N320635

N320635 August 23, 2021 CLA-2-30:OT:RR:NC:N3:138 CATEGORY: Classification; Country of Origin TARIFF NO.: 3004.90.9260 William Gerard Braier Radix Group International Dba DHL Global Forwarding 6120 Ace Industrial Drive Cudahy, WI 53110 RE: The tariff classification and country of origin of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg Dear Mr. Braier: In your letter dated July 22, 2021, filed on behalf of Dr. Reddy’s Laboratories, Inc., you requested a tariff classification ruling. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules is a medicinal preparation containing a fixed combination of Chlordiazepoxide hydrochloride (5 mg), a benzodiazepine, and Clidinium bromide (2.5 mg), an anticholinergic, as the active ingredients. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules are indicated to control emotional and somatic factors in gastrointestinal disorders. It may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. The applicable subheading for the Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules 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 merchandise may also be subject to the requirements of the Controlled Substances Act, which are enforced by the U.S. Drug Enforcement Administration (DEA), Office of Diversion Control. You may contact them at 2401 Jefferson Davis Highway, Alexandria, VA 22301, telephone (800) 882-9539. You also requested a country of origin determination. You stated that the active pharmaceutical ingredients (APIs), Chlordiazepoxide Hydrochloride and Clidinium Bromide, are both manufactured in Italy and that the finished capsules in dosage form are made in India. In India, the Chlordiazepoxide Hydrochloride and Clidinium Bromide APIs will be mixed with various inactive ingredients to produce the final capsules in dosage form. You suggest that the country of origin remains Italy, the country in which both APIs were manufactured. As explained below, we disagree. 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 determining whether a substantial transformation occurs in the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (“HQ”) 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. However, where the processing from bulk form into measured doses involves the combination of two or more APIs, and the resulting combination offers additional medicinal benefits compared to taking each API alone, CBP has held that a substantial transformation occurred. See, e.g., HQ 563207, dated June 1, 2005. In this instance we note that the two APIs serve different purposes. Here, as in HQ 563207, two separate APIs are mixed to create a fixed combination drug that offers additional medicinal benefits compared to taking each API alone. Chlordiazepoxide Hydrochloride is used to relieve symptoms of anxiety, including nervousness or anxiety that happens before a surgery. It may also be used to treat symptoms of alcohol withdrawal. Clidinium Bromide (INN) is an anticholinergic drug used to help symptoms of cramping and abdominal/stomach pain by decreasing stomach acid and slowing the intestines. It is commonly prescribed in combination with Chlordiazepoxide (a benzodiazepine derivative) using the brand name Librax. In this case, we find the mixing of the active ingredients Chlordiazepoxide Hydrochloride and Clidinium Bromide (both made in Italy) with the inactive ingredients into the final dosage capsules in India results in a substantial transformation and the country of origin will be India. 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