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151.252.1a

Statute ID: 15045

Statute Function ID: 32518

Licensing of Drug Manufacturers - Outsourcing facility

In Effect

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Statute Number:

151.252.1a

Enactment Date:

May 21, 2014

Effective Date:

Jul 1, 2014

Expiration Date:

Repealed?:

Summary Text:

Licensing of Drug Manufacturers - Outsourcing facility

Statute ID:

15045

Created:

Jun 16, 2014 by mnjis.legal.analyst@state.mn.us

Updated:

Jun 16, 2014 by mnjis.legal.analyst@state.mn.us

Last Update Action:

Added

Legal Analyst Comment:

Amended 2014 c 219 art 5 s 10; Incomplete

Summary Text:

Licensing of Drug Manufacturers - Outsourcing facility

Link to MN Statute Text:

https://www.revisor.leg.state.mn.us/stats/151/252.html

Legislative Session:

2014 - Regular

Session Law Text?:

Statute text last updated on:

Jun 16, 2014

(a) No person shall act as an outsourcing facility without first obtaining a license from the board and paying any applicable manufacturer licensing fee specified in section 151.065.
(b) Application for an outsourcing facility license under this section shall be made in a manner specified by the board and may differ from the application required of other drug manufacturers.
(c) No license shall be issued or renewed for an outsourcing facility unless the applicant agrees to operate in a manner prescribed for outsourcing facilities by federal and state law and according to Minnesota Rules.
(d) No license shall be issued or renewed for an outsourcing facility unless the applicant supplies the board with proof of such registration by the United States Food and Drug Administration as required by United States Code, title 21, section 353b.
(e) No license shall be issued or renewed for an outsourcing facility that is required to be licensed or registered by the state in which it is physically located unless the applicant supplies the board with proof of such licensure or registration. The board may establish, by rule, standards for the licensure of an outsourcing facility that is not required to be licensed or registered by the state in which it is physically located.
(f) The board shall require a separate license for each outsourcing facility located within the state and for each outsourcing facility located outside of the state at which drugs that are shipped into the state are prepared.
(g) The board shall not issue an initial or renewed license for an outsourcing facility unless the facility passes an inspection conducted by an authorized representative of the board. In the case of an outsourcing facility located outside of the state, the board may require the applicant to pay the cost of the inspection, in addition to the license fee in section 151.065, unless the applicant furnishes the board with a report, issued by the 
appropriate regulatory agency of the state in which the facility is located or by the United States Food and Drug Administration, of an inspection that has occurred within the 24 months immediately preceding receipt of the license application by the board. The board may deny licensure unless the applicant submits documentation satisfactory to the board that any deficiencies noted in an inspection report have been corrected.