(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.


History Note:        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.