# Title 75 — Department of Human Services

## Article 75-09.1 — Substance Abuse Treatment Programs

## Chapter 75-09.1-12 — Licensing Standards for Medication Units

### § 75-09.1-12-01. Definitions.

In this chapter, unless the context or subject matter otherwise requires:
1. "Condition" means a violation of the requirements of any applicable law or regulation has
occurred.
2. "Corrective action plan" means a plan developed by the medication unit and submitted to the
division identifying how the medication unit will correct a condition.
3. "Department" means the North Dakota department of human services.
4. "Division" means the behavioral health division of the department.
5. "Home-base opioid treatment program" means the opioid treatment program licensed
according to chapter 75-09.1-10 to operate the medication unit.
6. "Interim license" means the proposed medication unit has met state requirements to move
forward with federal requirements. A medication unit may not perform the duties of a
medication unit under an interim license.
7. "Medication unit" means a facility established as part of, but geographically separate from, an
opioid treatment program from which licensed private medical practitioners or pharmacists
dispense or administer an opioid agonist or antagonist treatment medication or collect
biological specimen samples for drug testing or analysis. Medication units are not required to
be free-standing entities and may be located within other facilities, including a hospital,
homeless shelter, correctional program, or public health location.
8. "Medication unit license" means a medication unit has met all state and federal requirements
to operate the medication unit.
9. "Patient" means an individual who undergoes treatment in an opioid treatment program who
may receive partial services at the medication unit.
10. "Recommendation" means a suggestion offered by the licensure team to strengthen and
enhance the medication unit and services offered by the medication unit.
History: Effective April 1, 2020.
General Authority: NDCC 50-31-09
Law Implemented: NDCC 50-31-09

### § 75-09.1-12-02. Requirements for medication unit license - Application.

1. A medication unit application for licensure to operate a medication unit shall hold a current
license in good standing as an opioid treatment program under chapter 75-09.1-01.
2. Before applying for a license, the home-based opioid treatment program shall submit an
assessment of need for the proposed location of a medication unit and obtain written approval
by the division. The assessment of need must include an assessment of the following criteria:
a. A description of other existing services and medication units of the type proposed to meet
the needs of the population proposed to be served in that location;
b. Justification for the need of a medication unit in the location;
c. Description of prospective operations for patient care at the medication unit; and
d. Community relations plan developed in consultation with the county, city, or tribal
authority, or designees.
3. Following written approval from the division to pursue licensure, the prospective medication
unit shall submit a medication unit application, including required documentation and the
application fee of one hundred fifty dollars to the department. Upon approval of the application
requirements, the prospective medication unit may receive an interim license.
4. Within ninety days of receiving the interim license, a prospective medication unit shall submit
to the division the following items for review:
a. Documentation of the updated certification by the United States department of health and
human services substance abuse and mental health services administration, including
the application and required materials sent for certification; and
b. Registration from the United States department of justice, drug enforcement
administration.
5. To renew a medication unit license, the following must occur:
a. A licensing renewal conducted by the division;
b. Submission of application with required documentation to the division; and
c. Application fee paid to the department.
History: Effective April 1, 2020.
General Authority: NDCC 50-31-03.1, 50-31-09
Law Implemented: NDCC 50-31-03.1, 50-31-09
### § 75-09.1-12-03. Issuing license to medication unit.

The division shall issue a license following:
1. A review and approval of application materials for up to one year and subsequent licenses for
three years;
2. A licensing review with no conditions issued; or
3. A review and approval of implementation of any corrective action plan required as a result of a
licensing review or investigation.
History: Effective April 1, 2020.

General Authority: NDCC 50-31-09
Law Implemented: NDCC 50-31-09
### § 75-09.1-12-04. Denial of application for medication unit.

The division shall deny an applicant's license:
1. When the applicant fails to meet the requirements of this chapter; or
2. The home-base opioid treatment program's license is not in good standing or has been
suspended or revoked.
History: Effective April 1, 2020.
General Authority: NDCC 50-31-09
Law Implemented: NDCC 50-31-09
### § 75-09.1-12-05. Licensing review requirements.

