How to apply for a State of Michigan Controlled Substance Research License

State of Michigan Controlled Substance Research License (Schedule 2-5) Application

The State of Michigan Controlled Substance Research License application packet consists of the following:

  • Fingerprinting Information
  • Fingerprinting Request Form (page 3) 
  • Two page - Application For Controlled Substance Research License 

Fingerprinting

Fingerprinting is performed outside of the University of Michigan by the following companies:

L-1 Identity Solutions (Safran)

Cogent Systems

Fingerprinting can be performed by either company prior to or after the Application For Controlled Substance Research License is mailed.

  • Agency ID Number = 71734k
  • Registration and payment for a fingerprinting appointment can be performed online.
  • Both fingerprinting companies have multiple sites within the Ann Arbor area and SE Michigan
  • The applicant must bring a completed ¿Livescan Request Form¿  and a drivers license or state or federal picture identification to the fingerprinting appointment. 

Application For Controlled Substance Research License

The following must be mailed to the State of Michigan

  • Application For Controlled Substance Research License (Two pages)
  • Document with Information to be Included With Application 
  • Brief NIH Biosketch
  • Check for $85.00 payable to the "State of Michigan"
  • Mail completed packet to: Michigan Department of Licensing and Regulatory Affairs, Board of Pharmacy, P.O. Box 30670, Lansing, MI 48909
Instructions for Application For Controlled Substance Research License
  1. Check box - Schedule 2-5 Research Fee: $85.00
  2. Name, DOB, SS#, and phone#
  3. Business Name: University of Michigan - ¿Department Name¿
  4. Business address:
    1. Building name
    2. Building street address
    3. Room number where controlled substances will be stored
    4. City, State, Zip code
  5. Federal Employer Number =  386006309 (University of Michigan)
  6. Answer 7 questions 
  7. Signature and Date
Instructions for Information to be Included With Application (All applicants). 

Include as a separate document with responses to the following:

Credentials to Conduct the Proposed Research (Including FDA and DEA approval):

  • Attach a NIH biosketch
  • Ignore FDA or DEA approval - Do not submit a DEA 225 researcher registration application until your state controlled substance research application is approved.

Protocol of the Proposed Research

  • Briefly describe your overall research goals in a non-scientific manner.
  • Indicate that controlled substances are needed for anesthesia and analgesia of laboratory animals. Indicate that all animal use protocols were reviewed and approved by University of Michigan regulatory committees. 
  • If applicable, indicate controlled substances will be used for in vitro or analytical research. 

List of Controlled Substances and Doses to be Used

  • List all controlled substances that would be stored for research purposes in your laboratory. Include name(s) of controlled substance(s), concentration or powder, and estimated number of vials or containers. Include dose used for anesthesia and analgesia.  
  • For example:
    • Buprenorphine: 5 x 1 ml vials, 0.3mg/ml, Dose = 0.05-0.1 mg/kg (mouse)
    • Ketamine: 4 x 10 ml vials, 100mg/ml, Dose = 80-120 mg/kg (mouse) 
    • Sodium pentobarbital: 1 x 50ml vial, 50mg/ml, Dose = 40 mg/kg (mouse)

 Procedures for Storage and Security of Drugs

 Indicate the following:

  • Controlled substances will be stored in a locked safe or cabinet bolted to an immovable object.
  • Controlled substances will be stored separately from other drugs and materials.
  • Only limited authorized personnel will have access to the controlled substances.
  • Authorized personnel will be screened per CFR 1301.90
  • Authorized personnel will receive controlled substance compliance training. 
  • An authorized personnel list will be maintained.
  • Only authorized personnel may secure new controlled substance shipments into the safe or cabinet. 
  • Controlled substance inventory and usage records will be reconciled on a routine basis.
  • Controlled substances will be stored in an area with minimum traffic flow.
  • Controlled Substance storage room will be locked when not in use.
  • University of Michigan Department of Public Safety is available 24/7.

 List of Other Staff/Persons Involved

  • List authorized personnel (including their job titles) who will have access to the storage cabinet or safe where controlled substances will be stored.
  • List all administrative staff that may accept delivery shipments or perform controlled substance ordering for the lab.

Analytical Labs Conducting Chemical Analysis With a Controlled Substance

  • Biomedical researchers can ignore this section

The State of Michigan controlled substance research license application requires approximately 6 months to finalize before a permanent ID number will be issued.

Once a permanent ID number is issued, a DEA researcher application can be submitted.

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