(1) Certification Requirements. Prior to delivering services, the organization must be certified as an opioid treatment program (OTP) by the department.

(A) The program shall comply with applicable federal, state, and local laws and regulations, including those under the jurisdiction of the U.S. Food and Drug Administration (FDA), U.S. Drug Enforcement Administration (DEA), Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (HHS/SAMHSA), and the Department of Health and Senior Services, Bureau of Narcotics and Dangerous Drugs (DHSS/BNDD).

(B) The organization shall comply with 9 CSR 10-5 General Program Procedures, 9 CSR 10-7 Core Rules for Psychiatric and Substance Use Disorder Treatment Programs, and 9 CSR 30-3 Substance Use Disorder Prevention and Treatment Programs, as applicable.

(2) Medication Administration, Dispensing, and Use. OTPs shall only utilize medications approved by the FDA for the treatment of opioid use disorder.

(A) Opioid agonist and partial agonist treatment medications shall be administered and dispensed by a practitioner licensed in Missouri and registered under the appropriate state and federal laws to administer or dispense opioid drugs.

(B) Written policies and procedures shall be maintained to ensure the following dosage form and initial dosing requirements are met:

1. Methadone is prescribed by a licensed physician, administered and dispensed only in oral form, and formulated in a manner to reduce its potential for parenteral abuse;

2. For newly admitted individuals, the initial dose of methadone does not exceed thirty (30) milligrams and the total dose for the first day does not exceed forty (40) milligrams, unless the program physi-cian documents in the individual record that forty (40) milligrams did not suppress opioid abstinence symptoms; and

3. Each opioid agonist medication is administered and dispensed in accordance with its approved product labeling. Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. These procedures must ensure any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the individual record.

(C) If a prescription drug monitoring program (PDMP) is available, the program physician and other staff, as permitted, shall register and utilize the PDMP in accordance with federal, state, and local regulations. Policies and procedures shall be maintained regarding use of the PDMP information for diversion control planning.

(D) Individuals admitted to an OTP may be provided with naloxone or, if insured, a prescription for naloxone.

(3) Program Administration. The OTP shall have a program sponsor and a medical director.

(A) The program sponsor shall be responsible for the general establishment, certification, accreditation, and operation of the program, ensuring it is in continuous compliance with all federal, state, and local laws and regulations related to the use of opioid agonist and partial agonist treatment medications in the treatment of opioid use disorder.

(B) The medical director must be a physician licensed in Missouri and is responsible for overseeing all medical services provided by the OTP, performing them directly or by delegating specific responsibilities to an authorized program physician and healthcare professionals functioning under his/her direct supervision. The medical director shall ensure all medical, psychiatric, nursing, pharmacy, toxicology, and other services offered by the OTP are conducted in compliance with federal, state, and local regulations at all times. Other responsibilities of the medical director include, but are not limited to:

1. Ensuring individuals meet admission criteria and receive the required physical examination(s) and laboratory testing;

2. Prescribing methadone and other FDA-approved medications with the individual's input, ensuring the prescribed dosage of medication is appropriate to his/her needs;

3. Reviewing and signing each individual's initial treatment plan and reviewing and updating the plan based on his/her needs; and

4. Coordinating care and consulting with each individual's clinical treatment team on a regular basis.

(4) Service Delivery Requirements. A range of treatment and rehabilitation services shall be provided to address the therapeutic needs of persons served. All medications approved by the FDA for treatment of opioid use disorder shall be available to meet individual needs.

(A) At a minimum, the following services as defined in 9 CSR 30- 3.110 or as specified in another regulation, must be available to all individuals based on needs and treatment goals:

1. Communicable disease counseling;

2. Community support;

3. Continuing recovery and discharge planning, as defined in 9 CSR 10-7.030(8);

4. Crisis prevention and intervention; Drug testing;

5. Family conference;

6. Family therapy;

7. Group counseling, including trauma and co-occurring disorders;

8. Group rehabilitative support;

9. Individual counseling, including trauma and co-occurring disorders;

10. Medication services;

11. Medication services support; and

12. Medical evaluations, as specified in this rule.

(B) The services must be available at the OTP's primary location or through a documented collaborative referral arrangement with another qualified service provider. Services shall be offered at least six (6) days per week. Medical and psychosocial services shall be available during the early morning and/or evening to ensure individuals have access to services.

