[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7.50]
[Page 72]
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 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.
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