§32.72. Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35. — Inbound Citations

(b) The regulations in part 32 that are not issued under subsections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 32.1, 32.2, 32.8, 32.11, 32.14, 32.18, 32.21, 32.22, 32.23, 32.24, 32.26, 32.27, 32.28, 32.30, 32.31, 32.51, 32.53, 32.57, 32.61, 32.71, 32.72, 32.74, 32.301, and 32.303.

(b) The approved information collection requirements contained in this part appear in §§ 32.11, 32.12, 32.14, 32.15, 32.16, 32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.30, 32.31, 32.32, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, 32.201, 32.210, and 32.211.

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

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

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

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

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in § 32.72(a)(2) of this chapter.

(2) The applicant meets the requirements under § 32.72(a)(2) of this part;

(4) Information identified in § 32.72(a)(3) of this chapter on the PET drugs to be noncommercially transferred to members of its consortium.

(i) Satisfy the labeling requirements in § 32.72(a)(4) of this chapter for each PET radioactive drug transport radiation shield and each syringe, vial, or other container used to hold a PET radioactive drug intended for noncommercial distribution to members of its consortium.

(3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in § 32.72(b)(2) of this chapter.

(i) an authorized nuclear pharmacist that meets the requirements in § 32.72(b)(2) of this chapter, or

(4) Is designated as an authorized nuclear pharmacist in accordance with § 32.72(b)(4).

Authorized user means a physician, dentist, or podiatrist who—

(4) A pharmacy, authorized under § 30.32(j) to produce PET radioactive drugs for noncommercial transfer to medical use licensees in its consortium that allows an individual to work as an authorized nuclear pharmacist, shall meet the requirements of § 32.72(b)(5) of this chapter.

(ii) Possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and meet the procedural, radioactivity measurement, instrument test, instrument check, and instrument adjustment requirements in § 32.72(c) of this chapter.