New! Renewals
for these tasks are accessible through the Michigan Business One Stop portal.
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: September 8, 2010
