Import Alert 56-02
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(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).
Import Alert # 56-02
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
Detention Without Physical Examination Of Enrofloxacin (Baytril) Labeled For Use In Poultry
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for Baytril 3.23% Concentrate Antimicrobial Solution for use in poultry and sponsored by Bayer Corporation has been withdrawn and its distribution and use are no longer permitted.
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:
Districts may 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 the CVM, Division of Compliance if you have any questions or concerns regarding entries of enrofloxacin.
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 the CVM, Division of Compliance if you have any questions or concerns regarding entries of enrofloxacin.
Product Description:
Enrofloxacin (Baytril 3.23%) 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
OASIS Charge Code - NEW VET DR
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(56 O - - 05) Enrofloxacin (Fluoroquinolone)
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