[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.9]

[Page 66-67]
 
                        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

[[Page 67]]

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 or the Director, 
Center for Drug Evaluation and Research.

[62 FR 39903, July 24, 1997, as amended at 70 FR 14984, Mar. 24, 2005]