CLA-2-30:OT:RR:NC:N1:138
Mr. Adam Dambrov
KPMG LLP
3001 Summer Street
Stamford, CT 06905
RE: The tariff classification of XaraColl® from Germany
Dear Mr. Dambrov:
In your letter dated September 14, 2018, on behalf of Innocoll, Inc., you requested a tariff classification ruling.
XaraColl is a biodegradable and fully resorbable collagen matrix impregnated with the local anesthetic, bupivacaine, which is under development for postoperative analgesia. The product is implanted during a surgical procedure and releases bupivacaine for local, sustained action at the site(s) of trauma, while maintaining low systemic levels well below the drug’s neurotoxicity and cardiotoxicity thresholds. Because XaraColl starts releasing bupivacaine immediately, the patient is already benefiting from its analgesic effect upon recovery from their general anesthesia. In your letter, you stated XaraColl is put up in measured doses and packed for retail sale without repacking. XaraColl will be packed in individual polyethylene pouch in a single carton containing three 100 mg bupivacaine hydrochloride collagen matrix implants.
The applicable subheading for the XaraColl® in dosage form will be 3004.90.9245, Harmonized Tariff Schedule of the United States (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: Other: Other: Other: Dermatological agents and local anesthetics.” The rate of duty will be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at https://hts.usitc.gov/current.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
You have also requested a classification ruling for the XaraColl® collagen matrix demonstration unit, which is identical to the XaraColl® except that the demonstration unit will lack the active pharmaceutical ingredient (API), bupivacaine hydrochloride. The demonstration unit will be used only for medical professionals and will not be used for clinical trials or any other scientific purpose. The packaging of the demonstration unit will contain a warning that the product does not contain an API and is not for human use. Before we can issue a binding ruling for the demonstration unit, we need a sample in the condition as imported. If you decide to resubmit your request, please include all of the material that we have returned to you and mail your request to Director, National Commodity Specialist Division, Customs and Border Protection, 201 Varick Street, Suite 501, New York NY 10014, attn: Binding Ruling Request.
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 Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division