HF4457 (Legislative Session 94 (2025-2026))

Pharmacy-related license and registration renewal and application procedures modified, inspection requirements modified, rulemaking authorized, and fees established.

Related bill: SF4523

AI Generated Summary

Purpose

  • The bill aims to modify how pharmacy-related licenses and registrations are applied for, renewed, and renewed after changes; update inspection and rulemaking authority related to licensure; and set or adjust associated fees. It also repeals an older statute and related rules.

Main Provisions

  • Application expiration

    • An initial license, registration renewal, or reinstatement application expires if the applicant does not complete it within 12 months of the board receiving it.
  • Relocation of a licensed/registered business

    • Anyone licensed or registered must file a new relocation application for each affected license before moving the physical location.
    • If fees are paid within the state’s fiscal year, many relocation-related fees are reduced (approximately by 5,000; and in one case by about 55,000).
    • If the relocation application is filed within 60–90 days before the current license expiration, the full standard fee must be paid. A new license is issued upon approval.
  • Change of ownership

    • A new application is required before changing ownership, with one application per affected license.
    • Fees for changes of ownership are similarly reduced if paid within the fiscal year, with the same 5,000 and 55,000 reductions.
    • A change of ownership includes: sale of assets, changes in partners, transfer of 20% or more voting stock or ownership, or a change in business structure for someone with 20%+ ownership.
    • If the voting stock is actively traded publicly, some clauses do not apply.
    • “Change in business structure” means changing between sole proprietorship, partnership, LLC, or corporation.
  • Change in business structure (new subdivision)

    • A new application is required before changing the business structure, with fee reductions similar to relocation/ownership changes.
  • Temporary use of license

    • If the license, ownership, or business structure changes, the original license expires when the new license is issued or 30 days after the change (whichever is earlier). An expired license becomes void and must be surrendered.
  • Posting requirement

    • License must be posted conspicuously at the licensed facility.
  • Renewal timelines and exceptions

    • Pharmacist license: expires February 30 and must be renewed by February 1 each year; late renewals incur a late filing fee.
    • Pharmacy license: expires June 30; renewal due by June 1; late renewals incur a late filing fee.
    • Manufacturer license: expires May 31; renewal due by May 1.
    • Wholesale distributor license: expires May 31; renewal due by May 1.
    • Third-party logistics provider license: expires October 31; renewal due by October 1.
    • Pharmacy technician registration: expires December 31; renewal due by December 1.
    • Controlled substance researcher permit: expires May 31; renewal due by May 1.
    • Medical gas dispenser registration: expires November 30; renewal due by November 1.
  • Time limits for renewal and ongoing practice

    • Pharmacists and pharmacy technicians cannot renew after certain thresholds (e.g., more than 24 months for reinstatement after expiration; 12 months for other licenses) without reinstatement or examination as applicable.
    • It's unlawful to practice with an expired license/registration until renewed or reinstated.
  • Reinstatement provisions

    • Reinstatement options are provided for those who have defaulted on renewal fees or want to reinstate expired licenses, with conditions such as paying due fees and meeting continuing education requirements.
  • Extension and prorating of initial late renewal/reinstatement

    • If an initial late renewal or reinstatement is filed within 90 days before expiration, the board may extend the license date into the next calendar year and prorate the application fee accordingly.
  • Pharmacy licensure requirements (out-of-state considerations)

    • No pharmacy may operate without a board license and applicable fee.
    • Applications for pharmacy licenses must comply with federal/state laws and board rules.
    • Licenses for pharmacies outside Minnesota must meet certain conditions, including licensure in their home state, cooperation with the board, and providing targeted information and services (like toll-free access) to Minnesota patients by a licensed pharmacist.
    • For out-of-state pharmacies, inspection may be required, and the applicant must cover inspection costs if the facility is outside Minnesota unless an inspection report from the other state is provided within the prior 24 months.
    • Additional provisions address disclosure of officers and pharmacists involved in dispensing to Minnesota residents, record-keeping, and dispensing arrangements (including unit-dose packaging for long-term care facilities and other delivery/logistics specifics).
    • An exception exists for certain dialysis-related products and arrangements involving manufacturers, wholesale distributors, or third-party logistics providers when specific criteria are met (for end-stage renal disease patients).
  • Repeal of prior rules and statute

    • The bill repeals Minnesota Statutes section 151.13 and certain Minnesota Rules parts (6800.0400 and 6800.1150).
  • Appendix: Repealed materials

    • The bill includes an appendix noting the repeal of the older renewal fee and continuing education provisions.

Significant Changes to Existing Law

  • Adds explicit deadlines and expiration for many license/registration applications.
  • Introduces and clarifies when relocation, ownership changes, and changes in business structure require new applications and how fees are adjusted.
  • Establishes temporary license mechanics during changes and requires surrender of expired licenses.
  • Expands posting and renewal timelines across pharmacist, pharmacy, and related licenses with defined deadlines and late- filing consequences.
  • Creates or strengthens requirements for out-of-state pharmacies serving Minnesota residents, including inspections, officer disclosure, and direct communication capabilities.
  • Introduces dialysis-related distribution/dispensing provisions for manufacturers/wholesale distributors/third-party logistics providers.
  • Repeals outdated statute and rules for renewal fees and continuing education, replacing them with updated processes.

Practical Effects and Implications

  • For licensees and facilities, the bill tightens and standardizes renewal/transfer processes, and may offer some fee savings if fees are paid within the fiscal year, while also introducing new requirements around relocation, changes of ownership, and business structure.
  • Out-of-state pharmacies must meet Minnesota-specific licensure and inspection expectations and provide certain operational commitments to Minnesota residents.
  • There will be a period of adjustment as new procedures (like temporary use of licenses and extension/proration options) are implemented.

