Section 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) Each individual's certification by the board of pharmaceutical specialties.

(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.

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.