IA #66-05 - 8/14/92 REVISED, "Foreign Labeled Finished Dosage Parenterals"
TYPE OF ALERT: Automatic Detention
PRODUCT : Parenteral drugs, human and veterinary use.
Antibiotics, human use only
PRODUCT CODE : 60---- thru 66----- (human drugs)
70---- (animal drugs)
56----(antibiotic, human use)
HARMONIZED
CODE : Various
PROBLEM : New Drug Without Approved New Drug Application (DNRD)
Uncertified Antibiotic (DRUA)
Not Labeled in English (MLNE)
PAC FOR
COLLECTION : 56008H
COUNTRY : All
MANUFACTURER/
SHIPPER : All
MANUFACTURER/
SHIPPER I.D.#: N/A
IMPORTER'S
I.D. # : N/A
CHARGES : For Human or Veterinary Drug Products, Charge:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a new drug within
the meaning of Section 201(p), without an effective new drug
application [Unapproved New Drug, Section 505(a)]."
OR
For Antibiotics (human use), Charge:
The article is subject to refusal of admission pursuant to
801(a)(3) in that it appears to be misbranded because it is
not exempt from the certification provisions of the Act,
Section 502(l), nor the subject of an Approved Antibiotic
Application as required by the Regulation 21 CFR 433.1(b)."
OR
Import Alert #66-05 Revised 7/27/92 Page 2
If not labeled in English, Charge:
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears not to be labeled in
English language [Misbranded, Section 502(a).]"
RECOMMENDING
OFFICE : CDER/Division of Drug Labeling Compliance (HFD-310)
REASON FOR
ALERT : In 1987, Chicago district detained a shipment of Doxorubicin
Hydrochloride for injection in finished dosage units labeled
in English for the United Kingdom. Entry was attempted under
the foreign manufacturer's (Farmatalia) NDA number, but that
NDA only applied to a product manufactured and labeled
according to NDA requirements. This article was purchased on
the world market, not directly from the manufacturer. Other
shipments of various finished dosage parenterals had earlier
been imported labeled in a foreign language.
CDER/Prescription Drug Compliance Branch, Division of Drug
Labeling Compliance, is concerned that such products were not
manufactured for marketing in the United States and are not
identical to the NDA approved product.
Review of detention data for FY90 - 92 indicates that
parenteral drug and antibiotic products, presented for entry
as either personal importations or commercial entries, are
being detained under this alert, therefore the alert will
remain in effect.
INSTRUCTIONS : Automatically detain parenteral drug products for human or
veterinary use, and antibiotics, (human use) with appropriate
charges cited above.
Questions concerning detentions and/or labeling requirements
for human drugs should be directed to CDER/Division of Drug
Labeling Compliance (HFD-310/FTS-8-295-8073). Questions for
veterinary drugs should be directed to HFV-210, FTS 8-443-
3044.
FOI : No purging is necessary.
KEYWORDS : Parenteral, antibiotic, veterinary, drugs, uncertified,
unapproved
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
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