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0831791989-04-12HeadquartersClassification

Application for Further Review of Protest No. 1704-700239, dated July 23, 1987, filed by Burditt, Bowles & Radzius, Ltd., on behalf of XXXXXXXXXXX, protesting your decision in the liquidation on April 24, 1987 and May 1, 1987, of entry XXXXXXXX and XXXXXXXX, dated March 16, 1987 and March 21, 1987, respectively, covering shipments of dimethoxyphenylacetonitrile (“DMPA”), imported from Belgium.

U.S. Customs and Border Protection · CROSS Database

Summary

Application for Further Review of Protest No. 1704-700239, dated July 23, 1987, filed by Burditt, Bowles & Radzius, Ltd., on behalf of XXXXXXXXXXX, protesting your decision in the liquidation on April 24, 1987 and May 1, 1987, of entry XXXXXXXX and XXXXXXXX, dated March 16, 1987 and March 21, 1987, respectively, covering shipments of dimethoxyphenylacetonitrile (“DMPA”), imported from Belgium.

Ruling Text

HQ 083179 April 12, 1989 CLA-2 CO:R:C:G 083179 LS CATEGORY: Classification TARIFF NO.: 412.10 District Director of Customs 1 East Bay Street Savannah, Georgia 31401 RE: Application for Further Review of Protest No. 1704-700239, dated July 23, 1987, filed by Burditt, Bowles & Radzius, Ltd., on behalf of XXXXXXXXXXX, protesting your decision in the liquidation on April 24, 1987 and May 1, 1987, of entry XXXXXXXX and XXXXXXXX, dated March 16, 1987 and March 21, 1987, respectively, covering shipments of dimethoxyphenylacetonitrile (“DMPA”), imported from Belgium. Dear Sir: This is our decision on the above-referenced Application for Further Review of Protest, which you forwarded to our office. Katten Muchin & Zavis has replaced the firm of Burditt, Bowles & Radzius, Ltd. As counsel for the protestant, XXXXXXXXXX. FACTS: The merchandise in question, DMPA, is a benzenoid nitrile-function chemical which is imported by XXXXXXXX for use in the manufacture of verapamil hydrochloride, the active ingredient of the brand name cardivasular drug, Calan. The protestant provides the following information about verapamil hydrochloride and DMPA. Verapamil hydrochloride is a calcium flux inhibitor used int the treatment of angina. This drug relaxes and prevents coronary artery spasms, and reduces the oxygen utilization of the heart by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle and contactile and contractile myocardial cells. Verapamil hydrocholoride, when imported by the protestant into the United States, is classified by Customs as a cardiovascular drug under item 412.12, Tariff Schedules of the United States Annotated (TSUSA). DMPA is an essential ingredient in the production of verapamil hydrochloride. Information provided by the protestant shows the DMPA molecule reacts with other ingredients and becomes s part of the chemical structure of verapamil -2- hydrochloride. Without the DMPA molecule, verapamil hydrochloride would not possess the chemical structure which is necessary for it to act as a calcium ion antagonist. The recognizes and reacts to the structural formula of verapamil hydrochloride to produce the physiological responses described above. DMPA is the ingredient which makes the drug effective. XXXXXXXXXX research of the professional literature shows no commercial usage of this chemical other than as a pharmaceutical intermediate in the manufacture of verapamil hydrochloride. XXXXXXXXXX entered the merchandise under item 405.60, TSUSA, which provides for “Cyclic organic chemical products in any physical form having a benzenoid, quinoid, or modified benzenoid structure, not provided for in subpart A or C of this part [Part 1 of Schedule 4]: Other: Other nitrogen-function compounds . . . and their derivatives: Other: Nitrile-function compounds: Other : Products provided for in the Chemical Appendix to the Tariff Schedules.” Your office liquidated the merchandise under item 405.60, TSUSA. The protestant claims the DMPA was incorrectly classified in item 405.60, TSUSA, and that the proper tariff provision is item 412.10, TSUSA, which provides for “Products suitable for medicinal use, and drugs: Obtained, derived, or manufactured in whole or in part from any product provided for in subpart A or B of this part [part 1 of Schedule 4]: Drugs: Other: Cardiovascular drugs, except alkaloids and their derivatives: Other: Products provided for in the Chemical Appendix to the Tariff Schedules.” XXXXXXXX contends that DMPA meets the definition of a drug set forth in Headnote 2 to Schedule 4, Part 3, TSUSA, because it has therapeutic properties and is chiefly used as an ingredient in verapamil hydrochloride. In support of this position the protestant relies on Austin Chemical Company v. United States, 659 F. Supp. 229 (Ct. Int’l Trade 1987), aff’d, 835 F. 2d 1423 (Fed. Cir. 1987). ISSUE: Whether DMPA is properly classifiable in item 405.60, TSUSA, as a benzenoid nitrile chemical, or in item 412.10, TSUSA, as a cardiovascular drug? LAW AND ANALYSIS: Item 405.60, TSUSA, is a provision within Schedule 4, Part 1, Subpart B. Schedule 4 provides for chemicals and related products and part 1 