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  [Code of Federal Regulations][Title 21, Volume 5][Revised as of April 1, 2008]From the U.S. Government Printing Office via GPO Access[CITE: 21CFR310.4][Page 7-8] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF PART 310_NEW DRUGS--Table of Contents Subpart A_General Provisions Sec. 310.4 Biologics; 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 Sec. 600.3(ee) of[[Page 8]]this chapter, manufacturers must comply with the provisions of Sec. 601.2(a) of this chapter.[64 FR 56448, Oct. 20, 1999, as amended at 70 FR 14981, Mar. 24, 2005]