Wis. Admin. Code DHS § DHS 157.68

Current through November 25, 2024
Section DHS 157.68 - Radioactive drugs for medical use
(1) PREPARATION. A licensee authorized to manufacture, prepare or transfer for commercial distribution or noncommercial transfer to medical use licensees in a consortium radioactive drugs shall ensure that any individual preparing the drugs is one of the following:
(a) An authorized nuclear pharmacist.
(b) An individual under the supervision of an authorized nuclear pharmacist.
(c) A pharmacist that meets any of the following criteria:
1. The requirements for an authorized nuclear pharmacist as specified in s. DHS 157.61 (9) and (11).
2. Is identified as an authorized nuclear pharmacist on a license issued by the department, an agreement state or the NRC.
3. Is identified as an authorized nuclear pharmacist by a licensee who is authorized by the department, an agreement state or the NRC to designate authorized nuclear pharmacists operating under their license.
4. Functioned as a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material, and practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009.
(2) DOCUMENTATION. A licensee shall provide to the department a copy of all the following, as appropriate:
(a) A copy of each individual's certification by a specialty board whose certification process has been recognized by the department, the NRC, or an agreement state as specified in s. DHS 157.61 (9).
(b) The department, NRC or agreement state license.
(c) The permit issued by a licensee of broad scope.
(d) A list of authorized nuclear pharmacists designated by a licensee under sub. (1) (c) 3.
(e) The state pharmacist licensure, no later than 30 days after the date that the licensee allows, under sub. (1) (c) 1. and 2., the individual to work as an authorized nuclear pharmacist.
(f) Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009.

Wis. Admin. Code Department of Health Services DHS 157.68

CR 06-021: cr. Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (1) (intro.) and (2) (e), cr. (1) (c) 4. and (2) (f) Register April 2010 No. 652, eff. 5-1-10.
Amended by, CR 22-015: am. (2) (a) Register June 2023 No. 810, eff. 7/1/2023