FDPD - Drug Program - Licensing

Drug Manufacturers, Wholesalers, and Repackers

Drug manufacturers, wholesalers, and repackers are required to register or license each location operating in North Carolina annually. Out-of-state prescription drug manufacturers, repackers, or wholesalers shipping directly to North Carolina are also required to be properly registered. The following lists the current license fees that are required to be renewed each calendar year:

  • Prescription drug manufacturers/virtual manufactures/outsourcing facility (Sterile 503B)/re-packagers/medical gas manufactures & re-packagers: $1000.00
  • Prescription drug wholesalers/distributor/reverse distributor only/Pseudoephedrine only/third party logistic provider only: $700.00.
  • Virtual manufacturers, outsourcing facility (Sterile 503B), Reverse Distributor Only, Pseudoephedrine Only, Third Party Logistic Provider Only, Medical Gases (Manufactures/Re-packagers and above if approved Medical Gas Distributor / Wholesalers)


Registration and Licensing

Registration and licensing activities involve prescription drug manufacturers, virtual manufactures, outsourcing facilities (Sterile 503B), re-packagers, medical gas manufactures, medical gas re-packagers, distributors, reverse distributors, wholesalers, third party logistic provider only and pseudoephedrine only. 


The Drug Branch of the Food and Drug Protection Division protects the health, welfare and economic interests of the state's consumers of drugs, cosmetics and medical devices. This is accomplished through a program of inspection which ensures such products are safe and properly labeled, stored, and handled. 

Drug Specialists conduct routine unannounced inspections of drug manufacturers, warehouses and distributors to ensure that drugs are safe, wholesome, produced under sanitary conditions, properly labeled, stored, distributed and held under sanitary conditions. Specialists verify compliance with North Carolina law and regulations to ensure the integrity of prescription drugs for human consumption.