Food & Drug Protection Division

Drug Program

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.

Food & Drug Protection Division

Drug Program

Drug Manufacturers, Wholesalers, and Repackers

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.