The country of origin of Chlorpromazine Hydrochloride Injection USP, 25 mg/mL

N330708 March 1, 2023 OT:RR:NC:N3:138 CATEGORY: Origin Pradeep Shah Zydus Pharmaceuticals USA Inc. 73 Route 31 NPennington, NJ 08534 RE: The country of origin of Chlorpromazine Hydrochloride Injection USP, 25 mg/mL Dear Mr. Shah: In your letter dated February 2, 2023, you requested a country of origin ruling on Chlorpromazine Hydrochloride Injection USP, 25 mg/mL. Chlorpromazine Hydrochloride Injection USP, imported in 25 mg/mL, is an anti-psychotic drug. It is indicated for the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 year to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. You stated that the active pharmaceutical ingredient (API), Chlorpromazine Hydrochloride, is manufactured in Italy and that the finished Chlorpromazine Hydrochloride Injection in dosage form is made in India. In India, the Chlorpromazine Hydrochloride will be mixed with various inactive ingredients to produce the final Chlorpromazine Hydrochloride Injection USP, 25 mg/mL 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 Chlorpromazine Hydrochloride (made in Italy) with the inactive ingredients into the final Chlorpromazine Hydrochloride injection in India does not result in a substantial transformation and the country of origin will be Italy. 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