H283420

 HQ H283420 June 14, 2024 OT:RR:CTF:CPMMA H283420 RRB CATEGORY: Marking JoAnne Colonnello, Center Director Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise U.S. Customs and Border Protection 6747 Engle Road Middleburg Heights, OH 44130 RE: Internal Advice; Country of origin marking requirements for repackaged prescription medication sold by CVS Health; ultimate purchaser; 19 U.S.C. § 1304; 19 C.F.R. § 134.1(d)(1); 19 C.F.R. § 134.25 Dear Center Director: This is in response to a request for internal advice, initiated by the Pharmaceuticals, Health, and Chemicals Center of Excellence and Expertise (“Center”), U.S. Customs and Border Protection (“CBP”), pursuant to the inquiry from an individual retail purchaser on January 11, 2017, concerning country of origin marking requirements for repackaged prescription medication by CVS Health pharmacy (“CVS”). Our decision follows. FACTS: The merchandise at issue consists of a drug known as Omeprazole, which is manufactured abroad and imported by Sandoz, a division of the pharmaceutical company Novartis, into the United States, where it is repackaged and sold by CVS to retail purchasers. As part of the initial inquiry, the submission included photographs of empty packaging for Omeprazole consisting of Sandoz’s original opaque white plastic container and an orange translucent plastic container into which the product was repackaged by CVS. Sandoz’s original packaging for the Omeprazole is marked with the country of origin as “Product of India.” However, CVS’s repackaged containers of Omeprazole do not contain any country of origin marking. After our office received this inquiry, we reached out to Sandoz through its parent company, Novartis, regarding the Omeprazole imports. In response to questions posed to Sandoz via email, dated March 10 and March 24, 2017, by the Center, Sandoz responded on March 17, April 17, and April 19, 2017, arguing in favor of having satisfied marking requirements under 19 U.S.C. § 1304 and that CVS is the ultimate purchaser. The inquirer argues that he and other CVS customers are the “ultimate consumers” (i.e., ultimate purchasers) of the merchandise. Accordingly, the inquirer asserts that where medications are repackaged by CVS and are not marked with the country of origin, CVS is not following country of origin marking requirements under 19 U.S.C. § 1304. ISSUE: Whether CVS, as the repackager/dispenser/seller, or consumers at retail, are the ultimate purchasers of imported prescription medication, pursuant to 19 C.F.R. § 134.1(d). LAW AND ANALYSIS: Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. § 1304), provides that unless excepted, every article of foreign origin imported into the United States 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. Congressional intent in enacting 19 U.S.C. § 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase, the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” United States v. Friedlander & Co., 27 C.C.P.A. 297, 302; C.A.D. 104 (1940). Part 134 of Title 19 of the Code of Federal Regulations (19 C.F.R. Part 134) implements the country of origin marking requirements and exceptions to 19 U.S.C. § 1304. Pursuant to 19 C.F.R. § 134.41(b), the ultimate purchaser in the United States must be able to find the marking easily and read it without strain. The degree of permanence of the marking should be at least sufficient to ensure that in any reasonably foreseeable circumstance, the marking shall remain on the article (or its container) until it reaches the ultimate purchaser, unless it is deliberately removed. Section 134.1(d) defines the ultimate purchaser as “generally the last person in the United States who will receive the article in the form in which it was imported.” Pursuant to 19 C.F.R. § 134.1(d)(3), if an imported article is to be sold at retail in its imported form, the purchaser at retail is the ultimate purchaser. In the instant matter, the Omeprazole is imported by Sandoz. CVS simply repackages and sells the Omeprazole to customers at CVS’s retail pharmacies. CBP has consistently held that repackaging does not constitute a substantial transformation for country of origin purposes. See, e.g., New York Ruling Letter (“NY”) N265425, dated June 17, 2015. Consequently, in the absence of a substantial transformation of the medication by CVS, the customer at the CVS retail pharmacy is the last person to receive the Omeprazole in the form that it was imported, i.e., the ultimate