NY N011123 - COUNTRY OF ORIGIN MARKING OF IMPORTED Clinical Trial Materials; ARTICLE 509 - United States International Trade Commision Rulings

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NY N011123

May 29, 2007

MAR-2 RR:E:NC:2:238

CATEGORY: MARKING

Mr. Lawrence Price
Wyeth Pharmaceuticals
200 Campus Drive
Collegeville, PA 19426

RE: COUNTRY OF ORIGIN MARKING OF IMPORTED Clinical Trial Materials; ARTICLE 509

Dear Mr. Price:

This is in response to your letter dated May 9, 2007 requesting a ruling on whether the proposed method of marking the outermost container in which clinical trial materials will be imported with the country of origin in lieu of marking the articles themselves is an acceptable country of origin marking. A marked sample container was not submitted with your letter for review.

The issue concerns a prospective importation of clinical trial materials that are provided free of charge to pharmaceutical investigators who are non-Wyeth personnel. The investigators in turn issue the clinical trial shipments to patients free of charge. You state that the imported materials are imported into the commerce of the United States meeting the first marking criterion as the outermost cartons are legibly marked with the country of origin “Made in Canada.” You further explain that, within the outermost cartons, the unmarked individual clinical trial materials are put up in vials, bottles and blister cards and may be further assembled also in visit cartons. The visit cartons may be then be further assembled into patient packages which contain medication for the patient for the entire clinical trial. The investigators distribute these packages to the patients.

The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR Part 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304.

The country of origin marking requirements for a "good of a NAFTA country" are also determined in accordance with Annex 311 of the North American Free Trade Agreement ("NAFTA"), as implemented by section 207 of the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat 2057) (December 8, 1993) and the appropriate Customs Regulations. The Marking Rules used for determining whether a good is a good of a NAFTA country are contained in Part 102, Customs Regulations. The marking requirements of these goods are set forth in Part 134, Customs Regulations.

Section 134.45(a)(2) of the regulations, provides that "a good of a NAFTA country may be marked with the name of the country of origin in English, French or Spanish. Section 134.1(g) of the regulations, defines a "good of a NAFTA country" as an article for which the country of origin is Canada, Mexico or the United States as determined under the NAFTA Marking Rules.

Part 134, Customs Regulations (19 CFR Part 134), implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.41(b), Customs Regulations (19 CFR 134.41(b)), mandates that the ultimate purchaser in the U.S. must be able to find the marking easily and read it without strain. Section 134.1(d) of the regulations, provides that the ultimate purchaser of a good of a NAFTA country is the last person in the United States who purchases the good in the form in which it was imported. If an imported article is to be sold at retail in its imported form, the purchaser at retail is the ultimate purchaser.

In the present case, the acceptable method of marking revolves around the identification of the ultimate purchaser as determined by circumstances. The Customs Service has ruled in the past that products that are imported for sale to or use by medical facilities need not be individually marked as to their country of origin, but, rather, could be marked on the packages, or on the outside of the containers in which the products were packed, provided the medical facility receives the products in such properly marked packages or containers. Furthermore, CBP has ruled that under certain circumstances, e.g., when the imported article is given to the recipient as part of a service, the recipient of the article is not the ultimate purchaser. Rather, the ultimate purchaser of the imported article is the one who distributes the article. In such a scenario, the decision by the customer or the patient was to purchase or receive the doctor’s service and not the product (drug). The very nature of clinical trials parallels the patient/doctor/medical facility scenario, with the investigator providing the service to the (volunteer) patient.

In the instant situation, it is the opinion of this office that the ultimate purchasers will be the investigators. Therefore, we find the method of marking described in your letter to be acceptable.

An article is excepted from marking under 19 U.S.C. 1304 (a)(3)(D) and section 134.32(d), Customs Regulations (19 CFR 134.32(d)), if the marking of a container of such article will reasonably indicate the origin of such article. Accordingly, if Customs is satisfied that the article will remain in its container until it reaches the ultimate purchaser and if the ultimate purchaser can tell the country of origin of the clinical trial materials by viewing the container in which it is packaged, the individual materials would be excepted from marking under this provision.

Clinical trial materials which are imported in containers that are marked in the manner described above, are excepted from marking under 19 U.S.C. 1304 (a)(3)(D) and 19 CFR 134.32(d). Accordingly, marking the container in which the clinical trial materials are imported and sold to the ultimate purchaser in lieu of marking the article itself is an acceptable country of origin marking, provided the port director is satisfied that the article will remain in the marked container until it reaches the ultimate purchaser.

This ruling is being issued under the provisions of Part 181 of the Customs Regulations (19 CFR Part 181).

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,

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