The country of origin of Aceclidine Ophthalmic Solution (Aceclidine Hydrochloride 1.75%)

N343405 November 7, 2024 OT:RR:NC:N3:138 CATEGORY: Origin Mahtab Fatemi Lenz Therapeutics, Inc 201 Lomas Santa Fe Drive, Suite 300Solana Beach, CA 92075 RE:  The country of origin of Aceclidine Ophthalmic Solution (Aceclidine Hydrochloride 1.75%) Dear Mr. Fatemi: In your letter dated October 17, 2024, you requested a country of origin ruling on Aceclidine Ophthalmic Solution. 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). You stated that the active pharmaceutical ingredient (API), Aceclidine Hydrochloride, is manufactured in the United States and that the finished Aceclidine Ophthalmic Solution in dosage form is made in Germany.  In Germany, the Aceclidine Hydrochloride will be mixed with inactive ingredients to produce the final Aceclidine Ophthalmic Solution in dosage form. Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as:The country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part; ….A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986).In this case, we find the mixing of the active ingredient Aceclidine Hydrochloride (made in the United States) with the inactive ingredients into the final dosage Aceclidine Ophthalmic Solution in Germany does not result in a substantial transformation and the country of origin will be the United States. 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