DHS 157.62(9)(a)4.4. Before leaving a client’s address, survey all areas of use to ensure compliance with the requirements in subch. III.
DHS 157.62(9)(b)(b) A mobile medical service may not have radioactive material delivered from the manufacturer or the distributor to the client unless the client has a license allowing possession of the radioactive material. Radioactive material delivered to the client shall be received and handled in conformance with the client’s license.
DHS 157.62(9)(c)(c) A licensee providing mobile medical services shall retain the letter required in par. (a) 1. and the record of each survey required in s. DHS 157.71 (12) (b).
DHS 157.62(10)(10)Decay-in-storage.
DHS 157.62(10)(a)(a) A licensee may hold radioactive material with a physical half-life of less than 120 days for decay-in-storage before disposal without regard to its radioactivity if the licensee does both the following:
DHS 157.62(10)(a)1.1. Monitors radioactive material at the surface before disposal and determines that its radioactivity cannot be distinguished from the background radiation level with an appropriate radiation detection survey meter set on its most sensitive scale and with no interposed shielding.
DHS 157.62(10)(a)2.2. Removes or obliterates all radiation labels except for material that will be handled as biomedical waste after it has been released.
DHS 157.62(10)(b)(b) A licensee shall retain a record of each disposal permitted under s. DHS 157.71 (13).
DHS 157.62 HistoryHistory: CR 01-108: cr. Register July 2002 No. 559, eff. — see Note at the start of the chapter; corrections in (9) (c) and (10) (b) made under s. 13.93 (2m) (b) 7., Stats., Register July 2002 No. 559; CR 06-021: am. (2) (a), (3) (b) 2. a., (4) (intro.) and (8) (d) Register October 2006 No. 610, eff. 11-1-06; CR 09-062: am. (1) (b) and (3) (c) 3., cr. (3) (b) 2. c. Register April 2010 No. 652, eff. 5-1-10; correction in (4) (b) made under s. 35.17, Stats., Register January 2018 No. 745; CR 22-015: r. and recr. (4), cr. (5) (b) 3. Register June 2023 No. 810, eff. 7-1-23.
DHS 157.63DHS 157.63Unsealed radioactive material — written directive not required.
DHS 157.63(1)(1)Use of unsealed radioactive material for uptake, dilution and excretion studies for which a written directive is not required. A licensee may use for uptake, dilution or excretion studies any unsealed radioactive material, except in quantities that require a written directive under s. DHS 157.61 (4), prepared for medical use that meets any of the following requirements:
DHS 157.63 NoteNote: Uptake, dilution and excretion studies determine the amount of radioactive material absorbed by a patient and the patient’s ability to excrete the remainder of the radioactive material.
DHS 157.63(1)(a)(a) Is obtained from any of the following:
DHS 157.63(1)(a)1.1. A manufacturer or preparer licensed under s. DHS 157.13 (4) (i), or equivalent NRC or other agreement state requirements.
DHS 157.63(1)(a)2.2. A PET radioactive drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other agreement state requirements.
DHS 157.63(1)(b)(b) Excluding production of PET radionuclides, is prepared by any of the following:
DHS 157.63(1)(b)1.1. An authorized nuclear pharmacist.
DHS 157.63(1)(b)2.2. A physician who is an authorized user and who meets the requirements in sub. (5), or sub. (5) (c) 2. g. and s. DHS 157.64 (4).
DHS 157.63(1)(b)3.3. An individual under the supervision, as specified in s. DHS 157.61 (10), of the authorized nuclear pharmacist in subd.1. or the physician in subd. 2.
DHS 157.63(1)(c)(c) Is obtained from an NRC or agreement state licensee for use in research under a radioactive drug research committee-approved protocol or an investigational new drug protocol accepted by the FDA.
DHS 157.63(1)(d)(d) Is prepared by the licensee for use in research under a radioactive drug research committee-approved application or an investigational new drug protocol accepted by the FDA.
DHS 157.63 NoteNote: Information on radioactive drugs or investigational new drug protocols may be obtained from the following FDA website: http://www.fda.gov/Radiation-EmittingProducts/default.htm.
DHS 157.63(2)(2)Use of unsealed radioactive material for imaging and localization studies for which a written directive is not required. A licensee may use for imaging and localization studies any unsealed radioactive material, except in quantities that require a written directive under s. DHS 157.61 (4), prepared for medical use that meets any of the following requirements:
DHS 157.63(2)(a)(a) Is obtained from any of the following:
DHS 157.63(2)(a)1.1. A manufacturer or preparer licensed under s. DHS 157.13 (4) (i), or equivalent NRC or other agreement state requirements.
DHS 157.63(2)(a)2.2. A PET radioactive drug producer licensed under s. DHS 157.13 (1) (j), or equivalent NRC or other agreement state requirements.
DHS 157.63(2)(b)(b) Is prepared by, excluding production of PET radionuclides, any of the following:
DHS 157.63(2)(b)1.1. An authorized nuclear pharmacist.
DHS 157.63(2)(b)2.2. A physician who is an authorized user and who meets the requirements in sub. (5), or s. DHS 157.64 (4) and sub. (5) (c) 2. g.