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  5. General Requirements for Importing Human Drugs
  1. Human Drug Imports

General Requirements for Importing Human Drugs

Human Drug Imports

All drugs manufactured for the U.S. market—whether produced domestically or abroad—must meet the same rigorous standards. FDA verifies that drugs imported or offered for import into the U.S. meet federal law requirements at the time of import to protect patients and consumers.

The agency’s actions at the border and ports of entry promote supply chain integrity. FDA ensures drugs imported into the U.S. comply with applicable legal and regulatory requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act) and the pertinent regulations in title 21 of the Code of Federal Regulations (21 CFR) including:

  • Drug approval or application: 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) and biologic license application (BLA), or be covered under over-the-counter monographs established under section 505G of the FD&C Act (for OTC drugs only) or an investigational new drug application (IND).
  • Foreign establishment registration: Foreign drug establishments that manufacture, repack, re-label or salvage drugs and whose drugs are imported or offered for import into the U.S. are required to register with FDA before their drugs are imported. These establishments must renew that registration annually. Visit section 510(i) of the FD&C Act, 21 CFR 207.17 for more information about who must register.

Additionally, foreign establishments required to register with FDA must list all known importers in their registration in accordance with section 510(i)(1)(A) of the FD&C Act, 21 CFR 207.25(h)(2).

  • Drug listing: Foreign drug manufacturers, repackers, relabelers and salvagers are required to list all their commercially distributed finished drugs with FDA. Visit section 510(j) of the FD&C Act, 21 CFR 207.41 for information about who must list drugs and what drugs they must list. A drug listing may be presented as the drug listing number or national drug code (NDC) number.
  • Drug labeling: Drug labels must comply with FDA labeling regulations under 21 CFR Part 201 and cannot be false or misleading. Specific drug labeling requirements depend on the type of finished drug. For example:
  • OTC or non-prescription drugs: FDA requires a standard label of important drug information for all finished OTC drugs. It must include Drug Facts panel and meet requirements described at 21 CFR 201.66.
  • Prescription drugs: Must state “Rx only” and meet requirements described at 21 CFR 201.57.
  • Drug current good manufacturing practice (CGMP) requirements: All drugs must be manufactured in conformance with CGMP requirements. Visit section 501(a)(2)(B) of the FD&C Act and 21 CFR Parts 210-211 for more information.

Components of drugs are defined as drugs Under section 201(g)(1)(D) of the FD&C Act. Therefore, active pharmaceutical ingredients and other components must comply with applicable human drug requirements.

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