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  1. Human Drug Imports

Importing Prescription Drugs

Human Drug Imports

Prescription drugs imported into the U.S. must comply with all the applicable requirements under the Federal, Food and Cosmetic Act (FD&C Act) and the pertinent regulations in Title 21 of the Code of Federal Regulations (21 CFR).

Prescription drugs imported into the U.S. must meet the following general admissibility requirements:

  • Foreign establishment registration: Foreign establishments that manufacture, repack, relabel or salvage drugs imported or offered for import into the U.S. must register with FDA. Visit section 510(i) of the FD&C Act, 21 CFR 207.17. 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 and 21 CFR 207.25(h)(2). Registration must be renewed annually.
  • Drug listing: Foreign drug manufacturers, repackers, relabelers and salvagers are required to list all their commercially distributed drugs with FDA. A drug listing may be presented as the Drug Listing (DLS) number or National Drug Code (NDC) number. Registrants must submit updated drug listing information to FDA twice annually if anything changes. Visit section 510(j) of the FD&C Act and 21 CFR 207.41 for more detailed information.
  • Drug approval: A new drug must have FDA approval before it may be marketed in the United States. Such approvals include a new drug application (NDA), abbreviated new drug application (ANDA) or biologic license application (BLA). Visit section 505(a) of the FD&C Act for more information.
  • Drug labeling: Drug labels must comply with FDA labeling regulations under 21 CFR part 201. Section 201.57 contains specific requirements for prescription drug labeling.
  • Current good manufacturing practice (CGMP) requirements: Under section 501(a)(2)(B) of the FD&C Act, prescription drugs must be manufactured in conformance with CGMP requirements. Visit 21 CFR Parts 210 and 211 for more information.

Additionally, prescription drugs manufactured in the U.S. that are exported and re-imported into the U.S. must be shipped to the original U.S. manufacturer, unless authorized by the Secretary in the case of a medical emergency. Visit section 801(d)(1), (d)(2) of the FD&C Act and 21 CFR 203.10 for more information.

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