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NY I89152




January 7, 2003

CLA-2-29:RR:NC:2:238 I89152

CATEGORY: CLASSIFICATION

TARIFF NO.: 2933.59.4600; 2937.22.0000; 2933.39.4100; 2922.19.0900; 2937.29.9050

Ms. Janice Lambertucci
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753-1317

RE: The tariff classification of Mirtazapine (CAS-61337-67-5), Mometasone Furoate (CAS-83919-23-7), Nifedipine (CAS-21829-25-4), Orphenadrine Citrate (CAS-83-98-7) and Oxandrolone (CAS-53-39-4), imported in bulk form, from Spain and Italy

Dear Ms. Lambertucci:

In your letter dated December 16, 2002, you requested a tariff classification ruling.

The first product, Mirtazapine, is indicated for the treatment of depression.

The second product, Mometasone Furoate, is a synthetic corticosteroid possessing anti-inflammatory properties. It is used to relieve the inflammatory and pruritic manifestations of corticosteroid-responsive skin diseases.

The third product, Nifedipine, is indicated for the treatment of angina.

The fourth product, Orphenadrine Citrate, is indicated for use as a skeletal muscle relaxant.

The fifth product, Oxandrolone, is a synthetic anabolic steroid. According to the monograph appearing in the 2002 Physicians’ Desk Reference®, Oxandrolone is the active ingredient in Oxandrin®, which “[i]s indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologicic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis.” The applicable subheading for Mirtazapine, imported in bulk form, will be 2933.59.4600, Harmonized Tariff Schedule of the United States (HTS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) in the structure: Other: Drugs: Aromatic or modified aromatic: Antidepressants, tranquilizers and other psychotherapeutic agents.” Pursuant to General Note 13, HTS, the rate of duty will be free.

The applicable subheading for Mometasone Furoate, imported in bulk form, will be 2937.22.0000, HTS, which provides for “Halogenated derivatives of adrenal cortical hormones.” The rate of duty will be free.

The applicable subheading for Nifedipine, imported in bulk form, will be 2933.39.4100, HTS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.

The applicable subheading for Orphenadrine Citrate, imported in bulk form, will be 2922.19.0900, HTS, which provides for “Oxygen-function amino-compounds: Amino-alcohols, other than those containing more than one kind of oxygen function, their ethers and esters; salts thereof: Other: Aromatic: Drugs.” Pursuant to General Note 13, HTS, the rate of duty will be free.

The applicable subheading for Oxandrolone, imported in bulk form, will be 2937.29.9050, HTS, which provides for “Steroidal hormones, their derivatives and structural analogues: Other: Other: Anabolic agents and androgens.” 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.

In addition, Oxandrolone may be subject to the requirements of the Controlled Substances Act and/or the Controlled Substances Import and Export Act, which are administered by the Drug Enforcement Administration (DEA). You may contact them at 1405 I Street N.W., Washington, D.C. 20460, telephone number 202- 307- 1000.

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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