North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 26 - MENTAL HEALTH, GENERAL › Subchapter E - MANUFACTURERS: DISTRIBUTORS: DISPENSERS AND RESEARCHERS OF CONTROLLED SUBSTANCES › Section .0400 - MISCELLANEOUS › Section 26E .0408 - SPECIAL CONTROLLED SUBSTANCES EMERGENCY KIT

Current through Register Vol. 39, No. 2, July 15, 2024
(a) A (special)
				  controlled substances emergency kit shall be permitted in those skilled nursing
				  facilities, intermediate care facilities and combination facilities which are
				  licensed with the Department of Health and Human Services:
(b) The controlled substances emergency kit
				  shall contain not more than seven controlled drug entities (Schedules II-V) as
				  determined by the medical staff of the facility with the approval of the
				  pharmaceutical services committee.
(c) Controlled substances for emergency use
				  shall be obtained through purchase orders from the licensed pharmacist who
				  regularly provides medications to the facility and its patients. When Schedule
				  II drugs are purchased, federal Drug Enforcement Administration order forms
				  must be used.
(d) Controlled
				  substances for emergency use shall be provided in a single unit-dose
				  form.
(e) A facility shall be
				  permitted to possess not more than five doses of each controlled drug entity
				  for each 50 licensed beds or fraction thereof. The five doses of each drug
				  entity may be of the same or differing concentrations.
(f) The controlled emergency drug supply
				  shall be used to meet the urgent needs of patients, consistent with good
				  medical practice. The need for such use shall be documented in the patient's
				  medical record consistent with applicable state and federal statutes and
				  regulations.
(g) The controlled
				  substance emergency kit shall be securely locked and stored with access limited
				  to authorized personnel.
(h) Only
				  those persons designated by the director of the facility shall have access to
				  the controlled substances emergency kit.
(i) The pharmacist-supplier of the controlled
				  drugs for emergency use shall have primary responsibility for the proper
				  control and accountability of such drugs in the facility.
(j) No person, individual, practitioner or
				  facility shall be permitted to perform by virtue of these regulations any act
				  otherwise prohibited by law.
(k)
				  Nothing in these regulations shall compel any licensed pharmacist to provide
				  controlled drugs for emergency use to any facility against his professional
				  judgment.
(l) Requirements
				  contained in North Carolina Board of Pharmacy rule
				  21 NCAC
				  46 .1414(i) relating to
				  emergency kits generally shall apply.
(m) Exceptions to these regulations shall not
				  be made unless otherwise provided by law.
(n) Each registrant desiring to maintain a
				  controlled substance emergency kit must be registered with the Federal Drug
				  Enforcement Administration or receive an exemption from registration by that
				  agency.
Authority
					 G.S.
					 90-100;
					 143B-147;
Eff. June
					 30, 1978;
Amended Eff. September 30, 1978;
Temporary
					 Amendment Eff. June 15, 1999;
Temporary Amendment Expired February
					 28, 2000;
Codifier determined that findings did not meet criteria
					 for temporary rule on May 22, 2000;
Temporary Amendment Eff. May
					 30, 2000;
Amended Eff. April 1, 2001;
Pursuant to
					 G.S.
					 150B-21.3A, rule is necessary without
					 substantive public interest Eff. February 2,
					 2016.