[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.160]

[Page 148]
 
                        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 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.