Chapter Phar 12

Chapter Phar 12

MANUFACTURER REQUIREMENTS

Phar 12.01   Authority.

Phar 12.02   Definitions.

Phar 12.03   License; application.

Phar 12.04   Inspections.

Phar 12.05   Compliance.

Phar 12.06   Authorized distributors of record.

Phar 12.01 Phar 12.01 Authority. The rules in this chapter are adopted under authority in ss. 15.08 (5) (b), 227.11 (2) (a) and 450.07 (4), Stats.

Phar 12.01 History History: Cr. Register, August, 1987, No. 380, eff. 9-1-87.

Phar 12.02 Phar 12.02 Definitions. In this chapter:

Phar 12.02(1) (1) “Device” has the meaning set forth in s. 450.01 (6), Stats.

Phar 12.02(2) (2) “Drug” has the meaning set forth in s. 450.01 (10), Stats.

Phar 12.02(3) (3) “Establishment” means a place of business under one management at one general physical location.

Phar 12.02(4) (4) “Manufacturer” means a person licensed by the board under this chapter.

Phar 12.02(5) (5) “Manufacturing” has the meaning set forth in s. 450.01 (13), Stats.

Phar 12.02(6) (6) “Prescription drug” has the meaning set forth in s. 450.01 (20), Stats.

Phar 12.02 History History: Cr. Register, August, 1987, No. 380, eff. 9-1-87; am. (3), Register, August, 1991, No. 428, eff. 9-1-91.

Phar 12.03 Phar 12.03 License; application.

Phar 12.03(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.

Phar 12.03(2) (2) To obtain a license a person shall do all of the following:

Phar 12.03(2)(a) (a) Submit an application on a form provided by the board.

Phar 12.03(2)(b) (b) Pay the fee specified in s. 440.05 (1), Stats.

Phar 12.03(2)(c) (c) Meet the inspection requirement under s. Phar 12.04.

Phar 12.03(2)(d) (d) Register with the food and drug administration and comply with all applicable requirements of 21 CFR 200, 201, 202, 207, 210 and 211.

Phar 12.03(2)(e) (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.

Phar 12.03 Note 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.

Phar 12.03(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.

Phar 12.03(4) (4) If the license is denied, the applicant may request a hearing before the board on the denial.

Phar 12.03(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.

Phar 12.03 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.

Phar 12.04 Phar 12.04 Inspections. Before a license is granted, an inspection of the establishment shall be conducted by the board or its representative to determine if the location meets the standards in 21 USC 351 and 352 (2022) and 21 CFR 210 and 211 (2022).

Phar 12.04 History History: Cr. Register, August, 1987, No. 380, eff. 9-1-87; CR 21-074: am. Register June 2023 No. 810, eff. 7-1-23.

Phar 12.05 Phar 12.05 Compliance. Failure to comply with all applicable federal and state laws and regulations shall be subject to disciplinary action by the board under s. 450.10, Stats.

Phar 12.05 History History: Cr. Register, August, 1987, No. 380, eff. 9-1-87.

Phar 12.06 Phar 12.06 Authorized distributors of record. A manufacturer shall maintain and update at least once per month a list of the manufacturer’s authorized distributors of record.

Phar 12.06 History History: EmR0815: emerg. cr. eff. 6-1-08; CR 08-051: cr. Register November 2008 No. 635, eff. 12-1-08.