IA#68-01, ---- 5/12/92, REVISED
Note: This revision updates information and reformats the text of the alert.
TYPE OF ALERT : Automatic Detention
PRODUCT : Chloramphenicol
PRODUCT CODE : 68-----
HARMONIZED
CODE : 2933
PROBLEM : New animal drug without an approved new animal drug
application (NADA) (DRAD)
COUNTRY : Multiple
MANUFACTURER : N/A
MANUFACTURER
ID NO. : N/A
SHIPPER : N/A
SHIPPER ID NO. : N/A
CHARGE : "The article is subject to refusal of admission within
the meaning of Section 801(a)(3) in that it appears to
be a new animal drug and no new animal drug application
(NADA) has been approved and/or no notice of claimed
investigational exemption is on file for this drug or the
drug is not from an approved foreign source as specified
in the approved NADA, (Adulteration, Section 501(a)(5)."
RECOMMENDING
OFFICE : Division of Import Operation and Policy
(HFC-131) and CVM/HFV-236.
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 the 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 (NADA's) which require approved NADA's.
FY 89-91 detention data indicated at least 6 detentions
of chloramphenicol have been made. 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.
INSTRUCTIONS : Automatically detain all entries of chloramphenicol
intended for animal drug use (including those destined
for use on aquarium fish) unless there is a exemption
(INAD) or an approved new animal drug application (NADA)
on file. Contact HFI-236/CVM FTS 8-295-8785 to check if
application is current.
PRIORITIZATION :
FOI : No purging required.
KEY WORDS : Chloramphenicol, NADA, Feed.
PREPARED
BY : Linda Wisniowski, DIOP, (301)443-6553.
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