IA #56-02 - 2/1/06,IMPORT ALERT #56-02, "DETENTION WITHOUT PHYSICAL EXAMINATION OF
ENROFLOXACIN (BAYTRIL) LABELED FOR USE IN POULTRY"
TYPE OF
ALERT: Detention Without Physical Examination (DWPE)
(Note: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or products(s) at
issue. It does not create or confer any rights for or on any person, and
does not operate to bind FDA or the public).
PRODUCT: Enrofloxacin (Baytril 3.23%) Labeled for Use in Poultry
PRODUCT
CODE: 56O[][]05
PROBLEM: Unapproved in poultry
PAF: AAP-Approval
PAC FOR
COLLECTION: 71002
COUNTRY: All countries
MANUFACTURER/
SHIPPER
FEI#: All manufacturers whose product is labeled for use in poultry
CHARGE: "The article is subject to refusal of admission pursuant to Section
801(a)(3) in that it appears to be a new animal drug within the meaning
of Section 201(w), without an approved new animal drug application as
required by Section 512 under the conditions prescribed, recommended, or
suggested by the label [Adulteration, Section 501(a)(5)]."
OASIS
CHARGE
CODE: NEW VET DR
RECOMMENDING
OFFICE: CVM/HFV-230
REASON FOR
ALERT: On October 4, 1996, FDA approved the use of enrofloxacin (Baytril 3.23%
Concentrate Antimicrobial Solution), a fluoroquinolone antimicrobial
drug, to control bacterial infections in poultry. FDA approved the use
of enrofloxacin only by prescription and under veterinary supervision.
The antibiotic was administered in the drinking water. Scientific data
has shown that continued use of enrofloxacin in poultry has resulted in
the emergence of fluoroquinolone-resistant Campylobacter in turkeys and
chickens who normally harbor this bacterium in their digestive tract
without causing them to become ill. These resistant bacteria spread
through transportation and slaughter, and are found on chicken carcasses
in slaughter plants and retail poultry meats. Campylobacter bacteria are
a significant cause of foodborne illness in the U.S. Fluoroquinolones
used in humans are ineffective if used to treat Campylobacter infections
that are resistant to them. This failure can significantly prolong the
duration of the infections and may increase the risk of complications.
The proportion of Campylobacter infections that are resistant to
fluoroquinolones has increased significantly since the use of
enrofloxacin in poultry was approved in the U.S.
As a consequence, effective September 12, 2005, the NADA for Baytril
3.23% Concentrate Antimicrobial Solution for use in poultry and sponsored
by Bayer Corporation has been withdrawn and its distribution and use are
no longer permitted.
GUIDANCE: Detain without physical examination entries of enrofloxacin labeled for
use in poultry. Do not detain other enrofloxacin products that are the
subject of an approved new animal drug application (NADA) and are labeled
for use in other animals (e.g. Baytril 100; Baytril Injectable;
Baytril Tablets; Baytril Taste Tabs ), or products that are the subject
of an investigational new animal drug application (INAD).
Contact Jack Geltman (240-276-9203) or the CVM, Division of Compliance
(240-276-9200) if you have any questions or concerns regarding entries of
enrofloxacin.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
KEYWORDS: Baytril, fluoroquinolones, enrofloxacin, Campylobacter, bacteria
resistance
PREPARED BY: Jack Geltman, CVM, HFV-232, 240-276-9241
Linda Wisniowski, DIOP, HFC-172, 301-443-6553
DATE LOADED
INTO FIARS: February 1, 2006
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