CLA-2-30:OT:RR:NC:N3:138
William Braier
Radix Group International, dba DHL Global Forwarding
6120 Ace Industrial Drive
Cudahy, WI 53110
RE: The tariff classification and country of origin of Dr. Reddy's Azurette Tablets (Desogestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) in dosage form
Dear Mr. Braier:
In your letter dated February 8, 2024, filed on behalf of Dr. Reddy's Laboratories, Inc., you requested a tariff classification and country of origin determination ruling.
Dr. Reddy's Azurette Tablets is a medicinal preparation containing a combination of Desogestrel (a progestin) and Ethinyl Estradiol (a steroidal estrogen), as the active ingredients. It is indicated for the prevention of pregnancy. The product is a combination oral contraceptive consisting of a cycle of 28 tablets. Each tablet dispenser contains 21 active dark blue tablets containing Desogestrel (0.15 mg) and Ethinyl Estradiol (0.02 mg), 5 active green tablets containing Ethinyl Estradiol (0.01 mg) and 2 inactive white tablets containing inert ingredients as a reminder tablet to facilitate ease of drug administration via a 28-day regimen. In your letter, you stated the active ingredients are from the Netherlands and or Italy but the finished tablets in dosage form will be made in China.
The applicable subheading for the Dr. Reddy's Azurette Tablets in dosage form will be 3006.60.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for Pharmaceutical goods specified in note 4 to this chapter: Chemical contraceptive preparations based on hormones, on other products of heading 2937 or on spermicides. 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 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.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
You also requested a country of origin determination. We need additional information in order to issue a country of origin ruling. The following detailed information should be included in your submission:
Countries where each of the source materials were made or harvested.
Countries where each of the various production steps took place.
Provide a detailed manufacturing flowchart showing the production steps in each country.
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 and Border Protection 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, please contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division