21 N.C. Admin. Code 46 .1419 - AUTOMATED DISPENSING OR DRUG SUPPLY DEVICES

(a) Automated dispensing or drug supply devices may be used in health care facility pharmacies and where a pharmacy permit exists for a patient profile dispensing system, provided the utilization of the devices is under the supervision of a pharmacist. The pharmacist-manager shall develop and implement procedures to assure safe and effective use of medications and shall assure that:

(1) only authorized personnel, as indicated by written policies and procedures, may obtain access to the drug inventories;

(2) a system of accountability exists for all drugs contained therein and the purity, potency, and integrity of the drugs is preserved;

(3) requirements for controlled substances security are met; and

(4) prior to the drug being released for access by the nurse, the pharmacist enters the medication order into a computerized pharmacy profile that is interfaced to the automated dispensing unit, so that drug allergy screening, therapeutic duplication, and appropriate dose verification is done prior to the drug being administered.

(b) Notwithstanding the provisions of 21 NCAC 46 .2501, a pharmacist is required to supervise only the following activities pursuant to this Rule:

(1) The packaging and labeling of drugs to be placed in the dispensing devices. Such packaging and labeling shall conform to all requirements pertaining to containers and label contents;

(2) The placing of previously packaged and labeled drug units into the dispensing device; and

(3) The restocking of automated dispensing devices.

(c) Only persons authorized by the pharmacist-manager may remove drugs from the dispensing devices and only in the quantity of doses needed to satisfy immediate patient needs. Should a violation of the foregoing occur, the pharmacist-manager shall conduct an investigation and report any violations to the entity having jurisdiction over these issues.

(d) Bar code scanning of drug packaging and storage units may be utilized as a quality control mechanism if this technology is available in the automated dispensing system.

(e) An automated dispensing or drug supply device that is used solely as an Auxiliary Medication Inventory as defined in 21 NCAC 46 .1414(d) shall be governed by the requirements of that Rule.

Notes

21 N.C. Admin. Code 46 .1419

Authority G.S. 90-85.6; 90-85.32; 90-85.33;
Eff. 4/1/1999;
Amended Eff. 3/1/2013; 8/1/2002;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. 10/3/2017;
Recodified from 21 NCAC 46 .1814 Eff. 5/1/2021.