M83426 M8 Ruling Active

The tariff classification of Emtricitabine (CAS-143491-57-0), Gemcitabine Hydrochloride (CAS-122111-03-9) and Primidone (CAS-125-33-7), imported in bulk form, from Italy and Spain

Issued May 17, 2006 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 2934.99.4700, 2933.59.5300

Headings: 2934, 2933

Product description

The first product, Emtricitabine, is indicated for the treatment of HIV-1 infection in adults. The second product, Gemcitabine Hydrochloride, is indicated for the treatment of breast cancer, non-small cell lung cancer, and pancreatic cancer. The third product, Primidone, is indicated for use as an anticonvulsant.

CBP rationale

The applicable subheading for Emtricitabine and Gemcitabine Hydrochloride, imported in bulk form, will be 2934.99.4700, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Drugs. The applicable subheading for Primidone, imported in bulk form, will be 2933.59.5300, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.

Full text

NY M83426 May 17, 2006 CLA-2-29:RR:NC:2:238 M83426 CATEGORY: Classification TARIFF NO.: 2934.99.4700; 2933.59.5300 Ms. Inge Forstenzer Ren-Pharm International, Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Emtricitabine (CAS-143491-57-0), Gemcitabine Hydrochloride (CAS-122111-03-9) and Primidone (CAS-125-33-7), imported in bulk form, from Italy and Spain Dear Ms. Forstenzer: In your letter dated May 2, 2006, you requested a tariff classification ruling. The first product, Emtricitabine, is indicated for the treatment of HIV-1 infection in adults. The second product, Gemcitabine Hydrochloride, is indicated for the treatment of breast cancer, non-small cell lung cancer, and pancreatic cancer. The third product, Primidone, is indicated for use as an anticonvulsant. The applicable subheading for Emtricitabine and Gemcitabine Hydrochloride, imported in bulk form, will be 2934.99.4700, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Other: Drugs.” Pursuant to General Note 13, HTSUS, the rate of duty for Emtricitabine and Gemcitabine Hydrochloride, imported in bulk form, will be free. The applicable subheading for Primidone, imported in bulk form, will be 2933.59.5300, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing a pyrimidine ring (whether or not hydrogenated) or piperazine ring in the structure: Other: Drugs: Aromatic or modified aromatic: Other.” 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 Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at: www.fda.gov. 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

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