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NY J82840

April 3, 2003

CLA-2-30:RR:NC:2:238 J82840


TARIFF NO.: 3004.50.5020

Ms. Jodi C. Latner
Livingston International Trade Services, Inc. Gateway Executive Park
3556 Lakeshore Road, Suite 200
Buffalo, NY 14219

RE: The tariff classification and country of origin marking of glass ampoules containing Hectorol® (doxercalciferol) Injection; ARTICLE 509

Dear Ms. Latner:

This is in response to your letter dated March 5, 2003, resubmitted March 25, 2003, on behalf of your client, Bone Care International, requesting a ruling on the tariff classification and country of origin of glass ampoules containing Hectorol® (doxercalciferol) Injection, a medicament containing doxercalciferol (a synthetic derivative of Vitamin D2) as the active ingredient. According to your client’s monograph in the 2002 edition of the Physicians’ Desk Reference®, Hectorol® Injection is indicated for the reduction of elevated iPTH (parathyroid hormone) levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.

The applicable subheading for Hectorol® (doxercalciferol) Injection supplied in glass ampoules willl be 3004.50.5020, 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other medicaments containing vitamins or other products of heading 2936: Other: Other: Single vitamins: 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 in your letter that doxercalciferol (i.e., the active ingredient) will be produced in Israel and imported into the U.S. in non-sterile, bulk form, for testing. After testing, the doxercalciferol will be exported to Canada, where it will be mixed with various excipients to form Hectorol®. The Hectorol® will then be put up in glass ampoules, thus forming the finished medicament, i.e. Hectorol® Injection. The ampoules, in turn, will then be packed in cartons (each carton to contain 50 ampoules) for shipment to and sale in the U.S.

Your letter also indicates the following: “Bone Care International does not sell individual ampoules and the patient does not see the ampoule or the carton. A dialysis clinic buys the product by the carton; a nurse selects an ampoule out of the carton, opens it, and draws the solution into a syringe. The Hectorol is then administered via the syringe. Bone Care International has indicated this product to be light sensitive. As such, a key design feature of the ampoule is that it is amber in color. Amber glass itself does not totally block light, and therefore, the cardboard carton is intended to further block the light from the product. As a result, this product would not be separated from the carton until it is administered by the nurse as to do so would compromise the utility of the Hectorol.”

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 to 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, i.e., the Israeli-produced doxercalciferol. We agree, therefore, with your contention that the country of origin of the imported ampoules is Israel. We also agree, pursuant to HQ 734232 and HQ 562012, with your contention that the ultimate purchaser of the ampoules is the dialysis clinic, and not the patient being treated at the clinic. Therefore, provided that the container in which the dialysis clinic receives the ampoules is properly marked with Israel as the country of origin, the individual ampoules will be excepted from the marking requirements. See 19 U.S.C. 1304(a)(3)(D) and 19 CFR 134.32(d).

Finally, you indicate in your letter that your client proposes to mark the carton as follows: “Made in Israel; Manufactured by Draxis Pharma, Inc., for Bone Care International, Inc.; Bone Care International, Inc.; Bone Care Center, 1600 Aspen Commons; Middleton, WI 53562.” For the record, we have no objection to marking the carton in this manner, provided the requirements of 19 CFR 134.41(b) and 19 CFR 134.46 are met.

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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