The tariff classification of Hydroxyprogesterone Caproate Injection in dosage form, from Spain

N301133 November 8, 2018 CATEGORY: Classification TARIFF NO.: 3004.39.0050 Mr. Rafal Czapla Slayback Pharma 301 Carnegie Center, Suite 303 Princeton, NJ 08540 RE: The tariff classification of Hydroxyprogesterone Caproate Injection in dosage form, from Spain Dear Mr. Czapla: Hydroxyprogesterone Caproate Injection, imported in 250 mg/ml in 1 ml and 5 ml vials, is a synthetic progestin. It is used to lower the risk of preterm birth in women who are pregnant with one baby and who have delivered one baby too early (preterm) in the past. The applicable subheading for the Hydroxyprogesterone Caproate Injection in dosage form will be 3004.39.0050, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments … 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, containing hormones or other products of heading 2937: 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 the World Wide Web at https://hts.usitc.gov/current. 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 Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division