Isosorbide dinitrate; Reconsideration of 826576

HQ 083175 March 13, 1990 CLA-2:CO:R:C:G 083175 SER CATEGORY: Classification TARIFF NO.: 3003.90.0000 Mr. Marvin Trief Arrow Chemical Inc. 189 Kinderkamack Road P.O. Box 580 Westwood, NJ 07675 RE: Isosorbide dinitrate; Reconsideration of 826576 Dear Mr. Trief: This is in reference to your request for reconsideration of the New York Ruling Letter (NYRL) 826576, dated December 17, 1987. In NYRL 826576 the merchandise at issue, isosorbide dinitrate, was classified under the Harmonized Tariff Schedule of the United States Annotated (HTSUSA), in subheading 3003.90.0000, HTSUSA, which provides for medicaments consisting of two or more constituents which may have been mixed together for therapeutic or prophylactic uses. FACTS: The merchandise at issue in this reconsideration are the chemicals: 1 - Isosorbide dinitrate with 25 percent lactose. 2 - Isosorbide dinitrate with 25 percent mannitol. The lactose and mannitol used in these products function as a stabilizer and as a diluent. Since the nitrogen compounds in these preparations are explosive in the pure state they must be diluted with a stablilizer for safe transportation. In addition, after importation these products contain the lactose and mannitol as diluents. ISSUE: Whether the products as properly classified as single chemical compounds in Chapter 29, HTSUSA, or as mixed drugs in Chapter 30, HTSUSA. -2- LAW AND ANALYSIS: Classification of goods under the HTSUSA is governed by the General Rules of Interpretation (GRI's), taken in order. GRI 1 provides that classification shall be determined according to the terms of the Headings and relative section or chapter notes. The inquirer states that the only reason the lactose and mannitol are added is because of transportation and related safety requirements, and thus, the products should be classified in Chapter 29, HTSUSA, which covers organic chemicals. But, the Explanatory Notes to Chapter 29 preclude classification of the goods at issue in this Chapter. The Explanatory Notes provide in General Note (A): [a] separate chemically defined compound is a single chemical compound of known structure, which does not contain other substances deliberately added during or after its manufacture. . . . Accordingly, a product consisting of saccharin mixed with lactose, for example, to render the product suitable for use as a sweetening agent is excluded from this Chapter. The merchandise at issue certainly are not single chemical compounds which have no additives, they are expressly excluded from classification in this Heading due to the additions of lactose and mannitol. Regardless of the reason for the addition of lactose and mannitol, imported merchandise is classified in its condition when imported. "Condition as imported" refers to the condition of the goods when they are brought within the jurisdiction of the United States with intent to unlade. Sherwin-Williams Co. v. United States, 38 CCPA 13, 18, C.A.D. 432 (1950). Heading 3003, HTSUS, 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 forms or packings for retail sale." The Explanatory Notes to Heading 3003, HTSUS, provide that this heading covers medicinal preparations for use in the internal or external treatment or prevention of human ailments. Further, note (2) of the Explanatory Notes to Heading 3003, HTSUS, state that preparations containing a single pharmaceutical substance together with an excipient, are included in this heading. Clearly the merchandise at issue are properly classified in this Heading. -3- HOLDING: The merchandise at issue is properly classified in subheading 3003.90.0000, HTSUSA, which provides for medicaments consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses: other. The rate of duty is 6 percent ad valorem. New York Ruling Letter 826576 is affirmed. Sincerely, John Durant, Director Commercial Rulings Division