[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: 21CFR601.15]

[Page 26]
 
                        TITLE 21--FOOD AND DRUGS
 
          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, shall be at least two final containers of each 
lot of product. A copy of the associated documents which describe and 
identify the shipment shall accompany the shipment for forwarding with 
the samples to the Director, Center for Biologics Evaluation and 
Research. 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 accompanies each shipment.

[38 FR 32052, Nov. 20, 1973, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11013, Mar. 26, 1990. Redesignated at 64 FR 26668, May 17, 1999. 
Further redesignated at 65 FR 59718, Oct. 6, 2000.]