Pharmacy - Manufacturer/Wholesaler License

New!  Renewals for these tasks are accessible through the Michigan Business One Stop portal.

A. NAME OF PERMIT OR APPROVAL:

Manufacturer/Wholesaler 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

Manufacturers or wholesale distributors of any prescription drug doing business in the State of Michigan, whether or not located in the State of Michigan, are required to possess a valid Manufacturer/Wholesaler License issued by the Michigan Department of Licensing and Regulatory Affairs, Bureau of Health Care Services. If a manufacturer/wholesaler's license lapses, a re-licensure application (included on the Manufacturer/Wholesaler License Application) must be submitted. If a manufacturer/wholesaler is transferred, changes location, has a partner or stockholder change or a name change, the Manufacturer/Wholesaler License Application must be submitted.

2.  Pre-Application Requirements

Manufacturer/wholesalers that are operating as a partnership or corporation must have been previously approved by the Department of Licensing and Regulatory Affairs' Corporation Division. If the manufacturer/wholesaler is operating under an assumed name, the assumed name must be registered with the appropriate County Clerk's Office.

3.  Application Submission Requirements

Manufacturer/Wholesaler License Application and supporting documents listed in instructions.

4.  Procedures and Time-Frame for Obtaining Permit or Approval

A Manufacturer/Wholesaler License Application and any required supporting documents will be reviewed for completeness. The review process normally takes up to 8 weeks.

5.  Operational Requirements

Manufacturer/Wholesaler Licenses must be renewed every 2 years.

6.  Fees

New Manufacturer/Wholesaler License - $85.00

Manufacturer/Wholesaler Relicensure - $105.00

Manufacturer/Wholesaler Transfer - $85.00

Manufacturer/Wholesaler Change of Location - $65.00

Manufacturer/Wholesaler Miscellaneous Change (Partner or Shareholder Change) - No Fee

Manufacturer/Wholesaler Miscellaneous Change (Name Change Fee) - $10.00 for each new license issued (reissuance of license(s) not required).

7.  Appeal Process

If the decision is made to deny a Manufacturer/Wholesaler 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 Care Services' website at www.michigan.gov/healthlicense.

E. Contact Information:

Contact Us

Revision:  September 2013