Section R. 338.563 - Wholesale distributor, wholesale distributor-broker; application for licensure; requirementsRule 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.(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.Mich. Admin. Code R. 338.563
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024