Mich. Admin. Code R. 338.563 - Wholesale distributor, wholesale distributor-broker; application for licensure; requirements
Rule 63.
(1) An
applicant for a wholesale distributor or wholesale distributor-broker license
shall submit to the department a completed application on a form provided by
the department with the requisite fee. A wholesale distributor includes virtual
manufacturers.
(2) An applicant
shall comply with all of the following:
(a)
Provide a criminal history background check required under section 17748(6) of
the code, MCL
333.17748.
(b) Disclose on the application form each
license, registration, or certification in a health profession or specialty
issued by another state, the United States military, the federal government, or
another country.
(c) Satisfy the
requirements of section 16174(2) of the code, MCL
333.16174, including 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.
(d) Provide certified
copies of articles of incorporation or certificates of partnership and assumed
names if applicable.
(e) Provide
the identity and address of each partner, officer, or owner as
applicable.
(f) Provide a completed
compliance checklist.
(g) Provide a
FEIN certificate.
(h) Unless exempt
under section 17748(2) of the code, MCL
333.17748, provide the name and
the 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 individuals
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 an associate's, bachelor's,
or 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 wholesale
distributor certified by the NABP drug distributor accreditation or of a
wholesale distributor-broker.
(iv) Current employment with the
applicant.
(i) Provide a
list or catalog of all drug products and devices to be distributed, if a
wholesale distributor.
(j) If a
wholesale distributor-broker, submit an affidavit, at the time of the
application for initial licensure, that the applicant facilitates deliveries or
trades for not less than 50 qualified pharmacies and that each pharmacy holds a
license in good standing as a pharmacy from the state in which it is located at
the time of application.
(3) A wholesale distributor or wholesale
distributor-broker that changes its facility manager shall submit all of the
information required in subrule (2)(h) of this rule to the department within 30
days after the change.
Notes
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