ML20310A143
| ML20310A143 | |
| Person / Time | |
|---|---|
| Issue date: | 11/05/2020 |
| From: | Maryann Ayoade NRC/NMSS/DMSST/MSEB |
| To: | |
| Maryann Ayoade/NMSS/MSST | |
| Shared Package | |
| ML20310A142 | List: |
| References | |
| Download: ML20310A143 (1) | |
Text
35.300 SUBCATEGORIES [from 35.390(b)(1)(ii)(G)]
Subcategory #1: Oral administration of less than or equal to 1.22 gigabecquerels 10 CFR 35.392 (33 millicuries) of sodium iodide I-131, for which a written directive is required Subcategory #2: Oral administration of greater than 1.22 gigabecquerels (33 10 CFR 35.394 millicuries) of sodium iodide I-131 Subcategory #3: Parenteral administration of any radioactive drug that contains 10 CFR 35.396 a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required 35.300 AUTHORIZED USER (AU) AUTHORIZATIONS Qualifications Proposed User Authorization Meets the requirements for subcategory #1, e.g. 10 CFR 35.300, limited to the oral 35.392; or 35.390 with a minimum of three cases administration of sodium iodide orally administering sodium iodide I-131 in I-131 in quantities less than or equal quantities less than or equal to 33 millicuries, to 33 millicuries for which a written directive is required Meets the requirements for subcategory #2*, e.g. 10 CFR 35.300, limited to the oral 35.394; or 35.390 with a minimum of three cases administration of sodium iodide orally administering sodium iodide I-131 in I-131 quantities greater than 33 millicuries, for which a written directive is required Meets the requirements for subcategory #3, e.g. 10 CFR 35.300, limited to the 35.396; or 35.390 with a minimum of three cases parenteral administration of parenterally administering any radioactive drug unsealed byproduct material that contains a radionuclide that is primarily used for its electron emission, beta radiation characteristics, alpha radiation characteristics, or photon energy of less than 150 keV, for which a written directive is required Meets the requirements for both subcategory #2 10 CFR 35.300 and Subcategory #3 Does not meet the requirements for 35.390, 392, 10 CFR 35.300, limited to the oral 394, or 396, but used I-131 under 35.200 prior to administration of sodium iodide October 24, 2002 (e.g., whole body scans for iodine-131 for imaging and thyroid carcinoma patients whose thyroids were localization studies removed) (Note that this authorization is not applicable for any new AU. New AUs or licensees or are no longer authorized solely for I-131 diagnostic uses.
- Note that experience with at least three cases in subcategory #2 also qualifies the user for subcategory #1 Last Updated: November 2020