[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: 21CFR7.3]
[Page 66-67]
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 A General Provisions
Sec. 7.3 Definitions.
(a) Agency means the Food and Drug Administration.
(b) Citation or cite means a document and any attachments thereto
that provide notice to a person against whom criminal prosecution is
contemplated of the opportunity to present views to the agency regarding
an alleged violation.
(c) Respondent means a person named in a notice who presents views
concerning an alleged violation either in person, by designated
representative, or in writing.
(d) Responsible individual includes those in positions of power or
authority to detect, prevent, or correct violations of the Federal Food,
Drug, and Cosmetic Act.
(e) [Reserved]
(f) Product means an article subject to the jurisdiction of the Food
and Drug Administration, including any food, drug, and device intended
for human or animal use, any cosmetic and biologic intended for human
use, and any item subject to a quarantine regulation under part 1240 of
this chapter. Product does not include an electronic product that emits
radiation and is subject to parts 1003 and 1004 of this chapter.
[[Page 67]]
(g) Recall means a firm's removal or correction of a marketed
product that the Food and Drug Administration considers to be in
violation of the laws it administers and against which the agency would
initiate legal action, e.g., seizure. Recall does not include a market
withdrawal or a stock recovery.
(h) Correction means repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a product
without its physical removal to some other location.
(i) Recalling firm means the firm that initiates a recall or, in the
case of a Food and Drug Administration-requested recall, the firm that
has primary responsibility for the manufacture and marketing of the
product to be recalled.
(j) Market withdrawal means a firm's removal or correction of a
distributed product which involves a minor violation that would not be
subject to legal action by the Food and Drug Administration or which
involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs, etc.
(k) Stock recovery means a firm's removal or correction of a product
that has not been marketed or that has not left the direct control of
the firm, i.e., the product is located on premises owned by, or under
the control of, the firm and no portion of the lot has been released for
sale or use.
(l) Recall strategy means a planned specific course of action to be
taken in conducting a specific recall, which addresses the depth of
recall, need for public warnings, and extent of effectiveness checks for
the recall.
(m) Recall classification means the numerical designation, i.e., I,
II, or III, assigned by the Food and Drug Administration to a particular
product recall to indicate the relative degree of health hazard
presented by the product being recalled.
(1) Class I is a situation in which there is a reasonable
probability that the use of, or exposure to, a violative product will
cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a
violative product may cause temporary or medically reversible adverse
health consequences or where the probability of serious adverse health
consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a
violative product is not likely to cause adverse health consequences.
(n) Consignee means anyone who received, purchased, or used the
product being recalled.
[42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978;
44 FR 12167, Mar. 6, 1979]
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