A facility at a single geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility with the Food & Drug Administration.
Http://Www.Ncagr.Gov/Fooddrug/Forms/Instateprescriptiondrugapp.Pdf
Annually
GS 106-140.1
Exemptions provided by 21 U.S.C. 353b(a) with respect to labeling, new drug registration and distribution supply chain requirements shall also apply to compounded drugs distributed in North Carolina by an outsourcing facility.
NC Department of Agriculture and Consumer Services
Food and Drug Protection Division
4000 Reedy Creek Rd
Raleigh, NC 27607-6465
919-733-7366