(a) The pharmacist-manager shall establish written procedures for the safe and effective distribution of pharmaceutical products. Procedures shall be reviewed annually to assure they reflect current practice in the facility. A copy of such procedures shall be available in the pharmacy.
(b) The pharmacist-manager is responsible for the safe and effective distribution of, control over and accountability for drugs, including intravenous and irrigation solutions. The pharmacist-manager may delegate responsibilities to other health care facility staff for ordering, distributing, and accounting for pharmaceutical materials to achieve this purpose. Whenever there is a violation of the rules in this Section, the facility's pharmacy permit is subject to action by the Board. In addition to the requirements of 21 NCAC 46 .2502, the pharmacist-manager is responsible for:
(1) the development of policies and procedures for the compounding, admixture, labeling, and dispensing of parenteral medications in the health care facility, including relevant education and training of all pharmacy and nursing personnel involved in the preparation of parenteral medications;
(2) the establishment of specifications or use of compendia specifications for procurement of all pharmaceuticals, including drugs, chemicals, and biologicals used in direct patient care, subject to approval of the appropriate committee of the health care facility;
(3) participation in development and maintenance of a drug formulary when required by the health care facility;
(4) participation in those aspects of pharmaceutical care that affect drug distribution and control;
(5) preparing, packaging, compounding and labeling all drugs;
(6) assuring that drugs are dispensed only by a pharmacist or other persons allowed by law to dispense and that supportive pharmacy personnel are directed and supervised in compliance with all applicable laws and regulations;
(7) the development and implementation of policies and procedures to ensure that discontinued drugs; outdated drugs; drugs recalled; containers with worn, illegible, or missing labels; or products that are otherwise unusable are returned to the pharmacy for disposition in compliance with all applicable laws and regulations;
(8) maintaining records and reports required by law to ensure patient health, safety and welfare;
(9) developing and implementing policies and procedures that effectively address the safeguarding and handling of all drugs and devices, as defined in G.S. 90-85.3(e), throughout the health care facility, or other locations where legend drug products are transferred, including medications that originate from a source outside the facility. When discrepancies in controlled substance counts are identified:
(A) they shall be reviewed, and a report of this action, including steps taken to prevent recurrence, where possible, shall be provided to the pharmacist-manager within 24 hours of occurrence. This report shall be maintained by the pharmacist-manager; and
(B) they shall be reported to the Board and the Drug Enforcement Administration in compliance with all applicable laws and regulations;
(10) developing and implementing policies and procedures to ensure that auxiliary medication inventories are inspected in accordance with the pharmacy's policies;
(11) all drugs and devices dispensed by the pharmacy as defined in G.S. 90-85.3(e) that are ordered for and used within the health care facility; and
(12) maintaining policies and procedures regarding drug samples and patient's personal medications.


21 N.C. Admin. Code 46 .1411
Authority G.S. 90-85.6; 90-85.21; 90-85.32;
Eff. May 1, 1997;
Amended Eff. March 1, 2013.

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