Importing Investigational New Drugs

An investigational new drug (IND) imported for use in clinical studies must be covered by an IND application, unless exempt per 21 CFR 312.2. The company should submit the IND to FDA before importing the drug into the U.S.

The following requirements must be met to import a drug covered under IND into the U.S.:

• Active IND application in accordance with 21 CFR 312.40.
• Consignee: A consignee in the U.S. is the sponsor of the IND, a qualified investigator named in the IND or the domestic agent of a foreign sponsor who is responsible for the control and distribution of the IND, and the IND identifies the agent and describes what, if any, actions the agent will take with respect to the IND (21 CFR 312.110(a)). FDA verifies that the entry documents match the sponsor, qualified investigator or domestic agent listed in the IND at the time of import.
• Proper labeling: INDs must have specific labeling to identify them as investigational drugs. The label must state: “Caution: New Drug – Limited by Federal Law for Investigational Use.” Visit 21 CFR 312.6 for additional information.

Drugs covered under an active IND are exempt from registration and listing requirements as described at 21 CFR 207.13. Drugs under IND are also exempt from the requirement to have an approved new drug application (NDA), abbreviated new drug application (ANDA) or biologic license application (BLA) because they are not approved.

Importing a drug under IND into the U.S. may be permitted if it is done in accordance with 21 CFR 312.110. Specifically, the drug must be subject to an IND that is in effect, the recipient in the U.S. must be the sponsor or qualified investigator, the drug must be imported for use in a clinical investigation authorized under the IND. Otherwise, such drugs may only be reimported—except for limited exception, by the original manufacturer—as described at section 801(d) of the FD&C Act.