New animal drug substances for which there are no approved New Animal Drug Applications (NADAs) or Investigational New Animal Drug (INAD) exemptions, consigned to veterinarians for use in their private practices, or to manufacturers, or distributors, may not be legally imported into the United States. These drugs will be considered adulterated under section 501(a)(5) of the Act, or misbranded under section 502(f)(1).
Bulk drug substances labeled for further manufacturing or processing and bearing some indication for veterinary use, are adulterated within the meaning of 501(a)(5) unless the recipient or distributor holds an approved NADA, ANADA, conditional NADA, or an INAD exemption for preparation of a finished dosage form drug or medicated feed premix from that particular bulk drug source, or an approval is not required at this time either by regulation or policy.
Bulk drug substances labeled for further manufacturing or processing, which do not bear any indications for veterinary use, may be misbranded under Section 502(f)(1) if they are intended for veterinary use. Such drugs are in violation of Section 502(f)(1) because they do not bear adequate directions for veterinary drug use and they are not exempt from adequate directions for use.
New animal drug substances may be imported only if the consignee is:
- the holder of an approved NADA, ANADA, or a conditional NADA for the imported new animal drug substance; or,
- the sponsor or investigator named in an INAD exemption for the imported drug substance; or,
- the investigator conducting tests in vitro and in laboratory research animals with drugs which comply with pertinent Federal regulations (21 CFR 511.1(a)); or,
- a distributor holding the requisite approvals or having an order from a consignee holding the appropriate approved NADA or INAD exemption.
FDA will take appropriate action to prevent importation of new animal drug substances if the importer does not meet one of these criteria. Field compliance officers will prevent illegal importation by detaining the drug substances at the port of entry. Veterinarians and others should be aware of these requirements when planning to import bulk drugs.