OT:RR:CTF:CPMM H304287 KSG
Mr. Kristopher Grube
Logistics & Trade Compliance Manager
Piramal Critical Care, Inc.
3950 Schelden Circle
Bethlehem, PA 18017-8936
RE: Tariff classification of Sevoflurane packaged in 250 ml bottles
Dear Mr. Grube:
This letter is in reference to your request on behalf of Piramal Critical Care, Inc. for a binding ruling regarding the tariff classification of Sevoflurane under the Harmonized Tariff Schedule of the United States (HTSUS).
FACTS:
Sevoflurane is an inhalation anesthesia. It is manufactured from Hexafluroisopropyl Methyl Ether sourced from India and/or China. It is packaged in bottles of 250 ml which are sold to pharmaceutical distributors in boxes of six. You state that Sevoflurane from a single 250 ml bottle may be used for one or more patients by the anesthesiologist, based on the particular patient. The sample label on the 250 ml bottle that you provided and package insert contain the NDC drug code number 66794-015-25, the RX, the name of the drug, USP, the expiration date, the MFG date, the lot number, storage information, the name and address of the manufacturer and the usual dosage as well as an entire page of medical information.
ISSUE:
Whether Sevoflurane packaged in a 250 ml bottle is classified in heading 2909, HTSUS, or in heading 3004, HTSUS?
LAW AND ANALYSIS:
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that the classification of goods shall be determined 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 GRIs 2 through 6 may then be applied in order.
The HTSUS subheadings under consideration are the following:
2909 Ethers, ether-alcohols, ether-phenols, ether-alcohol-phenols, alcohol peroxides, ether peroxides, ketone peroxides (whether or not chemically defined), and their halogenated, sulfonated, nitrated or nitrosated derivatives
Acrylic ethers and their halogenated, sulfonated, nitrated or nitrosated derivatives:
2909.19 Other:
Ethers of monohydric alcohols:
2909.19.18 Other
3004 Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale:
3004.90 Other:
3004.90.92 Other
In understanding the language of the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System, constitute the official interpretation of the Harmonized System at the international level. While neither legally binding nor dispositive, the ENs provide a commentary on the scope of each heading of the HTSUS and are generally indicative of the proper interpretation of these headings. See T.D. 89-80. 54 Fed. Reg. 35127, 35128 (August 23, 1989).
The General EN to Chapter 29 (D)(2)(a) states the following:
(2) Certain other separate chemically defined organic products, which would otherwise have been classified in Chapter 29, may be excluded when put up in certain forms, or if they have been subjected to certain treatments which leave their chemical composition unchanged. Examples are:
(a) Products for therapeutic or prophylactic uses, put up in measured doses or in forms or in packings for retail sale (heading 30.04).
The EN for heading 3004, HTSUS, states as follows:
This heading covers medicaments consisting of mixed or unmixed products, provided they are:
(a) Put up in measured doses or in forms such as tablets, ampoules (for example, re-distilled water, in ampoules of 1.25 to 10 cm3, for use either for the direct treatment of certain diseases, e.g., alcoholism, diabetic coma or as a solvent for the preparation of injectible medicinal solutions), capsules, cachets, drops or pastilles, medicaments in the form of transdermal administration systems, or small quantities of powder, ready for taking as single doses for therapeutic or prophylactic use. . . .
The heading applies to such single doses whether in bulk, in packings for retail sale, etc.; or
(b) In packings for retail sale for therapeutic or prophylactic uses. This refers to products …which, because of their packing and, in particular, the presence of appropriate indications (statement of disease or condition for which they are to be used, method of use or application, statement of dose, etc.) are clearly intended for sale directly to users (private persons, hospitals, etc.) without repacking, for the above purposes.
Since you acknowledge that the Sevoflurane packaged in 250 ml bottles are in a dosage used by anesthesiologists in a hospital, they would fall within the definition of being packaged clearly intended for sale directly to users. As stated above, the EN lists hospitals as an example of a user in the context of heading 3004. Further, all the critical medical information described above that is contained in the package insert and on the 250 ml bottle support the conclusion that the user will receive the Sevoflurane in the sample packaging. In Headquarters Ruling Letter ("HQ") 953450, dated April 19, 1993, CBP classified Sevoflurane imported in bulk in subheading 2909.19.10, HTSUS. While we recognize that patients receive somewhat differing dosages, based on age and weight and other factors, the instant 250 ml bottle is not a bulk quantity.
Based on the above, we conclude that Sevoflurane packaged in 250 ml bottles is classified in heading 3004, and particularly in subheading 3004.90.92, HTSUS.
HOLDING:
By application of GRI’s 1 and 6, Sevoflurane imported in 250 ml bottles is classified in subheading 3004.90.92, HTSUS. The column one, general rate of duty is Free.
Duty rates are provided for your convenience and subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided for at www.usitc.gov.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division
cc: NIS Judy Lee