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  1. Human Drug Imports

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Importing Active Pharmaceutical Ingredients

Human Drug Imports

Active pharmaceutical ingredients (APIs) imported or offered for import into the U.S. must comply with all the applicable requirements and regulations under the Food Drug & Cosmetic (FD&C) Act and Title 21 of the Code of Federal Regulations (21 CFR).

APIs imported into the U.S. generally must comply with the following requirements:

  • Foreign establishment registration: Foreign establishments that manufacture, repack, relabel or salvage APIs that are imported or offered for import into the US. must register with FDA. Visit section 510(i) of the Act and 21 CFR 207.17 for more information. Additionally, foreign establishments required to register with FDA must list all known importers in their registration per 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, including API, 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. At the time of importation, the listing provided must be the manufacturer’s API listing. 
  • Labeling: APIs are inherently misbranded under section 502(f)(1) of the FD&C Act because their labeling does not bear "adequate directions for use" by a consumer. APIs must therefore comply with specific labeling requirements, depending on the intended use, to be compliant with 21 CFR 201.122. Compliance with 21 CFR 201.122 is required for the API to be eligible for a labeling exemption.
  • Bulk drug substances used in compounding: Bulk drug substances, or API, used in compounding must comply with either section 503A or 503B of the FD&C Act.

Additionally, API manufactured in the U.S., that is 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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