Section R. 338.3132 - Controlled substance licenseRule 32.
(1) A person who manufactures, distributes, prescribes, or dispenses a controlled substance in this state or who proposes to engage in the manufacture, distribution, prescribing, or dispensing of a controlled substance in this state shall apply for a controlled substance license by submitting to the department a completed application on a form provided by the department along with the requisite fee.(2) In addition to meeting the requirements of section 7303 of the code, MCL 333.7303, an applicant's license shall be verified by the licensing agency of any state of the United States in which the applicant holds or has ever held a controlled substance license. This includes, but is not limited to, showing proof of any disciplinary action taken or pending against the applicant.(3) Except as otherwise provided in subrules (8) and (9) of this rule, a separate controlled substance license is required in each of the following circumstances: (a) For each principal place of business or professional practice where the applicant stores, manufactures, distributes, prescribes, or dispenses controlled substances.(b) Manufacturing and distributing a controlled substance in schedules 2-5. An individual, partnership, cooperative, association, private corporation, other legal entity, or governmental entity that is licensed in this state to manufacture a controlled substance listed in schedules 2 to 5 may also conduct chemical analysis and research with a substance that is listed in the schedules under the same controlled substance license.(c) Dispensing a controlled substance listed in schedules 2 to 5. A prescriber or practitioner who is licensed in this state to prescribe or dispense controlled substances listed in schedules 2 to 5 may also prescribe, dispense, administer, and conduct research with those substances under the same controlled substance license.(d) Conducting research and instructional activity with a controlled substance listed in schedule 1. An individual, partnership, cooperative, association, private corporation, other legal entity, or governmental entity that is licensed in this state to conduct research with controlled substances listed in schedule 1 may do both of the following: (i) Manufacture the specific substances as set forth in the research protocol that is filed and approved by the FDA and the DEA pursuant to the provisions of 21 CFR 1301.18 and submitted to the department with the application for licensure.(ii) Distribute the specific substances to others who are licensed by this state to conduct research or chemical analysis with the schedule 1 substances.(e) Conducting research with a controlled substance listed in schedules 2 to 5. An individual, partnership, cooperative, association, private corporation, other legal entity, or governmental entity who is licensed in this state to conduct research with the controlled substances listed in schedules 2 to 5 may also participate in all of the following activities:(i) Conduct chemical analysis with the specific substances listed in those schedules.(ii) Manufacture the specific substances if, and to the extent that, the manufacture of the specific controlled substances is set forth in a statement filed with the application for licensure.(iii) Distribute the specific substances to others who are licensed in this state to conduct research, chemical analysis, or instructional activity with the substances.(iv) Conduct instructional activities with the specific substances.(f) Conducting instructional activities with a specific controlled substance listed in schedules 2 to 5.(g) Conducting chemical analysis with a controlled substance listed in any schedule An individual, partnership, cooperative, association, private corporation, other legal entity, or governmental entity that is licensed in this state to conduct chemical analysis with all controlled substances may manufacture the substances for analytical or instructional purposes, distribute the substances to others who are licensed to conduct chemical analysis, instructional activity or research with the substances, and conduct instructional activities with the substances.(h) A pharmacy stocking patient medication in an automated device located at an affiliated hospital location pursuant to section 17760 of the code, MCL 333.17760, or a hospital, county medical care facility, nursing home, hospice, or other skilled nursing facility as defined in section 20109 of the code, MCL 333.20109. The pharmacy responsible for the device shall obtain an additional controlled substance license for each location. If substances are stored at a health facility without an onsite pharmacy or an automated device stocked by a pharmacy, a designated prescriber shall obtain a controlled substance license.(4) An applicant shall obtain a separate controlled substance license for each practitioner license issued under article 15 of the code, MCL 333.16101 to 333.18838. The controlled substance license must be renewed when the article 15 license is renewed and the controlled substance license is renewed for an equal number of years as the article 15 license.(5) An applicant who intends to conduct research involving controlled substances shall submit all of the following with his or her application required under subrule (1) of this rule: (a) The applicant's credentials to conduct the proposed research.(b) The protocol and description of the nature of the proposed research that is filed and approved by the FDA and the Federal Drug Enforcement Administration (DEA) pursuant to the provisions of 21 CFR 1301.18.(c) A list of the controlled substances and doses to be used.(6) An applicant who intends to conduct instructional activity involving controlled substances shall submit all of the following information with his or her application required under subrule (1) of this rule: (a) The applicant's credentials to conduct the proposed instructional activity.(b) A course outline for the proposed instructional activity.(c) A list of the controlled substances and doses to be used.(7) An applicant who intends to conduct chemical analysis involving controlled substances shall submit all of the following information with his or her application required under subrule (1) of this rule: (a) The applicant's credentials to conduct the proposed chemical analysis.(b) The protocol and description of the nature of the chemical analysis that is filed and approved by the FDA and the DEA pursuant to the provisions of 21 CFR 1301.18.(c) A list of the controlled substances and doses to be used.(8) A prescriber or practitioner who is licensed in this state to prescribe, administer, or dispense controlled substances at a principal place of business or professional practice consisting of multiple locations is not required to obtain a separate controlled substance license for each additional physical location of the business or professional practice if the prescriber or practitioner only prescribes controlled substances at each additional physical location of the business or professional practice.(9) A pharmacist shall maintain 1 controlled substance license in this state to dispense from any licensed pharmacy in this state.Mich. Admin. Code R. 338.3132
1979 AC; 1992 AACS; 2002 AACS; 2004 AACS; 2007 AACS; 2022 MR 1, Eff. 1/6/2022