Mich. Admin. Code R. 338.531 - Pharmacy license; remote pharmacy license; applications; requirements
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.
(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.
Notes
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