Minnesota Administrative Rules

6800.1400 DRUG MANUFACTURER OR WHOLESALER LICENSE.

Subpart 1.

Licensing; fees.

Every person engaged in manufacturing, wholesale distribution, or selling of drugs, medicines, chemicals, or poisons for medicinal purposes other than to the consuming public or patient, except as allowed under part 6800.9921, shall annually be licensed by the board. Upon the filing of an application, and upon payment of a fee under Minnesota Statutes, chapter 151, the board may issue or renew a license in such form as it may prescribe to the manufacturer or wholesale distributor. The license shall be exposed in a conspicuous place in the manufacturer's or wholesaler's place of business for which it is issued, shall expire at midnight on June 1 of each year, and shall be renewed annually upon the filing of an application therefor, on or before May 1 of each year together with the applicable fee. Renewal applications received after June 1 shall be subject to a late filing fee of one-half of the renewal fee in addition to the amount of the renewal fee. An application for a manufacturer or wholesaler license which has not been completed within 12 months of the date on which the board received the application is no longer valid.

Subp. 2.

Prohibition.

No license may be issued to any manufacturer or wholesale distributor whose intended place of business is a personal residence.

Subp. 3.

Separate licenses required.

A separate license is required for each separate location involved in wholesale drug distribution within this state and each separate out-of-state location from which drugs are shipped into this state. A manufacturer that does not ship drugs into this state from any location that it directly operates must still obtain a license according to Minnesota Statutes, section 151.25, if it does business with accounts in this state. Doing business in this state includes any sale of a manufacturer's drug to any individual or business in Minnesota.

Statutory Authority:

MS s 151.06; 151.12; 151.13; 151.19; 151.25; 151.42; 151.47; 151.48; 151.49; 152.02; 214.06

History:

16 SR 1913; 25 SR 81; 31 SR 1673; 36 SR 237

Published Electronically:

September 21, 2011