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Inspection Requirements for Nonresident Pharmacies

Iowa Code Section 155A.13A requires all pharmacies located outside of the state of Iowa that provide prescription drugs or devices to ultimate users located in Iowa to be licensed with the Iowa Board of Pharmacy as a nonresident pharmacy. 

Inspections: 657 IAC 19.2(1) dictates specific inspection requirements for license eligibility. Inspection requirements must be met to be eligible for licensure - no exceptions will be made.  Nonresident pharmacies must submit an inspection report with initial or renewal application that satisfies requirements of Iowa Code Section 155A.13A. 

If an inspection report that satisfies the requirements in 657 IAC 19.2(1) is not or will not be available prior to the submission of an initial application or when renewing the Iowa nonresident pharmacy license, please contact your home state board of pharmacy to request an inspection be performed. 

The Iowa Board of Pharmacy accepts an inspection report in lieu of a home-state inspection that has been conducted by the following entities:

  1. NABP Verified Pharmacy Program (note that if the pharmacy is a sterile compounder and the inspection is conducted virtually, the inspection must include video review of the compounding facility)
  2. Iowa Board of Pharmacy - Please complete the request form to request an inspection be performed by the Iowa Board of Pharmacy (at your expense)
    1. For initial applicants, a completed application and applicable fees must be submitted prior to requesting an inspection 
  3. Gates Healthcare Associates (note that if the pharmacy is a sterile compounder and the inspection is conducted virtually, the inspection must include video review of the compounding facility)
  4. To discuss alternative entities that may be qualified to perform the inspection please contact the Board's licensing specialist assigned to pharmacy licensing

The Iowa Board of Pharmacy has reviewed and specifically declines an inspection report provided by the following entities:

  • Drug Enforcement Administration
  • Pharmacy Compounding Accreditation Board (PCAB), a subsidiary of the Accreditation Commission for Healthcare (ACHC)
  • Accreditation Commission for Healthcare (ACHC)
  • The Joint Commission

If the pharmacy cannot meet the statutory requirements for licensure, the license cannot be issued or renewed.  Failure to submit an inspection report that complies with these requirements with the application will result in the application being  considered incomplete and a pharmacy license will not be issued or renewed.  If a license is renewed online and an audit finds that the inspection report does not meet the statutory requirements, the license may be rescinded.  Applications that do not meet statutory requirements will be held for a period of six (6) months from the date of receipt.  If a compliant inspection report is not received within that time frame, the application will be voided.  Application fees are nonrefundable and nontransferable.