Mich. Admin. Code R. 338.3132

Current through Vol. 24-22, December 15, 2024

Section R. 338.3132 - Controlled substance license

Rule 32.

(1) A person that manufactures, distributes, prescribes, or dispenses a controlled substance in this state or 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 required fee.

(2) In addition to meeting the requirements of section 7303 of the code, MCL 333.7303, an applicant's license must be verified by the licensing agency of a state where the applicant holds or has ever held a controlled substance license. This includes, but is not limited to, showing proof of 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 listed 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 submitted to the department with the application for licensure and filed and approved by the FDA and the DEA under 21 CFR 1301.18.

(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 that 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 that 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 a 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 that 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 under section 17760 of the code, MCL 333.17760, or a hospital, county medical care facility, nursing home, hospice, or other skilled nursing facility, as that term is 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 for the address where the drugs are stored. If a controlled substance is stored in an emergency kit, a controlled substance license solely for the emergency kit is not required by this rule.

(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 if the license issued under article 15 of the code, MCL 333.16101 to 333.18838 is renewed and the controlled substance license is renewed for an equal number of years.

(5) An applicant who intends to conduct research involving controlled substances shall submit all of the following with the 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 contains the following information:

(i) The following investigator information:

(a) Name, address, and DEA registration number, if any.

(b) Institutional affiliation.

(c) Qualifications, including a curriculum vitae and an appropriate list of publications.

(ii) The following research project information:

(a) Title of project.

(b) Statement of the purpose.

(c) Name of the controlled substance or substances involved and the amount of each needed.

(d) Description of the research to be conducted, including the number and species of research subjects, the dosage to be administered, the route and method of administration, and the duration of the project.

(e) Location where the research will be conducted.

(f) Statement of the security provisions for storing the controlled substances in accordance with R 338.3143 and for dispensing the controlled substances in order to prevent diversion.

(g) If the investigator desires to manufacture any controlled substance, a statement of the quantity to be manufactured and the sources of the chemicals to be used.

(iii) The following authorization information:

(a) Institutional approval.

(b) Approval of a Human Research Committee for human studies.

(c) Indication of an approved active Notice of Claimed Investigational Exemption for a New Drug (number).

(d) Indication of an approved funded grant (number), if any.

(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 the 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 the 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 contains the following information:

(i) The following investigator information:

(a) Name, address, and DEA registration number, if any.

(b) Institutional affiliation.

(c) Qualifications, including a curriculum vitae and an appropriate list of publications.

(ii) The following chemical analysis project information:

(a) Title of project.

(b) Statement of the purpose.

(c) Name of the controlled substance or substances involved and the amount of each needed.

(d) Description of the chemical analysis and instructional activity to be conducted, and the duration of the project.

(e) Location where the chemical analysis will be conducted.

(f) Statement of the security provisions for storing the controlled substances in accordance with R 338.3143.

(g) If the investigator desires to manufacture any controlled substance for analytical or instructional purposes, a statement of the quantity to be manufactured and the sources of the chemicals to be used.

(iii) The following authorization information:

(a) Institutional approval.

(b) Approval of a Human Research Committee for human studies.

(c) Indication of an approved funded grant (number), if any.

(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 a licensed pharmacy in this state.

Mich. Admin. Code R. 338.3132

1979 AC; 1992 AACS; 2002 AACS; 2004 AACS; 2007 AACS; 2022 AACS; 2024 MR 10, Eff. 5/28/2024