(a)  Every person doing business in North Carolina and operating as a prescription drug manufacturer, repackager or wholesaler shall submit a completed prescription drug registration form to the department.  A separate registration form shall be submitted for each establishment operating in the State of North Carolina.  Each registration form shall be signed by the owner or individual in charge.

(b)  A fee of five hundred dollars ($500.00) for manufacturers or repackagers and a fee of three hundred fifty dollars ($350.00) for wholesalers shall be submitted with each registration or renewal form.

(c)  On or before December 31 of each year, every person registered in accordance with Paragraph (a) of this Rule shall submit a renewal form furnished by the division.

(d)  Prescription Drug Registration Forms may be obtained from the Food and Drug Protection Division.


History Note:        Authority G.S. 106‑140.1;

Eff. June 1, 1988;

Amended Eff. January 1, 1992;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. March 22, 2015.