Relevant Terms

  • pharmacist license, pharmacy license, license renewal, registration renewal, reinstatement
  • relocation, change of ownership, ownership change, business structure
  • board, inspection, fee, late filing fee, extension, prorate
  • out-of-state pharmacy, in-state residents, federal/state law compliance
  • toll-free telephone service, records, disclosure of officers, dispensing to Minnesota residents
  • unit-dose packaging, long-term care facilities, dialysate, end-stage renal disease
  • third-party logistics provider, wholesale drug distributor, manufacturer
  • repealer, Minnesota Rules 6800.0400, Minnesota Rules 6800.1150

Bill text versions

Actions

DateChamberWhereTypeNameCommittee Name
March 18, 2026HouseActionIntroduction and first reading, referred toHealth Finance and Policy

Citations

 
[
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Establishes expiration rule for applications for initial license or registration renewal or reinstatement, requiring completion within 12 months of receipt by the board.",
      "modified": [
        "Sets a time-bound expiration for initial license/registration applications."
      ]
    },
    "citation": "151.064",
    "subdivision": ""
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Relocation of a licensee's business location triggers a new license/registration requirement and related fee adjustments.",
      "modified": [
        "Requires a new license or registration when relocating the business location.",
        "Adjusts relocation-related application fees compared to the standard application fee structure."
      ]
    },
    "citation": "151.065",
    "subdivision": "4a"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Defines what constitutes a change of ownership for licensees or registrants and enumerates triggers.",
      "modified": [
        "Adds explicit triggers for change of ownership, including sale of assets, changes in partnerships, and significant ownership transfers (e.g., 20% or more).",
        "Addresses treatment of ownership changes when stock is actively traded."
      ]
    },
    "citation": "151.065",
    "subdivision": "4b"
  },
  {
    "analysis": {
      "added": [
        "New subdivision detailing applications and fees for changing business structure."
      ],
      "removed": [],
      "summary": "Adds a subdivision addressing changes in business structure and related application/fee implications.",
      "modified": []
    },
    "citation": "151.065",
    "subdivision": "4c"
  },
  {
    "analysis": {
      "added": [
        "Temporary license/registration provisions during transitional changes."
      ],
      "removed": [],
      "summary": "Temporary use of license or registration when changes occur in ownership, location, or business structure.",
      "modified": []
    },
    "citation": "151.065",
    "subdivision": "4d"
  },
  {
    "analysis": {
      "added": [
        "Posting requirement added."
      ],
      "removed": [],
      "summary": "Requires licensees or registrants to post the most recently issued license or registration in the licensed facility.",
      "modified": []
    },
    "citation": "151.099",
    "subdivision": ""
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Sets expiration dates and renewal deadlines for several license types (pharmacist, pharmacy, manufacturer, wholesale distributor, third-party logistics provider) and references associated late filing rules.",
      "modified": [
        "Clarifies renewal deadlines: pharmacist by February 1, pharmacy by June 1, manufacturer by May 1, wholesale distributor by May 1, third-party logistics provider by October 1."
      ]
    },
    "citation": "151.125",
    "subdivision": "1"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Sets renewal deadlines for registrations and permits (pharmacy technician, controlled substance researcher permit, medical gas dispenser registration) and related late fees.",
      "modified": [
        "Establishes annual renewal deadlines for technician registrations and related permits; includes late filing provisions."
      ]
    },
    "citation": "151.125",
    "subdivision": "2"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Time limits for renewal and reinstatement; prescribes reinstatement under section 151.14 if renewal is not pursued within certain time frames.",
      "modified": [
        "Imposes renewal time limits and directs reinstatement options as an alternative."
      ]
    },
    "citation": "151.125",
    "subdivision": "3"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Prohibition on practicing if a license or registration has expired until renewal or reinstatement.",
      "modified": [
        "Reinforces prohibition on practice after expiration until renewal or reinstatement."
      ]
    },
    "citation": "151.125",
    "subdivision": "4"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Reinstatements; allows reinstatement after default in renewal payments, subject to education and fee requirements; outlines general reinstatement provisions.",
      "modified": [
        "Provides reinstatement pathways, including education requirements and compliance with renewal-related fees."
      ]
    },
    "citation": "151.14",
    "subdivision": ""
  },
  {
    "analysis": {
      "added": [
        "Authority to extend license/registration dates for late applications and prorate fees."
      ],
      "removed": [],
      "summary": "Extends and prorates initial late renewal or reinstatement applications; allows extension to the subsequent calendar year.",
      "modified": []
    },
    "citation": "151.145",
    "subdivision": ""
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Pharmacy licensure requirements; license display; conditions for operating a pharmacy; licensure for out-of-state facilities; inspection-related provisions.",
      "modified": [
        "Updates licensure requirements and display requirements; addresses out-of-state facilities and inspection-related prerequisites."
      ]
    },
    "citation": "151.19",
    "subdivision": "1"
  },
  {
    "analysis": {
      "added": [],
      "removed": [
        "Repeal of 151.13 (Renewal Fee and Continuing Education)."
      ],
      "summary": "Repeals Minnesota Statutes 2024 section 151.13 (Renewal Fee Continuing Education).",
      "modified": []
    },
    "citation": "151.13",
    "subdivision": ""
  }
]

Progress through the legislative process

17%
In Committee
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