Proposed Rules

Proposed Permanent Amendment of Rule 10A NCAC 26E .0406, Disposal of Unused Controlled Substance from Nursing Home
Purpose of Rule Action: On July 26, 2024, Stericycle, the owners of the only incinerator in North Carolina capable of destroying controlled substances to the point that they are non-retrievable, notified long-term care pharmacies in North Carolina that they will no longer accept bookings for witnessed destruction of controlled substances. Stericycle’s business decision to no longer provide long-term care pharmacies the option of destruction of unused controlled substances from nursing homes by an incinerator within the State was not foreseen by the Department. Rule 10A NCAC 26E .0406 was amended via emergency and temporary procedures, effective September 25, 2024 and January 2, 32025 respectively, to provide immediate clarity regarding the use of federally recognized options for disposing of and destroying unused controlled substances from nursing homes, including outsourcing the destruction to reverse distributors, in order to help ensure safe, secure, and timely disposal and destruction of unused controlled substances in North Carolina. The rule is now proposed for permanent adoption.

The Notice of Text for the proposed permanent amendment of this rule will be available in Volume 39 Issue 24 of the North Carolina Register scheduled for publication June 16, 2025 and accessible via this link: https://www.oah.nc.gov/documents/north-carolina-register?combine=&page=0

Economic Analysis: The Fiscal Note is accessible via the link provided.

Public Comment Period: June 17, 2025 through August 15, 2025. Written comments to the proposed rule must be submitted electronically to dmhddsasrules@dhhs.nc.gov or mailed to W. Denise Baker 3001 Mail Service Center Raleigh, NC 27699-3001.

Public Hearing: A person may demand a public hearing on the proposed rule by submitting a request in writing to W. Denise Baker, 3001 Mail Service Center, Raleigh, NC 27699-3001.

Procedure for Subjecting a Proposed Rule to Legislative Review: If an objection is not resolved prior to the adoption of the rule, a person may also submit written objections to the Rules Review Commission. If the Rules Review Commission receives written and signed objections in accordance with G.S. 150B-21.3(b2) from 10 or more persons clearly requesting review by the legislature and the Rules Review Commission approves the rule, the rule will become effective as provided in G.S. 150B-21.3(b1). The Commission will receive written objections until 5:00 p.m. on the day following the day the Commission approves the rule. The Commission will receive those objections by mail, delivery service, hand delivery, or email. If you have any further questions concerning the submission of objections to the Commission, please call a Commission staff attorney at 984-236-1850.

Proposed Permanent Adoption of Rule 10A NCAC 27G .3605, Medication Units and Mobile Units
Purpose of Rule Action: S.L. 2023-65 enacted G.S. 122C-35 which granted the Commission for Mental Health, Developmental Disabilities, and Substance Abuse Services authority to adopt emergency, temporary, and permanent rules for the licensure, inspection, and operation of opioid treatment program medication units and opioid treatment program mobile units, including rules concerning any of the following: (1) Compliance with all applicable Substance Abuse and Mental Health Services Administration and federal Drug Enforcement Agency regulations governing opioid treatment program mobile units and opioid treatment program medication units.(2) Identification of the location of opioid treatment program medication units and opioid treatment program mobile units.(3) Schedules for the days and hours of operation to meet client needs. (4) Maintenance and location of records. (5) Requisite clinical staff and staffing ratios to meet immediate client needs at each opioid treatment program medication unit or opioid treatment program mobile unit, including client needs for nursing, counseling, and medical care.(6) Emergency staffing requirements to ensure service delivery.(7) Criteria for policies and procedures for a clinical and individualized assessment of individuals to receive services at an opioid treatment medication unit or opioid treatment mobile unit that consider medical and clinical appropriateness and accessibility to individuals served.(8) Number of clients allowed per opioid treatment program medication unit and opioid treatment program mobile unit, based on staffing ratios.(9) Criteria to ensure the opioid treatment program facility is providing the required counseling to individuals receiving services at an opioid treatment program medication unit or opioid treatment program mobile unit. (10) Criteria for the opioid treatment program facility to ensure that individuals receiving services at an opioid treatment program medication unit or opioid treatment program mobile unit receive medical interventions when necessary.

Economic Analysis: The Fiscal Note is accessible via the link provided.

Public Hearing: A person may demand a public hearing on the proposed rule by submitting a request in writing to W. Denise Baker, 3001 Mail Service Center, Raleigh, NC 27699-3001.

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