[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: 21CFR601.15]

[Page 28-29]
 
                        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. 601.15  Foreign establishments and products: samples for each 

importation.

    Random samples of each importation, obtained by the District 
Director of Customs and forwarded to the Director, Center for Biologics 
Evaluation and Research or the Director, Center for Drug Evaluation and 
Research (see

[[Page 29]]

mailing addresses in Sec. 600.2 of this chapter) must be at least two 
final containers of each lot of product. A copy of the associated 
documents which describe and identify the shipment must accompany the 
shipment for forwarding with the samples to the Director, Center for 
Biologics Evaluation and Research or the Director, Center for Drug 
Evaluation and Research (see mailing addresses in Sec. 600.2). For 
shipments of 20 or less final containers, samples need not be forwarded, 
provided a copy of an official release from the Center for Biologics 
Evaluation and Research or Center for Drug Evaluation and Research 
accompanies each shipment.

[70 FR 14983, Mar. 24, 2005]