1. (1) No person may engage in the manufacturing of any drug or device in this state unless a license is granted to the person by the board under this chapter.

2. (2) To obtain a license a person shall do all of the following:

   1. (a) Submit an application on a form provided by the board.
   2. (b) Pay the fee specified in s. 440.05 (1), Stats.
   3. (c) Meet the inspection requirement under s. Phar 12.04.
   4. (d) Register with the food and drug administration and comply with all applicable requirements of 21 CFR 200, 201, 202, 207, 210 and 211.

   5. (e) If applicable, register with the drug enforcement administration and comply with all appropriate requirements of 21 CFR 1301, 1302, 1303, 1304, 1305, 1307, 1311 and 1312.

      Note: An application form may be obtained from the board office, 1400 East Washington Avenue, Madison, Wisconsin 53702. Copies of federal applications, laws and regulations may be obtained from the Food and Drug Administration, 5600 Fischers Lane, Rockville, Maryland 20857 and the Drug Enforcement Administration, 500 Dirksen Federal Building, 219 Dearborn, Chicago, Illinois 60604.

3. (3) A manufacturer license may not be transferred from one establishment to another nor from one person to another. Each establishment requires a separate license.
4. (4) If the license is denied, the applicant may request a hearing before the board on the denial.
5. (5) The board shall act on the application for a license within 60 business days after receiving the completed application, as provided in s. SPS 4.03.

History

History: Cr. Register, August, 1987, No. 380, eff. 9-1-87; am. (2) (intro.), (a), (b), (c), (d) and (5), Register, December, 1998, No. 516, eff. 1-1-99; CR 00-157: am. (2) (d) and (e) Register May 2002 No. 557, eff. 6-1-02; correction in (5) made under s. 13.92 (4) (b) 7., Stats., Register November 2011 No. 671.