1. A person other than a wholesale distributor, licensed pharmacy, or practitioner, shall not engage in any of the following activities in this state without a limited distributor license:

 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, medical convenience kit, intravenous fluid or electrolyte, dialysis solution, radioactive drug, or 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.

Terms Used In Iowa Code 155A.42

  • Board: means the board of pharmacy. See Iowa Code 155A.3
  • Device: means a medical device, as classified by the United States food and drug administration, intended for use by a patient that is required by the United States food and drug administration to be ordered or prescribed for a patient by a practitioner. See Iowa Code 155A.3
  • drug: means a drug, as classified by the United States food and drug administration, that is required by the United States food and drug administration to be prescribed or administered to a patient by a practitioner prior to dispensation. See Iowa Code 155A.3
  • following: when used by way of reference to a chapter or other part of a statute mean the next preceding or next following chapter or other part. See Iowa Code 4.1
  • License: means a license issued by the state under this chapter to a hearing aid specialist. See Iowa Code 154A.1
  • Limited distributor: means a person operating or maintaining a location, regardless of the location, where prescription drugs or devices are distributed at wholesale or to a patient pursuant to a prescription drug order, who is not eligible for a wholesale distributor license or pharmacy license. See Iowa Code 155A.3
  • Manufacturer: means manufacturer as defined by the federal Drug Supply Chain Security Act, 21 U. See Iowa Code 155A.3
  • Medical convenience kit: means a collection of devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or ultimate user. See Iowa Code 155A.3
  • Medical gas: means a gas or liquid oxygen intended for human consumption. See Iowa Code 155A.3
  • Person: means a natural person. See Iowa Code 154A.1
  • Pharmacist: means a person licensed by the board to practice pharmacy. See Iowa Code 155A.3
  • Pharmacy: means a location where prescription drugs are compounded, dispensed, or sold by a pharmacist and where prescription drug orders are received or processed in accordance with the pharmacy laws. See Iowa Code 155A.3
  • Practitioner: means a physician, dentist, podiatric physician, prescribing psychologist, veterinarian, optometrist, physician assistant, advanced registered nurse practitioner, or other person licensed or registered to prescribe, distribute, or dispense a prescription drug or device in the course of professional practice in this state or a person licensed by another state in a health field in which, under Iowa law, licensees in this state may legally prescribe drugs. See Iowa Code 155A.3
  • Prescription drug order: means a written, electronic, or facsimile order from a practitioner or an oral order from a practitioner or the practitioner's authorized agent who communicates the practitioner's instructions for a prescription drug or device to be dispensed. See Iowa Code 155A.3
  • Product: means the same as defined in 21 U. See Iowa Code 155A.3
  • Repackager: means a person who owns or operates an establishment that repackages or relabels a product or package for further sale or for distribution without a further transaction. See Iowa Code 155A.3
  • Rule: includes "regulation". See Iowa Code 4.1
  • State: means a state, territory, or possession of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. See Iowa Code 152E.3
  • United States: includes all the states. See Iowa Code 4.1
  • Wholesale distributor: means a person, other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or repackager, engaged in the wholesale distribution of a drug. See Iowa Code 155A.3
 2. The board shall adopt rules establishing the requirements for a limited distributor license, licensure fees, compliance standards, and any other relevant matters. A limited distributor shall not be required to have an onsite pharmacist.
 3. The board may deny, suspend, or revoke a limited distributor’s license, or otherwise discipline a limited distributor, for failure to meet the applicable standards or for a violation of the laws of this state, another state, or the United States, or for a violation of this chapter, chapter 124, 124B, 126, or 205, or a rule of the board.
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