[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.2]

[Page 60-61]
 
                        TITLE 21--FOOD AND DRUGS
 
          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) General. Samples of any lot of any licensed product, except for 
radioactive biological products, 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. 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

[[Page 61]]

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) Radioactive biological products. Samples of any lot of a 
radioactive biological product, as defined in Sec. 600.3(ee) of this 
chapter, together with the protocols showing results of applicable 
tests, may at any time be required to be sent to the Food and Drug 
Administration for official release. Upon notification by the Director, 
Center for Drug Evaluation and Research, a manufacturer shall not 
distribute a lot of a radioactive 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.

(Information collection requirements approved by the Office of 
Management and Budget under control number 0910-0206)

[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]