means a terminally sterilized aqueous drug product packaged in a single-dose container with a capacity of 100 milliliters or more and intended to be administered or used intravenously in a human.
310.4Biologics; products subject to license control.#
(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.
(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.
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Key facts
Type
CFR part · 21 CFR Part 310
Made by
Chapter I—Food and Drug Administration, Department of Health and Human Services