THE COUNTRY OF ORIGIN MARKING OF DUTOPROL™ Extended Release Tablets (metoprolol succinate extended release/hydrochlorothiazide)

N234615 November 21, 2012 MAR-2 OT:RR:NC:2:238 CATEGORY: MARKING Ms. Jennifer Plitsch Covington & Burling 1201 Pennsylvania Avenue, N.W. Washington D.C. 20004-2401 RE: THE COUNTRY OF ORIGIN MARKING OF DUTOPROL™ Extended Release Tablets (metoprolol succinate extended release/hydrochlorothiazide) Dear Ms. Plitsch: This is in response to your letter dated October 16, 2012, on behalf of AstraZeneca LP requesting a ruling on whether the proposed marking “Product of Sweden” is an acceptable country of origin marking for imported DUTOPROL™ Extended Release Tablets (metoprolol succinate extended release/hydrochlorothiazide). A marked sample was not submitted with your letter for review. The subject product, DUTOPROL™ Extended Release Tablets (metoprolol succinate extended release/hydrochlorothiazide), is an antihypertensive medicament in tablet form, containing a combination of two different drugs: metoprolol succinate (beta1-selective adrenoceptor blocking agent) and hydrochlorothiazide (a diuretic), as the active ingredients. The tablets are available in three different strengths and are indicated for the treatment of hypertension, to lower blood pressure. You state that metoprolol succinate will be manufactured in India and imported into Sweden, where it will be combined with hydrochlorothiazide which is produced from a manufacturer in Italy. The two-drug combination will then be formulated with various excipients to produce the finished medicament, DUTOPROL™ Extended Release Tablets for exportation to the United States. The marking statute, section 304 Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR Part 135) implements the country or origin marking requirements and exceptions of 19 U.S.C. 1304. 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 the instant case, we find that the combining of two active pharmaceutical ingredients (API’s) metoprolol succinate (India-produced) and hydrochlorothiazide (Italian-produced) in Sweden results in a new product, DUTOPROL™ Extended Release Tablets (metoprolol succinate extended release/hydrochlorothiazide), which has an identity and character medicinally distinct from the materials from which it was produced. Therefore, we find that metoprolol succinate and hydrochlorothiazide undergo a substantial transformation as a result of the operations performed in Sweden, and that the country of origin of DUTOPROL™ Extended Release Tablets (metoprolol succinate extended release/hydrochlorothiazide) is Sweden. Since the tablet, per se, is, of course, incapable of being marked, it is excepted from being marked (19 C.F.R. Section 134.32(a)). Accordingly, marking the container “Product of Sweden” in which the DUTOPROL™ Extended Release Tablets are imported and sold to the ultimate purchaser is an acceptable country of origin marking. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR Part 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 (646) 733-3033. Sincerely, Thomas J. Russo Director National Commodity Specialist Division