§ 35.300. Use of unsealed byproduct material for which a written directive is required.

218 words·~1 min read·/us/cfr/t10/s§ 35.300·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

A licensee may use any unsealed byproduct material identified in § 35.390(b)(1)(ii)(G) prepared for medical use and for which a written directive is required that is—

(a)Obtained from:

(1)A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or

(2)A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or

(b)Excluding production of PET radionuclides, prepared by:

(1)An authorized nuclear pharmacist;

(2)A physician who is an authorized user and who meets the requirements specified in §§ 35.290, 35.390, or

(3)An individual under the supervision, as specified in § 35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this section or the physician who is an authorized user in paragraph (b)(2) of this section; or

(c)Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with an Investigational New Drug

(IND)protocol accepted by FDA; or

(d)Prepared by the licensee for use in research in accordance with an Investigational New Drug

(IND)protocol accepted by FDA. [67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 71 FR 15009, Mar. 27, 2006; 72 FR 55932, Oct. 1, 2007; 83 FR 33107, July 16, 2018]

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§ 35.300

Use of unsealed byproduct material for which a written directive is required.

Fed. Reg.×17

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