Overview

This folio 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 Heart for Drug Evaluation and Research (CDER) is the FDA Center responsible for overseeing the drug plan 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.

  • Overview
    • What is a drug?
    • What drug requirements are verified at the time of importation?
    • How can I make up one's mind if a homo drug product is on an import alert?
    • How does the FDA verify compliance with the drug requirements at the time of importation?
  • Registration and Listing
    • How does the FDA verify registration and listing at the time of importation?
    • How do I obtain the manufacturer's registration and listing information?
  • Types of Drug Applications
  • How does the FDA verify drug application information at the time of importation?
  • Drug Labeling
  • Import for Consign
  • Affirmations of Compliance codes for human drugs
  • Combination Products
  • Tin can my drug be considered a personal importation?

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What is a drug?

The FDA defines a drug, in part, equally  "intended for use in the diagnosis, cure, mitigation, handling, or prevention of affliction" and "manufactures (other than nutrient) intended to affect the construction or any function of the body of man or other animals." Refer to department 201(g) of the Federal Food Drug and Cosmetic Act (FD&C Act).

The definition too includes components of drugs, such as active pharmaceutical ingredients.

If yous are unsure if your product is a drug or a cosmetic, visit the Is Information technology a Cosmetic, a Drug, or Both? (Or Is Information technology Lather?) folio for more information.

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What drug requirements are verified at the time of importation?

Imported drugs must meet FDA'south standards for quality, rubber and effectiveness. FDA will verify compliance with the following requirements as applicative:

  • Registration
  • Listing
  • Drug application
  • Drug labeling
  • Drug current expert manufacturing practices (cGMPs)

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How tin I determine if a human drug production is on an import warning?

The FDA provides a list important alerts by manufacture.  To view the list of import alerts related to human drug products visit the import alert for drug products folio.

How does the FDA verify compliance with the drug requirements at the time of importation?

FDA entry reviewers are trained to verify compliance with applicative product requirements. The FDA entry reviewers utilize the information provided to FDA in the importer's entry manual, such every bit:

  • Declared Manufacturer
  • Declared Importer/Consignee
  • Production Description
  • Affirmations of Compliance (A of C)
  • Intended utilize code

These entry declarations are compared to information in FDA'due south internal information systems. If the information matches, then compliance is verified; if the data does not lucifer, FDA may demand to gather additional data or may detain the product. The FDA too 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 candy electronically and not held for manual review. FDA's screening tool, PREDICT, has the power to verify the declared data against FDA internal data systems.

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

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Registration and Listing

Strange drug establishments that manufacture, repack, re-label or relieve drug products and whose drugs are imported or offered for import into the Usa are required to register with the FDA before offer a drug for import and renew annually.

These regulations also requires foreign drug establishments to identify a U.South. 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 data to FDA twice each year, in June and December, notifying FDA if this information has changed.

See the Electronic Drug Registration and List Organisation folio for more data, including how to annals and list.

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How does the FDA verify registration and listing at the time of importation?

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 alleged importer or consignee in their registration.  If the information does not match, the FDA may demand to get together additional information or may detain the product.

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How practise I obtain the manufacturer's registration and list data?

Yous may search the Drug Establishments Current Registration (DECRS) page for specific registration information for whatsoever drug establishment that is registered with FDA. In order to obtain the listing number, you volition have to contact the house that listed the drug.

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Types of Drug Applications

Drugs may crave an approved marketing application before being imported into the U.Due south. 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 folio for additional information.

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How does the FDA verify drug application information at the time of importation?

When required, the FDA will verify the declared NDA, ANDA, BLA or IND by comparison 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, information technology may filibuster the review of your entry.  If the information does not match, the FDA may assemble additional data 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 man drug approval process and/or human being drug requirements, please refer to the CDER Contact Information page.

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Drug Labeling

All drug products offered for importation into the The 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 full general drug label provisions. For more data on prescription and OTC drug labeling search inside the Guidances (Drugs) folio.

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Import for Export

The FDA allows unapproved drugs and drug products into the Us that are only intended for further processing or incorporation into another product and subsequent export as long as certain atmospheric condition are met. Visit the Import for Export page for more information.

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Affirmations of Compliance codes for human drugs

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 volition be held for further review during the FDA'southward 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 non 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 data, including a full list of  drug affidavit 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.

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Combination Products

Combination products are therapeutic and diagnostic products that combine drugs, medical devices, and/or biological products.  Based on master mode of action, a combination production is assigned to a "lead-center" that has chief jurisdiction for its regulation.  For more information on combination products, including product jurisdiction and consignment of the lead center, visit the Often Asked Questions About Combination Products folio.

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Can my drug be considered a personal importation?

The FDA has specific criteria for personal importation of drug products.  See the Personal Importation page for more than data.

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