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HQ 965391




March 11, 2002

CLA-2 RR:CR:GC 965391AM

CATEGORY: CLASSIFICATION

TARIFF NO.: 2922.19.09 duty free

Area Port Director
U.S. Customs Service
#1 La Puntilla
San Juan, Puerto Rico

RE: Internal Advice 009/01; Atomoxetine hydrochloride

Dear Port Director:

This is in regard to your memorandum (FIS 4-08: FO:CM:PR:AP: SIS), dated November 8, 2001, forwarding a request for internal advice initiated by letter dated October 17, 2001, by counsel on behalf of Eli Lilly, Inc., which seeks verification that a name change of the product will not effect its duty free status under General Note 13 to the Harmonized Tariff Schedule of the United States (HTSUS).

FACTS:

Tomoxetine hydrochloride (CAS-82248-59-7) is the hydrochloride salt of Tomoxetine (CAS-83015-26-3), which represents the International Nonproprietary Name ("INN"). "Tomoxetine" is listed in Table 1 of the Pharmaceutical Appendix to the HarmonizedTariff Schedule, while the suffix "Hydrochloride" is listed in Table 2 of said Appendix.

Tomoxetine hydrochloride is presently classified in subheading 2922.19.09, HTSUS, the provision for "[O]xygen-function amino-compounds: [A]mino-alcohols, their ethers and esters, other than those containing more than one kind of oxygen function; salts thereof: [O]ther: [A]romatic: [D]rugs." The "Special" subcolumn for this provision contains the word “Free” followed by the symbol “K” in parentheses.

"Atomoxetine" has become the newly established United States Adopted Name (USAN), replacing the name "Tomoxetine." However, the INN remains "Tomoxetine." USP Dictionary of USAN and International Drug Names, 2001 USP Dictionary Supplement 3, Vol.27, No. 6, Nov.-Dec. 2001. We note that "[n]o procedure or mechanism currently exists for changing a recommended INN." USP Quality Review, p. 2.

ISSUE:

Is Atomoxetine hydrochloride entitled to duty free status under General Note 13, HTSUS?

LAW AND ANALYSIS:

Merchandise imported into the United States is classified under the HTSUS. The Pharmaceutical Appendix was incorporated into the HTSUS by Presidential Proclamation. See Proclamation No. 6763, 60 Fed. Reg. 1007 (1994). This Proclamation also added General Note 13 to the HTSUS. General Note 13 states the following:

Pharmaceutical products. Whenever a rate of duty of "Free" followed by the symbol "K" in parentheses appears in the "Special" subcolumn for a heading or subheading, any product (by whatever name known) classifiable in such provision which is the product of a country eligible for tariff treatment under column 1 shall be entered free of duty, provided that such product is included in the pharmaceutical appendix to the tariff schedule. Products in the pharmaceutical appendix include the salts, esters and hydrates of the International Non-proprietary Name (INN) products enumerated in table 1 of the appendix that contain in their names any of the prefixes or suffixes listed in table 2 of the appendix, provided that any such salt, ester or hydrate is classifiable in the same 6-digit tariff provision as the relevant product enumerated in table 1.

Atomoxetine hydrochloride remains duty free under General Note 13, HTSUS, because its INN is listed in Table 1 and its suffix is listed in Table 2 of the Pharmaceutical Appendix to the HTSUS.

HOLDING:

Atomoxetine hydrochloride, INN tomoxetine hydrochloride, is classified in subheading 2922.19. 09, HTSUS, and entitled to duty free entry under General Note 13, HTSUS.

You are directed to mail this decision to the internal advice applicant, no later than 60 days from the date of this letter. On that date the Office of Regulations and Rulings will make the decision available to Customs personnel, and to the public on the Customs Home Page on the World Wide Web at www.customs.gov, by means of the Freedom of Information Act, and other public methods of distribution.

Sincerely,

John Durant, Director
Commercial Rulings Division

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