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NY I88116

November 15, 2002

CLA-2-30:RR:NC:2:238 I8116


TARIFF NO.: 3004.90.9140

Mr. Brian Kavanaugh
Deringer Logistics Consulting Group
1 Lincoln Blvd., Suite 225
Rouses Point, NY 12979

RE: The tariff classification and country of origin marking of ampoules containing Apomorphine Hydrochloride as the active ingredient; ARTICLE 509

Dear Mr. Kavanaugh:

This is in response to your letter dated October 29, 2002, on behalf of your client, Draxis Pharma, requesting a ruling on the tariff classification and country of origin of ampoules containing the emetic Apomorphine Hydrochloride as the active ingredient. For the record, we note, as indicated in your letter, that this office, in NY H89094, dated March 25, 2002, ruled that Apomorphine Hydrochloride, imported in bulk form, was properly classifiable within subheading 2933.99.7000, HTS.

The applicable subheading for ampoules containing Apomorphine Hydrochloride as the active ingredient will be 3004.90.9140, Harmonized Tariff Schedule of the United States (HTS), which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Medicaments primarily affecting the central nervous system: Other.” The general rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

You state that Apomorphine Hydrochloride will be produced in France and exported to Canada. In Canada, the Apomorphine Hydrochloride will be mixed with Sodium Hydroxide (produced in Sweden) and Hydrochloric Acid (produced in the United States), for pH adjustment, and then put up in ampoules. The ampoules will then be packaged and labeled, using packaging materials and labels of Canadian origin, for shipment to the United States. Based on the foregoing circumstances, it is our determination that, pursuant to General Note 12(b)(ii)(A), HTS, the imported product qualifies as “goods originating in the territory of a NAFTA party.”

The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate the ultimate purchaser in the U.S. the English name of the country of origin of the article. Part 134 of the Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304.

The country of origin marking requirements for a "good of a NAFTA country" are also determined in accordance with Annex 311 of the North American Free Trade Agreement ("NAFTA"), as implemented by section 207 of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat 2057) (December 8, 1993) and the appropriate Customs Regulations. The Marking Rules used for determining whether a good is a good of a NAFTA country are contained in Part 102 of the Customs Regulations. The marking requirements of these goods are set forth in Part 134 of the Customs Regulations.

Section 134.45(a)(2) of the Customs Regulations, provides that "a good of a NAFTA country” may be marked with the name of the country of origin in English, French or Spanish. Section 134.1(g) of the regulations, defines a "good of a NAFTA country" as an article for which the country of origin is Canada, Mexico or the United States as determined under the NAFTA Marking Rules.

Applying the NAFTA Marking Rules set forth in Part 102 of the Customs Regulations to the facts of this case, we find that, having failed to satisfy any of the criteria set forth in §102.11(a), §102.11(b)(1) is the rule which must be applied to the imported ampoules. Under this rule, the country of origin of the imported ampoules is the country or countries of origin of the single material that imparts the essential character to them. In this case, the essential character is imparted by the active ingredient, (the French-produced) Apomorphine Hydrochloride. It is, therefore, our determination that the country of origin of the imported goods is France.

This ruling is being issued under the provisions of Part 181 of the Customs Regulations (19 C.F.R. Part 181).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.


Robert B. Swierupski

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