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NY K83806




March 15, 2004
CLA-2-30:RR:NC:2:238 K83806

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9185; 3004.90.9115; 3004.90.9120

Mr. Ron Reuben
Danzas AEI Customs Brokerage Services
5510 West 102nd Street
Los Angeles, CA 90045

RE: The tariff classification of Pulmozyme® (dornase alfa) Inhalation Solution; Raptiva® (Efalizumab) for injection, subcutaneous; Rituxan® (Rituximab); TNKase™ (Tenecteplase); and Xolair® (Omalizumab) for subcutaneous use

Dear Mr. Reuben:

In your letter dated February 26, 2004, on behalf of your client, Genentech, Inc., you requested a tariff classification ruling.

The first product, Pulmozyme® (dornase alfa) Inhalation Solution, is a medicament containing recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA, as the active ingredient. It is indicated for the treatment of Cystic fibrosis. Pulmozyme® (dornase alfa) Inhalation Solution is supplied as a sterile, clear, colorless, aqueous solution in single-use ampules.

The second product, Raptiva® (Efalizumab) for injection, subcutaneous, is a medicament containing Efalizumab, an immunosuppressive recombinant humanized IgGI kappa isotype monoclonal antibody, as the active ingredient. It is indicated for the treatment of adults with with chronic moderate-to-severe plaque psoriasis. Raptiva® (Efalizumab) for injection is supplied as a lyophilized, sterile powder to deliver 125 mg of efalizumab per single-use vial. Each Raptiva® carton contains four trays, with each tray containing one single-use vial designed to deliver 125 mg of efalizumab, one single-use prefilled diluent syringe containing 1.3 mL sterile water for injection, two 25 gauge x inch needles, two alcohol prep pads, and a package insert with an accompanying patient information insert.

The third product, Rituxan® (Rituximab), is a medicament containing Rituximab (a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes) as the active ingredient. It is intended for use in the treatment of CD20-positive, B-cell non-Hodgkin’s lymphoma. Rituxan® (Rituximab) is supplied as a sterile, clear, colorless, preservative-free liquid put up in single-use vials.

The fourth product, TNKase™ (Tenecteplase), is a medicament containing Tenecteplase, a tissue plasminogen activator (tPA) produced by recombinant DNA technology, as the active ingredient. It is indicated for the treatment of acute myocardial infarction. TNKase is supplied as a sterile, lyophilized powder in a 50 mg vial. Each vial is packaged with one 10 mL vial of sterile water for injection (for reconstitution), the B-D® 10 cc syringe with TwinPak™ Dual Cannula Device, and three alcohol prep pads.

The fifth product, Xolair® (Omalizumab) for subcutaneous use, is a medicament containing Omalizumab [a recombinant DNA-derived humanized IgG1 kappa monoclonal antibody that selectively binds to human immunoglobulin E (IgE)] as the active ingredient. It is indicated for the treatment of asthma. Xolair® (Omalizumab) for subcutaneous use is supplied as a lyophilized, sterile powder in a single-use, 5-cc vial that is designed to deliver 150 mg of Xolair® upon reconstitution with 1.4 mL of sterile water.

The applicable subheading for Pulmozyme® (dornase alfa) Inhalation Solution and Xolair® (Omalizumab) will be 3004.90.9185, 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: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other.” The rate of duty will be free.

The applicable subheading for Raptiva® (Efalizumab) for injection, subcutaneous and Rituxan® (Rituximab) will be 3004.90.9115, 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: Other: Other: Antineoplastic and immunosuppressive medicaments.” The rate of duty will be free.

The applicable subheading for TNKase™ (Tenecteplase) 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 (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Other: Other: Other: Cardiovascular medicaments.” 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 1-888-443-6332.

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.

Sincerely,

Robert B. Swierupski

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