Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 120.000 - The Control of Radiation
SPECIFIC REQUIREMENTS FOR THE USE OF RADIOACTIVE MATERIAL FOR UPTAKE, DILUTION, OR EXCRETION STUDIES
Section 120.544 - Use of Unsealed Radioactive Material for Uptake, Dilution, or Excretion Studies for Which a Written Directive Is Not Required

Universal Citation: 105 CMR 120.000 MA Code of Regs 120.544

Current through Register 1531, September 27, 2024

A licensee may use any unsealed radioactive material, in quantities that do not require a written directive, for a diagnostic use involving measurements of uptake, dilution, or excretion:

(A)

(1) Obtained from a manufacturer or preparer licensed pursuant to 105 CMR 120 128(J) or equivalent regulations of another Agreement State, or the Nuclear Regulatory Commission; or

(2) A PET radioactive drug producer licensed under 105 CMR 120.100 or equivalent regulations of the Nuclear Regulatory Commission or equivalent Agreement State requirements; or

(B) Excluding production PET radionuclides, prepared by:

(1) an authorized nuclear pharmacist;

(2) A physician who is an authorized user and who meets the requirements specified in 105 CMR 120.551, or 120.556 and 120.551(C)(1)(b)7.; or

(3) An individual under the supervision, as specified in 105 CMR 120.519, of the authorized nuclear pharmacist in 105 CMR 120.544(B)(1) or the physician who is an authorized user in 105 CMR 120.544(B)(2); or

(C) Obtained from and prepared by an Agency, Nuclear Regulatory Commission, Agreement State 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 in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA for use in research.

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