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NY L83262

March 25, 2005

CLA-2-90:RR:NC:N1:105 L83262


TARIFF NO.: 9019.20.0000, 3004.31.0000

Mr. Thomas Czubak
Pfizer Inc.
100 Route 206 North MS 920
Peapack, NJ 07977

RE: The tariff classification of a Dry Powder Insulin Inhaler and Certain Parts Thereof from the United Kingdom

Dear Mr. Czubak:

In your letter dated March 2, 2005, you requested a tariff classification ruling. A sample was submitted.

You state: “Through a collaborative agreement with Pfizer, Nektar is providing the advanced inhalation technology being used by Pfizer in the development of Exubera, an inhaled, rapid-acting, dry-powder insulin. Exubera is being developed for patients with Type 1 and Type 2 diabetes. The Nektar Pulmonary Inhaler (sample enclosed) disperse fine, dry respirable powders (insulin in a foil dosage format) in a reproducible fashion for optimal systemic or local lung delivery. The medical device (a sample is provided) will be manufactured in the United Kingdom by a Nektar subsidiary and imported by Pfizer.

The aforementioned inhaler will be imported into Indianapolis and other mid-western ports as a completed article and certain replacement parts. The completed inhaler will contain a base, chamber and transjector. Separately, the chamber and transjector will also be imported. The insulin (in a foil dosage format) may or may not be imported together with the completed inhaler.

It is our contention that the complete inhaler with insulin is properly classifiable under HTS 3004.90.9120 and is duty free.

The complete inhaler without insulin is properly classifiable under HTS 8424.20.1000 dutiable at 2.9%.

The transjector part of the inhaler is properly classifiable under HTS 3626.90.9880 dutiable at 5.3%.

The chamber part of the inhaler is properly classifiable under HTS 3626.90.9880 dutiable at 5.3%.”

Exubera® (inhaled insulin), consists of a short-acting insulin preparation, in powder form, that is inhaled into the lungs, prior to eating, using a specially designed pulmonary inhaler. The insulin preparation is put up in single-dose foil packets, which are inserted into the inhaler for pulmonary delivery. The product is indicated for the treatment of type 1 and type 2 diabetes. A press release found on the Worldwide Web, dated March 2, 2005, announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing, a new drug application (NDA) for Exubera® (inhaled insulin).

You propose classification in 8424 for the complete inhaler without insulin. Note 1(m) excludes articles of Chapter 90 from Section XVI; hence, 8424 is not appropriate. Aerosol Therapy or Other Therapeutic Respiration Apparatus is not limited to those used as therapy for the respiratory system per se noting the periodontal aerosol-type hand sprays in Harmonized System Explanatory Note VI to 9019.

You propose classification of the inhaler chamber in subheading 3926.90.9880, Harmonized Tariff Schedule of the United States (HTS), which provides for other articles of plastics, other. The chamber is included as a part in heading 9019 of the HTS, which is in Chapter 90. It is clear from its very particular and elaborate dimensions that it is made specifically to be used as an element of the complete inhaler, which is sufficient per the principle in Headquarters Ruling Letter 965546 GOB, 8-6-02. Articles of Chapter 90 are precluded from classification in any of the provisions of Chapter 39 by legal Note 2(r) to Chapter 39. It does not appear to be excluded from HTS Chapter 90 by its Note 2-a or 1 or by HTS Add. US Rule of Interp. 1-c (see HRL 965968, 12-16-02.)

The applicable HTS subheading for the single-dose foil packets containing insulin preparation, imported with the inhalation delivery device, will be 3004.31.0000, HTS, which provides for “Medicamentsconsisting 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: Containing hormones or other products of heading 2937 but not containing antibiotics: Containing insulin.” The rate of duty will be free.

The applicable subheading for the complete inhaler without insulin and the chamber part will be 9019.20.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for, inter alia, ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus and parts and accessories thereof. The rate of duty will be free.

The sample is being returned to you in a separate mailing.

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

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.

Regarding the “transjector” part, it is not clear if it will be excluded from HTS Chapter 90, especially by its Note 2-a. Therefore, regarding it, we are returning your request for a ruling, and any related samples, exhibits, etc.

We need additional information in order to issue a ruling. Please submit:
descriptive literature or a detailed explanation on the use of the item
descriptive literature or a detailed explanation on how the item operates/functions
specifically, details of the function of what appear to be metal and black rubber subcomponents. Also, is the transjector designed to control the flow of the gas and powder which apparently will go through it? If so, exactly how?

If you decide to resubmit your request, please include all of the material that we have returned to you regarding the transjector and mail your request to U.S. Customs and Border Protection, Customs Information Exchange, 10th Floor, One Penn Plaza, New York, NY 10119, attn: Binding Rulings Section.

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 J. Sheridan at 646-733-3012.


Robert B. Swierupski

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