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A. NAME OF PERMIT OR APPROVAL:
Controlled Substance Research License
B. STATUTORY AUTHORITY:
Public Act 368 of 1978, as amended; Article 7 titled Controlled Substances; Parts 71-75
C. APPLICABLE REGULATION:
Administrative Rules of the Board of Pharmacy
D. SUMMARY OF PERMIT/APPROVAL PROCESS:
1. Applicability
A Controlled Substance Research License is required for every person who conducts research with Schedule 1-5 drugs or who conducts chemical analysis with any controlled substance.
2. Pre-Application Requirements
Must have a valid Michigan health professional license such as a medical doctor or doctor of osteopathic medicine and surgery. Also must have a valid DEA license issued by the federal Drug Enforcement Administration.
3. Application Submission Requirements
Controlled Substance Research License Application
4. Procedures and Time-Frame for Obtaining Permit or Approval
A Controlled Substance Research License Application is reviewed for completeness. The review process normally takes up to 8 weeks.
5. Operational Requirements
Controlled Substance Research licenses must be renewed every 2 years.
6. Fees
Pharmacy Controlled Substance Research 2-5 Research License (includes instructional) - $85.00
Pharmacy Controlled Substance Schedule 1 Research License (includes instructional) - $85.00
Pharmacy Controlled Substance Analytical Laboratory Research License - $85.00
7. Appeal Process
If the decision is made to deny a Controlled Substance Research License, a Notice of Intent to Deny Licensure is issued. The applicant would then be entitled to an administrative hearing and the Administrative Law Examiner's Proposal for Decision would be reviewed by the Board of Pharmacy for review and disposition.
8. Public Input Opportunities
If changes to the Board of Pharmacy's administrative rules have been approved by the Board of Pharmacy, a public hearing would be conducted for public comment and public comments could also be submitted via email. The proposed changes would also be available on the Bureau of Health Professions' website at www.michigan.gov/healthlicense.
E. Contact Information:
Contact Us
Creation/Revision Date: October 2010
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