Section He-P 4035.31 - Use of Unsealed Byproduct Material for Imaging and Localization Studies for Which a Written Directive Is Not Required 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.N.H. Admin. Code § He-P 4035.31
(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
Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10897, Effective 7/22/2015, Expires1/18/2016.Amended by Volume XXXVI Number 01, Filed January 7, 2016, Proposed by #11011, Effective 1/15/2016, Expires 1/15/2026.Amended by Volume XL Number 24, Filed June 11, 2020, Proposed by #13048, Effective 6/2/2020, Expires 6/2/2030.Amended by Volume XLII Number 45, Filed November 10, 2022, Proposed by #13473, Effective 10/25/2022, Expires 10/25/2032