(C) All medical services shall be offered and occur simultaneously with clinical therapy, education, development of positive social supports, and ongoing treatment and rehabilitation for substance use disorders and related life problems.

(D) OTPs shall directly provide, or make available through referral to adequate and reasonably accessible community resources, other support services including, but not limited to, rehabilitation, education, and employment for individuals who request such services or have been determined by program staff to be in need of these services.

(E) Information and education shall be provided in areas such as community resources, substance use disorders, and behavioral health disorders.

(F) Services may be provided via telehealth to enhance accessibility for individuals served.

(5) Admission Criteria. Individuals shall be admitted to maintenance treatment by qualified staff who use accepted medical criteria, such as those listed in the Diagnostic and Statistical Manual for Mental Disorders (DSM-5), 2013, to determine the person is currently addicted to an opioid drug and he/she became addicted at least one (1) year before admission for treatment. The DSM-5 is hereby incorporated by reference and made a part of this rule, as published by the American Psychiatric Association, 1000 Wilson Boulevard, Suite 1825, Arlington VA 22209-3901. This rule does not incorporate any subsequent amendments or additions to this publication.

(A) The program physician shall ensure each individual voluntar-ily chooses maintenance treatment, all relevant facts concerning the use of the opioid drug are clearly and adequately explained to him/her, and each individual provides informed, written consent to treatment.

(B) Documentation in the individual record must indicate clinical signs and symptoms of opioid use disorder.

(C) Decisions regarding the most appropriate medication shall be individualized, based on personal needs and goals, throughout the individual's engagement in treatment.

(D) If clinically appropriate, the program physician may waive the requirement of a one- (1-) year history of addiction for

1. Women who are pregnant;

2. Individuals released from a correctional facility with a documented history of opioid use disorder, within six (6) months after release; and

3. Individuals who have been previously treated, up to two (2) years after discharge.

(E) Individuals under the age of eighteen (18) are required to have had two (2) documented unsuccessful attempts at short-term medical withdrawal (detoxification) or drug-free treatment within a twelve- (12-) month period to be eligible for methadone maintenance treatment.

1. Individuals under the age of eighteen (18) shall not be admit-ted to maintenance treatment unless a parent/guardian or responsible adult designated by the relevant state authority consents in writing to such treatment. This requirement is applicable to methadone and does not pertain to buprenorphine.

(6) Admission for Priority Populations. OTPs that have a contract with the department shall ensure priority admission for

(A) Women who are pregnant and use intravenous drugs;

(B) Women who are pregnant or postpartum, up to one (1) year after delivery;

(C) Individuals who use intravenous drugs;

(D) Women who have children and are at risk of losing custody or are attempting to regain custody;

(E) Individuals who test positive for the human immunodeficiency virus (HIV);

(F) Individuals determined to be high risk and are referred for treatment by Department of Corrections' institutions and the Division of Probation and Parole via the designated referral form and protocol, as well as individuals referred from federal correctional institutions; and

(G) Individuals who are applying for or receiving Temporary Assistance for Needy Families (TANF) and are referred for treatment by the Department of Social Services, Family Support Division, via the designated electronic referral process and protocol.

1. Women who are pregnant shall receive immediate admission.

2. High-risk referrals from correctional institutions and probation and parole shall be assessed and admitted within five (5) working days of initial contact or scheduled release date, including week-ends and holidays.

3. If the OTP is unable to assess and admit an individual who uses intravenous drugs within forty-eight (48) hours of receiving such a request, interim services shall be available in accordance with department contract requirements.

(H) Interim maintenance treatment, as defined in section (16) of this rule, shall be available for individuals who are eligible for treat-ment but cannot be immediately admitted to the OTP where services are being sought or through referral arrangements with another OTP.

(I) Individuals seeking treatment who are participants in the MO HealthNet program and do not meet priority population criteria shall be given an appointment in a timely manner and shall not be placed on a wait list.

(7) Admission Protocol. Prior to admission, staff shall verify and document the individual seeking services is not currently enrolled in another opioid treatment program utilizing a central registry, if available, or other client enrollment/admission database, such as the department's Customer Information, Management, Outcomes, and Reporting (CIMOR) system, for verification purposes.

(A) An individual currently enrolled in an OTP shall not be permitted to obtain treatment in any other OTP except in exceptional circumstances.

1. If the medical director or program physician of the OTP where the individual is currently enrolled determines exceptional circumstances exist, the individual may be granted permission to seek treatment at another OTP. Justification for the exceptional circumstances must be included in the individual record at both program locations.

