CLA-2-29:RR:NC:2:238 H86776

Ms. Lisa M. Conzo
Interchem Corporation
120 Route 17 North
P.O. Box 1579
Paramus, NJ 07653-1579

RE: The tariff classification of Amikacin Sulfate (CAS-39831-55-5), Butorphanol Tartrate (CAS-58786-99-5), and Modafinil (CAS-68693-11-8), all imported in bulk form, from Italy, the Czech Republic, and Italy, respectively

Dear Ms. Conzo:

In your letter dated December 10, 2001, you requested a tariff classification ruling.

The first product, Amikacin Sulfate, is a semisynthetic aminoglycoside antibiotic, derived from kanamycin. It is indicated for use as an antibacterial drug.

The second product, Butorphanol Tartrate, is a synthetic opioid analgesic, belonging to the group of compounds known as morphinans. Although the morphinans are similar in structure to the analogues of morphine, they lack, inter alia, the “E” (tetrahydrofuran) ring found in the naturally occurring opioids.

The third product, Modafinil, is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

The applicable subheading for Amikacin Sulfate, imported in bulk form, will be 2941.90.5000, Harmonized Tariff Schedule of the United States (HTS), which provides for “Antibiotics: Other: Other: Other.” The rate of duty will be free.

Pursuant to the Explanatory Notes to heading 2939, HTS, the applicable subheading for Butorphanol Tartrate, imported in bulk form, will be 2933.49.2600, HTS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing in the structure a quinoline or isoquinoline ring-system (whether or not hydrogenated), not further fused: Other: Other: Drugs: Other. Pursuant to General Note 13, HTS, the rate of duty will be free.

The applicable subheading for Modafinil, imported in bulk form, will be 2930.90.2900, HTS, which provides for “Organo-sulfur compounds: Other: Aromatic: Other: Other.” Pursuant to General Note 13, HTS, the rate of duty will be free.

These products 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.

Butorphanol Tartrate and Modafinil may also 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
Director,
National Commodity
Specialist Division