The tariff classification of safety needles and pen cartridge holders from China

N362922 July 22, 2026 CLA-2-90:OT:RR:NC3:143 CATEGORY: Classification TARIFF NO.: 9018.32.0000; 9018.39.0050 Zachary Litchman PharmaEssentia USA Corporation 35 Corporate Drive, Suite 325 Burlington, MA 01803-4223 RE: The tariff classification of safety needles and pen cartridge holders from China Dear Mr. Litchman: In your letter dated July 7, 2026, you requested a tariff classification ruling. The items under consideration are safety needles and pen cartridge holders. Both items are imported separately, not in assembled form, and without any medication or active substance included. They are distinct items used exclusively in the assembly of the BesremiPen - a prefilled, self-injector device. The safety needles are sterile, single-use needles designed with a snap-fit mechanism rather than a threaded design. This prevents removal and reuse after use, consistent with their intended safety purpose. As previously submitted information, the safety needles are packaged in boxes containing 12 cartons, with each carton holding 100 units. The primary function of the safety needles is to deliver formulation buffers to a skin injection pad. Each safety needle is valued at less than $1. The pen cartridge holders are components designed with a snap-fit mechanism. Upon importation into the United States, they are intended to be assembled with the cartridge, stopper plunger, and dosing mechanism device port to form a subassembly of the BesremiPen. Their primary function is to connect a compatible safety needle to the rest of the device. Based on previously submitted information and the image provided, the pen cartridge holders are packaged in boxes containing 100 units, with each unit valued at less than $1. After importation, the safety needles and pen cartridge holders undergo a structured, multi-stage domestic preparation process to create demonstration articles used exclusively for soliciting orders for BesremiPen. You state that these demonstration articles are clearly distinguished from the ordinary commercial BesremiPen, as they are prefilled with saline or buffer solution rather than the actual medication, distributed free of charge to healthcare professionals along with an injection pad, and safely disposed of following the demonstration. You also claim that the company maintains traceable internal records demonstrating that the imported items are used solely for demonstration and solicitation of orders and can track the items from importation through use and disposal. You suggest the tariff classification for the safety needles and pen cartridge holders under the subheading 9811.00.60, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Any sample (except samples covered by heading 9811.00.20 or 9811.00.40), valued not over $1 each, or marked, torn, perforated or otherwise treated so that it is unsuitable for sale or for use otherwise than as a sample, to be used in the United States only for soliciting orders for products of foreign countries.” We disagree. In Headquarters (HQ) Ruling 555619 (dated October 29, 1990), concerning pharmaceutical tablets, it is stated that “if the tablets are imported in bulk and not individually marked or treated in some way to distinguish them from the standard merchandise, they cannot be considered to fall within the scope of the term ‘samples.’” Similarly, in HQ 557248 (dated October 18, 1993), which addresses active ingredients of pharmaceutical samples imported in bulk in drums, CBP found that “the mere marking of the outer container or drum as for ‘sample production only’ is not sufficient to ensure that the finished product is unsuitable for sale or for use otherwise than as a sample.” This is notwithstanding the petitioner’s assertion that the individual identity of the lots designated as samples could be maintained through a computerized inventory control system. In addition, the ingredients as imported are not the same article that will be distributed as samples for soliciting orders for products of foreign countries. Based on the documents provided, at the time of importation, the safety needles and pen cartridge holders are packed in bulk and are not individually marked as “samples,” “Professional Sample - Not for Sale,” or similar wording. These items are indistinguishable from the standard commercial component parts of the BesremiPen. Upon importation, the safety needles are fully functional, and the pen cartridge holders are simply component parts of the BesremiPen subassembly. The pen cartridge holders are not the same articles that will be distributed as samples for soliciting orders for products of foreign countries; rather, they must undergo a multi-stage process post importation to become the finished product that is ultimately used for soliciting orders. Accordingly, the safety needles and pen cartridge holders cannot be considered as "samples" within subheading 9811.00.60, HTSUS. The applicable subheading for safety needles will be 9018.32.0000, HTSUS, which provides for “Tubular metal needles and needles for sutures and parts and accessories thereof.” The rate of duty will be free. The applicable subheading for pen cartridge holders will be 9018.39.0050, HTSUS, which provides for “instruments and appliances used in medical, surgical, dental or veterinary sciences; "other" syringes, needles, catheters, cannulae and the like and parts and accessories thereof.” The rate of duty will be free. The duties cited above are current as of this ruling’s issuance. 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/. This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs. For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies. 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. 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 Dionisia Melman at dionisia.y.melman@cbp.dhs.gov. Sincerely, (for) James P. Forkan Director National Commodity Specialist Division