The tariff classification of Benzylpenicillin Benzathine (CAS No. 1538-09-6) mixed with Lecithin (CAS No. 8002-43-5) in bulk form, from Spain

N296851 June 1, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3003.10.0000 Ms. Sheila Heerdt Ren Pharm International Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753 RE: The tariff classification of Benzylpenicillin Benzathine (CAS No. 1538-09-6) mixed with Lecithin (CAS No. 8002-43-5) in bulk form, from Spain Dear M. Heerdt: In your letter dated May 8, 2018, you requested a tariff classification ruling. Benzylpenicillin Benzathine is also known as penicillin G benzathine, an antibiotic. In your letter, you stated Benzylpenicillin Benzathine will be imported as a combination product in powder form mixed with lecithin, as an excipient. Benzylpenicillin Benzathine mixed with lecithin is indicated for the treatment of bacterial infections such as strep throat, rheumatic fever and syphilis. The applicable subheading for the Benzylpenicillin Benzathine mixed with Lecithin in bulk powder form will be 3003.10.000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Medicaments ... consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale: Containing penicillins or derivatives thereof, with a penicillanic acid structure, or streptomycins or their derivatives.” 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 the 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. 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 judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division