[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: 21CFR7.42]
[Page 69-70]
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. 7.42 Recall strategy.
(a) General. (1) A recall strategy that takes into account the
following factors will be developed by the agency for a Food and Drug
Administration-requested recall and by the recalling firm for a firm-
initiated recall to suit the individual circumstances of the particular
recall:
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is obvious to the
consumer or user.
(iv) Degree to which the product remains unused in the market-place.
(v) Continued availability of essential products.
(2) The Food and Drug Administration will review the adequacy of a
proposed recall strategy developed by a recalling firm and recommend
changes as appropriate. A recalling firm should conduct the recall in
accordance with an approved recall strategy but need not delay
initiation of a recall pending review of its recall strategy.
(b) Elements of a recall strategy. A recall strategy will address
the following elements regarding the conduct of the recall:
(1) Depth of recall. Depending on the product's degree of hazard and
extent of distribution, the recall strategy will specify the level in
the distribution chain to which the recall is to extend, as follows:
(i) Consumer or user level, which may vary with product, including
any intermediate wholesale or retail level; or
(ii) Retail level, including any intermediate wholesale level; or
(iii) Wholesale level.
(2) Public warning. The purpose of a public warning is to alert the
public that a product being recalled presents a serious hazard to
health. It is reserved for urgent situations where other means for
preventing use of the
[[Page 70]]
recalled product appear inadequate. The Food and Drug Administration in
consultation with the recalling firm will ordinarily issue such
publicity. The recalling firm that decides to issue its own public
warning is requested to submit its proposed public warning and plan for
distribution of the warning for review and comment by the Food and Drug
Administration. The recall strategy will specify whether a public
warning is needed and whether it will issue as:
(i) General public warning through the general news media, either
national or local as appropriate, or
(ii) Public warning through specialized news media, e.g.,
professional or trade press, or to specific segments of the population
such as physicians, hospitals, etc.
(3) Effectiveness checks. The purpose of effectiveness checks is to
verify that all consignees at the recall depth specified by the strategy
have received notification about the recall and have taken appropriate
action. The method for contacting consignees may be accomplished by
personal visits, telephone calls, letters, or a combination thereof. A
guide entitled ``Methods for Conducting Recall Effectiveness Checks''
that describes the use of these different methods is available upon
request from the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The
recalling firm will ordinarily be responsible for conducting
effectiveness checks, but the Food and Drug Administration will assist
in this task where necessary and appropriate. The recall strategy will
specify the method(s) to be used for and the level of effectiveness
checks that will be conducted, as follows:
(i) Level A--100 percent of the total number of consignees to be
contacted;
(ii) Level B--Some percentage of the total number of consignees to
be contacted, which percentage is to be determined on a case-by-case
basis, but is greater that 10 percent and less than 100 percent of the
total number of consignees;
(iii) Level C--10 percent of the total number of consignees to be
contacted;
(iv) Level D--2 percent of the total number of consignees to be
contacted; or
(v) Level E--No effectiveness checks.
[43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14363, Mar. 28, 1994; 68 FR 24879, May 9, 2003]
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