The tariff classification of a U.S.-made insulin-delivery device returned from abroad because it is no longer useable

NY L87110 September 12, 2005 CLA-2-30:RR:NC:2:238 L87110 CATEGORY: Classification TARIFF NO.: 3006.80.0000 Eleanore Kelly-Kobayashi, Esq. Rode & Qualey 55 West 39th Street New York, NY 10018 RE: The tariff classification of a U.S.-made insulin-delivery device returned from abroad because it is no longer useable Dear Ms. Kobayashi: In your letter dated August 18, 2005, on behalf of your client, Becton Dickinson Company, you requested a tariff classification ruling. The subject product, the B-D® Pen insulin delivery device (“pen”), is an insulin delivery device that resembles a pen. The pen is supplied in a zippered carrying case that, in turn, is placed in an outer paperboard box for retail sale. The insulin cartridges and pen needles used with the pen are not supplied with the pen, and must be purchased separately by the patient. The pens are manufactured in the U.S. and sold to various pharmaceutical companies, who then export them, along with the insulin cartridges (and, presumably, the pen needles) used with the pens, to various countries. From time to time, a pen malfunctions and is returned to your client for evaluation. In almost all cases, the pen is returned without the carrying case. The pens returned by patients to the pharmaceutical companies or sellers overseas may be empty, have a residue of insulin, or contain nearly a fully loaded cartridge. The companies do not sort the pens when they receive them. Rather, all of the returned pens are commingled as they are received, packaged, and then shipped to your client. You stress that the pens returned to your client from overseas, regardless of their condition, “are no longer useable.” The applicable subheading for the subject pens will be 3006.80.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for “Waste pharmaceuticals.” The rate of duty will be free. This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which are administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 1-888-463-6332. 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 Harvey Kuperstein at 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division