IMPORT ALERT #66-05                         REVISED 7/27/92


This alert was inadvertently cancelled on May 22, 1992.  This revision
updates the information and reformats the text of the alert.


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

               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.