Importing Drugs into the U.S.

FDA Requirements for Drug Importation

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA regulations define the term drug, in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

Therefore, almost any ingested or topical or injectable product that, through its label or labeling (including internet websites, promotional pamphlets, and other marketing material), is claimed to be beneficial for such uses will be regulated by FDA as a drug.  The definition also includes components of drugs, such as active pharmaceutical ingredients.

FDA reviews shipments of imported drugs to determine whether they are admissible into the U.S.  An imported drug may be refused entry if, for example, it appears to be:

• Adulterated – Federal law requires manufacturers to comply with quality manufacturing regulations. A drug may be adulterated if, for example, it was not manufactured in compliance with these quality manufacturing requirements.

• Misbranded – Appropriate label information is an important aspect of marketing a drug because it gives patients the information they need to take medications correctly. A drug label must comply with FDA regulations. A drug may be misbranded if, for example, its label is false or misleading, it lacks FDA-required information, or otherwise does not follow FDA’s label rules.

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)

Manufacturers also must register and list their drugs with the FDA. A drug may be misbranded if a manufacturer has not complied with these requirements. A drug may also be misbranded if it is a prescription drug offered for sale without a prescription.

• Unapproved – Drugs must be proven to be safe and effective for use before companies can market them in the U.S. A drug that lacks the required FDA-approval is considered to be unapproved.

This page provides an overview of human drugs and the requirements that the FDA verifies/enforces at the time they are imported or offered for import into the United States.  The Center for Drug Evaluation and Research (CDER) is the FDA Center responsible for overseeing the drug program which includes over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

FDA Establishment Registration and Drug Listing Compliance Program

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

What drug requirements are verified at the time of importation?

At the time of importation, the FDA will verify compliance with the following requirements as applicable:

• Registration
• Listing

Additionally:

• Certain drug products also may need to have an approved New Drug or Abbreviated New Drug Application (NDA or ANDA).
• FDA conducts field examinations and analyzes samples of drug products to ensure they comply with applicable standards and/or label requirements.
• FDA lists foreign manufacturers not in compliance with the drug current good manufacturing practices (GMPs) on Import Alert 66-40. 

In-Depth Coverage: Marketing and Advertising Compliance

• Federal Trade Commission (FTC) Advertising Rules
• Made in USA Standard
• FTC Regulation on Environmental Claims
• Adverting and Marketing on the Internet
• Label Claims for Conventional Foods and Dietary Supplements
• Dietary Supplement Advertising: What is FTC's Truth-in-Advertising Law?
• USDA Country of Origin Labeling (COOL)
• FTC Rules & Regulations on Food Advertisement

Establishment Registration and Drug Listing

Foreign drug establishments whose drugs are imported or offered for import into the United States are required to register with FDA and submit listing information for their drugs intended for commercial distribution in the United States.

Additionally, if the foreign manufacturer has not previously registered, they are required to register with the FDA within 5 days after submitting a drug application, biological license application, or medicated feed mill license application.

These regulations also require importers to identify a U.S. Agent.  Registration and listing must be completed electronically with CDER unless a waiver from the electronic submission requirement is obtained.

How does FDA verify registration and listing?

FDA will verify that the declared manufacturer is registered by comparing the submitted information to CDER’s establishment registration and listing databases.  FDA will also verify the declared importer is registered.  Listing of the declared product is verified by comparing the declared product description to CDER’s establishment registration and listing databases.   If the information matches, then compliance is verified; if the information does not match, FDA may need to gather additional information or may detain the product.

How do I obtain the manufacturer’s registration and listing information?

You may search the Drug Establishments Current Registration Site (DECRS) for specific registration information for any drug establishment that is registered with the FDA. In order to obtain the listing number, you will have to contact the firm that listed the drug.   

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)

Types of Drug Applications

FDA requires that all drugs in the United States be shown to be both safe and effective prior to marketing.

New Drug Application (NDA)

Every new drug must have an approved NDA before becoming available for sale in the United States. When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States.  For internal tracking purposes, all NDA's are assigned an NDA number.  

Abbreviated New Drug Application (ANDA)

An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. 

5 Things You Need to Know About the Drug Approval Process

Investigational New Drug (IND)

FDA requires that certain drugs be the subject of an approved marketing application (NDA/ANDA) before it is offered for importation into the United States. To submit a marketing application for approval, data must be gathered during animal and human clinical trials. A sponsor must seek an exemption from this legal requirement in order to import the drug for these clinical trials.  The IND is the means through which the sponsor technically obtains this exemption from the FDA.

Over-the-Counter Drugs (OTC)

Over-the-counter (OTC) drugs play an increasingly vital role in America's health care system. OTC drug products are those drugs that are available to consumers without a prescription. There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products. As with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks. Read more…

Biologic License Application (BLA)

Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. 

In-Depth Coverage: Customs Valuation

• What is the Price Actually Paid or Payable?
• What is an assist?
• What is the First Sale Rule?
• Rebates Subsequent to Importation
• Transaction Value for Related Party Transaction
• Buying and Selling Commissions in the Transaction Value
• Valuation of Merchandise Imported on Consignment

How does FDA verify pre-market submission information?

When required, FDA will verify the declared NDA, ANDA or IND by comparing the submitted information to CDER’s data systems.  If the NDA, ANDA or IND information is not supplied or is incomplete or inaccurate, it may delay the review of your entry.  If the information matches, then compliance is verified; if the information does not match, FDA may need to gather additional information or may detain the product.

Drug Labeling

All drug products offered for importation into the United States are subject to labeling requirements.  FDA may review drug labeling at the time the product is offered for import to verify compliance with the regulations.  Specific drug labeling requirements depend on the type of drug product. Over–the-counter drugs, prescription drugs, and drugs imported for drug efficacy studies are subject to specific labeling requirements in addition to the general drug label provisions.

Import for Export

FDA allows unapproved drugs and drug products into the United States that are only intended for further processing or incorporation into another product and subsequent export as long as certain conditions are met.

Import for export (IFE) allows for the importation of a product that is unapproved or otherwise does not comply with FDA laws and regulations if it is coming into the U.S. for further processing and ultimately exported out of the U.S. 

In order to qualify for this exemption from refusal, at the time the products are offered for import, you must provide FDA with certain information regarding your intention to further process the product. Products imported under the IFE provision may not be distributed or sold in the U.S.

Affirmations of Compliance Codes for Human Drugs

Affirmation of Compliance codes (A of C) are three letter codes that can be provided at the time of import to facilitate FDA review. Providing the correct A of C codes reduces the likelihood that your shipment will be held for further FDA entry review during FDA’s import screening process.

FDA uses A of C codes to assist in verifying that your product meets the appropriate requirements. Submission of A of C codes is only mandatory in some instances and is not required for all scenarios.

Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.  

Combination Products

Combination products are therapeutic and diagnostic products that combine drugs, medical devices, and/or biological products.  Based on the primary mode of action, a combination product is assigned to a “lead-center” that has primary jurisdiction for its regulation. 

Quick Link To U.S. Customs & Import Requirements

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.

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.

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

The goods imported into 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.

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.

Customs Binding Ruling

Taking steps to ensure compliance is very important in order to avoid potential problems during the clearance process. The Customs binding ruling program enables importers to receive a binding ruling from CBP on the treatment of your goods when entering the U.S. 

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. 

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. 

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?