Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - General Rules › PHARMACY SERVICES IN MEDICAL INSTITUTIONS › Part 3 - PHARMACY LICENSES › Section R. 338.531 - Pharmacy license; remote pharmacy license; applications; requirements

Current through Vol. 24-12, July 15, 2024
Rule 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.
(c) A FEIN certificate.
(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.