OT:RR:CTF:CPM H202562 CkG
TARIFF NO: 2924.29.62
Ms. Inge Forstenzer
Ren-Pharm International, LTD
350 Jericho Turnpike
Suite 204
Jericho, NY 11753
RE: Revocation of NY N180809 and Modification of NY N043304; classification of Aliskiren Hemifumarate
Dear Ms. Forstenzer:
This letter is in relation to New York Ruling Letters (NY) N180809 and N043304, issued to you on September 16, 2011, and November 7, 2008, respectively, regarding the classification of aliskiren hemifumarate under the HTSUS.
In NY N180809 and NY N043304, aliskiren hemifumarate in bulk form was classified in subheading 2924.29.6250, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Carboxyamide-function compounds; amide-function compounds of carbonic acid: Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof: Other: Aromatic: Other: Drugs: Other: Other." There is no dispute that aliskiren hemifumarate is properly classified in 2924.29.62, HTSUS; however, neither NY N180809 nor NY N043304 afforded aliskiren hemifumarate duty free treatment under General Note 13. For the reasons set forth below, we have determined that the failure to grant aliskiren hemifumarate duty free treatment pursuant to General Note 13 was in error.
Pursuant to section 625(c)(1), Tariff Act of 1930 (19 U.S.C. §1625(c)(1)), as amended by section 623 of Title VI, notice proposing to revoke NY N180809 and NY N043304 was published on November 1, 2017, in Volume 51, Number 44 of the Customs Bulletin. No comments were received in response to the proposed action.
FACTS:
Aliskiren hemifumarate is an orally active renin inhibitor used in the treatment of hypertension. The chemical formula is C64H110N6O16. The prefix “hemi” refers to the ratio of fumarate to aliskiren molecules; specifically, 2 molecules of aliskiren for each molecule of fumarate. The CAS number for aliskiren hemifumarate is 173334-58-2.
The chemical structure is included below:
ISSUE:
Whether aliskiren hemifumarate is eligible for duty free entry in accordance with General Note 13, HTSUS.
LAW AND ANALYSIS:
Merchandise is classifiable under the HTSUS in accordance with the General Rules of Interpretation (GRIs). GRI 1 provides that classification shall be determined according to the terms of the headings 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 or notes do not require otherwise, the remaining GRIs 2 through 6 may be applied.
The HTSUS provisions under consideration are as follows:
2924: Carboxyamide-function compounds; amide-function compounds of carbonic acid:
Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof:
2924.29: Other:
Aromatic:
Other:
Drugs:
2924.29.62: Other…
* * * * *
The Harmonized Commodity Description and Coding System Explanatory Notes (“ENs”) 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).
EN 29.24 provides as follows::
This heading covers amide derivatives of carboxylic acids and of carbonic acid (but not amide derivatives of other inorganic acids - heading 29.29).
Amides are compounds which contain the following characteristic groups :
(–CONH2)
((–CO)2NH)
((–CO)3N)
Primary amide
Secondary amide
Tertiary amide
The hydrogen of the (–NH2) or (NH) groups may be substituted by alkyl or aryl radicals, in which case the products are N– substituted amides.
Some amides of this heading also contain a diazotisable amine group. These amides and their salts, diluted to standard strengths for the production of azo dyes, are also included here.
(B) CYCLIC AMIDES
(1) Ureines and ureides.
The main ureines include :
(i) p-Ethoxyphenylurea (dulcin).
(ii) Diethyldiphenylurea (centralite)*.
(2) Acetanilide, methyl- and ethylacetanilide, acet-p- phenetidide (phenacetin),
p acetamidophenol and p-acetamidosalol, used in medicine.
(3) Phenylacetamide.
(4) N-Acetoacetyl derivatives of cyclic amines, e.g., acetoacetanilide; amides of
hydroxynaphthoic acid, e.g., 3-hydroxy-2-naphthanilide; diatrizoic acid and its salts, used as opacifiers in radiography. Some of these compounds are known in trade as “arylides”.
(5) 2-Acetamidobenzoic acid. Colourless to yellowish crystals in the form of
needles, plates or rhomboids. Used as a precursor in the production of methaqualone (INN) (see the list of precursors at the end of Chapter 29).
(6) Alachlor (ISO). 2-Chloro-N-(2,6-diethylphenyl)-N-(methoxymethyl)acetamide.
(C14H20ClNO2).
This heading excludes, however, heterocyclic ureides, e.g., malonylurea (barbituric acid) and hydantoin (heading 29.33).
* * * *
There is no dispute that Aliskiren Hemifumarate is classified in heading 2924, specifically subheading 2924.29.62; the compound contains an organic amide group which makes Aliskiren Hemifumarate a cyclic amide as described in EN 29.24; the presence of an aromatic ring results in subheading 2924.29. As it is a drug, prescribed for the management of hypertension, and it is not provided for subheading 2924.29.57, Aliskiren Hemifumarate falls under subheading 2924.29.62, HTSUS, as an “other” aromatic drug.
The issue is whether Aliskiren Hemifumarate is eligible for duty free entry in accordance with General Note 13, HTSUS.
General Note 13 states as follows:
Pharmaceutical products. Whenever a rate of duty of "Free" followed by the symbol "K" in parentheses appears in the "Special" subcolumn for a heading or subheading, any product (by whatever name known) classifiable in such provision which is the product of a country eligible for tariff treatment under column 1 shall be entered free of duty, provided that such product is included in the pharmaceutical appendix to the tariff schedule. Products in the pharmaceutical appendix include the salts, esters and hydrates of the International Non-proprietary Name (INN) products enumerated in table 1 of the appendix that contain in their names any of the prefixes or suffixes listed in table 2 of the appendix, provided that any such salt, ester or hydrate is classifiable in the same 6-digit tariff provision as the relevant product enumerated in table 1.
Both aliskiren and fumarate are listed in the pharmaceutical appendix to the HTSUS; aliskiren in Table 1, and fumarate in Table 2. Any combination of a base product listed in Table 1 and a prefix or suffix listed in Table 2 of the appendix is eligible for treatment under GN 13, provided that such combination is classified in the same 6-digit provision as the relevant product in table 1. Although “hemifumarate” is not specifically listed in table 2, aliskiren hemifumarate is considered synonymous with aliskiren fumarate, as the prefix “hemi” merely identifies the ratio of fumarate to aliskiren molecules (i.e., one molecule of fumarate for every two of aliskiren). Both aliskiren fumarate and aliskiren hemifumarate share the same chemical formula (C64H110N6O16) and CAS number (173334-58-2); therefore, as aliskiren fumarate is eligible for duty free treatment under GN 13, so is aliskiren hemifumarate.
HOLDING:
By application of GRIs 1 and 6, aliskiren hemifumarate is classified in heading 2924, HTSUS, specifically subheading 2924.29.62, HTSUS, which provides for “Carboxyamide-function compounds; amide-function compounds of carbonic acid: Cyclic amides (including cyclic carbamates) and their derivatives; salts thereof: Other: Aromatic: Other: Drugs: Other.”
Aliskiren hemifumarate is eligible for duty free treatment under General Note 13, HTSUS.
EFFECT ON OTHER RULINGS:
NY N180809, dated September 16, 2011, is hereby revoked. NY N043304, dated November 7, 2008, is hereby modified with respect to the rate of duty applicable to aliskiren hemifumarate.
In accordance with 19 U.S.C. §1625(c), this ruling will become effective 60 days
after its publication in the Customs Bulletin.
Sincerely,
Myles B. Harmon, Director,
Commercial and Trade Facilitation Division