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NY F82374

February 14, 2000

CLA-2-30:RR:NC:2:238 F82374


TARIFF NO.: 3004.90.9090

Jack D. Mlawski, Esq.
Galvin & Mlawski
440 Park Avenue South, 9th Floor
New York, NY 10016-8067

RE: The tariff classification and country of origin marking for single-dose diluent syringes prefilled with sterile water

Dear Mr. Mlawski:

In your letter dated January 24, 2000, on behalf of your client, Merck & Co., Inc., you requested a tariff classification and country of origin marking ruling. A label bearing the marking your client intends to use for the subject product, along with an unmarked sample of the prefilled syringe with its plunger (minus the needle), was also submitted with your request

The subject product, designated as SINGLE-DOSE PREFILLED STERILE DILUENT SYRINGE FOR USE WITH M-M-R®II ONLY, consists of a kit containing five single-dose diluent syringes (with plungers) prefilled with 0.7 ml of sterile water (the diluent) , and ten 25-gauge 5/8” needles. The syringes are manufactured - and prefilled - by Becton Dickinson in France and will be imported solely for use by medical personnel in order to reconstitute dried M-M-R®2 (measles-mumps-rubella) vaccines, prior to their administration to patients. In this respect, we note the appearance of the words, “Diluent not for direct injection,” on the label. In actual use, the health practitioner, after attaching a needle (i.e., one of the ten needles imported with the kit) to the prefilled syringe, first injects the sterile-water diluent into a vial containing dried vaccine, in order to reconstitute it (i.e., the dried vaccine). The reconstituted vaccine is then drawn back into the syringe, and the needle removed and discarded. A new needle is now attached to the syringe for injection of the reconstituted vaccine into the patient. You state that, as imported, the five prefilled syringes (with plungers) will be contained in a tray, with the barrel of each syringe labeled as follows:

No. 4987 Dist. By:
Single Dose 0.7 mL Syringe MERCK & CO., INC. STERILE DILUENT West Point, PA 19486, USA FOR USE WITH M-M-R® II ONLY Manuf. by: Becton Dickinson France S.A. 38800-France (Sterile Water) Made in France

The tray is sealed with a tamper-proof seal, and a single blister pack containing the ten needles is placed on top of of the sealed tray. The sealed tray and the blister pack will, in turn, be sealed in a sales carton with a label (i.e., the submitted label) bearing, in addition to all of the information listed on the syringe-barrel label (above), the following: “This package also contains 10 25 gauge 5/8” needles.” You also state that the sealed and labeled sales carton constitutes the product that is actually sold and delivered to the health care provider (i.e., the end user/ultimate purchaser).” Finally, we note that the country of origin designation: “Made in France,” is in close proximity to and the same size as the wording appearing on both the aforementioned syringe-barrel and sales-carton labels showing your client’s U.S. locality (i.e., West Point, PA 19486, USA).

Pursuant to Explanatory Note 30.04(a),the applicable subheading for the subject product will be 3004.90.9090, 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: Other." The 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.

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, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.41(b), Customs Regulations (19 CFR 134.41(b)), mandates that the ultimate purchaser in the U.S. must be able to find the marking easily and read it without strain. Section 134.1(d), defines the ultimate purchaser as generally the last person in the U.S. who will receive the article in the form in which it was imported. If an imported article is to be sold at retail in its imported form, the purchaser at retail is the ultimate purchaser. In this case, the ultimate purchaser of the subject product is the health care provider who purchases it at retail.

An article is excepted from marking under 19 U.S.C. 1304 (a)(3)(D) and section 134.32(d), Customs Regulations (19 CFR 134.32(d)), if the marking of a container of such article will reasonably indicate the origin of such article. Accordingly, if Customs is satisfied that the article will remain in its container until it reaches the ultimate purchaser, and if the ultimate purchaser can tell the country of origin of the components making up each of the subject products by viewing the container in which each product is packaged, the individual components would be excepted from marking under this provision.

Section 134.46, Customs Regulations (19 CFR 134.46), deals with cases in which the words "United States," or "American," the letters "U.S.A.," any variation of such words or letters, or the name of any city or locality in the United States, or the name of any foreign country or locality other than the country or locality in which the article was manufactured or produced, appears on an imported article or its container, and those words, letters or names may mislead or deceive the ultimate purchaser as to the actual country of origin. In such a case, there shall appear, legibly and permanently, in close proximity to such words, letters, or name, and in at least a comparable size, the name of the country of origin preceded by "Made in," “Product of," or other words of similar meaning. In order to satisfy the close proximity requirement, the country of origin marking must generally appear on the same side(s) or surface(s) in which the name or locality other than the actual country of origin appears.

In our opinion, the country of origin marking appearing on the label of the sealed sales carton satisfies the marking requirements of 19 U.S.C. 1304 and 19 CFR Part 134, and is an acceptable country of origin marking for the components comprising the imported product.

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 212-637-7068.


Robert B. Swierupski

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