IA #68-09, 10/9/03, IMPORT ALERT #68-09, "NEW BULK ANIMAL DRUG SUBSTANCES"
Note: This revision updates the CVM contacts and the format of
the import alert. New information is designated by
asterisks (***). The attachment remains the same.
TYPE OF ALERT: Surveillance
PRODUCT: New Animal Drugs (Bulk) (see attachment) due to
lack of approved new animal drug application
PRODUCT CODES: 56[]J[][][]***
56[]K[][][]***
56[]X[][][]***
68[][]S[][]***
69[][][][][]
PAC: 71002
PAF: AAP***
PROBLEM: Misbranding and/or adulteration
COUNTRY: ALL
MANUFACTURER/
SHIPPER: ALL
CHARGE: NADA:
Detain importations of bulk new animal drug substances
bearing indications for animal drug use, which are not
consigned to individuals or firms holding approved NADA'S
or INAD exemptions or are not from approved suppliers as
specified in the approved NADAs; charging:
"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 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))."
***(OASIS CHARGE CODE: NEW VET DR)***
Detain if the bulk new animal drug substance does not bear
any indications for animal use; charging:
"The article is subject to refusal of admission within the
meaning of Section 801(a)(3) in that it does not bear
adequate directions for use (Misbranding, Section
502(f)(1))."
***(OASIS CHARGE CODE: DIRECTIONS)***
INAD:
When bulk new animal drugs are offered for entry for
investigational (INAD) use, contact *** Jack Geltman,
Division of Compliance (HFV-232), Center for Veterinary
Medicine (240-276-9203) *** to determine whether the
requirements of 21 CFR 511.1(b)(9) have been met. *** For
any drugs being imported for fish, contact Fran Pell, CVM,
Division of Compliance (HFV-235) at 240-276-9211. *** If
prior notification (or statement from a scientific
institution) has not been given and CVM cannot make an
immediate determination that the import is to a legitimate
sponsor, detain the entry, charging:
"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 has been
approved and no notice of claimed investigational exemption
is on file for this drug."
***(OASIS CHARGE CODE: NEW VET DR)***
RECOMMENDING
OFFICE: Division of Import Operations and Policy, HFC-170 and CVM,
HFV-230
REASON FOR
ALERT: NADA - Imported bulk new animal drug substances labeled for
further manufacturing and processing, or labeled as
chemical substances, are frequently destined for
veterinarians and to pharmaceutical processors that
formulate animal drugs. These drug substances, consigned
to individuals or processors who formulate and distribute
animal drugs, may be adulterated under Section 501(a)(5) of
the Act or misbranded under Section 502(f)(1). It is the
responsibility of the distributor, whether the importer or
some other firm, to assure that these drugs are only
shipped to processors legally entitled to receive them.
INAD - Sponsors of investigational new animal drug (INAD)
exemptions frequently import from foreign countries either
the dosage form or bulk drug substances for use in
laboratory research or clinical trials. However, some
importers have found that they could obtain entry of large
amounts of unapproved new animal drugs if they would merely
advise the FDA that the entry was for investigational use
and supply an INAD number as reference. The FDA has
learned that some of these have not been legitimate.
Internally, the Center for Veterinary Medicine has
tightened its procedures for the issuance of INAD numbers.
The procedures in part implement the special notification
requirements of 21 CFR 511.1(b)(9). This regulation
pertains to the importation into the United States of a new
animal drug for use in clinical trials. The regulation
requires:
1. Prior notification to the FDA of the importer's
intention to import the new animal drug for
investigational use. This may be done by the INAD
sponsor or his agent; or
2. The new animal drug for investigational use is
shipped directly to an appropriate scientific
institution which has submitted a statement to the
FDA as sponsor of the clinical investigation.
GUIDANCE: Bulk new animal drug substances labeled for further
manufacturing or processing, or as harmless chemicals, and
bearing some indication for veterinary use, consigned to
veterinarians, veterinary drug distributors or processors,
should be detained since they are unapproved new animal
drugs in violation of 501(a)(5) unless the recipient holds
an approved NADA or an INAD exemption for preparation of a
finished dosage form drug or medicated feed premix from
that particular bulk drug source, or an approval is not
required at this time either by regulation or policy.
Bulk new animal drug substances labeled for further
manufacturing or processing, which do not bear any
indications for veterinary use, may be misbranded under
Section 502(f)(1) if they are intended for veterinary use
or for further processing as animal drugs. Intended use
may be established by showing the substances are consigned
to veterinarians, veterinary drug distributors or
processors, or by other evidence. Such drugs are in
violation of Section 502(f)(1) because they do not bear
adequate directions for use, except as specified in the
following paragraph.
21 CFR 201.122 exempts a drug from adequate directions for
use when labeled for further manufacturing and processing
and when used to manufacture a new animal drug which is
covered by an approved application or an investigational
exemption under Part 511. 21 CFR 201.150 exempts a drug,
which is intended to be further processed or manufactured,
from adequate directions when it is shipped under the terms
of a written agreement which, if followed, will assure the
finished product is not adulterated or misbranded.
Therefore, bulk new animal drug substances labeled for
further manufacturing and processing and shipped to
pharmaceutical manufacturers or processors are exempted
from applicable provisions of section 501 and 502 only if
shipped in accord with 21 CFR 201.122 and/or 21 CFR
201.150.
***Contact Jack Geltman, Division of Compliance (HFV-232)
Center for Veterinary Medicine (240-276-9203) *** to
determine the NADA approval status, the existence of a
valid INAD (Investigational exemption) or to determine if
the drugs are from approved foreign sources as specified in
the approved NADA's. In addition, be alert to the
importation of any new animal drug substance not consigned
to an approved NADA holder which bears the trade name of an
approved new animal drug.
