CLA-2-30:OT:RR:NC:N1:138
Ms. Lea M. Ford
DF Young Inc.
504 McCormick Drive, Suite K
Glen Burnie, MD 21061
RE: The tariff classification of a Ztlido™ (Lidocaine topical system) 1.8% from Spain
Dear Ms. Ford:
In your letter dated May 1, 2018, you requested a tariff classification ruling on behalf of Scilex Pharmaceuticals Inc.
Ztlido consists of a transdermal patch measuring 10 cm x 14 cm containing 36 mg of lidocaine, a local anesthetic, as the active ingredient. This lidocaine topical system is indicated for pain relief associated with post-herpetic neuralgia (PHN).
The applicable subheading for the Ztlido (Lidocaine topical system) 1.8% 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 (including those in the form of transdermal administration systems) 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 also inquired about the country of origin marking requirements. We need additional information to make this determination. Please provide a step-by-step manufacturing flow chart detailing the operations performed in each country. Include the starting materials. Provide a complete component breakdown by weight of all ingredients totaling 100 percent with their respective country or countries of origin for each component, material or substance. Provide a clear and legible picture of the labels packed for retail sale. 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. If your request was submitted electronically and the information required does not involve sending a sample, you can re-submit your request and the additional information electronically.
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