21 N.C. Admin. Code 46.2304

Current through Register Vol. 39, No. 9, November 1, 2024

Section 46 .2304 - AUTOMATED DATA PROCESSING SYSTEMS

An automated data processing system may be employed as a record-keeping system in a pharmacy if the following conditions are met:

(1) The system has the capability of producing sight-readable documents of all original and refilled prescription information. The term "sight-readable" means that a regulatory agent is able to examine the record and read the information. In administrative proceedings before the Board, records must be provided in a readable paper printout form.

(2) Information includes the prescription requirements and records of dispensing as indicated in Rules .2301 and .2302 of this Section.

(3) The individual pharmacist responsible for completeness and accuracy of the entries to the system provides documentation of the fact that prescription information entered into the computer is correct.

(4) Documentation in Item (3) of this Rule is provided in the pharmacy within 72 hours of date of dispensing.

(5) An auxiliary recordkeeping system is established for the documentation of refills if the automated data processing system is inoperative for any reason. When the automated data processing system is restored to operation, the information regarding prescriptions filled, refilled or transferred during the inoperative period shall be entered into the automated data processing system within the time equal to the number of inoperative days times three; for example, if the system were inoperative for five days then all interim data shall be entered within 15 days of the last inoperative day. However, nothing in this Item precludes the pharmacist from using professional judgment for the benefit of a patient's health and safety. The auxiliary record keeping system shall be backed up at least weekly.

(6) The pharmacy makes arrangements with the supplier of data processing services or materials to assure that the pharmacy continues to have adequate and complete prescription and dispensing records if the relationship with the supplier is terminated for any reason. A pharmacy shall assure continuity in the maintenance of records.

(7) A current version of drug interactions software is used and policies and procedures are established to address overriding the software's alerts of any drug interactions.

21 N.C. Admin. Code 46 .2304

Authority G.S. 90-85.6(a); 90-85.26; 90-85.32; 90-107;
Eff. December 31, 1985;
Amended Eff. March 1, 2013; April 1, 1999; May 1, 1989;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. October 3, 2017.

Authority G.S. 90-85.6(a); 90-85.26; 90-85.32; 90-107;
Eff. December 31, 1985;
Amended Eff. March 1, 2013; April 1, 1999; May 1, 1989.