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The tariff classification of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex from Ireland
Issued April 4, 2002 by U.S. Customs and Border Protection.
Cite this ruling
Copies to clipboardH8 H89591 (April 4, 2002)
Tariff classification
HTS codes: 3002.90.5150
Headings: 3002
Product description
The subject product, BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex, is described in the 2002 Physicians’ Desk Reference® as “[a] sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose and yeast extract. It is puried from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing human albumin and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.” BOTOX® (which is supplied in a single-use vial) is indicated for the treatment of cervical dystonia, strabismus, and blepharospasm associated with dystonia.
CBP rationale
The applicable subheading for the subject product will be 3002.90.5150, Harmonized Tariff Schedule of the United States (HTS), which provides for “Human blood; … ; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other: Other: Other.
Full text
NY H89591 April 4, 2002 CLA-2-30:RR:NC:2:238 H89591 CATEGORY: Classification TARIFF NO.: 3002.90.5150 Ms. Iliana G. Fuller Allergan, Inc. 2525 Dupont Drive P.O. Box 19534 Irvine, CA 92623-9534 RE: The tariff classification of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex from Ireland Dear Ms. Fuller: In your letter dated March 14, 2002, you requested a tariff classification ruling. The subject product, BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex, is described in the 2002 Physicians’ Desk Reference® as “[a] sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose and yeast extract. It is puried from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing human albumin and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.” BOTOX® (which is supplied in a single-use vial) is indicated for the treatment of cervical dystonia, strabismus, and blepharospasm associated with dystonia. The applicable subheading for the subject product will be 3002.90.5150, Harmonized Tariff Schedule of the United States (HTS), which provides for “Human blood; … ; vaccines, toxins, cultures of micro-organisms (excluding yeasts) and similar products: Other: Other: Other.” The rate of duty will be free. This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544. This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division
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