The country of origin of Albuterol Sulfate Inhaler

N325498 May 12, 2022 CLA-2:OT:RR:NC:N3:138 CATEGORY: Country of Origin Nicolas Guzman Faegre Drinker Biddle & Reath LLP 320 S. Canal St Chicago, IL 60606 RE: The country of origin of Albuterol Sulfate Inhaler Dear Mr. Guzman: In your letter dated April 15, 2022, filed on behalf of Lupin Inc., you requested a country of origin ruling determination on the Albuterol Sulfate Inhaler. Albuterol Sulfate Inhaler is a medicinal preparation containing, albuterol sulfate, a bronchodilator, as the active ingredient. It is indicated for the treatment of bronchospasm in people with asthma or certain types of chronic obstructive pulmonary disease (COPD). It is also used to prevent exercise-induced bronchospasm. In your letter, you stated the Albuterol Sulfate Inhaler is made from a single active pharmaceutical ingredient (API) Albuterol Sulfate, that is combined with excipients and placed into a delivery mechanism that allows for aerosol delivery of the drug product to the user. You stated that the API, Albuterol Sulfate, is manufactured in Italy and that the final Albuterol Sulfate Inhaler in dosage form is processed in India. 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 processing of the active ingredient Albuterol Sulfate (made in Italy) into the Albuterol Sulfate Inhaler in India does not result in a substantial transformation and the country of origin will be Italy. Based upon the labels provided, the subject product does not appear to be legally marked with the proper country of origin. The labels state the product is manufactured in India. However, the country of origin is Italy where the API is made and should be marked “Made in,” “Product of,” or other words of similar meaning with “Italy” as the country of origin. It is also acceptable to mark the product with Albuterol Sulfate Inhaler as “Made in Italy, formulated in India.” 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 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 [email protected]. Sincerely, Steven A. Mack Director National Commodity Specialist Division