[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: 21CFR610.2]

[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 A_Release Requirements
 
Sec. 610.2  Requests for samples and protocols; official release.

    (a) Licensed biological products regulated by CBER. Samples of any 
lot of any licensed product together with the protocols showing results 
of applicable tests, may at any time be required to be sent to the 
Director, Center for Biologics Evaluation and Research (see

[[Page 67]]

mailing addresses in Sec. 600.2 of this chapter). Upon notification by 
the Director, Center for Biologics Evaluation and Research, a 
manufacturer shall not distribute a lot of a product until the lot is 
released by the Director, Center for Biologics Evaluation and Research: 
Provided, That the Director, Center for Biologics Evaluation and 
Research, shall not issue such notification except when deemed necessary 
for the safety, purity, or potency of the product.
    (b) Licensed biological products regulated by CDER. Samples of any 
lot of any licensed product together with the protocols showing results 
of applicable tests, may at any time be required to be sent to the 
Director, Center for Drug Evaluation and Research (see mailing addresses 
in Sec. 600.2) for official release. Upon notification by the Director, 
Center for Drug Evaluation and Research, a manufacturer shall not 
distribute a lot of a biological product until the lot is released by 
the Director, Center for Drug Evaluation and Research: Provided, That 
the Director, Center for Drug Evaluation and Research shall not issue 
such notification except when deemed necessary for the safety, purity, 
or potency of the product.

[40 FR 31313, July 25, 1975, as amended by 49 FR 23834, June 8, 1984; 50 
FR 10941, Mar. 19, 1985; 55 FR 11013 and 11014, Mar. 26, 1990; 67 FR 
9587, Mar. 4, 2002; 70 FR 14984, Mar. 24, 2005]