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 4035.35 - Use of Unsealed Byproduct Material-Written Directive Required

Universal Citation: NH Admin Rules He-P 4035.35

Current through Register No. 40, October 3, 2024

A licensee shall use any unsealed byproduct material identified in He-P 4035.65(b)(2)b., prepared for medical use and for which a written directive is required that is:

(a) Obtained from one of the following:

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

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

(b) Excluding production of PET radionuclides, prepared by:

(1) An authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified under He-P 4035.64 or 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 4035.35(b)(1) or the physician who is an authorized user in He-P 4035.35(b)(2); or

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

(d) Is prepared by the licensee for use in research in accordance with 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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