MAR-2 OT:RR:NC:2:238
Ms. Jennifer Plitsch
Covington & Burling LLP
102 Pennsylvania Avenue, N.W.
Washington, D.C. 20004
RE: THE COUNTRY OF ORIGIN MARKING OF OMIDRIA™ (phenylephrine and ketorolac injection)
Dear Plitsch:
This is in response to your letter received on October 2, 2014, filed on behalf of Omeros Corporation, requesting a ruling on the country of origin marking requirements for imported OMIDRIA™ (phenylephrine and ketorolac injection). A marked sample was not submitted with your letter for review.
The subject product, OMIDRIA™ (phenylephrine and ketorolac injection), is a sterile aqueous solution concentrate containing a combination of two active pharmaceutical ingredients (APIs): 1 % of phenylephrine hydrochloride (alpha 1-adrenergic receptor agonist) and 0.03 % of ketorolac tromethamine (a nonsteroidal anti-inflammatory drug (NSAID)). It is indicated for maintaining pupil size by preventing intraoperative miosis and for reducing postoperative pain during cataract surgery or intraocular lens replacement. OMIDRIA™ is supplied in a single use, 5 mL glass vial designed to deliver 4.0 mL of OMIDRIA™ for dilution into 500 mL of irrigation solution.
In your letter, you stated that the phenylephrine hydrochloride is manufactured in Germany, while the ketorolac tromethamine is manufactured in India. The two separately sourced APIs (phenylephrine hydrochloride and ketorolac tromethamine) will be combined at manufacturing facilities in the Unites States or Italy. Here, the two APIs will be mixed with other inactive ingredients, sterilized and packaged into single use vials, to produce the finished medicament, OMIDRIA™ (phenylephrine and ketorolac injection). You believe that the country of origin for OMIDRIA™ should be the United States or Italy, depending on where the two APIs are combined.
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 United States the English name of the country of origin of the article. Part 134, Customs Regulations (19 CFR Part 135) implements the country or origin marking requirements and exceptions of 19 U.S.C. 1304.
Section 134.1(b), Customs Regulations (19 CFR 134.1(b)), defines "country of origin" as:
the country of manufacture, production or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the "country of origin" within the meaning of this part;….
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986).
In the instant case, we find that the combining of two active pharmaceutical ingredients (APIs)
phenylephrine hydrochloride (Germany-produced) and ketorolac tromethamine (India-produced)
in Italy or the United States results in a new product, OMIDRIA™ (phenylephrine and ketorolac injection), which has a new name, character and use distinct from the two APIs that were used in the production of the finished product. Based on the facts presented, a substantial transformation has occurred as a result of the operations performed in Italy or the United States. Therefore, the country of origin of the imported OMIDRIA™ (phenylephrine and ketorolac injection), is Italy or the Unites States, depending on where the two APIs were combined. Since the solution, per se, is, of course, incapable of being marked, it is excepted from being marked (19 C.F.R. Section 134.32(a)).
Accordingly, marking the container with the proper country of origin in which the OMIDRIA™ (phenylephrine and ketorolac injection) is imported and sold to the ultimate purchaser is an acceptable country of origin marking.
If a good is determined to be an article of U.S. origin, it is not subject to the country of origin marking requirements of 19 U.S.C. §1304. Whether an article may be marked with the phrase “Made in the USA” or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC). We suggest that you contact the FTC Division of Enforcement, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580 on the propriety of proposed markings indicating that an article is made in the U.S.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 CFR Part 177).
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.
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,
Gwenn Klein Kirschner
Director
National Commodity Specialist Division