Section He-P 4035.27 - Use of Unsealed Byproduct Material for Uptake, Dilution, and Excretion Studies for Which a Written Directive is Not Required(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.N.H. Admin. Code § He-P 4035.27
(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