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 4 - MANUFACTURER LICENSE › Section R. 338.551 - Manufacturer license; application

Current through Vol. 24-12, July 15, 2024
Rule 51.
(1)
						An applicant for a manufacturer license shall submit to the department a
						completed application on a form provided by the department with the requisite
						fee.
(2) An applicant shall provide
						all of the following information:
(a) A
						criminal history background check required under section 17748(6) of the code,
						MCL 333.17748.
(b) A FEIN certificate.
(c) Certified copies of articles of
						incorporation or certificates of partnership and assumed name certificates, if
						applicable.
(d) The identity and
						address of each partner, officer, or owner, as applicable.
(e) A completed compliance checklist for
						manufacturers.
(f) A list or a
						catalog of all drug products or devices to be manufactured by the
						facility.
(g) Unless exempt under
						section 17748(2) of the code, MCL
						333.17748, the name and license
						number of the pharmacist designated as the PIC or the name of the facility
						manager. If a PIC or facility manager is unable to fulfil his or her duties for
						120 consecutive days, the pharmacy shall appoint a new PIC or facility manager
						and notify the department as required in section 17748(4) of the code, MCL
						333.17748. For an individual who
						is designated as a facility manager, the applicant shall provide proof, in the
						form of an affidavit, that the facility manager has achieved the following:
(i) A high school equivalency education, or
						higher, defined as 1 of the following:
(A) A
						high school diploma.
(B) A
						GED.
(C) A parent-issued diploma
						for home schooled individuals.
(D)
						Completion of post-secondary education, including either an associate's,
						bachelor's, or a master's degree.
(ii) Completion of a training program that
						includes, but is not limited to, all of the following subjects:
(A) Knowledge and understanding of laws in
						this state and federal laws relating to the distribution of drugs and
						devices.
(B) Knowledge and
						understanding of laws in this state and federal laws relating to the
						distribution of controlled substances.
(C) Knowledge and understanding of quality
						control systems.
(D) Knowledge and
						understanding of the USP standards relating to the safe storage and handling of
						prescription drugs.
(E) Knowledge
						and understanding of pharmaceutical terminology, abbreviations, dosages, and
						format.
(iii) Experience
						equal to either of the following:
(A) A
						minimum of 1 year of work experience related to the distribution or dispensing
						of prescription drugs or devices where the responsibilities included, but were
						not limited to, recordkeeping.
(B)
						Previous or current employment as a designated representative of a
						manufacturer.
(iv)
						Employment with the applicant.
(h) A copy of the FDA certification for the
						site to be licensed, if an applicant is a manufacturer of
						biologicals.
(i) An inspection from
						the FDA, or manufacturer's resident state board of pharmacy, that is dated not
						more than 2 years before application or current NABP drug distributor
						accreditation.
(j) An applicant
						that is or has ever been licensed, registered, or certified as a manufacturer
						by another state, the United States military, the federal government, or
						another country, 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.