CLA-2-:RR:NC:2:238 M80803

Ms. Inge Forstenzer
Ren-Pharm International, Ltd.
350 Jericho Turnpike, Suite 204
Jericho, NY 11753

RE: The tariff classification of Phenytoin (CAS-57-41-0), Pseudoephedrine Sulfate (CAS-7460-12-0) and Quetiapine Fumarate (CAS-111974-72-2), imported in bulk form, from Brazil, Brazil, and Spain, respectively

Dear Ms. Forstenzer:

In your letter dated January 27, 2006, you requested a tariff classification ruling.

The first product, Phenytoin, is indicated for use as an anticonvulsant drug.

The second product, Pseudoephedrine Sulfate, is indicated for use as a decongestant.

The third product, Quetiapine Fumarate, is indicated for the treatment of bipolar mania and schizophrenia. The applicable subheading for Phenytoin, imported in bulk form, will be 2933.29.2000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused imidazole ring (whether or not hydrogenated) in the structure: Other: Aromatic or modified aromatic: Other: Drugs.” Pursuant to General Note 13, HTSUS, the rate of duty will be free.

The applicable subheading for Pseudoephedrine Sulfate, imported in bulk form, will be 2939.42.0000, HTSUS, which provides for “Vegetable alkaloids, natural or reproduced by synthesis, and their salts, ethers, esters and other derivatives: Ephedrines and their salts: Pseudoephedrine and its salts.” The rate of duty will be free.

The applicable subheading for Quetiapine Fumarate, imported in bulk form, will be 2934.99.3000, HTSUS, which provides for “Nucleic acids and their salts, whether or not chemically defined, other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs.” Pursuant to General Note 13, HTSUS, the rate of duty will be free.

Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on World Wide Web at http://www.usitc.gov/tata/hts/.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which are administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-463-6332. Pseudoephedrine Sulfate may also be subject to the requirements of the Controlled Substances Act, which are enforced by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. You may contact them at 2401 Jefferson Davis Highway, Alexandria, VA 22301, telephone (800) 882-9539. 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