10A NCAC 26E .0406      DISPOSAL OF UNUSED CONTROLLED SUBSTANCES FROM NURSING HOME

Controlled substances dispensed for inpatient administration to individuals residing in a licensed nursing home, which, for any reason, are unused, shall be returned to the pharmacy from which they were received. The pharmacy that receives these controlled substances shall return them to its stock or dispose of and destroy them in accordance with 21 CFR 1317.05(a). The pharmacy shall keep a record of the disposal and destruction of unused controlled substances available for a minimum of two years. This record of disposal and destruction shall be kept on the Division of Mental Health, Developmental Disabilities, and Substance Use Services (Division) form entitled "Record of Controlled Substances Destroyed pursuant to Rule 10A NCAC 26E .0406". This form is available upon request at Drug Control Unit 3008 Mail Service Center Raleigh, NC 27699-3008 or nccsareg@dhhs.nc.gov. Controlled substances returned to stock must be in a hermetically sealed container or in a pure uncontaminated condition and be identifiable. A pharmacy may outsource destruction of the unused controlled substances to a reverse distributor in accordance with 21 CFR 1317.05(a)(2), provided the pharmacy must first verify the reverse distributor is registered with the federal Drug Enforcement Agency (DEA) as a reverse distributor and maintains compliance with all applicable federal and State laws and regulations governing reverse distributors and destruction of unused controlled substances per 21 CFR 1317.15. Compliance with this Rule is subject to audit by the Division Director or their designated representative.

History Note:        Authority G.S. 90‑100; 143B-147;

Eff. June 30, 1978;

Amended Eff. September 15, 1980; May 15, 1979;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. February 2, 2016;

Emergency Amendment Eff. September 25, 2024;

Temporary Amendment Eff. January 2, 2025.