CLA-2-30:OT:RR:NC:N3:138
Sateesh Reddy Ambati
Slayback Pharma LLC
301 Carnegie Center Princeton, NJ 08540
RE: The tariff classification of PREVDUO (neostigmine methylsulfate and glycopyrrolate) injection in dosage form, from India
Dear Mr. Ambati:
In your letter dated February 9, 2023, you requested a tariff classification ruling.
PREVDUO is a fixed dose combination medicament consisting of Neostigmine Methylsulfate (cholinesterase inhibitor) and Glycopyrrolate (antimuscarinic agent), as the active ingredients. It is indicated in patients age two years and above for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration. It will be imported as 3 mg/3 mL of neostigmine methylsulfate and 0.6 mg/3 mL of glycopyrrolate (1 mg/mL of neostigmine methylsulfate and 0.2 mg/mL of glycopyrrolate) in a single-dose 3 mL Prefilled Syringe for intravenous use only.
The applicable subheading for the PREVDUO injection in dosage form will be 3004.90.9240, 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 central nervous 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 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 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