1.
License required.
A pharmacy located outside of this state that delivers, dispenses, or distributes by any method, prescription drugs or devices to an ultimate user in this state shall obtain a nonresident pharmacy license from the board. The board shall make available an application form for a nonresident pharmacy license and shall require such information it deems necessary to fulfill the purposes of this section. A nonresident pharmacy shall do all of the following in order to obtain a nonresident pharmacy license from the board:
a. Submit a completed application form and an application fee as determined by the board.
b. Submit evidence of possession of a valid pharmacy license, permit, or registration issued by the home state licensing authority.
c. (1) Submit an inspection report that satisfies all of the following requirements:
(a) Less than two years have passed since the date of inspection.
(b) The inspection occurred while the pharmacy was in operation. An inspection prior to the initial opening of the pharmacy shall not satisfy this requirement.
(c) The inspection report addresses all aspects of the pharmacy’s business that will be utilized in Iowa.
(d) The inspection was performed by or on behalf of the home state licensing authority, if available.
(e) The inspection report is the most recent report available that satisfies the requirements of this paragraph “c”.
(2) If the home state licensing authority has not conducted an inspection satisfying the requirements of this paragraph “c”, the pharmacy may submit an inspection report from the national association of boards of pharmacy’s verified pharmacy program, or the pharmacy may submit an inspection report from another qualified entity if preapproved by the board, if the inspection report satisfies all of the other requirements of this paragraph “c”.
(3) The board may recover from a nonresident pharmacy, prior to the issuance of a license or renewal, the costs associated with conducting an inspection by or on behalf of the board for purposes of satisfying the requirement in subparagraph (1), subparagraph division (d). In addition, the nonresident pharmacy shall submit evidence of corrective actions for all deficiencies noted in the inspection report and shall submit evidence of compliance with all legal directives of the home state regulatory or licensing authority.
d. Submit evidence that the nonresident pharmacy maintains records of the controlled substances delivered, dispensed, or distributed to ultimate users in this state.
2.
Pharmacist license requirement.
The pharmacist who is the pharmacist in charge of the nonresident pharmacy shall be designated as such on the nonresident pharmacy license application or renewal. Any change in the pharmacist in charge shall be reported to the board within ten days of the change. The pharmacist in charge must be registered, not licensed, according to rules established by the board of pharmacy.
3.
License renewal.
A nonresident pharmacy shall renew its license on or before January 1 annually. In order to renew a nonresident pharmacy license, a nonresident pharmacy shall submit a completed application and fee as determined by the board, and shall fulfill all of the requirements of subsection 1. A nonresident pharmacy shall pay an additional fee for late renewal as determined by the board.
4.
License denial.
The board shall refuse to issue a nonresident pharmacy license for failure to meet the requirements of subsection 1. The board may refuse to issue or renew a license for any grounds under which the board may impose discipline. License or renewal denials shall be considered contested cases governed by chapter 17A.
5.
Discipline.
The board may fine, suspend, revoke, or impose other disciplinary sanctions on a nonresident pharmacy license for any of the following:
a. Any violation of the federal Food, Drug, and Cosmetic Act or federal regulations promulgated under the Act. A warning letter issued by the United States food and drug administration shall be conclusive evidence of a violation.
b. Any conviction of a crime related to prescription drugs or the practice of pharmacy committed by the nonresident pharmacy, pharmacist in charge, or individual owner, or if the pharmacy is an association, joint stock company, partnership, or corporation, by any managing officer.
c. Refusing access to the pharmacy or pharmacy records to an agent of the board for the purpose of conducting an inspection or investigation.
