CLA-2 OT:RR:CTF:TCM H048947 CkG
Ms. Inge Forstenzer Ren-Pharm International, Ltd. 350 Jericho Turnpike, Suite 204 Jericho, NY 11753
Re: Modification of NY N044081; classification of donepezil hydrochloride
Dear Ms. Forstenzer,
This is in reference to New York Ruling Letter (NY) N044081, issued by the Customs and Border Protection (CBP) National Commodity Specialist Division on November 21, 2008, regarding the classification under the Harmonized Tariff Schedule of the United States (HTSUS) of the drugs donepezil hydrochloride and Exenatide. We have reconsidered this decision, and for the reasons set forth below, have determined that classification of donepezil hydrochloride in subheading 2933.39.31, HTSUS, as an antidepressant, tranquilizer or other psychotherapeutic agent, is incorrect.
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 N044081 was published on June 9, 2010, in Volume 44, Number 24, of the Customs Bulletin. CBP received no comments in response to the notice.
FACTS:
Donepezil Hydrochloride (CAS # 120011-70-3), is the salt of Donepezil (CAS 120014-06-4), with a chemical formula of C24H29NO3HCl. It is a reversible inhibitor of the enzyme acetylcholinesterase. It is indicated for the treatment of mild to moderate dementia in patients with Alzheimer's Disease, and imported in bulk form. Its chemical structure is included in the diagram below:
ISSUE:
Whether donepezil hydrochloride is classifiable in subheading 2933.39.31, HTSUS, as an antidepressant, tranquilizers or other psychotherapeutic agent, or in subheading 2933.39.41, as an “other” drug of heading 2933.
LAW AND ANALYSIS:
Merchandise is classifiable under the Harmonized Tariff Schedule of the United States (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 and, provided such headings or notes do not otherwise require, according to the remaining GRIs 2 through 6. GRI 6, HTSUS, requires that the GRI's be applied at the subheading level on the understanding that only subheadings at the same level are comparable. The GRI's apply in the same manner when comparing subheadings within a heading.
The HTSUS provisions under consideration are as follows:
2933: Heterocyclic compounds with nitrogen hetero-atom(s) only:
Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure:
2933.39: Other:
Other:
Drugs:
2933.39.31: Antidepressants, tranquilizers and other
psychotherapeutic agents…..
2933.39.41: Other…..
* * * *
The introductory language to Table 1 of the HTSUS Pharmaceutical Appendix states:
This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule…
DONEPEZIL 120014-06-4
The introductory language to Table 2 of the HTSUS Pharmaceutical Appendix states:
Salts, esters and hydrates of the products enumerated in table 1 above that contain in their names any of the prefixes or suffixes listed below shall also be entered free of duty under general note 13 to the tariff schedule, 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.
…
HYDROCHLORIDE
* * * *
Heading 2933, HTSUS, provides for heterocyclic compounds with nitrogen hetero-atom(s) only. Heterocyclic compounds are organic compounds containing at least one atom of carbon, and at least one element other than carbon, such as sulfur, oxygen or nitrogen within a ring structure. These structures may comprise either simple aromatic rings or non-aromatic rings. Donepezil hydrochloride is composed of multiple carbon rings, one of which includes a nitrogen atom. Donepezil is thus a heterocyclic compound classifiable in heading 2933, HTSUS. Donepezil hydrochloride further contains an unfused pyridine ring (a six-membered ring of five carbon atoms and one nitrogen atom), and is thus classifiable at the six-digit level in subheading 2933.39, HTSUS. The issue arises at the eight-digit tariff rate level.
In NY N044081, CBP classified the subject merchandise in subheading 2933.39.31, HTSUS. However, donepezil does not act as an antidepressant, tranquilizer, or psychotherapeutic agent. Rather, it is used to improve cognitive function and slow the progression of dementia due to Alzheimer’s disease. As an inhibitor of the enzyme acetylcholinesterase, donepezil inhibits the cholinesterase enzyme from
breaking down acetylcholine, increasing both the level and duration of action of the neurotransmitter acetylcholine, which is thought to excite neuronal activity in certain areas of the brain, and to play a role in learning and short-term memory. Thus, the appropriate classification for donepezil hydrochloride at the eight-digit subheading level is 2933.39.41, HTSUS.
HOLDING:
By application of GRI 1 and 6, donepezil hydrochloride is classified in subheading 2933.39.41, HTSUS, which provides for “Heterocyclic compounds with nitrogen hetero-atom(s) only: Compounds containing an unfused pyridine ring (whether or not hydrogenated) in the structure: Other: Other: Drugs: Other.”
Pursuant to GN 13 of the HTSUS, donepezil hydrochloride is entered free of duty.
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 on the World Wide Web at www.usitc.gov/tata/hts/.
EFFECT ON OTHER RULINGS:
NY N044081, dated November 21, 2008, is hereby modified with respect to the classification of donepezil hydrochloride.
In accordance with 19 U.S.C. §1625(c), this ruling will become effective 60 days after publication in the Customs Bulletin.
Sincerely,
Myles B. Harmon, Director,
Commercial and Trade Facilitation Division