1. The division shall conduct a licensing review within one year of the initial license and at least
every three years thereafter to determine continued compliance with the standards contained
in this chapter.
2. The division may conduct scheduled or unscheduled visits at times other than routine
licensing reviews.
3. Within thirty days of the licensing review, the division shall send a licensure review report to
the medication unit.
4. A licensure review report must contain a description of:
a. The medication unit reviewed;
b. Any conditions issued; and
c. Any recommendations.
5. A medication unit receiving a condition shall submit to the division a corrective action plan
within thirty days from receipt identifying how the medication unit will become compliant with
the standards contained in this article.
6. The medication unit has sixty days after the corrective action plan is submitted to implement
the actions to become compliant with the standards contained in this chapter.
7. The division shall require documentation or conduct an onsite review or both to ensure the
medication unit has implemented its corrective action plan.
History: Effective April 1, 2020.
General Authority: NDCC 50-31-09
Law Implemented: NDCC 50-31-09
### § 75-09.1-12-06. Suspension and revocation of license for medication unit - Appeal.

1. The division may suspend or revoke a license for one or more of the following reasons:
a. The home-based opioid treatment program's license has been suspended or revoked;
b. The medication unit has violated any rules of the department; or

c. If the medication unit fails to correct conditions or fails to provide a sufficient explanation
for its failure to take action, the division may suspend or revoke the medication unit's
license or require other corrective measures from the medication unit.
2. An applicant for or a holder of a license may appeal a decision to deny, suspend, or revoke a
license as set forth in section 75-09.1-01-27.
History: Effective April 1, 2020.
General Authority: NDCC 50-31-09
Law Implemented: NDCC 50-31-09
### § 75-09.1-12-07. Medication unit requirements.

All licensed medication units shall:
1. Provide medication dosing and may provide urine screen collection and shall adhere to all
state and federal regulations for those services. Any other services provided at the medication
unit must have prior approval by the division;
2. Develop and implement a policy on the physical operations of a medication unit in conjunction
with services at the home-based opioid treatment program;
3. Develop and implement a policy identifying the criteria a patient must meet to receive services
offered at the medication unit;
4. Identify in a patient's treatment plan the services received at a medication unit;
5. Provide orientation to each patient regarding the services offered through the medication unit;
6. Develop treatment plans that reflect the utilization of a medication unit;
7. Develop and implement a process for a patient's continuity of care between services
conducted at the medication unit and the home-based opioid treatment program;
8. Ensure all employee requirements required in chapter 75-09.1-10 occur for employees of the
medication unit;
9. Ensure the facility is clean and well-maintained; and
10. Provide protection of patient confidentiality, in accordance with federal and state confidentiality
requirements.
History: Effective April 1, 2020.
General Authority: NDCC 50-31-09
Law Implemented: NDCC 50-31-09
### § 75-09.1-12-08. Health and safety.

A medication unit shall:
1. Maintain health and safety policies and procedures;
2. Develop and implement a written emergency plan that addresses provisions for dealing with
bomb threats, active shooter and other violent actions, fires, medical emergencies, natural
disasters, and power failures;
3. Have staff certified in basic first aid and basic cardiac life support, and trained to respond to a
suspected overdose;

4. Have overdose reversal medication readily available;
5. Make readily available first-aid equipment and supplies; and
6. Implement a written policy that addresses the use of nicotine products.
History: Effective April 1, 2020.
General Authority: NDCC 50-31-09
Law Implemented: NDCC 50-31-09
### § 75-09.1-12-09. Medication unit closures.

If a medication unit closes involuntarily or voluntarily, the home-based opioid treatment program
shall:
1. Provide the division with a plan detailing the procedures to ensure continuity of care for
patients; and
2. Notify the division of the anticipated closure at least ninety days prior to the closure and
identify the rationale for closure and the efforts to establish continuity of care for patients.
History: Effective April 1, 2020.
General Authority: NDCC 50-31-09
Law Implemented: NDCC 50-31-09
