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HQ 964020

September 18, 2000

CLA-2 RR:CR:GC 964020 AM


TARIFF NO.: 3004.90.90

Port Director
2nd and Chestnut Streets
Philadelphia, PA 19106

RE: Protest 1101-00-100042; ZD 1839 tablets

Dear Port Director:

This is in regard to protest 1101-00-100042, concerning your classification of ZD 1839 tablets under the Harmonized Tariff Schedule of the United States (HTSUS). Protestant argues that ZD 1839 tablets should be classified under subheading 3004.90.90 HTSUS.


ZD 1839 100 milligram tablets are imported from Great Britain for use in Food and Drug Administration (FDA) clinical trials. ZD 1839 is being investigated for use in the treatment of various cancers, especially non-small cell lung cancer. ZD 1839 has the chemical name 4-quinazolineamine, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl)propoxy] and the CAS registry number of 184475-35-2, which is listed in Table 3 of the Pharmaceutical Appendix to the Tariff Schedule. After completion of clinical trials, and pending approval of a new drug application by the FDA, the manufacturer intends to market ZD 1839, put up in tablet form, under the trade name, IRESSA™.

The merchandise was entered on June 2, 1999 and liquidated on November 19, 1999 under the subheading 2921.42.90 HTSUS, as an "other aromatic mono-amines." A protest was timely filed February 15, 2000.


Whether tablets containing ZD 1839 used in clinical trials for the treatment of non-small cell lung cancer are classified in subheading 3004.90.90.


In the May 24, 2000, CUSTOMS BULLETIN, Vol. 35, No 21, Customs published a document entitled “Guidance Concerning the Tariff Classification of Pharmaceutical Products Imported for Clinical Research.” There, Customs announced its intention to classify Pharmaceutical Products imported in dosage form for use in clinical trials as "medicaments" of heading 3004, HTSUS. Here, the chemical compound comprising ZD 1839 tablets is listed in table 3 of the Pharmaceutical Appendix. The substance has been approved by the FDA for Investigational New Drug [IND] status and has been issued IND #54576. Presently, the tablets are imported for use in clinical trials where they are administered to patients suffering from a specific disease (lung cancer), so as to cure such condition. Hence, ZD 1839 is used as a medicine and should be classified as a medicament when in tablet form.


The protest is ALLOWED. Tablets containing ZD 1839 as their active ingredient are classified in subheading 3004.90.90, HTSUS, as “other” medicaments and should be entered free of duty.

In accordance with Section 3A(11)(b) of Customs Directive 099 3550065, dated August 4, 1993, Subject: Revised Protest Directive, you are to mail this decision, together with the Customs Form 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry or entries in accordance with the decision must be accomplished prior to mailing the decision.

Sixty days from the date of the decision, the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other methods of public distribution.


John Durant, Director

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