For Industry

Human Drugs

Overview

This page provides an overview of human drugs and the requirements that 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.

Visit the Drug webpage for more information.

Back to top

What is a drug?

The Federal Food Drug and Cosmetic Act (FD&C Act) and 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.

For more information on intended use, visit Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

Back to top

What drug requirements are verified at the time of importation?

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

  • Registration
  • Listing

Additionally:

Back to top

How does FDA verify compliance with the drug requirements?

FDA entry reviewers are trained to verify compliance with applicable product requirements. The FDA Entry Reviewers use the information provided to FDA in the importer’s entry transmission, such as:

These entry declarations are compared to information in FDA’s internal data systems. 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.

The submission of correct and accurate entry data and A of C codes will help expedite the entry review process. This increases the likelihood that your shipment may be processed electronically and not held for manual review. FDA’s screening tool, PREDICT, has the ability to verify the declared information against FDA internal data systems. 

Note:  Submitting inaccurate or incomplete information may delay the review of your entry.

Back to top

Registration and 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.

Please see more information on electronic registration and listing here.

Back to top

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.

Back to top

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 FDA.    In order to obtain the listing number, you will have to contact the firm that listed the drug.   

Back to top

Types of Drug Applications

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

Back to top

NDA (New Drug Application)

Every new drug must have an approved NDA before becoming available for sale in the United States. For more information visit our NDA page.

Back to top

ANDA (Abbreviated New Drug Application)

The ANDA contains data which provides for the review and ultimate approval of a generic drug product. For more information visit our ANDA page.

Back to top

IND (Investigational New Drug)

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. For more information visit our IND page.

Back to top

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.

If the product requires a NDA, ANDA or IND and does not have one, it will be subject to refusal.   

For further technical information or questions regarding the human drug approval process and/or human drug requirements, please contact CDER’s Division of Drug Information/Human Drug Informationdisclaimer icon.

Back to top

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. Visit our Drug Labeling, OTC Drug Facts Panel, and OTC Guidance for more information.

Back to top

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. Visit the Import for Export page for more information.

Back to top

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.  

For information on drug affirmation of compliance codes as well as examples of drug affirmation of compliance codes, refer to the “Affirmation Of Compliance References” at the bottom of the affirmation of compliance codes page.

Back to top

Combination Products

Combination products are therapeutic and diagnostic products that combine drugs, medical devices, and/or biological products.  Based on primary mode of action, a combination product is assigned to a “lead-center” that has primary jurisdiction for its regulation.  For more information on combination products, including product jurisdiction and assignment of the lead center, visit the Frequently Asked Questions About Combination Products page

Back to top

Can my drug be considered a personal importation?

FDA has guidance for personal importation of drug products.  For more information on FDA’s Personal Importation Policy visit our Personal Importations page

Back to top

Contact FDA

Toll Free
(855) 543-3784, or
(301) 796-3400
Human Drug Information

Division of Drug Information (CDER)

Office of Communications

Feedback Form

10001 New Hampshire Avenue

Hillandale Building, 4th Floor

Silver Spring, MD 20993

Page Last Updated: 09/14/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English