The tariff classification of Ursodiol Capsules in dosage form, from Italy and Glycopyrrolate Injection in dosage form, from India

N314751 October 21, 2020 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification TARIFF NO.: 3004.90.9260 Mr. Pradeep Shah Zydus Pharmaceuticals USA, Inc. 73 Route 31 North Pennington, NJ 08534 RE: The tariff classification of Ursodiol Capsules in dosage form, from Italy and Glycopyrrolate Injection in dosage form, from India Dear Mr. Shah: In your letter dated September 23, 2020, you requested a tariff classification ruling. Ursodiol, imported in 300 mg capsules, is a bile acid. It is indicated for patients with radiolucent, noncalcified gallbladder stones less than 20 mm in their greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. In your letter, you stated this product will be imported from India. Glycopyrrolate Injection, imported in 0.2 mg/mL, 0.4 mg/2 mL, 1 mg/5 mL and 4 mg/20 mg/mL vials, is an anticholinergic drug. It is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. Glycopyrrolate is also used to treat peptic ulcers in adults. The applicable subheading for the Ursodiol Capsules and Glycopyrrolate Injection in dosage form will be 3004.90.9260, 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: Other: Other: Medicaments primarily affecting the digestive system: 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