Decision on Application for Further Review of ProtestNo. 0401-92-100657, concerning the tariff classification ofLanreotide (CAS 108736-35-2)

HQ 956784 March 7, 1995 CLA-2 CO:R:C:F 956784 ASM CATEGORY: Classification TARIFF NO: 2937.99.8050; 2937.99.9550 District Director of Customs 10 Causeway St. Room 603 Boston, MA 02222-1059 RE: Decision on Application for Further Review of Protest No. 0401-92-100657, concerning the tariff classification of Lanreotide (CAS 108736-35-2) Dear Sir: This is a decision on an application for further review of Protest No. 0401-92-100657, against your decision in the classification and liquidation of Lanreotide (CAS 108736-35-2). FACTS: You classified the merchandise under subheading 2934.90.2500, Harmonized Tariff Schedule of the United States Annotated (HTSUSA), as "Other heterocyclic compounds: Other: Aromatic or modified aromatic: Other: Drugs" which is dutiable at the general column one rate of duty, 6.9 percent ad valorem. The merchandise was liquidated under this classification on July 17, 1992. The Protestant asserts that the subject is properly classifiable within subheading 2937.10.0000, HTSUSA, which provides for "Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones: Pituitary (anterior) or similar hormones, and their derivatives," dutiable at 1.8 percent ad valorem. Protestant has indicated that Lanreotide is also under investigation for, among other things, use as a cardiovascular drug. Lanreotide (also known by the trade names "Somatuline" and "Angiopeptin") is a synthetic analogue of Somatostatin, which is defined in Henderson's Dictionary of Biological Terms (10th edition) as a "14-amino acid peptide hormone, produced by the hypothalamus, inhibiting the secretion of growth hormone, insulin and glucagon." The USAN and the USP Dictionary of Drug Names (1994 edition), categorizes Lanreotide as an antineoplastic drug. - 2 - ISSUE: What is the proper classification of Lanreotide (CAS 108736- 35-2)? LAW AND ANALYSIS: Classification of merchandise under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA), is made in accordance with the General Rules of Interpretation (GRI's). The systematic detail of the harmonized system is such that virtually all goods are classified by application of GRI 1, that is, according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRI's may then be applied. The Explanatory Notes to the Harmonized Commodity Description and Coding System (EN's), which represent the official interpretation of the tariff at the international level, facilitate classification under the HTSUSA by offering guidance in understanding the scope of the headings and GRI's. In Headquarter's Ruling Letter (HRL) 952317, dated April 12, 1994, it was determined that a product named Pentetreotide, which was described as "...a synthetic polypeptide derived from octreotide, a synthetic analogue of the naturally occurring hormone, somatostatin (emphasis supplied)," was classifiable an "Other" hormone within subheading 2937.99.80, HTSUSA (now superseded by subheading 2937.99.95, HTSUSA). Like the product in HRL 952317, Lanreotide is also a synthetically produced analogue of the natural hormone Somatostatin. Accordingly, we have determined that Lanreotide is properly classifiable as an "Other" hormone derivative within heading 2937, HTSUSA. The EN's to heading 2937 state that the heading not only includes natural and synthetic hormones, but also derivatives of natural or synthetically reproduced hormones, provided that their primary use is as a hormone. However, based on the fact that the hormone Somatostatin is produced by the hypothalamus, and not the pituitary gland, and is not listed in the explanatory notes naming anterior pituitary hormones or similar hormones (see EN's 29.37 (II)(A)), we do not believe that Lanreotide is properly classifiable within subheading 2937.10.0000, HTSUSA, as a derivative of an anterior pituitary or similar hormone. It is our determination that, based on its hormonal effect and its derivation from the hypothalamic hormone, Somatostatin, the product Lanreotide, should have been classified within subheading 2937.99.8050, HTSUSA, which provides for "Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones: Other hormones and their derivatives; other steroids used primarily as hormones: Other: Other, Other."  - 3 - HOLDING: The product identified as Lanreotide (CAS 108736-35-2), was properly classifiable within subheading 2937.99.8050 (now 2937.99.9550), HTSUSA, which provides for "Hormones, natural or reproduced by synthesis; derivatives thereof, used primarily as hormones; other steroids used primarily as hormones: Other hormones and their derivatives; other steroids used primarily as hormones: Other: Other, Other." The applicable duty at the general column one rate is 3.2 percent ad valorem. The protest should be denied except to the extent that classification as indicated above results in a partial refund. A copy of this decision should be attached to the Form 19 to be returned to the Protestant. In accordance with Section 3A(11)(b) of Customs Directive 099 3550-065, dated August 4, 1993, Subject: Revised Protest Directive, this decision should be mailed by your office to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry in accordance with the decision must be accomplished prior to mailing of the decision. Sixty days from the date of the decision, the Office of Regulations and Rulings will take steps to make the decision available to Customs personnel via the Customs Rulings Module in ACS, and to the public via the Diskette Subscription Service, Freedom of Information Act and other public access channels. Sincerely, John Durant, Director Commercial Rulings Division