10A NCAC 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:

(1)           Data shall be at least 128B encryption in transmission and at rest; or

(2)           Data shall be transmitted via secure file transfer protocol.  Once received, data at rest shall be encrypted.

(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:

(1)           The dispenser does not have a computerized record keeping system; or

(2)           The dispenser is unable to conform to the submission format required by the database administrator without incurring expenses over three thousand dollars ($3,000).

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

 

History Note:        Authority G.S. 90-113.70; 90-113.73; 90-113.76;

Temporary Adoption Eff. January 1, 2007;

Eff. April 1, 2007;

Amended Eff. January 1, 2012;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. February 2, 2016.