[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR601.20]

[Page 29]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 601_LICENSING--Table of Contents
 
                      Subpart C_Biologics Licensing
 
Sec. 601.20  Biologics licenses; issuance and conditions.

    (a) Examination--compliance with requirements. A biologics license 
application shall be approved only upon examination of the product and 
upon a determination that the product complies with the standards 
established in the biologics license application and the requirements 
prescribed in the regulations in this chapter including but not limited 
to the good manufacturing practice requirements set forth in parts 210, 
211, 600, 606, and 820 of this chapter.
    (b) Availability of product. No biologics license shall be issued 
unless:
    (1) The product intended for introduction into interstate commerce 
is available for examination, and
    (2) Such product is available for inspection during all phases of 
manufacture.
    (c) Manufacturing process--impairment of assurances. No product 
shall be licensed if any part of the process of or relating to the 
manufacture of such product, in the judgment of the Director, Center for 
Biologics Evaluation and Research or the Director, Center for Drug 
Evaluation and Research, would impair the assurances of continued 
safety, purity, and potency as provided by the regulations contained in 
this chapter.
    (d) Inspection--compliance with requirements. A biologics license 
shall be issued or a biologics license application approved only after 
inspection of the establishment(s) listed in the biologics license 
application and upon a determination that the establishment(s) complies 
with the standards established in the biologics license application and 
the requirements prescribed in applicable regulations.
    (e) One biologics license to cover all locations. One biologics 
license shall be issued to cover all locations meeting the establishment 
standards identified in the approved biologics license application and 
each location shall be subject to inspection by FDA officials.

[64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005]