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NY K81388




December 11, 2003
CLA-2-38:RR:NC:2:239 K81388

CATEGORY: CLASSIFICATION

TARIFF NO.: 3824.90.9150

Mr. Chad Craig
Gambro BCT, Inc.
10811 W. Collins Avenue
Lakewood, CO 80215

RE: The tariff classification of Anticoagulant Citrate Dextrose Solution A (ACD-A) (Catalog No. 777967-000) and Additive Solution Formula 3 (AS-3) (Catalog No. 777965-000) from the United Kingdom

Dear Mr. Craig:

In your letter dated November 25, 2003, you requested a tariff classification ruling.

The first submitted sample, Anticoagulant Citrate Dextrose Solution A (ACD-A), consists of a sealed, plastic pouch, with two port plugs at one end, filled with 750 mL of a clear, colorless, sterile liquid. The liquid consists of Dextrose monohydrate USP, Sodium citrate dihydrate USP, and Citric acid (anhydrous) USP dissolved in water. According to the label on the pouch, each 100 mL contains 2.45 grams of Dextrose monohydrate USP, 2.2 grams of Sodium citrate dihydrate USP, and 0.73 grams of Citric acid (anhydrous) USP. You describe the subject solution as “[a]n anticoagulant solution used only with the automated apheresis device to prevent the clotting of the blood during the collect and separation process.”

The second submitted sample, Additive Solution Formula 3 (AS-3), consists of a sealed, plastic pouch, with two port plugs at one end, filled with 100 mL of a clear, colorless, sterile liquid. The liquid consists of Dextrose monohydrate USP, Sodium citrate dihydrate USP, Sodium chloride USP, Monobasic sodium phosphate Monohydrate USP, Citric acid monohydrate USP, and Adenine USP dissolved in water. According to the label on the pouch, each 100 mL contains 1.10 grams of Dextrose monohydrate USP, 0.588 grams of Sodium citrate dihydrate USP, 0.410 grams of Sodium chloride USP, 0.276 grams of Monobasic sodium phosphate monohydrate USP, 0.042 grams of Citric acid monohydrate USP, and 0.030 grams of Adenine USP. You describe the subject solution as “[a] red blood cell storage solution to extend the length of time red blood cells can be stored following an automated collection by an automated apheresis medical device.”

You request that the two submitted samples be classified as medicaments within subheading 3004.90.9190, HTS. However, based on the description provided by you in your letter for each product (see above), we are of the opinion that neither is intended to treat or prevent a particular disease or ailment, as required by the statutory language of heading 3004, HTS. Accordingly, it is our determination that the two subject products are excluded from classification as medicaments under heading 3004, HTS.

The applicable subheading for the two subject products will be 3824.90.9150, Harmonized Tariff Schedule of the United States (HTS), which provides for “chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), 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. The rate of duty will remain the same in 2004.

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. See 21 CFR 640.64. 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 Andrew Stone at 646-733-3032.

Sincerely,

Robert B. Swierupski

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