Limited Distributor Licensure

Summary

• Code Citation:
  • Iowa Code section 155A.42
  • 481 Iowa Administrative Code Chapter 551 (Licensing)
  • 481 Iowa Administrative Code Chapter 554 (Standards)
• Nonrefundable Fee:
  • $175 (Initial and Annual Renewal)
• Additional Information:
  • Required for the distribution of prescription drugs and medical devices not subject to the Drug Supply Chain Security Act, such as medical gases and medical devices (See Iowa Code 155A.42)
  • Each application must be accompanied by a facility self-inspection

Activities That Require a License

A limited distributor license is required for the following activities conducted in or into Iowa:

• Wholesale or prescription-based distribution of medical gases or devices
• Wholesale distribution of prescription animal drugs
• Wholesale or brokered distribution of prescription drugs by a manufacturer, co-licensed partner, or repackager
• Intracompany distribution of prescription drugs (e.g., within pharmacy chains)
• Wholesale distribution of:
  • Combination products
  • Medical convenience kits
  • Intravenous fluids or electrolytes
  • Dialysis solutions
  • Radioactive drugs
  • Irrigation or sterile water solutions intended for prescription-only use
• Distribution of dialysis solutions directly to patients by a manufacturer or agent, provided a licensed pharmacy processes the prescription

Activities Where a License Is Optional

A limited distributor license is optional but available for those involved in:

• Distributing nonprescription drugs or devices, with or without a patient-specific prescription
• Distributing medical devices for professional use only by health care providers
• Distributing blood and blood products that are not regulated under the federal Drug Supply Chain Security Act (DSCSA)

Updating Your License

• Notification of the following changes must be provided within 30 days of the change on a Board form:
  • Facility Manager
  • Business Type
  • Ownership
• Notification of the following changes must be provided within the given timeframes by the submission of a Limited Distributor License application and fee:
  • For resident LDs, at least 30 days prior to the change
  • For nonresident LDs, within 30 days of a change to the home state license, if applicable
  • Name
  • Location

Resources

• Applications
  • Limited Distributor Application (Online - new, change or modified licenses)
  • Limited Distributor Application (Online - renewal)
  • Limited Distributor Application (Paper - new, change, renewal or modified licenses)
• Forms
  • Self-Inspection Form
  • Attestation and Acknowledgement Form
• Other Resources
  • Contact Us