Country of Origin: Chemical and Pharmaceutical Products

Country of Origin: Tablet in Dosage Form

The pharmaceutical product under consideration is Albendazole imported in 200 mg tablets. The active pharmaceutical ingredient (API), Albendazole, is manufactured in Mexico and the finished tablets in dosage form are made in India. In India, the Albendazole is mixed with various inactive ingredients to produce the final tablets in dosage form.

What is the country of origin of the tablet?

Country of Origin and Substantial Transformation Standard: The “country of origin” of a good is the country in which the good is wholly manufactured, produced, or grown. Such an article is said to be “wholly the growth or product” of that country and as such, it is considered to be “originating” in that country.

Similarly, articles that are processed or manufactured exclusively in a country from domestic materials that have been wholly grown or produced in that same country are also considered to be “wholly the product or manufacture” of that country.

When a good is not wholly the growth, product, or manufacture of that one country, that is, when the product incorporates or reflects foreign materials or processing, or both, which are attributable to two or more countries other than the country where the final product is made, origin determinations become more complex.

In such cases, the impact of materials or processing that originate in countries other than the country of final manufacturing and/or processing must be considered when determining the country of origin of the finished good.

In-Depth Coverage: Country of Origin

• Country of Origin of Imported Merchandise
• Customs Ruling: Country of Origin
• Country of Origin: Food Products
• Country of Origin: Chemical and Pharmaceutical Products
• Country of Origin & Country of Manufacture: CBP vs. FDA
• Country of Origin: Substantial Transformation or Country of Assembly Test
• Country of Origin and Free Trade Agreement
• Country of Origin and Section 301

If the article in question is not wholly manufactured, produced, or grown within a single country, then we must consider the source or origin of any component or material that is used in the manufacture, production, or assembly of the good, and whether the further work or material added to an article in a subsequent country effected a “substantial transformation” on that part, component or material, so as to render such other country the “country of origin” of the end product. (19 CFR Part 134.1)

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. However, 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 determining whether a substantial transformation occurs in the manufacture of products from chemicals, CBP has consistently examined whether a chemical reaction occurs when two or more chemicals are mixed to produce the final product. When chemical compounds are mixed together and undergo chemical change to form a new substance and the individual properties of each raw material are no longer discernable, they have undergone a substantial transformation.

In this case, CBP holds that the mixing of the active ingredient Albendazole (Mexican origin) with the inactive ingredients into the final dosage tablets in India does not result in a substantial transformation and therefore the country of origin to be Mexico.

Customs Ruling―N305889: The country of origin of Albendazole Tablets in dosage form (September 18, 2019)

In-Depth Coverage: Importing Medical Device 

• Importing Medical Devices into the U.S.
• Medical Device Facility Registration and Device Listing
• Premarket Requirements for Imported Medical Devices
• Medical Device – Premarket Notification 510(k)
• Medical Device – Premarket Approval (PMA)
• Medical Device – Investigational Device Exemption (IDE)

Country of Origin: Capsule in Dosage Form

The product under consideration is Isotretinoin, imported in 10 mg, 20 mg, 30 mg and 40 mg capsules. Isotretinoin is a synthetic Vitamin A acid derivative known as 13-cis-retinoic acid. The active pharmaceutical ingredient (API), Isotretinoin, is manufactured in Italy and that the finished capsules in dosage form are made in India. In India, the Isotretinoin will be mixed with various inactive ingredients to produce the final capsules in dosage form.

In this case, CBP holds that the mixing of the active ingredient Isotretinoin (Italian origin) with the inactive ingredients into the final dosage capsules in India does not result in a substantial transformation and the country of origin will be Italy.

Customs Ruling―N305685: The tariff classification and country of origin of Dr. Reddy’s Isotretinoin Capsules in dosage form, from Italy (September 5, 2019)

Country of Origin: Injectable Emulsion in Dosage Form

The product under consideration is Phytonadione Injectable Emulsion 10 mg/mL, also known as vitamin K1. The active pharmaceutical ingredient (API), Phytonadione, is manufactured in Switzerland. In India, the Phytonadione will be mixed with inactive ingredients sourced from various countries to produce the final product, Phytonadione Injectable Emulsion 10 mg/mL in dosage form.

In this case, CBP holds that the mixing of the active ingredient Phytonadione (made in Switzerland) with the inactive ingredients into the final dosage injectable emulsion in India does not result in a substantial transformation and the country of origin will be Switzerland.

