New Bulk Animal Drug Substances

Why FDA issued it

Note: The revision to this import alert dated 10/26/2022 updates reason for the alert section, updates program contacts, and updates product description and PAF. Changes are noted and bracketed by three asterisks (***). ***Imported bulk active pharmaceutical ingredients (APIs) labeled for further manufacturing and processing or labeled as chemical substances, are frequently destined for veterinarians and to pharmaceutical processors that formulate unapproved new animal drugs from these APIs. These drug substances, consigned to individuals or processors who formulate and distribute animal drugs, may be adulterated under Section 501(a)(5) of the Act or misbranded under Section 502(f)(1). It is the responsibility of the distributor, whether the importer or some other firm, to assure that these drugs are only shipped to processors legally entitled to receive them. Sponsors of investigational

Quoted from the “Reason for Alert” section of the FDA page for 68-09, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.