[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.50]

[Page 103-104]
 
                        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 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

[[Page 104]]

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.