Iowa Administrative Code
Agency 657 - PHARMACY BOARD
Chapter 19 - NONRESIDENT PHARMACY PRACTICE
Rule 657-19.2 - Nonresident pharmacy license

Universal Citation: IA Admin Code 657-19.2

Current through Register Vol. 46, No. 19, March 20, 2024

A nonresident pharmacy shall apply for and obtain, pursuant to provisions of rule 657-8.35 (155A), a nonresident pharmacy license from the board prior to providing prescription drugs, devices, or pharmacy services to an ultimate user in this state. All requirements of rule 657-8.35 (155A) regarding licensure are applicable to nonresident pharmacies unless otherwise provided in this rule. Any pharmacy that dispenses controlled substances to Iowa residents shall also register pursuant to 657-Chapter 10.

(1) Inspection requirements. In lieu of the inspection requirement identified in 657-subrule 8.35(4), a nonresident pharmacy submitting any application for licensure, except when related to a change in location, shall submit with its application and fee an inspection report that satisfies the following requirements:

a. Less than two years have passed since the date of the inspection and the inspection report is the most recent inspection report available that satisfies the requirements of these rules.

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.

(2) Qualified inspector. If the home state licensing authority has not conducted an inspection satisfying the inspection requirements, the nonresident pharmacy shall submit an inspection report issued by one of the following:

a. The verified pharmacy program offered by the National Association of Boards of Pharmacy®.

b. Another qualified entity if the entity is preapproved by the board.

c. An authorized agent of the board. The board may recover from a nonresident pharmacy, prior to the issuance of a nonresident pharmacy license, the costs associated with conducting an inspection.

(3) Corrective action. The nonresident pharmacy shall submit evidence of corrective action taken to satisfy any deficiency identified in the inspection report and of compliance with all legal directives of the home state licensing authority.

(4) Nonresident pharmacy license changes. A nonresident pharmacy shall submit a completed application and fee pursuant to 657-subrule 8.35(6) except as provided in this rule.

a. Name. A change of the pharmacy name which is provided to patients shall require submission of a pharmacy license application and fee within ten days after issuance by the home state regulatory authority of a license bearing the new name.

b. Location. A change of pharmacy location shall require submission of a pharmacy license application, with the exception of the inspection requirements pursuant to subrule 19.2(1), and fee within ten days after issuance by the home state regulatory authority of a license bearing the new address.

c. Pharmacist in charge. A change in the pharmacist in charge shall require submission of a pharmacy license application and fee within ten days of the identification of a permanent pharmacist in charge pursuant to 657-subrule 8.35(6). If a temporary pharmacist in charge is identified, written notification shall be provided to the board pursuant to 657-paragraph 8.35(6)"d." The temporary pharmacist in charge shall not be required to be registered pursuant to rule 657-19.3 (155A).

d. Ownership. A change of ownership of a pharmacy shall require submission of a pharmacy license application and fee within ten days after issuance by the home state regulatory authority of a license under the new ownership or within ten days of the change if the home state does not require issuance of a new license for a change of ownership. A change of ownership occurs when the owner listed on the pharmacy's most recent application changes. A pharmacy undergoing a change in ownership is required to notify the pharmacist in charge and patients of the change in accordance with subrule 8.35(7). A change of ownership effectively consists of closing a pharmacy and opening a new pharmacy.

(5) Closing pharmacy or discontinuation of services. If a nonresident pharmacy is closing, the pharmacy shall comply with the requirements in 657-subrule 8.35(7). If a nonresident pharmacy is discontinuing provision of pharmacy services to Iowa, but not closing, the pharmacy shall comply with the requirements in the introductory paragraph of 657-subrule 8.35(7) as it relates to transferring patient records to another Iowa-licensed pharmacy and 657-paragraphs 8.35(7)"b" and"d." The notice requirements of this rule shall not apply in the case of a board-approved emergency or unforeseeable closure, including but not limited to emergency board action, foreclosure, fire, or natural disaster. The nonresident pharmacy shall return to the board the nonresident pharmacy license certificate and, if registered, the Iowa controlled substances Act registration certificate within ten days following the closure or discontinuation of service.

(6) Access to pharmacist via toll-free telephone number. Each nonresident pharmacy that dispenses or proposes to dispense any prescription drug or device directly to a patient located in Iowa shall provide on its application for nonresident pharmacy licensure evidence of labeling which provides a toll-free telephone number for patients to access a pharmacist who has access to the patient's medication record during the pharmacy's regular business hours.

Disclaimer: These regulations may not be the most recent version. Iowa may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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