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Title: 503B Outsourcing Facility
Alternate Title:
Description: Minnesota Board of Pharmacy
Subject: Drugs
Pharmaceuticals
Pharmacies
Creation Date: 11/15/2021 2:12:35 PM
Modification Date: 9/10/2024 1:04:57 PM
Agency Name: Pharmacy, Minnesota Board of
Agency URL: https://mn.gov/boards/pharmacy/
Agency Description: The Minnesota Board of Pharmacy exists to promote, preserve, and protect the public health, safety, and welfare by fostering the safe distribution of pharmaceuticals and the provision of quality pharmaceutical care to the citizens of Minnesota.
Agency Phone: 651-201-2825
Agency Fax: 612-617-2262
Agency URL: https://mn.gov/boards/pharmacy/
Agency Address:
335 Randolph Ave., Suite 230

St. Paul
MN
55102
Division Name: Email
Division URL:
Division Description:
Division Phone: Division Fax: Division URL:
Audience: Hold Application URL:
Renewal URL:
Versa URL:
Requirements:

Minnesota regulations require that 503B Outsourcing Facilities be registered as both drug manufacturers and drug wholesalers. If your 503B Outsourcing Facility will be filling patient-specific prescriptions, you will also need to be licensed as a non-resident pharmacy. Click on the links below for relevant laws, rules, and application for each type of license.

 
 

Rules: 6800.0100 - .1460

Statutes: 151.01
151.361
152.101

Forms:

Applications are available at Manufacturer, Pharmacy and Wholesaler


Fees:
Period of Issuance:

June 1 - May 31 annually


Length of Determination:
Approximately 60 days.

Other Info:
Activity: Drugs (Human and Veterinary)
License Detail URL:
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