N.H. Admin. Code § He-P 4035.19

Current through Register No. 45, November 7, 2024

Section He-P 4035.19 - Assay of Dosages of Unsealed Byproduct Material for Medical Use

A licensee shall meet the following requirements for determination of dosages of unsealed byproduct material:

(a) A licensee shall determine and record the activity of each dosage prior to medical use;

(b) For a unit dosage, this determination shall be made by:

(1) Direct measurement of radioactivity; or

(2) A decay correction, based on the activity or activity concentration determined by:

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 DHHS/RHS, or an 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

c. A PET radioactive drug producer licensed under He-P 4032.05, the equivalent requirements of an agreement state, or the Nuclear Regulatory Commission;

(c) For other than unit dosages, this determination shall be made by:

(1) Direct measurement of radioactivity; and either

(2) Combination of measurement of radioactivity and mathematical calculations; or

(3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:

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

b. A PET radioactive drug producer licensed under He-P 4032.05, the equivalent requirements of an agreement state, or Nuclear Regulatory Commission;

(d) Unless otherwise directed by the authorized user, a licensee shall not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent; and

(e) A licensee shall retain a record of the dosage determination required by He-P 4035.19 for 3 years. The record shall include:

(1) The radiopharmaceutical;

(2) The patient's or human research subject's name, or identification number if one has been assigned;

(3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 megabecquerels (30 microcuries);

(4) The date and time of the dosage determination; and

(5) The name of the individual who determined the dosage.

N.H. Admin. Code § He-P 4035.19

(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