The tariff classification of five PHASULIN® human insulin preparations, supplied in glass vials for injection, from China
Issued November 10, 2004 by U.S. Customs and Border Protection.
Tariff classification
HTS codes: 3004.31.0000
Headings: 3004
Product description
The five subject products, namely: PHASULIN® Insulin R (Regular); PHASULIN® Insulin N; PHASULIN® Insulin L; PHASULIN® Insulin 50/50 (50% N + 50% R, by weight); and PHASULIN® Insulin 70/30 (70% N + 30% R, by weight), are medicinal preparations containing human insulin of rDNA origin as the active ingredient. All five products are indicated for the treatment of diabetes, and are supplied in glass vials (10 mL per vial) for injection.
CBP rationale
The applicable subheading for all five products will be 3004.31.0000, Harmonized Tariff of the United States (HTS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: Containing insulin.
Full text
NY L80595 November 10, 2004 CLA-2-30:RR:NC:2:238 L80595 CATEGORY: Classification TARIFF NO.: 3004.31.0000 Mr. Albert Mendez Atlas Pharma Corporation 250 Everglade Avenue Palm Beach, FL 33480 RE: The tariff classification of five PHASULIN® human insulin preparations, supplied in glass vials for injection, from China Dear Mr. Mendez: In your letter dated October 18, 2004, you requested a tariff classification ruling. The five subject products, namely: PHASULIN® Insulin R (Regular); PHASULIN® Insulin N; PHASULIN® Insulin L; PHASULIN® Insulin 50/50 (50% N + 50% R, by weight); and PHASULIN® Insulin 70/30 (70% N + 30% R, by weight), are medicinal preparations containing human insulin of rDNA origin as the active ingredient. All five products are indicated for the treatment of diabetes, and are supplied in glass vials (10 mL per vial) for injection. The applicable subheading for all five products will be 3004.31.0000, Harmonized Tariff of the United States (HTS), which provides for “Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale: Containing hormones or other products of heading 2937 but not containing antibiotics: Containing insulin.” 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 1-888-443-6332. 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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