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§ 32.1 Purpose and scope.(a) This part prescribes requirements for the issuance of specific licenses to persons who manufacture or initially transfer items containing byproduct material for sale or distribution to: (1) Persons exempted from the licensing requirements of part 30 of this chapter, or (2) Persons generally licensed under part 31 or 35 of this chapter. This part also prescribes certain regulations governing holders of these licenses. In addition, this part prescribes requirements for the issuance of specific licenses to persons who introduce byproduct material into a product or material owned by or in the possession of the licensee or another and regulations governing holders of such licenses. Further, this part describes procedures and prescribes requirements for the issuance of certificates of registration (coverning radiation safety information about a product) to manufacturers or initial transferors of sealed source or devices containing sealed sources which are to be used by persons specifically licensed under part 30 of this chapter or equivalent regulations of an Agreement State. (b) The provisions and requirements of this part are in addition to, and not in substitution for, other requirements of this chapter. In particular, the provisions of part 30 of this chapter apply to applications, licenses and certificates of registration subject to this part. (c)(1) The requirements in this part,
including provisions that are specific to
licensees, shall apply to Government (2) The requirements in this part,
including provisions that are specific to
licensees, shall apply to all persons
other than those included in paragraph
(c)(1) of this section with respect to
accelerator-produced radioactive
material or discrete sources of radium-226 on August 8, 2009, or earlier as
noticed by the NRC, except that these
persons may continue to manufacture or
initially transfer items containing
accelerator-produced radioactive
material or discrete sources of radium-226 for sale or distribution to persons
exempted from the licensing
requirements of part 30 of this chapter,
and to persons generally licensed under
part 31 of this chapter, and to sell or
manufacture radioactive drugs and
sources and devices to medical use
licensees until the date of the NRC's
final licensing determination, provided [30 FR 8192, June 26, 1965, as amended at 52 FR 27786, July 24, 1987; 63 FR 1896, Jan. 13, 1998; 72 FR 55928 Oct. 1, 2007] |
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