This page provides an overview of human drugs and the requirements that FDA verifies and 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 Human Drugs Import page for more information on import requirements.
- Registration and Listing
- Types of Drug Applications
- How does the FDA verify drug application information at the time of importation?
- Drug Labeling
- Import for Export
- Affirmations of Compliance codes for human drugs
- Combination Products
- Can my drug be considered a personal importation?
The FDA defines a drug, in part, as “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.” Refer to section 201(g) of the Federal Food Drug and Cosmetic Act (FD&C Act).
The definition also includes components of drugs, such as active pharmaceutical ingredients.
If you are unsure if your product is a drug or a cosmetic, visit the Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) page for more information.
Imported drugs must meet FDA’s standards for quality, safety and effectiveness. FDA will verify compliance with the following requirements as applicable:
- Drug application
- Drug labeling
- Drug current good manufacturing practices (cGMPs)
The FDA provides a list of import alerts by industry. To view the list of import alerts related to human drug products visit the import alert for drug products page.
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:
- Declared Manufacturer
- Declared Importer/Consignee
- Product Description
- Affirmations of Compliance (A of C)
- Intended use code
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 FDA also conducts field examinations and analyzes samples of drug products to ensure they comply with applicable standards and/or label requirements.
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.
Foreign drug establishments that manufacture, repack, re-label or salvage drug products and whose drugs are imported or offered for import into the United States are required to register with the FDA before offering a drug for import and renew annually.
These regulations also requires foreign drug establishments to identify a U.S. Agent and include all known importers in their drug registration.
Registrants are also required to list with FDA each drug manufactured at their establishment(s) intended for commercial distribution and submit updated drug listing information to FDA twice each year, in June and December, notifying FDA if this information has changed.
See the Electronic Drug Registration and Listing System page for more information, including how to register and list.
The FDA verifies that the declared manufacturer is registered and the product is listed, by comparing the information submitted to the FDA against the FDA’s drug registration and listing databases. The FDA also verifies the foreign manufacturer has identified the declared importer or consignee in their registration. If the information does not match, the FDA may need to gather additional information or may detain the product.
You may search the Drug Establishments Current Registration (DECRS) page 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.
Drugs may require an approved marketing application before being imported into the U.S. Types of drug applications include New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Investigational New Drug Application (IND), and Biologic License Application (BLA). Visit the Types of Applications page for additional information.
When required, the FDA will verify the declared NDA, ANDA, BLA or IND by comparing the information submitted to the FDA's data systems. If the NDA, ANDA, BLA or IND information is not supplied, or is incomplete or inaccurate, it may delay the review of your entry. If the information does not match, the FDA may gather additional information or may detain the product.
If the product requires a NDA, ANDA, BLA 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 refer to the CDER Contact Information page.
All drug products offered for importation into the United States are subject to labeling requirements. The 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. For example, over–the-counter drugs, prescription drugs, investigational drugs and drugs imported for drug efficacy studies (DESI drugs) are subject to specific labeling requirements in addition to the general drug label provisions. For more information on prescription and OTC drug labeling search within the Guidances (Drugs) page.
The 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.
Affirmation of Compliance codes (A of C) are three letter codes that are 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 review during the FDA’s import screening process. The 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. Some of the A of C codes used for drug products include:
- REG (Drug Registration Number),
- DLS (Drug Listing Number),
- DA (Drug Application Number)
For information, including a full list of drug affirmation of compliance codes refer to the ACE affirmations of compliance document. To determine the mandatory and optional A of C’s for your product, refer to the Industry Quick Reference Guide to the FDA ACE Supplemental Guide.
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.
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