Import Alert 68-01
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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 # 68-01
Published Date: 07/27/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Chloramphenicol"
Reason for Alert:
Marketing of chloramphenicol for aquarium fish has occurred for a number of years. Like many other aquarium fish products, chloramphenicol was permitted to be marketed without formal approval, although, it has never been demonstrated to be safe and effective for use in aquarium fish.
It is now recognized that a potential health risk exists due to a causal relationship between use of chloramphenicol and the development of a usually irreversible aplastic anemia in man. The case fatality rate is approximately 70%, and those who recover experience a high incidence of acute leukemia. This irreversible aplastic anemia does not seem to be related to the frequency or level of exposure to the drug. In fact, there appears to be a significant subgroup of the population with an apparent predisposed sensitivity to chloramphenicol. This type of blood dyscrasia has been associated with extremely low levels of exposure to the drug. An example is a rancher diagnosed as having aplastic anemia four months after he began treating his cattle with chloramphenicol. The treatment of aquarium fish with chloramphenicol presents the same health risk.
In view of the public health risk and the fact the safety and effectiveness of chloramphenicol in aquarium fish has not been established, CVM has concluded that all chloramphenicol products intended for aquarium use are New Animal Drugs (NAD's) which require approved NADA's for legal marketing.
We have previously permitted the importation of chloramphenicol if labeling or import records indicated the use only in aquarium fish. No further entries of either bulk chloramphenicol powder, capsules or tablets, or retail packaged chloramphenicol for any use should be permitted unless there is an exemption (INAD) or approved new animal drug application (NADA) on file. (Bulk chloramphenicol is also covered under Import Alert #68-09 as one of the common bulk chemicals that will not be released until or unless it is to be shipped to a holder of an approved NADA.
It is now recognized that a potential health risk exists due to a causal relationship between use of chloramphenicol and the development of a usually irreversible aplastic anemia in man. The case fatality rate is approximately 70%, and those who recover experience a high incidence of acute leukemia. This irreversible aplastic anemia does not seem to be related to the frequency or level of exposure to the drug. In fact, there appears to be a significant subgroup of the population with an apparent predisposed sensitivity to chloramphenicol. This type of blood dyscrasia has been associated with extremely low levels of exposure to the drug. An example is a rancher diagnosed as having aplastic anemia four months after he began treating his cattle with chloramphenicol. The treatment of aquarium fish with chloramphenicol presents the same health risk.
In view of the public health risk and the fact the safety and effectiveness of chloramphenicol in aquarium fish has not been established, CVM has concluded that all chloramphenicol products intended for aquarium use are New Animal Drugs (NAD's) which require approved NADA's for legal marketing.
We have previously permitted the importation of chloramphenicol if labeling or import records indicated the use only in aquarium fish. No further entries of either bulk chloramphenicol powder, capsules or tablets, or retail packaged chloramphenicol for any use should be permitted unless there is an exemption (INAD) or approved new animal drug application (NADA) on file. (Bulk chloramphenicol is also covered under Import Alert #68-09 as one of the common bulk chemicals that will not be released until or unless it is to be shipped to a holder of an approved NADA.
Guidance:
Districts may detain all entries of chloramphenicol intended for animal drug use (including those destined for use on aquarium fish) unless there is an exemption (INAD) or an approved new animal drug application (NADA) on file.
Product Description:
Chloramphenicol
Charge:
"The article is violative within the meaning of 801(a)(3) in that it appears to be a new animal drug without an effective New Animal Drug Application."
OASIS charge code - NEW VET DR
OASIS charge code - NEW VET DR
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(56 K - - 10) Chloramphenicol (Certifiable)
(68 - - - --) Animal Devices and Diagnostic Products
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