North Carolina Administrative Code
Title 10A - HEALTH AND HUMAN SERVICES
Chapter 26 - MENTAL HEALTH, GENERAL
Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES
Section .0600 - CONTROLLED SUBSTANCES REPORTING SYSTEM
Section 26E .0603 - REQUIREMENTS FOR TRANSMISSION OF DATA

(a) Each dispenser shall transmit to the Department the data as set forth in G.S. 90-113.73. The data shall be transmitted in the ASAP Telecommunication Format for Controlled Substances, published by the American Society for Automation in Pharmacy that is in use in the majority of states operating a controlled substance reporting system.

(b) The dispenser shall transmit the data electronically unless the Department approves a request for submission on paper as set forth in Paragraphs (e) and (f) of this Rule.

(c) The dispenser's electronic transfer data equipment including hardware, software and internet connections shall be in compliance with the Health Insurance Portability and Accountability Act as set forth in 45 CFR, Part 164.

(d) Each electronic transmission shall meet data protection requirements as follows:

(e) The data may be submitted on paper if the dispenser submits a written request to the Department and receives prior approval.

(f) The Department shall consider the following in granting approval of the request:

(g) The dispenser shall report the data pursuant to the requirements of G.S. 90-113.73(a).