CLA-2-30:OT:RR:NC:2:238
Mr. Stephen S. Spraitzar
Law Office of George R. Tuttle
1 Embarcadero Center, Suite 730
San Francisco, CA 94111
RE: The tariff classification of Velphoro® (Sucroferric oxyhydroxide) chewable tablets, imported in dosage form, from Germany and Switzerland
Dear Mr. Spraitzar:
In your letter dated February 11, 2014, you requested a tariff classification ruling on behalf of Fresenius Medical Care North America.
The subject product, Velphoro® chewable tablets, is a medicinal preparation containing the active ingredient, Sucroferric oxyhydroxide, a phosphate binder. It is indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. You indicated that the purpose of Velphoro® is to eliminate excess phosphorous from the body and to prevent the onset of hyperphosphatemia. Hyperphosphatemia is an electrolyte disturbance in which there is an abnormally elevated level of phosphate in the blood. In your letter you indicated that it will be packed ready for retail sale in bottles containing 90 tablets and imported in 500 mg chewable tablet form. It is available by prescription only.
The applicable subheading for the Velphoro® chewable tablets imported in dosage form will be 3004.90.9170, 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.
Samples of Velphoro® chewable tablets will also be imported. In your letter you indicated that the samples will be given away to doctors and medical clinics, free of charge, for the purpose of soliciting future orders in the United States. You included a picture of the label of the sample. The label states the product as Velphoro® (Sucroferric oxyhydroxide) chewable tablets, 500 mg, tablets must be chewed, 30 tablets, Physician Sample – Not for Sale. The prescribing direction indicates that the recommend dosage and administration for Velphoro® chewable tablets is 3 tablets per day, administered as 1 tablet, 3 times daily with meals. Based upon the recommended dosage and administration, the sample bottle of Velphoro® chewable tablets containing 30 tablets, consumed three times a day, is sufficient only for 10 days of treatment.
In your letter you suggest that the samples of Velphoro® chewable tablets may be eligible for duty free treatment under subheading 9811.00.60, HTSUS. This subheading provides for the free entry of any sample (except samples covered by heading 9811.00.20 or 9811.00.40), valued not over $1.00 each, or marked, torn, perforated, or otherwise treated so that it is unsuitable for sale or for use otherwise than as a sample, to be used in the United States only for soliciting orders for products of foreign countries. The controlling factor under this statute is whether the importer uses the samples for the purpose of soliciting purchase orders for foreign merchandise and the creation of demand for future orders. The purpose behind the importation and distribution of the samples must be the stimulation of sales through exposure for public consumption.
CBP has held in HRL 555619, dated October 29, 1990, that if the tablets in their condition as imported are individually marked “Sample,” they could be treated as samples and could be eligible for free entry under subheading 9811.00.60, HTSUS, upon proof that the tablets will be distributed to physicians to give to their patients in order to stimulate future orders of the foreign product. Based upon the information submitted, the samples of Velphoro® (Sucroferric oxyhydroxide) chewable tablets are entitled to free entry under subheading 9811.00.60, HTSUS, provided they are marked as samples, not for sale, produced in a foreign country and only used in the U.S. for soliciting orders for products of foreign countries.
The applicable subheading for the samples of Velphoro® (Sucroferric oxyhydroxide) chewable tablets, 500 mg, imported in bottles containing 30 tablets marked with Physician Sample – Not for Sale, and used in the United States only for soliciting orders for products of foreign countries, will be 9811.00.60, HTSUS, which provides for “any sample (except samples covered by heading 9811.00.20 or 9811.00.40), valued not over $1 each, or marked, torn, perforated or otherwise treated so that it is unsuitable for sale or for use otherwise than as a sample, to be used in the United States only for soliciting orders for products of foreign countries.” 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 http://www.usitc.gov/tata/hts/.
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,
Gwenn Klein Kirschner
Acting Director
National Commodity Specialist Division