CLA-2-30:OT:RR:NC:N1:138
Mr. William G. Braier
Radix Group International
dba DHL Global Forwarding
6120 Ace Industrial Drive
Cudahy, WI 53110
RE: The tariff classification and country of origin marking of Sevelamer Carbonate Tablets in dosage form, from Taiwan
Dear Mr. Braier:
In your letter dated April 17, 2018, you requested a tariff classification ruling on behalf of Dr. Reddy’s Laboratories, Incorporated.
The subject product, Sevelamer Carbonate imported in tablets of 800 mg, is a phosphate binder that is available by prescription only. It is indicated for the treatment of hypocalcaemia (low levels of calcium in the human body) caused by elevated phosphorus. Sevelamer Carbonate is also used to control phosphorus levels in patients with chronic kidney disease who are on dialysis.
The applicable subheading for the Sevelamer Carbonate Tablets in dosage form will be 3004.90.9270, 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: Preparations primarily affecting the electrolytic, caloric or water balance: 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 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.
You also inquired about the country of origin marking requirements and have provided a picture of the label in retail packaging. You stated that the active pharmaceutical ingredient, Sevelamer Carbonate, is sourced from Taiwan and shipped in bulk form to India where it will be combined with various inactive ingredients to produce the final film coated tablet in dosage form.
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 134) 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 this case, we find the mixing of the active ingredient Sevelamer Carbonate (Taiwan origin) with the inactive ingredients into the final film coated tablets in dosage form does not result in a substantial transformation and the country of origin will be Taiwan.
With regard to the permanency of a marking, section 134.41(a), Customs Regulations (19 CFR 134.41(a)), provides that as a general rule marking requirements are best met by marking worked into the article at the time of manufacture. For example, it is suggested that the country of origin on metal articles be die sunk, molded in, or etched. However, section 134.44, Customs Regulations (19 CFR 134.44), generally provides that any marking that is sufficiently permanent so that it will remain on the article until it reaches the ultimate purchaser unless deliberately removed is acceptable.
In order to meet the marking requirements, the Sevelamer Carbonate Tablets must be conspicuously, legibly and permanently marked with the country of origin in satisfaction of the marking requirements of 19 U.S.C. 1304 and 19 CFR Part 134. 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 outer most container “Product of Taiwan” in which the Sevelamer Carbonate tablets are imported and sold to the ultimate purchaser is an acceptable country of origin marking.
If a U.S. reference appears on the imported Sevelamer Carbonate Tablets or the packages when they are imported into the United States (U.S.), it is necessary to consider the necessity for additional marking. Section 134.46, Customs Regulations (19 CFR 134.46), deals with cases in which the words “United States,” or “American,” the letters “U.S.A.,” any variation of such words or letters, or the name of any city or locality in the United States, or the name of any foreign country or locality other than the country or locality in which the article was manufactured or produced, appears on an imported article or its container, and those words, letters or names may mislead or deceive the ultimate purchaser as to the actual country of origin. In such a case, there shall appear, legibly and permanently, in close proximity to such words, letters, or name, and in at least a comparable size, the name of the country of origin preceded by “Made in,” Product of,” or other words of similar meaning. The purpose of this requirement is to prevent the possibility of misleading or deceiving the ultimate purchaser of an article as to the actual origin of the imported good.
Based upon the label provided, the subject product is not legally marked with the proper country of origin. The label indicates that the product is manufactured by Dr. Reddy’s Laboratories Limited- Srikakulam - 532 409 INDIA and Distributor by Dr. Reddy’s Laboratories Limited with a U.S. address. Therefore, we suggest adding “Made in”,” Product of,” or other words of similar meaning with “Taiwan” as the country of origin in close proximity.
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