CLA-2 OT: RR: CTF: TCM: H252416 ERB
Mr. Pradeep Shah
Director, Supply Chain
Zydus Pharmaceuticals USA, Inc.
73, Route 31 North
Pennnington, NJ 08534
RE: Tariff classification of Sirolimus tablets, imported in dosage form
Dear Mr. Shah:
This is in reply to your letter dated November 6, 2013 to the U.S. Customs and Border Protection (CBP) National Commodity Specialist Division (NCSD) in New York, on behalf of Zydus Pharmaceuticals (USA), Inc. (Zydus), seeking a prospective ruling under the Harmonized Tariff Schedule of the United States (HTSUS), regarding the tariff classification of Sirolimus tablets. Your request was forwarded to this office for a response. No samples were provided to this office, but a sample was provided by Zydus to CBP’s Laboratories and Scientific Services for analysis.
FACTS:
The subject merchandise is described in your ruling request as sirolimus tablets, in 0.5 mg, 1 mg, and 2 mg doses, used for prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. It is imported in tablet form.
Sirolimus also known as rapamycin, is an immunosuppressant drug that is used to prevent rejection in organ transplantation because of its immunosuppressive and antiproliferative properties. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. It is a naturally occurring antibiotic. The chemical name of sirolimus and its chemical structure is as follows:
(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows.
A sample of the Sirolimus tablets was sent to CBP’s Laboratories and Scientific Services. Laboratory Report NY20140116, dated January 28, 2014 states the following:
Product name: Sirolimus
INN: Sirolimus
CAS Number: 53123-88-9; listed in Table 1 of the Pharmaceutical Appendix to the HTSUS (2013)
Approved Use: Immunosuppressant
Sirolimus, also known as rapamycin, is a macrocyclic lactone (macrolide) secreted by Streptomyces hygroscopicus. Sirolimus is a potent immunosuppressant and is approved by the United States Food and Drug Administration for the prevention of organ rejection in kidney transplant patients. Sirolimus also possesses antifungal activity and is the subject of active investigation as an antifungal agent.
ISSUE:
Whether sirolimus, a natural antibiotic, here imported in measured dosage form, is classified in heading 3004, as a medicament put up in measured doses.
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 may then be applied in their appropriate order.
The HTSUS heading under consideration are the following:
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:
3004.20 Containing other antibiotics
The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While not legally binding, the ENs provide a commentary on the scope of each heading of the HS and are thus useful in ascertaining the proper classification of merchandise. See T.D. 89-90, 54 Fed. Reg. 35127 (August 23, 1989).
The EN to heading 2941, HTSUS, states in relevant part: Antibiotics are substances secreted by living micro-organisms which have the effect of killing other micro-organisms or inhibiting their growth. They are used principally for their powerful inhibitory effect on pathogenic micro-organisms, particularly bacteria or fungi, or in some cases on neoplasms. They can be effective at a concentration of a few micrograms per ml in the blood.
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This heading also includes chemically modified antibiotics used as such. These may be prepared by isolating ingredients produced by natural growth of the micro-organism and then modifying the structure by chemical reaction or by adding sidechain precursors to the growth-medium so that desired groups are incorporated into the molecule by the cell-processes (semi-synthetic penicillins); or by bio-synthesis (e.g. penicillins from selected amino-acids).
Natural antibiotics reproduced by synthesis (e.g. chloramphenicol) are classified in this heading, as are certain synthetic products closely related to natural antibiotics and used as such (e.g., thiamphenicol).
The EN to heading 30.04 states
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 injectable 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.
Sirolimus also known as rapamycin, is an immunosuppressant drug that is used to prevent rejection in organ transplantation. In its condition as imported, the subject sirolimus is in tablet form. This means, in its condition as imported, it is ready to be used as a medical treatment. The subject merchandise is therefore considered a medicament, and classification under chapter 30 is appropriate. Specifically, heading 3004, HTSUS, which provides for medicaments, consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale.
Sirolimus is a naturally occurring antibiotic, though it is not penicillin or a derivative thereof. The EN to heading 29.41 which provides for antibiotics, directs that naturally occurring antibiotics are to be classified as such. As noted above, the subject merchandise is a medicament, and is therefore classified in Chapter 30 which provides for pharmaceutical products. The subject merchandise is in its condition imported in measured doses of sirolimus, a natural antibiotic, and therefore, it is classified in subheading 3004.20, HTSUS, which provides for medicaments, put up in measured doses, containing other antibiotics. See NY N016271, dated September 7, 2007 (classifying Sirolimus imported in bulk form, in heading 3003, HTSUS, which provides for Medicaments…not put up in measured doses or in forms or packings for retail sale: Containing other antibiotics”); and see NY N161616, dated May 3, 2001 (classifying sirolimus in bulk form, not mixed with other ingredients, in subheading 2941.90, HTSUS, which provides for antibiotics).
HOLDING:
By application of GRI 1, the subject sirolimus tablets, is classified in heading 3004, HTSUS. Specifically, it is provided for in subheading 3004.20.0060, HTSUSA (Annotated), which provides for. “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: Containing other antibiotics: Other: Other.” The 2015 column one, general rate of duty for merchandise of this subheading is free.
Duty rates are subject to change. The text of the most recent HTSUS and the accompany duty rates are provided at www.usitc.gov A copy of this ruling letter should be attached to the entry documents filed at the time the goods are entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the CBP officer handling the transaction.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation