[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.9]

[Page 64]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                      Subpart B--General Provisions
 
Sec. 610.9  Equivalent methods and processes.


    Modification of any particular test method or manufacturing process 
or the conditions under which it is conducted as required in this part 
or in the additional standards for specific biological products in parts 
620 through 680 of this chapter shall be permitted only under the 
following conditions:
    (a) The applicant presents evidence, in the form of a license 
application, or a supplement to the application submitted in accordance 
with Sec. 601.12(b) or (c), demonstrating that the modification will 
provide assurances of the safety, purity, potency, and effectiveness of 
the biological product equal to or greater than the assurances provided 
by the method or process specified in the general standards or 
additional standards for the biological product; and
    (b) Approval of the modification is received in writing from the 
Director, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448.

[62 FR 39903, July 24, 1997]