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NY K82458

January 27, 2004
CLA-2-38:RR:NC:2:238 K82458


TARIFF NO.: 3824.90.9150

Mr. Lawrence Sweeney
Genzyme Corporation
11 Pleasant Street Connector
P.O. Box 9322
Framingham, MA 01701-9322

RE: The tariff classification of Celsior™ from France

Dear Mr. Sweeney:

In your letter dated January 12, 2004, you requested a tariff classification ruling.

The subject product, Celsior™, is a clear-to-slightly-yellow, sterile, nonpyrogenic, extracellular solution for hypothermic flushing and storage of hearts. It is intended for flushing and cold storage of hearts at the time of their removal from the donor, in preparation for storage, transportation, and eventual transplantation into a recipient. The quantitative composition of Celsior™ is as follows: Mannitol (60mmol), Lactobionic Acid (80 mmol), Glutamic Acid (20 mmol), Histidine (30 mmol), Calcium Chloride (0.25 mmol), Potassium Chloride (15 mmol), Magnesium Chloride (13 mmol), Sodium Hydroxide (100 mmol), Reduced Glutathione (3 mmol) and Water for Injection (Up to 1 liter). Celsior™ is supplied put up in 1-liter bags

You state in your letter that the “primary ingredient” in Celsior™ is Lactobionic Acid, whose CAS number (CAS-96-82-2) is listed in Table 3 of the Pharmaceutical Appendix to the Tariff Schedule. You also state that “Celsior includes drug components that were approved by the FDA.” Lastly, you opine that Celsior™ is properly classifiable as a medicament under heading 3004, HTS.

The classification of substances as “drugs” - for tariff purposes - is predicated upon the principles enunciated in Lonza, Inc. v. U.S., 46 F.3d 1098 (Fed. Cir. 1995). The first part of the Lonza test requires that a substance have “therapeutic or medicinal” properties. “Therapeutic” and “medicinal” have been judicially construed to mean “[h]aving healing or curative powers” and “curing, healing, or relieving,” respectively. The second requirement for classification as “drugs” under Lonza is that substances be “chiefly used as medicines or as ingredients in medicines.”

The phrase “chiefly used” indicates that classification as a drug depends upon principal use. “[A] tariff classification controlled by use (other than actual use) is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation . . ..” Additional U.S. Rule of Interpretation 1(a), HTSUS. We were able to locate an article on the World Wide Web suggesting that, based on preliminary experiments, topical application of Lactobionic Acid may be useful in enhancing wound healing. See www.neostrata.com.: “Lactobionic Acid - a Novel Polyhydroxy Bionic Acid for Skincare.” However, we were unable to locate any reference to Lactobionic Acid (or any of the other ingredients making up Celsior™, for that matter) which would lead us to believe that it is principally used as a medicine or as an ingredient in a medicine. Nor, for the reasons cited in Headquarters Ruling Letter 963030, dated October 23, 2000, can it be argued that inclusion in the Pharmaceutical Appendix of the Tariff Schedule automatically imbues a substance with therapeutic properties. It is, therefore, our determination, based on the facts presented above, that the subject product is excluded from classification as a medicinal preparation (i.e., medicament) under heading 3004, HTS.

The applicable subheading for the subject product will be 3824.90.9150, Harmonized Tariff Schedule of the United States (HTS), which provides for “[c]hemical products and preparations of the chemical and allied industries , not elsewhere specified or included; residual products of the chemical or allied industries, not elsewhere specified or included: Other: Other: Other: Other: Other: Other.” The rate of duty will be 5 percent ad valorem.

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.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

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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