Mich. Admin. Code 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.
Notes
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