definiens: shall mean ( i ) any animal drug or veterinary medicinal product or component that is subject to the regulatoryauthority of the FDA pursuant to the Federal Food, Drug, and Cosmetic Act and subsequent amending statutes ( 21 U.S.C. Chapter 9 ), thePublic Health Service Act and subsequent amending statutes ( 42 U.S.C. Chapter 6A ), any subsequent statutes administered by the FDAand any regulations promulgated or otherwise issued by the FDA, and ( ii ) any vaccine or other veterinary biologic that is subject to theregulatory authority of the USDA, via the Animal and Plant Health Inspection Service Center for Veterinary Biologics, pursuant to theVirus - Serum - Toxin - Act ( 21 U.S.C. Chapter 5 ), and any subsequent amending statutes and regulations promulgated thereunder