CLA-2-29:OT:RR:NC:N1:138
Ms. Kelly Jo Cox
Mylan Pharmaceuticals Inc.
781 Chestnut Ridge Road
Morgantown, WV 26505
RE: The tariff classification of Palbociclib (CAS No. 571190-30-2) in bulk form, from India
Dear Ms. Cox:
In your letter dated May 23, 2018, you requested a tariff classification ruling.
Palbociclib is a kinase inhibitor indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2)-negative advanced or metastatic breast cancer. In your letter, you stated Palbociclib will be imported in bulk form to be further manufactured into the final dosage form.
You suggest classification in subheading 2934.99.3000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Nucleic acids and their salts, whether or not chemically defined; other heterocyclic compounds: Other: Other: Aromatic or modified aromatic: Other: Drugs.” However, the chemical structure of Palbociclib contains a lactam structure as well as a pyridine ring and a piperazine ring, which are heterocyclic compounds with nitrogen hetero-atoms only of heading 2933.
Pursuant to Chapter 29 Note 3, the applicable subheading for Palbociclib in bulk form will be 2933.79.0800, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Lactams: Other Lactams: Aromatic or modified aromatic: Other: Products described in additional U.S. note 3 to section VI.” The rate of duty will be 6.5 percent ad valorem. Currently, Palbociclib is not listed in the Pharmaceutical Appendix to the Tariff Schedule.
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division