[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.160]

[Page 156-157]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 820_QUALITY SYSTEM REGULATION--Table of Contents
 
       Subpart L_Handling, Storage, Distribution, and Installation
 
Sec. 820.160  Distribution.

    (a) Each manufacturer shall establish and maintain procedures for 
control and distribution of finished devices to ensure that only those 
devices approved for release are distributed and that purchase orders 
are reviewed to ensure that ambiguities and errors are

[[Page 157]]

resolved before devices are released for distribution. Where a device's 
fitness for use or quality deteriorates over time, the procedures shall 
ensure that expired devices or devices deteriorated beyond acceptable 
fitness for use are not distributed.
    (b) Each manufacturer shall maintain distribution records which 
include or refer to the location of:
    (1) The name and address of the initial consignee;
    (2) The identification and quantity of devices shipped;
    (3) The date shipped; and
    (4) Any control number(s) used.