The tariff classification of Aceclidine Ophthalmic Solution in dosage form, from the United States

N347096
April 2, 2025
CLA-2-30:OT:RR:NC:N3:138
CATEGORY: Classification
TARIFF NO.: 3004.90.9289
Mahtab Fatemi LENZ Therapeutics, Inc 201 Lomas Santa Fe Drive, Suite 300 Solano Beach, CA 92075 RE: The tariff classification of Aceclidine Ophthalmic Solution in dosage form, from the United States Dear Mr. Fatemi: In your letter dated March 25, 2025, you requested a tariff classification ruling. The country of origin determination of this product was separately addressed under NY N343405 dated November 7, 2024. Aceclidine Ophthalmic Solution is a medicinal preparation containing Aceclidine Hydrochloride, a parasympathomimetic miotic agent, as the active ingredient. Currently it is under development for the treatment of presbyopia in adult patients, an age-related eye condition that makes it difficult to focus on nearby objects. The Aceclidine Ophthalmic Solution will be packaged in single-use, blow-fill seal (BFS) ampoules (0.4 mL nominal fill volume) and shipped in cartons containing 5 pouches of 5 ampoules each (25 ampoules total). In your letter, you stated Aceclidine Ophthalmic Solution will be imported from Germany and the country of origin is the United States. The applicable subheading for the Aceclidine Ophthalmic Solution in dosage form will be 3004.90.9289, 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 eyes, ears or respiratory system: 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 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