An entity that engages in the manufacture of a prescription drug for which it: owns the NDA or ANDA; contracts with a contract manufacturing organization for the physical manufacture of the drug product; is not involved in the physical manufacture of the drug product; and at no time takes physical possession of, or stores, the drug product for wholesale distribution.
Http://Www.Ncagr.Gov/Fooddrug/Forms/Instateprescriptiondrugapp.Pdf
Annually
GS 106-140.1
NC Department of Agriculture and Consumer Services
Food and Drug Protection Division
4000 Reedy Creek Rd
Raleigh, NC 27607-6465
919-733-7366