(a) If a drug has an approved license under section 351 of the Public Health Service Act (42 U.S.C. § 262 et seq.) or under the animal virus, serum, and toxin law of March 4, 1913 (21 U.S.C. § 151 et seq.), it is not required to have an approved application under section 505 of the act.

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(b) To obtain marketing approval for radioactive biological products for human use, as defined in § 600.3(ee) of this chapter, manufacturers must comply with the provisions of § 601.2(a) of this chapter.

[64 FR 56448, Oct. 20, 1999, as amended at 70 FR 14981, Mar. 24, 2005]