THE COUNTRY OF ORIGIN MARKING OF VARIOUS ORAL CONTRACEPTIVE TABLETS

N259164 December 9, 2014 MAR-2 OT:RR:NC:2:238 CATEGORY: MARKING Mr. J. Michael Taylor King & Spalding, LLP 1700 Pennsylvania Avenue, NW Washington D.C. 20006 RE: THE COUNTRY OF ORIGIN MARKING OF VARIOUS ORAL CONTRACEPTIVE TABLETS Dear Mr. Taylor: This is in response to your letter dated November 7, 2014, on behalf of Afaxys, Inc., requesting a ruling on the country of origin marking requirements for imported Lyza® (Norethindrone Tablets), ella® (Ulipristal Acetate Tablets) and EContra™ EZ (Levonorgestrel Tablets). Marked samples were not submitted with your letter for review. The first product, Lyza® (Norethindrone Tablets), is a progestin-only oral contraceptive (POP) that is indicated for the prevention of pregnancy. Each tablet contains 0.35 mg of Norethindrone, as the active pharmaceutical ingredient (API). You state that the active ingredient, Norethindrone is manufactured in the Netherlands and then shipped to India for further processing into tablet form. In India, Norethindrone, will be mixed with excipients, formulated into tablets and then packaged inside a monocarton containing a 28-tablet blister pack. The second product, ella® (Ulipristal Acetate Tablets), is a progesterone agonist/antagonist emergency oral contraceptive that is indicated for the prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Each tablet contains 30 mg of Ulipristal Acetate, as the active pharmaceutical ingredient. You state that the active ingredient, Ulipristal Acetate is manufactured in Spain and then shipped to France for further processing into tablet form. In France, Ulipristal Acetate will be mixed with excipients, formulated into tablets and then packaged inside a monocarton containing a 1-tablet blister pack. The third product, EContra™ EZ (Levonorgestrel Tablets), is a progestin-only emergency oral contraceptive that is indicated for the prevention of pregnancy after birth control failure or unprotected sex. Each tablet contains 1.5 mg of Levonorgestrel, as the active ingredient. You state that the active pharmaceutical ingredient, Levonorgestrel is manufactured in Germany and then shipped to India for further processing into tablet form. In India, Levonorgestrel will be mixed with excipients and formulated into tablets and then packaged inside a monocarton containing a 1-tablet blister pack. You state that the processing in India and France consists of blending the APIs with excipients, measuring the product into dosage form, and packaging the final tablets. You believe that the formulation of the bulk pharmaceutical APIs into finished tablets for oral use does not constitute a substantial transformation. 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 processing performed in India and France does not result in a change in the medicinal use of the finished product and the APIs retain their chemical and physical properties. The APIs do not undergo a change in name, character or use. Based on the facts presented, no substantial transformation has occurred as a result of the operations performed in India or France. Therefore, the country of origin of the imported Lyza® (Norethindrone Tablets), ella® (Ulipristal Acetate Tablets) and EContra™ EZ (Levonorgestrel Tablets) are the Netherlands, Spain and Germany, respectively. Since the tablets are incapable of being marked, they are excepted from being marked (19 C.F.R. Section 134.32(a)). Accordingly, marking the outermost container with the proper country of origin in which the Lyza® (Norethindrone Tablets), ella® (Ulipristal Acetate Tablets) and EContra™ EZ (Levonorgestrel 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 judy.h.lee@cbp.dhs.gov. Sincerely, Gwenn Klein Kirschner Director National Commodity Specialist Division