CLA-2 OT:RR:CTF:FTM H278992 GaK
AstraZeneca Pharmaceuticals, LP
1800 Concord Pike, FOP4-221
Wilmington, DE 19850
RE: Country of Origin and Marking of Crestor® (rosuvastatin calcium salt) tablets imported in bulk containers
Dear Mr. Weinraub:
This letter is in response to your letter dated July 20, 2016, filed on behalf of iPR Pharmaceuticals, Inc. (“IPR”), requesting a reconsideration of Headquarters Ruling Letter (“HQ”) H240193, dated July 29, 2013, pursuant to 19 C.F.R. § 177.12 regarding the country of origin marking requirements for the tablets imported in bulk containers. While you state that there have been no changes to the facts presented in HQ H240193, we have determined that a reconsideration is not warranted due to new facts presented in your letter. Therefore, we are issuing this prospective ruling pursuant to 19 C.F.R. § 177.1(a)(1).
FACTS:
According to the information submitted, IPR imports the fungible active pharmaceutical ingredient (“API”) into Puerto Rico from two different countries. The API will be marked with a country of origin at the time of importation. The API is further manufactured into finished pharmaceutical tablets of various concentrations at IPR’s facility in Puerto Rico. The finished tablets are then packed into bulk drums and shipped from Puerto Rico to AstraZeneca Pharmaceuticals, LP’s (“AZ”)’s manufacturing/packing facility in Delaware. The tablets are repacked into the finished Crestor® package and marked with the appropriate country of origin as determined in HQ H240193 (the country of origin was determined to be based on the API). IPR states that it has provided AZ with the appropriate notice of marking requirements under 19 C.F.R. § 134.25, and that AZ is able to certify that the finished packages of pharmaceutical tablets are properly marked and meet all requirements in 19 C.F.R. § 134.
ISSUE:
Whether the bulk drums must be marked when shipped from Puerto Rico to the mainland United States for further repacking.
LAW AND ANALYSIS:
Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. § 1304), provides that, unless excepted, every article of foreign origin imported into the United states 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 United States the English name of the country of origin of the article. By enacting 19 U.S.C. § 1304, Congress intended to ensure that the ultimate purchaser would be able to know by inspecting the marking on the imported goods the country of which the goods are the product. “The evident purpose is to mark the goods so that at the time of purchaser the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” United States v. Friedlaender & Co., 27 C.C.P.A. 297, 302 C.A.D. 104 (1940).
19 C.F.R. § 134.1(d) provides that:
The “ultimate purchaser” is generally the last person in the United States who will receive the article in the form in which it was imported; however, for a good of a NAFTA country, the “ultimate purchaser” is the last person in the United States who purchases the good in the form in which it was imported.
Under the principle set forth in U.S. v. Gibson-Thomsen Co., Inc., 27 C.C.P.A. 269 (1940), if an imported article will be used in domestic manufacture, the manufacturer may be the “ultimate purchaser” if he subjects the imported article to a process which results in a substantial transformation of the article. However, if the manufacturing process is a minor one which leaves the identity of the imported article intact, the consumer or user of the article, who obtains the article after the processing, will be regarded as the “ultimate purchaser.” 19 C.F.R. § 134.1(d)(1) and (2).
As noted above, this is IPR’s second ruling request regarding the country of origin marking of the pharmaceutical tablets. The facts in the second ruling request is the same as the facts in HQ H240193, except in this second case, API proposes not marking the bulk drums with the country of origin when sent to AZ in Delaware for further repackaging.
The first ruling request, in response to which H240193 was issued, asserted that “IPR will place a label on the bulk drum of tablets [to be shipped from Puerto Rico to mainland U.S.] that states either ‘Product of XX’ or ‘Product of YY’ depending on which country the API was from.” CBP determined in HQ H240193 that the manufacturing process in Puerto Rico does not result in a substantial transformation of the API because there was no change in the medicinal use of the finished product, the API retained its chemical and physical properties, and was merely put into a dosage form and packaged. Therefore, the “ultimate purchaser” of the pharmaceutical tablets is not AZ, the packing facility, but the retail purchaser. Accordingly, upon importation into the U.S., the API must be marked to indicate to the ultimate purchaser its country of origin. Further, H240193 indicated the origin that should be included on the labels proposed to be placed on the outermost container of the finished tablets.
In the revised fact situation, we can agree that the outermost container of the bulk tablets, when shipped from Puerto Rico to the processer in the mainland U.S., is not required to be marked. In this regard, we note that 19 C.F.R. § 134.26 may be applicable, which provides, in pertinent part:
[i]f an article subject to these requirements is intended to be repacked in retail containers (e.g., blister packs) after its release from customs custody, or if the Center director has reason to believe such article will be repacked after its release, the importer shall certify to the Center director that: (1) If the importer does the repacking, he shall not obscure or conceal the country of origin marking appearing on the article, or else the new container shall be marked to indicate the country of origin of the article in accordance with the requirements of this part; or (2) if the article is intended to be sold or transferred to a subsequent purchaser or repacker, the importer shall notify such purchaser or transferee, in writing, at the time of sale or transfer, that any repacking of the article must conform to these requirements.
It is important to note that the procedures set forth at 19 C.F.R. § 134.26 apply only to articles which are legally marked at the time of importation. If the articles are not legally marked at the time of importation, the presentation to Customs of the certification and notice to subsequent purchasers or repackers specified in 19 C.F.R. § 134.26 will not serve to satisfy the importer’s obligations under 19 U.S.C. § 1304 and Part 134, Customs Regulations (19 C.F.R. Part 134).
In this case, IPR states that the API will be marked with a country of origin at the time of importation, and 19 C.F.R. § 134.26 is applicable. Therefore, we find that, provided that IPR certifies to the Port Director that it will provide AZ with the appropriate notice of marking requirements under 19 C.F.R. § 134.25, the bulk drums do not need to be marked with the country of origin when transported from Puerto Rico to Delaware.
HOLDING:
The bulk drums do not need to be marked with a country of origin when shipped from Puerto Rico to the mainland United States for further repacking, provided that the API is marked with the country of origin at the time of importation and the certification requirements under 19 C.F.R. § 134.26 are met.
A copy of this ruling letter should be attached to the entry documents filed at the time this merchandise is entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the Customs officer handling the transaction.
Sincerely,
Myles B. Harmon, Director
Commercial Trade & Facilitation Division