A number of bulk new animal drugs, generally labeled or
declared as "harmless chemicals" or "for ornamental fish
use only", or similar wording, may be actually intended for
direct use in commercial food-fish aquaculture, despite
their labeling, and are frequently diverted for such food
fish use. These drugs may be adulterated under Section
501(a)(5) or misbranded under Section 502(f)(1), because of
such actual intended use in aquaculture. Importer's claims
for intended sale only for manufacture of, or direct user
as, drugs for ornamental fish use should be considered
suspicious at best. When such drugs are encountered,
contact *** Fran Pell, Division of Compliance (HFV-235),
Center for Veterinary Medicine (240-276-9211) *** for
guidance.
FOI: No purging is required
KEYWORDS: NADA, INAD, New Animal Drugs, Bulk Animal Drugs, Dosage
forms
PREPARED BY: Linda Wisniowski, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS: October 9, 2003
Attachment - Import Alert #68-09 Revised 11/09/93 Page 1
COMMON NEW ANIMAL DRUG SUBSTANCES
*** Acriflavin (Acriflavine)
Albendzaole
*** Amoxicillin
Benzathine penicillin G with or without procaine penicillin G
*** Benzocaine
Carbadox -1 2-(2-Quinoxalinylmethylene) hydrazinecarboxylic acid methyl
ester N,N4 -dioxide
*** Carp Pituitary Extract (CPE)
Chloramphenicol-D(-)threo-2,2-dichloro-N-[B-hydroxy-2-(hydroxymethyl)-p-
nitrophenethyl]acetamide
Chlortetracycline
*** Crystal Violet (gentian violet)
*** Cytochalasin B
Diethylstilbestrol (DES) - (E)-4,4 - (1,2,-Diethyl-1,2-ethenediyl)
bisphenol
*** Difloxacin
Dihydrostreptomycin
Dimethylsufoxide (DMSO) - Sulfinylbis [methane], methyl sulfoxide
Dimetridazole - 1,2-Dimethyl-5nitro-1H-imidazole
*** Enrofloxacin
*** Erythromyocin Phosphate
*** Flumequine
*** Formaldehyde (Formalin)
Furosemide - 5-(aminosulfonyl)-4-chloro-2[(2-furanylmethyl)amino]
benzoic acid
*** GNRHa
Gentamicin and Salts
Hexachloroethane
*** Human Chorionic Gonadotropin (HCG)
Ipronidazole - 1-Methyl-2-(1-methylethyl)-5-nitro-1H-imidazole
Iron polysaccharides (dextran & destrin)
Ivermectin
*** Kanamycin (Kanamycin Sulfate)
Ketamine - 2-(o-Chlorophenyl)-2-(methylamino-cyclohexanone
Lasaloid sodium
Levamisole (L-tetramisole) -
L-(-)2,3,5,6,-Tetrahydro-6-phenyl-imidazo-[2,1-b] thiazole
*** LHRHa
Linocomycin
*** Malachite Green (crystal and solution) (AKA victoria green)
Melengestrol acetate-17a-hydroxy-6-16-methyl-16-methylenepregna-4,
6-diene-3,2-dione
*** Methylene Blue
*** Metronidazole
Monensin
*** Nalixidic Acid
*** Neomycin Sulfate
*** Nifurpirinol
Nitrofurans (furazolidone, nitrofurazone, furaltadone, nihydrazone,
furacin)
Novobiocin sodium
*** Oxolinic Acid
Oxytetracyline (Oxytetracycline HCL)
Parbendazole - (5-Butyl-1H-benzimidazol-2-yl)-carbamic acid methyl
ester
Attachment - Import Alert #68-09 Revised 11/09/93 Page 2
COMMON NEW ANIMAL DRUG SUBSTANCES
Phenylbutazone - 4-butyl,1,2-diphenyl-3,5-pyrazolidinedione
Prostaglandins
*** Quinaldine Sulfate
*** Sarafloxacin
*** Salmonid Pituitary Extract (SPE)
Streptomycin
*** Streptomycin Sulfate
Sulfachloropyridazine - 4-animo-N-(6-chloro-3-pyridazinyl)
benzenesulfonamide
Sulfaethoxypyradizine - N-(6-ethoxy-3-pyridazinyl)-Sylfanilamide
Sulfadiazine - 4-amino-N-2-(2,6-dimethoxy-4 pyrimidinyl)
benzenesulfonamide
Sulfaethoxypyradizine - N-(6-ethoxy-3-pyridazinyl)-Sulfanilamide
Sulfadiazine - 4-amino-N-2-pyrimidinyl-benzenesulfonamide
*** Sulfamerazine - 4-amino-N-(4-methyl-4--2-pyrimidinyl)-Sulfanilamide
Sulfamethazine - (sulfadimidine_-4-amino-N(4,6-Dimethyl-2-pyrimidinyl)
Sulfathiazole - 4-amino-N-(5-methyl-3-isoxazoly) benzenesulfonamide)
Sulfathiazole - 4-amino-N-2-thiazolylbenzenesulfonamide
Tetracycline
Tetramisole - (+)-2,3,5,6,-tetrahydro-6-phenyl-imidazo[2,1-b]thiazole
Virginiamycin
Xylazine - N-(2,6-Dimethylphenyl)5,6-dihydro-4H-1,3-thiazin-2-imine
Zinc Bacitracin
Zoalene (Dinitolmide) - 2-Methyl-3,5-dinitrobenzamide
*** Drugs likely intended for use in aquaculture
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