purchaser pursuant to 19 C.F.R. § 134.1(d)(3). As we have previously ruled, drugs: “…are exempt from individual marking by virtue of 19 U.S.C. § 1304(a)(3)(J) and 19 C.F.R. § 134.33, since ‘[c]hemicals, drugs, medicinal, and similar substances, when imported in capsules, pills, tablets, lozenges, or troches’ are J-List articles. Articles on the J-List are exempt from individual marking, however the outermost container that ordinarily reaches the ultimate purchaser of a J-List article must be marked with the country of origin of the article.” Headquarters Ruling Letter (“HQ”) 731640, dated April 20, 1989. Thus, while the Omeprazole tablets or pills themselves need not be individually marked, the outermost container must be marked with the country of origin. Based on pictures submitted by the inquirer, it appears that the original bulk packaging from Sandoz is properly marked with the country of origin. However, when CVS repackages the Omeprazole for sale to customers at retail, the orange container does not include the country of origin marking. Therefore, the retail consumers, as the ultimate purchasers, upon inspection, are unable to know the country of origin of the medication. We are not aware of any existing rulings or other guidance which addresses the specific issue of country of origin marking of repackaged pharmaceuticals purchased from a retail pharmacy. Sandoz cited, and we confirmed, only two rulings on pharmaceuticals where a healthcare service provider provides the pharmaceutical to a patient. First, Sandoz cited to HQ 734232, dated November 20, 1991. In that ruling, single dose vials of Carnitor, an intravenous medication to be mixed in parenteral solutions of Sodium Chloride 0.9% or Lactated Ringer’s in concentrations ranging from 250 mg/500 mL (0.5 mg/mL) to 4200 mg/500 mL (0.8 mg/mL), packaged in cartons of five vials per container, were marked as a product of Italy on the side panel of the carton. The issue in HQ 734232 was whether this marking was adequate given that the name of the U.S. distributor was on the side and back panels of the carton. In deciding that issue, the ruling states that the ultimate purchaser of the cartons of five vials is the hospital pharmacy that dispenses the properly mixed medication to a healthcare provider who delivers it intravenously to the patient. CBP ruled that the country of origin must appear on both panels of the carton, next to the U.S. distributor address. Once the carton of five vials is properly marked, it is received as such by the ultimate purchaser, the hospital, and each individual vial need not be marked. The patient receives the medication from one of the vials mixed with intravenous fluid as part of the service of delivering healthcare, not in the form it was imported. Hence, CBP determined that there was no requirement to mark each individual vial if the carton of five vials was properly marked. Sandoz also cited to HQ H243931, dated December 5, 2013. In that ruling, 

Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. § 1304), provides that unless excepted, every article of foreign origin imported into the United States 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. Congressional intent in enacting 19 U.S.C. § 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase, the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” United States v. Friedlander & Co., 27 C.C.P.A. 297, 302; C.A.D. 104 (1940). Part 134 of Title 19 of the Code of Federal Regulations (19 C.F.R. Part 134) implements the country of origin marking requirements and exceptions to 19 U.S.C. § 1304. Pursuant to 19 C.F.R. § 134.41(b), the ultimate purchaser in the United States must be able to find the marking easily and read it without strain. The degree of permanence of the marking should be at least sufficient to ensure that in any reasonably foreseeable circumstance, the marking shall remain on the article (or its container) until it reaches the ultimate purchaser, unless it is deliberately removed. Section 134.1(d) defines the ultimate purchaser as “generally the last person in the United States who will receive the article in the form in which it was imported.” Pursuant to 19 C.F.R. § 134.1(d)(3), if an imported article is to be sold at retail in its imported form, the purchaser at retail is the ultimate purchaser.In the instant matter, the Omeprazole is imported by Sandoz. CVS simply repackages and sells the Omeprazole to customers at CVS’s retail pharmacies