Customs Ruling―N305364: The tariff classification and country of origin of Phytonadione Injectable Emulsion 10 mg/mL in dosage form, from Switzerland (August 13, 2019)

In-Depth Coverage: Importing Cosmetics

• Importing Cosmetics into the U.S.
• Cosmetics – Regulations and Enforcement by FDA
• Organic Cosmetic Products
• Shelf Life and Expiration Date of Cosmetics
• Cruelty-Free or Not Tested on Animals Labeling or Claims
• Cosmetics, Drugs, or Cosmetics and Drugs
• Voluntary Cosmetic Registration Program (VCRP)

Customs Clearance and Import Requirements

• Entry of Imported Merchandise
• What is Section 321 Entry?
• What is Automated Commercial Environment (ACE)
• What is an Automated Broker Interface (ABI)?
• Who is Ultimate Consignee?
• What is Non-Resident Importer Program?
• Country of Origin of Imported Merchandise
• What is the Country of Assembly?
• What is the FDA's Country of Manufacture?
• Marking of Country of Origin on U.S. Imports
• What is Customs Bond?
• Reconciliation Prototype and Bond Rider
• Who Needs a Customs Broker?
• What is Customs Ruling Program?
• Classification of Imported Goods
• How is imported merchandise appraised?
• What are Import Quotas?
• What are Trade Remedy Duties?
• Antidumping Duty (AD) and Countervailing Duty (CVD)
• What is Foreign Trade Zone (FTZ)?
• What is Importer Security Filing (ISF)?
• What is Temporary Importation under Bond (TIB)
• What is In-Bond Process?

Guidance on customs & logistics solution for traditional and e-commerce importers and exporters

Importer Security Filing (ISF)

An ISF is required when cargo (ocean only) laden on vessel at a foreign port is destined for shipment to the U.S.  Under ISF rule, some importing information and details regarding cargo must be transmitted to the CBP at least 24 hours before goods are loaded onto the vessel, or at least 24 hours prior to the departure to the U.S. 

Freight Forwarding

Looking for a freight forwarding partner?  To move your cargo from its current location through customs to its final destination we will partner with you to find the best way for your business. Whatever your transportation, logistics or customs clearance needs, we will do our best to customize a solution for your needs. 

Customs Clearance

All goods imported into the customs territory of the U.S. are required to be declared to CBP. Our customs broker will help you stay in compliance with customs laws and regulations and clear your goods quickly and efficiently with our electronic Automated Commercial Environment (ACE) and Automated Broker Interface (ABI) Single Window System.

Warehousing & Distribution

Our warehouse facility offers great potential for serving as a regional hub with over 145,000 SF storage capacity close to Los Angeles Airport & Los Angeles/Long Beach Sea port. With our extensive experience in freight services, your import/export cargo will be handled quickly and effectively.

Section 321 Entry

Section 321 entry allows importing free of duty and tax for shipments imported by one person on one day having a fair retail value in the country of shipment not more than $800. We provide our resident and non-resident clients with dedicated ACE eManifest solutions for Section 321 entry of all modes of transportation. 

Non-resident Importer Program

If you want to sell your products in U.S. marketplaces, but you are a business owner located outside of the U.S. and do not have an entity or presence in the U.S., you need to be established as a Foreign Importer of Record before your products can be imported into the U.S. We can help you.

E-Commerce

The Internet has made it easy to find and purchase items from almost anywhere in the world. Our e-commerce experts will help you find the right solution for your international transportation, customs clearance, and delivery to your final destination.  We also provide value-added repackaging, warehousing and distribution services. 

FDA-Regulated Products and Import Requirements

• What is Food Safety Modernization Act (FSMA)?
• Prior Notice of Imported Foods
• Food Facility Registration
• Risk-Based Preventive Controls for Human Food
• Risk-Based Preventive Control for Animal Food
• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
• What is Foreign Supplier Verification Program (FSVP)?
• Protect Food against Intentional Adulteration
• FDA Regulated Product in Foreign Trade Zone (FTZ)
• Entry Review Process for FDA Regulated Products
• Country of Origin  VS  Country of Manufacture
• Foods Regulated by FDA or USDA: What is the Difference?
• Label and Labeling Claims for Conventional Food and Dietary Supplements
• What is USDA Country of Origin Labeling (COOL)?
• Import for Export of FDA Regulated Products
• FDA Regulated Products in Personal Baggage or Sending by Mail or Courier
• International Mail Facility (IMF) and FDA Regulation
• Importing Biological Product Regulated by CBER
• Importing Cosmetics and Voluntary Cosmetic Registration Program (VCRP)
• Importing Drugs into the U.S.
• Importing OTC Drugs into the U.S.
• Importing Veterinary Drugs into the U.S.
• Importing Tobacco Products into the U.S.
• Importing Medical Devices into the U.S
• Importing Food Products into he U.S.
• Importing Radiation-Emitting Products into the U.S.

Quick Link To U.S. Customs & Import Requirements