Michigan Administrative Code › Department - Licensing and Regulatory Affairs › Bureau of Professional Licensing › Board of Pharmacy › Board of Pharmacy - Controlled Substances › Part 3 - LICENSES › Section R. 338.3132 - Controlled substance license

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