N047282 N0 Ruling Active

The tariff classification of Dutasteride (CAS- 164656-23-9) in bulk form, from China

Issued December 23, 2008 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 2937.29.9090

Headings: 2937

Product description

The subject product, Dutasteride, is a synthetic steroid analogue. It functions as an anti-androgen by inhibiting the enzyme that converts testosterone (an androgenic hormone) to 5a-dihydrotestosterone (DHT). Dutasteride is presently approved for the treatment of benign prostatic hyperplasia. Dutasteride is also in development for prostate cancer risk reduction and for the treatment of male pattern baldness in the vertex region of the scalp.

CBP rationale

Corp. 7820 SW 196 Terrace Miami, FL 33189 RE: The tariff classification of Dutasteride (CAS- 164656-23-9) in bulk form, from China Dear Mr. Cuneo: In your letter dated December 17, 2008, you requested a tariff classification ruling. The subject product, Dutasteride, is a synthetic steroid analogue. It functions as an anti-androgen by inhibiting the enzyme that converts testosterone (an androgenic hormone) to 5a-dihydrotestosterone (DHT). Dutasteride is presently approved for the treatment of benign prostatic hyperplasia. Dutasteride is also in development for prostate cancer risk reduction and for the treatment of male pattern baldness in the vertex region of the scalp. The applicable subheading for the Dutasteride will be 2937.29.9090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Steroidal hormones, their derivatives and structural analogues: Other: Other: Other.” 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.

Full text

N047282 December 23, 2008 CLA-2-29:OT:RR:E:NC:2:238 CATEGORY: Classification TARIFF NO.: 2937.29.9090 Mr. Cesar Eduardo Cuneo Firstmed Holding Corp. 7820 SW 196 Terrace Miami, FL 33189 RE: The tariff classification of Dutasteride (CAS- 164656-23-9) in bulk form, from China Dear Mr. Cuneo: In your letter dated December 17, 2008, you requested a tariff classification ruling. The subject product, Dutasteride, is a synthetic steroid analogue. It functions as an anti-androgen by inhibiting the enzyme that converts testosterone (an androgenic hormone) to 5a-dihydrotestosterone (DHT). Dutasteride is presently approved for the treatment of benign prostatic hyperplasia. Dutasteride is also in development for prostate cancer risk reduction and for the treatment of male pattern baldness in the vertex region of the scalp. The applicable subheading for the Dutasteride will be 2937.29.9090, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Steroidal hormones, their derivatives and structural analogues: Other: Other: Other.” 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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