Mich. Admin. Code R. 338.551 - Manufacturer license; application
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.
(3) A separate license is
required for each location where prescription drugs or devices are
manufactured.
(4) A manufacturer who
changes its facility manager shall submit all of the information required in
subrule (2)(g) of this rule to the department within 30 days after the
change.
Notes
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