Current through Vol. 24-22, December 15, 2024
Section R. 338.531 - Pharmacy license; remote pharmacy license; applications; requirementsRule 31.
(1) An applicant for a pharmacy license or a remote pharmacy license shall submit to the department a completed application on a form provided by the department together with the requisite fee.(2) An applicant shall submit all of the following information:(a) Certified copies of articles of incorporation or partnership certificates and certified copies of assumed name certificates, if applicable.(b) Submission of fingerprints for the purpose of a criminal history background check required under section 17748(6) of the code, MCL 333.17748.(d) The name and license number of the pharmacist in this state designated as the PIC under section 17748(2) of the code, MCL 333.17748, who must have a valid and unrestricted license. If a PIC is unable to fulfill his or her duties for 120 consecutive days, the pharmacy shall appoint a new PIC and notify the department as required in section 17748(4) of the code, MCL 333.17748.(e) The identity and address of each partner, officer, or owner, as applicable.(f) A completed self-inspection form.(g) If the applicant is an out-of-state pharmacy that will not provide sterile compounding services, an inspection report that satisfies the requirements of R 338.534.(h) If the applicant is an in-state pharmacy that intends to compound sterile pharmaceutical products, the applicant shall submit to an inspection under R 338.534a.(i) If the applicant is a governmental entity, an individual shall be designated as the licensee. The licensee and the pharmacist on duty are responsible for complying with all federal and state laws regulating the practice of pharmacy and the dispensing of prescription drugs.(j) If the applicant is applying for a remote pharmacy license, the applicant shall submit the following:(i) Ownership documents to demonstrate to the satisfaction of the department that the parent pharmacy and the proposed remote pharmacy share common ownership.(ii) Copies of the policies and procedure manual required in section 17742b of the code, MCL 333.17742b.(iii) A map showing all of the existing pharmacies within 10 miles of the proposed remote pharmacy if the remote pharmacy will not be located at a hospital or mental health facility.(k) If the applicant is or has ever been licensed, registered, or certified as a pharmacy by another state, the United States military, the federal government, or another country, the applicant shall do both of the following:(i) Disclose each license, registration, or certification on the application form.(ii) Submit verification from the issuing entity showing that disciplinary proceedings are not pending against the applicant and sanctions are not in force at the time of application.(3) The department shall issue only 1 pharmacy license per address. If an applicant has more than 1 location at which drugs are prepared or dispensed, each address location must obtain a separate license.Mich. Admin. Code R. 338.531
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024