California Code of Regulations
Title 9 - Rehabilitative and Developmental Services
Division 4 - Department of Alcohol and Drug Programs
Chapter 4 - Narcotic Treatment Programs
Subchapter 2 - Licensure of Narcotic Treatment Programs
Article 1 - Program Licensure
Section 10020 - Medication Units

Universal Citation: 9 CA Code of Regs 10020

Current through Register 2024 Notice Reg. No. 38, September 20, 2024

(a) A medication unit may lawfully operate if:

(1) The Department approves the primary NTP's supplemental written protocol as described in subsection (b);

(2) The primary NTP has approval from SAMHSA to operate the medication unit; and

(3) The medication unit is registered with the DEA.

(b) The primary NTP program sponsor shall submit an Initial Application Coversheet form DHCS 5014 (04/16) and supplemental written protocol to the Department to serve as an application to add a medication unit to the primary NTP license. The supplemental written protocol shall include all of the following information and the designated forms below:

(1) A description of the geographical surrounding areas to be served, as required by the Facility and Geographical Area form DHCS 5025 (04/16), herein incorporated by reference;

(2) The population of the area to be served, as required by the Facility and Geographical Area form DHCS 5025 (04/16);

(3) Each staff member's resume and the Staff Information form DHCS 5026 (04/16), herein incorporated by reference;

(4) A facility address including the geographic relationship of the medication unit to the primary NTP, as required by the Facility and Geographical Area form DHCS 5025 (04/16);

(5) The days and hours of medication dispensing, as required by the Facility and Geographical Area form DHCS 5025 (04/16);

(6) The days and hours for collection of samples for drug testing or analysis, if applicable, as required by the Facility and Geographical Area form DHCS 5025 (04/16);

(7) The type of services to be provided and the hours of use of the facility, if the facility is also used for purposes other than a medication unit, as required by the Facility and Geographical Area form DHCS 5025 (04/16);

(8) A facility description including a diagram showing dimensions of the facility housing the medication unit and an accompanying narrative that describes patient flow. The diagram and narrative shall specify waiting areas, office space, medication administration area, patient body specimen collection locations for testing or analysis of samples for illicit drug use, record storage area, and parking or transportation access, as required by the Facility and Geographical Area form DHCS 5025 (04/16);

(9) The approximate number of patients to be served and a description of how every patient who is assigned to the medication unit will participate in the regular treatment provided by the primary NTP, as required by the Facility and Geographical Area form DHCS 5025 (04/16); and

(10) The written policies and procedures to be followed in the event of an emergency or disaster.

(c) In addition to the supplemental written protocol, the primary NTP shall submit to the Department an Affiliated and Associated Acknowledgement form DHCS 5134 (04/16), herein incorporated by reference.

(d) The Department shall notify the primary NTP, in writing, within 60 days of receipt of the Initial Application Coversheet form DHCS 5014 (04/16), supplemental written protocol, and the Affiliated and Associated Acknowledgement form DHCS 5134 (04/16), whether the documents are:

(1) Complete, including all required documents specified in subsections (b) and (c), and accepted for review; or

(2) Incomplete, and the Department shall specify the missing or incomplete information or documentation. The primary NTP shall have 60 days from the date of the notification to provide the missing information or documentation. The Department shall terminate review of the application if the primary NTP does not provide the required information or documentation within 60 days. Upon termination of review, the incomplete application shall be returned to the primary NTP. A primary NTP may reapply by submitting a new application to the Department. Termination of review of the application shall not constitute a licensing action.

(e) The proposed medication unit shall be subject to a site inspection by the Department prior to approval of the supplemental written protocol.

(f) The Department shall either approve or deny, in writing, a complete application for approval of a medication unit within 60 days after the application is accepted for review.

(g) The primary NTP shall notify the Department, in writing, at least 30 days prior to the closure of a medication unit. In the event that a medication unit ceases to provide services, the primary NTP shall be responsible for providing those services.

(h) The licensed patient capacity of the primary NTP and any of its medication unit(s) and/or OBNTN(s) shall not exceed the patient capacity set forth on the primary NTP license.

(i) A medication unit shall be subject to the same inspection and monitoring by the Department as a narcotic treatment program, to ensure that operations are in accordance with the applicable laws and regulations.

(j) The primary NTP shall be responsible for submission and implementation of all required corrective action plans of its medication unit(s). The license of the primary NTP shall be subject to licensing action, as described in Section 10057, for any violation by its medication unit of these regulations or provisions under Article 1, Chapter 10, Part 2, Division 10.5 of the Health and Safety Code.

(k) A medication unit shall post the primary NTP license under which it is operating that identifies all addresses of all facilities providing treatment services in a conspicuous place visible within the facility.

(l) The Department's approval to operate a medication unit shall automatically terminate if SAMHSA withdraws or revokes its approval of the medication unit, or if the DEA revokes the medication unit's registration.

(m) Treatment services at a medication unit are limited to the administering and dispensing of medications and/or the collection of patient body specimens for testing or analysis of samples for illicit drug use. The primary NTP shall be responsible for ensuring that patients have access to all other treatment services not provided at the medication unit.

1. Change without regulatory effect renumbering and amending former sections 10020 and 10022 to 10020 filed 6-3-91 pursuant to section 100, title 1, California Code of Regulations (Register 91, No. 34).
2. Amendment of section filed 3-15-96 as an emergency; operative 3-15-96 (Register 96, No. 11). A Certificate of Compliance must be transmitted to OAL by 7-13-96 or emergency language will be repealed by operation of law on the following day.
3. Amendment of section refiled 7-8-96 as an emergency; operative 7-12-96 (Register 96, No. 28). A Certificate of Compliance must be transmitted to OAL by 11-12-96 or emergency language will be repealed by operation of law on the following day.
4. Amendment of section refiled 10-23-96 as an emergency; operative 10-29-96 (Register 96, No. 43). A Certificate of Compliance must be transmitted to OAL by 2-26-97 or emergency language will be repealed by operation of law on the following day.
5. Amendment of section refiled 2-11-97 as an emergency; operative 2-24-97 (Register 97, No. 7). A Certificate of Compliance must be transmitted to OAL by 6-24-97 or emergency language will be repealed by operation of law on the following day.
6. Certificate of Compliance as to 2-11-97 order transmitted to OAL 3-4-97; disapproved by OAL and order of repeal as to 2-11-97 order filed 4-15-97 (Register 97, No. 16).
7. Amendment filed 4-15-97 as an emergency; operative 4-15-97 (Register 97, No. 16). A Certificate of Compliance must be transmitted to OAL by 8-13-97 or emergency language will be repealed by operation of law on the following day.
8. Certificate of Compliance as to 4-15-97 order, including amendment of section heading and section, transmitted to OAL 6-2-97 and filed 6-13-97 (Register 97, No. 24).
9. Change without regulatory effect amending NOTE filed 4-19-2006 pursuant to section 100, title 1, California Code of Regulations (Register 2006, No. 16).
10. Amendment of section heading, section and NOTE filed 5-7-2020; operative 7-1-2020 (Register 2020, No. 19).

Note: Authority cited: Sections 11750, 11755, 11835, 11839.3, 11839.6 and 11839.20, Health and Safety Code. Reference: Sections 11839.3 and 11839.6, Health and Safety Code.

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