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 5 - WHOLESALE DISTRIBUTOR AND WHOLESALE DISTRIBUTOR-BROKER LICENSE › Section R. 338.563 - Wholesale distributor, wholesale distributor-broker; application for licensure; requirements

Current through Vol. 24-12, July 15, 2024
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.