"Foreign Labeled Finished Dosage Parenterals"

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/***Office of 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.

Districts may detain without physical examination 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 ***the CDER/Office of Compliance (OC), Imports Exports Compliance Branch. The CDER/OC/Imports Exports Compliance Branch can be contacted at cderimportsexports@fda.hhs.gov***.

Questions for veterinary drugs should be directed to HFV-210.

Parenteral drugs, human and veterinary use.

Antibiotics, human use only

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)]."

OASIS charge code - UNAPPROVED


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)."

OASIS charge code - ANTIBIOTIC

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).]"


OASIS charge code - NO ENGLISH