Mich. Admin. Code R. 338.551

Current through Vol. 24-17, October 1, 2024

Section 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.

Mich. Admin. Code R. 338.551

2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024