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  1. Human Drug Imports

Importing Over-The-Counter Drugs

Human Drug Imports

Over-the-counter (OTC) or non-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).

The general admissibility requirements for OTC drugs are:

  • Foreign establishment Registration: Foreign establishments that manufacture, repack, relabel or salvage drugs that are imported or offered for import into the U.S. must register with FDA. Visit section 510(i) of the Act and 21 CFR 207.17 for more information. 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).
  • Drug listing: Foreign drug manufacturers, repackers, relabelers and salvagers are required to list all their commercially distributed drugs with FDA. Visit section 510(j) of the FD&C Act and 21 CFR 207.41 for more information. A drug listing may be presented as the drug listing number or national drug code (NDC) number.
  • Drug approval: A drug must have FDA-approved new drug application (NDA) or abbreviated new drug application (ANDA) before it may be marketed in the U.S., or the drug must comply with an OTC drug monograph under section 505 of the FD&C Act if it meets the requirements of section 505G of the FD&C Act (including applicable conditions in an OTC monograph), as well as other applicable requirements. Visit status of OTC rulemakings for OTC monographs and ingredients covered by the monographs. 
  • Drug labeling: Drug labels must comply with FDA labeling regulations under 21 CFR Part 201.
  • Current good manufacturing practice (CGMP) requirements: Section 501(a)(2)(B) of the FD&C Act requires drugs to be manufactured in conformance with CGMP requirements. This section applies to OTC and prescription drugs. Visit 21 CFR Parts 210 and 211 for more information on CGMP requirements.

U.S. manufactured OTC drugs may be offered for re-importation into the U.S. for a variety of reasons, including redistribution of stock, quality issues and/or product recall.

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