New Hampshire Code of Administrative Rules
He - Department of Health and Human Services
Subtitle He-P - Former Division of Public Health Services
Chapter He-P 4000 - NEW HAMPSHIRE RULES FOR THE CONTROL OF RADIATION
Part He-P 4035 - USE OF RADIONUCLIDES IN THE HEALING ARTS
Section He-P 4035.31 - Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive Is Not Required

Universal Citation: NH Admin Rules He-P 4035.31

Current through Register No. 40, October 3, 2024

Except for quantities that require a written directive under He-P 4035.13(c), a licensee may use any unsealed byproduct material prepared for medical use for imaging and localization studies that is:

(a) Obtained from:

(1) A manufacturer or preparer licensed under He-P 4032.05, the equivalent requirements of an agreement state, or Nuclear Regulatory Commission; or

(2) A PET radioactive drug producer licensed under He-P 4030.07(k), the equivalent requirements of an agreement state, or Nuclear Regulatory Commission; or

(b) Prepared by, excluding production of PET radionuclides:

(1) An authorized nuclear pharmacist;

(2) An authorized user physician who meets the requirements of He-P 4035.64 or He-P 4035.64(c)(1)b.7 and He-P 4035.65; or

(3) An individual under the supervision, as specified in He-P 4035.11, of the authorized nuclear pharmacist in He-P 4035.31(b)(1) or the physician who is an authorized user in He-P 4035.31(b)(2);

(c) Obtained from and prepared by DHHS/RHS, another agreement state, or a Nuclear Regulatory Commission licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or

(d) Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.

(See Revision Note at part heading for He-P 4035) #6942, eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07

New. #8959, eff 8-7-07

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