[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.50]

[Page 82-83]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 7--ENFORCEMENT POLICY--Table of Contents
 
Subpart C--Recalls (Including Product Corrections)--Guidance on Policy, 
                Procedures, and Industry Responsibilities
 
Sec. 7.50  Public notification of recall.

    The Food and Drug Administration will promptly make available to the 
public in the weekly FDA Enforcement

[[Page 83]]

Report a descriptive listing of each new recall according to its 
classification, whether it was Food and Drug Administration-requested or 
firm-initiated, and the specific action being taken by the recalling 
firm. The Food and Drug Administration will intentionally delay public 
notification of recalls of certain drugs and devices where the agency 
determines that public notification may cause unnecessary and harmful 
anxiety in patients and that initial consultation between patients and 
their physicians is essential. The report will not include a firm's 
product removals or corrections which the agency determines to be market 
withdrawals or stock recoveries. The report, which also includes other 
Food and Drug Administration regulatory actions, e.g., seizures that 
were effected and injunctions and prosecutions that were filed, is 
available upon request from the Office of Public Affairs (HFI-1), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.