North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .1400 - HOSPITALS: OTHER HEALTH FACILITIES › Section 46 .1411 - RESPONSIBILITIES OF THE PHARMACIST-MANAGER

Current through Register Vol. 39, No. 2, July 15, 2024
(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				policies and procedures to ensure that discontinued drugs; outdated drugs;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.