CLA-2-29:OT:RR:NC:N3:138
Paula Finn Sanofi 450 Water Street Cambridge, MA 02141 RE: The tariff classification of Insulin Glargine (CAS No. 160337-95-1) in bulk form, from Germany Dear Ms. Finn: In your letter dated March 5, 2025, you requested a tariff classification ruling. Insulin Glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). It is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. You suggest classification in subheading 2937.12.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Polypeptide hormones, protein hormones and glycoprotein hormones, their derivatives and structural analogues: Insulin and its salts.” However, this subheading does not provide for insulin analogues. The applicable subheading for the Insulin Glargine in bulk form will be 2937.19.0000, 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 at https://hts.usitc.gov/. 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.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Steven A. Mack Director National Commodity Specialist Division