Limited Distributors

Beginning January 1, 2019, no person other than a licensed wholesale distributor, licensed pharmacy, or practitioner, shall engage in any of the activities found herein in this state without a limited distributor license. Where operations are conducted at more than one location by a single distributor, each location shall be separately licensed. The applicant shall submit a completed application along with a nonrefundable fee of $175. 

LICENSE REQUIRED - A person engaged in the following activities shall obtain a limited distributor license prior to distribution in or into Iowa: 

a. Distribution of a medical gas or device at wholesale or to a patient pursuant to a prescription drug order. 

b. Wholesale distribution of a prescription animal drug. 

c. Wholesale distribution of a prescription drug, or brokering the distribution of a prescription drug at wholesale, by a manufacturer, a manufacturer’s co-licensed partner, or a repackager. 

d. Intracompany distribution of a prescription drug, including pharmacy chain distribution centers. 

e. Distribution at wholesale of a combination product as defined by the United States food and drug administration, a medical convenience kit, an intravenous fluid or electrolyte, a dialysis solution, a radioactive drug, or an irrigation or sterile water solution to be dispensed by prescription only. 

f. Distribution of a dialysis solution by the manufacturer or the manufacturer’s agent to a patient pursuant to a prescription drug order, provided that a licensed pharmacy processes the prescription drug order. 

LICENSE OPTIONAL - A person engaged in the following activities may, but is not required to, obtain a limited distributor license for distribution in or into Iowa: 

a. Distribution of non-prescription drugs or devices with or without a patient-specific prescription. b. Distribution of medical devices exclusively to a health care practitioner for use in the practitioner’s normal course of professional practice (“professional use”). 

c. Distribution of blood and blood products that are not subject to the federal Drug Supply Chain Security Act (DSCSA). 

LICENSE CHANGES – A change of name, ownership, or location requires the submission of a limited distributor license application and fee. 

In-state location change- if the new location was not a licensed limited distributor immediately prior to the relocation, you are required to complete a self-inspection of the new location prior to relocating.

Ownership change - a change of ownership occurs when the owner listed on the limited distributor's most recent application changes or when there is a change affecting the majority ownership interest of the owner listed on the limited distributor's most recent application 

Limited Distributor Application including Self-Inspection Form (New or Changes)

Self-Inspection Form

 

Printed from the Iowa Board of Pharmacy website on December 04, 2020 at 8:46pm.