - donated drugs and supplies - adulterated - misbranded - tampered with - safe for dispensing - environmental conditions - hazardous waste - recall - Class I recall - Class II recall - lot number - destruction record - record of destruction - controlled substances - drugs requiring manufacturer registry - inventory separation - medication repository program