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 4035.27 - Use of Unsealed Byproduct Material for Uptake, Dilution, and Excretion Studies for Which a Written Directive is Not Required
Universal Citation: NH Admin Rules He-P 4035.27
Current through Register No. 40, October 3, 2024
(a) 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 uptake, dilution, or excretion studies that is:
(1) Obtained from:
a. A manufacturer or preparer licensed under
He-P
4032.05, or the equivalent requirements of an
agreement state, or the Nuclear Regulatory Commission;
b. 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.
(2) Prepared
by, excluding production of PET radionuclides:
a. An authorized nuclear
pharmacist;
b. A physician who is
an authorized user and who meets the requirements specified in
He-P
4035.64, or
He-P
4035.65 and
He-P
4035.64(c)(1)b.7;
c. An individual under the supervision, as
specified in He-P 4035.11, of the authorized
nuclear pharmacist in
He-P
4035.27(a)(2)a. or the physician who
is an authorized user in
He-P
4035.27(a)(2)b.; or
(3) Obtained from and prepared by
a DHHS/RHS, or an agreement state, or the 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
(4) 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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