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 UNSEALED BYPRODUCT MATERIAL WRITTEN DIRECTIVE REQUIRED
Section 120.552 - Use of Unsealed Byproduct Material for Which a Written Directive Is Required
Current through Register 1531, September 27, 2024
A licensee may use any unsealed radioactive material identified in 105 CMR 120.556(B)(1)(b)6. prepared for medical use and for which a written directive is required that is:
(A) Obtained from a manufacturer or preparer licensed in accordance with 105 CMR 120.128(J) or a PET radioactive drug producer licensed in accordance with 105 CMR 120.128(A), or equivalent Nuclear Regulatory Commission or Agreement State requirements; or
(B) Excluding production of PET radionuclides, prepared by an authorized nuclear pharmacist, or a physician who is an authorized user and who meets the requirements specified in 105 CMR 120.551 or 120.556, or an individual under the supervision of either as specified in 105 CMR 120.519; or
(C) Obtained from and prepared by an Agency, Nuclear Regulatory Commission, or Agreement State licensee in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by the FDA for use in research; or
(D) Prepared by the licensee in accordance with a Radioactive Drug Research Committee-approved application or an IND protocol accepted by FDA for use in research.
