[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
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 HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
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

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this chapter, manufacturers must comply with the provisions of 601.2(b) 
of this chapter.

[64 FR 56448, Oct. 20, 1999]