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NY I82896




June 18, 2002

CLA-2-30:RR:NC:2:238 I82896

CATEGORY: CLASSIFICATION

TARIFF NO.: 2932.29.5050; 3004.90.9120

Jack D. Mlawski, Esq.
Galvin & Mlawski
470 Park Avenue South
Suite 200 - South Tower
New York, NY 10016-6819

RE: The tariff classification of Lovastatin (CAS-75330-75-5), and the tariff classification and country of origin marking of Mevacor® (Lovastatin) tablets; ARTICLE 509

Dear Mr. Mlawski:

This is in response to your letter dated June 5, 2002, on behalf of your client, Merck & Co., Inc., requesting a ruling on the country of origin of Mevacor® (Lovastatin) tablets (a medicament containing the lipid-lowering drug, Lovastatin, as the active ingredient) imported from Canada. Eight (8) mock-ups of labels, which may be used as labels on the outer containers or bottles of the imported tablets, were submitted with your request. In addition to the information you assert is required by the U.S. Food & Drug Administration (FDA) to appear on pharmaceutical labels, four of the submitted labels also contain the following wording:

“Lovastatin (active ingred.) made in USA Formulated in Canada”

Although not requested by you, this office is also ruling on the tariff classification of the active ingredient , i.e., Lovastatin, as well as the Mevacor® tablets, in the interest of the sound administration of the Customs and related laws.

The applicable subheading for Lovastatin will be 2932.29.5050, Harmonized Tariff Schedule of the United States (HTS), which provides for “Heterocyclic compounds with oxygen hetero-atom(s) only: Lactones: Other lactones: Other: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free. The applicable subheading for Mevacor® (Lovastatin) tablets will be 3004.90.9120, 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: Cardiovascular medicaments.” 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 Lovastatin is produced in the United States and exported to Canada, where it will be mixed with various excipients to produce the finished product, i.e., Mevacor® tablets. The tablets are then packaged for shipment to the United States. Accordingly, it is our determination that, pursuant to §181.1(q) and the appendix to Part 181 (see Part II, Section 4, subpart (3)) of the Customs Regulations, and General Note 12(b)(iii), HTS, the tablets qualify as an originating good under the NAFTA.

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. §134.1(c) of the Customs Regulations defines “Foreign origin” as referring to “[a] country of origin other than the United States .“ Therefore, since an article of U.S. origin is not of foreign origin, it is not subject to the country of origin marking requirements of Part 134 of the Customs Regulations.

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 tablets. Under this rule, the country of origin of the tablets is the country or countries of origin of the single material that imparts the essential character to them. In this case, we agree with your assertion, for the reason cited in HQ 735146, that the essential character is imparted by the active ingredient (i.e., the U.S.-produced Lovastatin). It is, therefore, our determination that the country of origin of the Mevacor® tablets is the United States. As such, they are not subject to the country of origin marking requirements of Part 134 of the Customs Regulations.

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.

Sincerely,

Robert B. Swierupski

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