The tariff classification of Setmelanotide Acetate (CAS No. 1504602-49-6) in bulk form, from Taiwan

N320982 March 9, 2022 CLA-2-29:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 2937.19.0000 Ms. Yaling Lo Pharmaports LLC 1 E Uwchlan Ave. Exton, PA 19341 RE: The tariff classification of Setmelanotide Acetate (CAS No. 1504602-49-6) in bulk form, from Taiwan Dear Ms. Lo: In your letter dated August 10, 2021, you requested a tariff classification ruling on behalf of Chunghwa Chemical Synthesis & Biotech Co., Ltd. We apologize for the delay as the information was sent to our laboratory for analysis. Setmelanotide Acetate is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency. According to our laboratory, Setmelanotide is a synthetic peptide that is based on the structure of the natural hormone a-MSH (alpha-melanocyte stimulating hormone). It is an a-MSH receptor agonist and a hormone analogue of a-MSH. The applicable subheading for the Setmelanotide Acetate in bulk powder form will be 2937.19.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Hormones, prostaglandins, thromboxanes and leukotrienes, natural or reproduced by synthesis; derivatives and structural analogues thereof, including chain modified polypeptides, used primarily as hormones: Polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues: 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division