provides for benzenoid chemicals and products. Subpart B provides for industrial organic chemicals. - 3 - Item 412.10 is a provision within Schedule 4, Part 1, Subpart C. Subpart C provides for finished organic chemical products, which include drugs which are derived from products provided for in Subpart B. Headnote 1 to Schedule 4, part 1 states that any product which is described in both Subparts B and C of part 1 shall be classified in Subpart C. DMPA is described in item 405.60, TSUSA, which is in Subpart B, because (1) it is a cyclic organic chemical product which has a benzenoid structure, and (2) it is a nitrile-function compound which is provided for in the Chemical Appendix to the Tariff Schedules under Chemical Abstracts Service (C.A.S.) Registry number 93-17-4. The superior heading to item 412.10, TSUSA, which is in Subpart C, provides for “products suitable for medicinal use, and drugs.” Since item 412.10 is under the inferior heading which provides for drugs, we must determine whether DMPA is a drug so as to be classfiable in that provision. If DMPA is classifiable in both items 405.60 and 412.10, TSUSA, item 412.10 will prevail pursuant to Headnote 1 to Schedule 4, Part 1. Headnote 9 to Schedule 4, Part 1, Subpart C states: The term “drugs” in this subpart means those substances having therapeutic or medicinal properties and chiefly used as medicines or as ingredients in medicines. We must first determine whether DMPA has therapeutic or medicinal properties. The term “therapeutic” is defined in Webster’s Third New international Dictionary (1971) as “of or relating to the treatment of disease or disorders b remedial agents or methods: curative, medicinal.” In Austin Chemical Co. v. United States, supra, the Court of International Trade found that mandelic acid, which is used in the manufacture of an antibiotic drug, has therapeutic properties, and is thus a drug, because it imparts such properties to other substances with which it is combined . When mandelic acid is combined with those substances it produces the physiological action which corrects the deficient condition. Thus, it was not necessary that the mandelic acid alone be used as a curative. The court relied upon Synthetic Patents Co. v. United States, 12 Cust. Ct. 148, C.D. 845 (1944), which found that a chemical substance, tachysterol, was a drug even though it had to undergo a chemical change after importation to give its therapeutic properties practical application. Relying on the reasoning of the court in Austin Chemical Co., supra, we likewise find that DMPA has therapeutic - 4 - properties. Because DMPA is an essential part of the calcium channel antagonist mechanism which produces the therapeutic effect in relieving the symptoms of angina, it itself is considered to possess therapeutic properties. We next reach the question of whether DMPA is chiefly used as medicines or as ingredients in medicines. “Ingredient” is defined in Webster’s Third New International Dictionary (1971) as “something that enters into a compound or is a component part of any combination or mixture: constituent.” DMPA is used as an ingredient in the medicine, verapamil hydrochloride, because it enters into the formation of that compound. In Austin Chemical Co., supra, the Court of International Trade held that the term “ingredients,” as used in Headnote 9 of Schedule 4, Part 1, Subpart C, includes the component substances of a compound which exist prior to the chemical reaction which forms the compound. Thus, the court found that the tariff term “ingredients in medicine” was not limited to the final compound or medicine itself, but included a component substance, mandelic acid, which entered into the formation of the drug and was crucial for the drug to be effective. XXXXXXXXX has also demonstrated that DMPA is chiefly used as an ingredient in medicine. Chief used is defined in General Interpretative Rule 10(e)(I) an “the use which exceeds all other uses (if any) combined.” The research conducted by XXXXXXXX shows that the primary use of DMPA is an a hydrochloride. Studies of other possible uses of DMPA show little or not industrial significance. Thus, DMPA satisfies both elements of the definition of a drug, i.e., it has therapeutic properties and is chiefly used an as an ingredient in a medicine. Since it is as an essential ingredient of a cardiovascular drug, verapamil hydrochloride, and it is provided for in the Chemical Appendix to the Tariff Schedules under C.A.S. registry number 93-17-4, it is classifiable in item 412.10, TSUSA. Although DMPA is also described in item 405.60 an a benzenoid chemical, we are required to classify it in item 412.10 TSUSA, in accordance with Headnote 1 to Schedule 4, Part 1. HOLDING: In view of the foregoing, the product, DMPA is correctly classifiable in item 412.10, TSUSA. The rate of duty at the time of importation was 8 percent ad valorem. The protest should be allowed. - 5 - A copy of this decision should be furnished to the protestant along with the Form 19 Notice of Action. Sincerely, John Durant, Director Commercial Rulings Division