Wisconsin Administrative Code
Pharmacy Examining Board
Chapter Phar 12 - Manufacturer Requirements
Section Phar 12.03 - License; application

Universal Citation: WI Admin Code ยง Phar 12.03

Current through August 26, 2024

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

(a) Submit an application on a form provided by the board.

(b) Pay the fee specified in s. 440.05(1), Stats.

(c) Meet the inspection requirement under s. Phar 12.04.

(d) Register with the food and drug administration and comply with all applicable requirements of 21 CFR 200, 201, 202, 207, 210 and 211.

(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) 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) If the license is denied, the applicant may request a hearing before the board on the denial.

(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.

Disclaimer: These regulations may not be the most recent version. Wisconsin may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.