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The tariff classification of AZELEX® (azelaic acid cream) 20%, put up in 30-gm collapsible tubes for retail sale, from Germany
Issued May 7, 1999 by U.S. Customs and Border Protection.
Cite this ruling
Copies to clipboardE8 E81352 (May 7, 1999)
Tariff classification
HTS codes: 3004.90.9045
Headings: 3004
Product description
The subject product, AZELEX® (azelaic acid cream) 20%, put up in 30-gm collapsible tubes for retail sale, is a dermatological medicament containing 0.2 gm azelaic acid (20% w/w) as the active ingredient. According to the monograph appearing in the 1999 Physicians’ Desk Reference, Azelex® is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris, and is dispensed by prescription only.
CBP rationale
The applicable subheading for the subject product will be 3004.90.9045, Harmonized Tariff Schedule of the United States (HTS), which provides for “[M]edicaments .
Full text
NY E81352 May 7, 1999 CLA-2-30:RR:NC:2:238 E81352 CATEGORY: Classification TARIFF NO.: 3004.90.9045 Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of AZELEX® (azelaic acid cream) 20%, put up in 30-gm collapsible tubes for retail sale, from Germany Gentlemen: In your letter dated April 26, 1999, you requested a tariff classification ruling. The subject product, AZELEX® (azelaic acid cream) 20%, put up in 30-gm collapsible tubes for retail sale, is a dermatological medicament containing 0.2 gm azelaic acid (20% w/w) as the active ingredient. According to the monograph appearing in the 1999 Physicians’ Desk Reference, Azelex® is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris, and is dispensed by prescription only. The applicable subheading for the subject product will be 3004.90.9045, Harmonized Tariff Schedule of the United States (HTS), which provides for “[M]edicaments ... consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Dermatological agents and local anesthetics.” 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. 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 212-637-7068. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division
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