Section He-P 4035.32 - Permissible Molybdenum-99, Strontium-82, Strontium-85 Concentrations, and Strontium-90 Sources for Ophthalmic Treatments(a) A licensee shall not administer to humans a radiopharmaceutical that contains: (1) More than 0.15 kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (0.15 microcurie of molybdenum-99 per millicurie of technetium-99m); or(2) More than 0.02 kilobecquerel of strontium-82 per megabecquerel of rubidium-82 chloride injection (0.02 microcurie of strontium-82 per millicurie of rubidium-82 chloride); or more than 0.2 kilobecquerel of strontium-85 per megabequerel of rubidium-82 chloride injection (0.2 microcurie of strontium-85 per millicurie of rubidium-82).(b) A licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate from a generator to demonstrate compliance with He-P 4035.32(a).(c) A licensee that uses a strontium-82/rubidium-82 generator for preparing a rubidium-82 radiopharmaceutical shall, before the first patient use of the day, measure the concentration of radionuclides strontium-82 and strontium-85 to demonstrate compliance with He-P 4035.32(a).(d) If a licensee is required to measure the molybdenum-99 concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a record of each measurement. A licensee shall maintain the record for 3 years. The record shall include: (1) For each measured elution of technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per megabecquerel of technetium-99m (or microcuries of molybdenum per millicurie of technetium), the time and date of the measurement, and the name of the individual who made the measurement; or(2) For each measured elution of rubidium-82, the ratio of the measures expressed as kilobecquerel of strontium-82 per megabecquerel of rubidium-82 (or microcuries of strontium-82 per millicurie of rubidium) and kilobecquerel of strontium-85 per megabecquerel of rubidium-82 (or microcuries of strontium-85 per millicurie of rubidium), the time and date of the measurement, and the name of the individual who made the measurement.(e) The licensee shall report any measurement that exceeds the limits in He-P 4035.32(a) at the time of generator elution, in accordance with the following: (1) The licensee shall notify by telephone DHHS/RHS and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in He-P 4035.32(a) at the time of generator elution. The telephone report to DHHS/RHS shall include the manufacturer, model number, and serial number (or lot number) of the generator; the results of the measurement; the date of the measurement; whether dosages were administered to patients or human research subjects, when the distributor was notified, and the action taken.(2) By an appropriate method listed in He-P 4001.08, the licensee shall submit a written report to DHHS/RHS within 30 calendar days after discovery of an eluate exceeding the permissible concentration at the time of generator elution. The written report shall include the action taken by the licensee; the patient dose assessment; the methodology used to make this dose assessment if the eluate was administered to patients or human research subjects; and the probable cause and an assessment of failure in the licensee's equipment, procedures or training that contributed to the excessive readings if an error occurred in the licensee's breakthrough determination; and the information in the telephone report as required by He-P 4035.32(e)(1).(f) Licensees who use strontium-90 for ophthalmic treatments shall ensure that certain activities as specified in He-P 4035.32(g) and (h) are performed by either:(1) An authorized medical physicist; or(2) An individual who is identified as an ophthalmic physicist on a specific medical use license issued by DHHS\RHS, an agreement state, or the Nuclear Regulatory Commission; permit issued by DHHS/RHS, an agreement state, or a Nuclear Regulatory Commission broad scope medical use licensee; medical use permit issued by a Nuclear Regulatory Commission master material license; or permit issued by a Nuclear Regulatory Commission master material licensee broad scope medical use permittee; anda. Holds a master's or doctor's degree in physics, medical physics, other physical sciences, engineering, or applied mathematics from an accredited college or university; andb. Has successfully completed 1 year of full-time training in medical physics and an additional year of full-time work experience under the supervision of a medical physicist; and has documented training in:1. The creation, modification, and completion of written directives;2. Procedures for administrations requiring a written directive; and3. Performing the calibration measurements of brachytherapy sources as detailed in He-P 4035.46.(g) The individuals who are identified in He-P 4035.32(f) shall calculate the activity of each strontium-90 source that is used to determine the treatment times for ophthalmic treatments. The decay calculation shall be based on the activity determined under He-P 4035.46.(h) The individuals who are identified in He-P 4035.32(f) shall assist the licensee in developing, implementing, and maintaining written procedures to provide high confidence that the administration is in accordance with the written directives. These procedures shall include the frequencies that the individual meeting the requirements in He-P 4035.32(f) will: (2) Review the treatment methodology;(3) Calculate treatment time for the prescribed dose; and(4) Review records to verify that the administrations were in accordance with the written directives.(i) A licensee shall retain a record of the activity of each strontium-90 source required by He-P 4035.32(f) and (g) for the life of the The record shall include: (1) The date and initial activity of the source as determined under He-P 4035.46; and(2) For each decay calculation, the date and the source activity as determined under He-P 4035.32(g).N.H. Admin. Code § He-P 4035.32
(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