(B) Each individual shall undergo a complete and fully documented physical evaluation prior to admission by a program physician, primary care physician, or authorized healthcare professional working under the supervision of a program physician. The full physical examination, including the results of serology and other tests, must be completed within fourteen (14) days following admission.

1. Women should have a pregnancy test as deemed clinically appropriate.

(C) Screening shall determine the risk of undiagnosed conditions such as hepatitis C, HIV, sexually transmitted infections, cardiopulmonary disease, and sleep apnea to determine if further diagnostic testing such as laboratory analysis, a cardiogram, or others are needed.

1. Positive screening results or disease risks should have a care coordination plan that is seen through to completion, regardless of whether this is accomplished via services provided directly by the OTP or through referral to another provider.

(D) A complete medical history, physical examination, and laboratory testing shall not be required for an individual who has had such medical evaluation within the prior thirty (30) days. The program shall have documentation of the medical evaluation and any significant findings in the individual record.

(8) Pregnant and Postpartum Women. Written policies and procedures shall be maintained and implemented to address the needs of women who are pregnant and postpartum. Prenatal care and other gender-specific services for women who are pregnant must be provided by the OTP or by referral to an appropriate healthcare provider.

(A) For pregnant women who are receiving methadone or buprenorphine, the program shall have written policies and procedures in place to ensure

1. The initial dose of medication for a newly admitted woman who is pregnant, and the subsequent induction and maintenance dosing strategy, reflect the same effective dosing protocols used for all other individuals;

2. The methadone dose is carefully monitored, especially during the third (3rd) trimester when pregnancy induces changes such as the rate at which methadone is metabolized or eliminated from the system, potentially necessitating either an increased or a split dose; and

3. Women who become pregnant during treatment are maintained at their pre-pregnancy dosage, if effective, and are managed with the same dosing principles used with women who are not pregnant.

(B) Women who are pregnant are eligible to receive ongoing maintenance treatment up to one (1) year post-partum, including evaluation of their current dose to determine if an adjustment is needed during the postpartum period. Women shall be offered education about signs and symptoms of oversedation which may occur after delivery.

(C) Medically supervised withdrawal after pregnancy shall occur as clinically indicated and documented, or is requested by the individual.

(D) When a planned discharge occurs, OTP staff shall document the contact information of the physician or other authorized healthcare professional to whom the individual has been referred, including the reason for discharge.

(E) Mothers shall be educated about neonatal abstinence syndrome, its symptoms, potential effects on their infant, and need for treatment if it occurs.

(9) Safety and Health. The program shall implement written policies, procedures, and practices which ensure access to services and address the safety and health of individuals served. The provider shall

(A) Ensure continued opioid treatment for individuals in the event of an emergency, pandemic, or natural disaster by cooperating with other OTPs, including those in surrounding states, to develop and maintain medication dosing arrangements;

(B) Utilize a central registry, if available, or other client enrollment/admission system such as the department's CIMOR system, to coordinate services;

(C) Ensure treatment to persons regardless of serostatus, HIVrelated conditions, tuberculosis (TB), or hepatitis C;

(D) Provide information and education to individuals on prevention and transmission of HIV-related conditions;

(E) Provide or arrange HIV testing and pre- and post-test counseling for individuals;

(F) Provide or arrange testing for TB, hepatitis C, and sexually transmitted infections upon admission and at least annually thereafter;

(G) Provide medical evaluations to individuals upon admission and at least annually thereafter, including cardiac risk assessment;

(H) Utilize infection control procedures in accordance with federal, state, and local regulations; and

(I) Arrange medical care for women during pregnancy, if necessary, and document the arrangements made and action taken by the individual.

(10) Staff Training. All direct service staff and medical staff shall complete four (4) clock hours of training relevant to service delivery in an opioid treatment setting during a two- (2-) year period. This training applies to the required thirty-six (36) clock hours of training during a two- (2-) year period specified in 9 CSR 10-7.110(2)(F)1.

(11) Testing and Screening for Drug Use. The program shall use drug testing as a as a clinical tool for purposes such as diagnosis and treatment planning.

(A) Each individual shall have an initial toxicology test as part of the admission process. At a minimum, admission samples shall be analyzed for opiates, methadone, marijuana, cocaine, barbiturates, benzodiazepines, buprenorphine, amphetamines, fentanyl, and alcohol.

(B) If there is a history of misuse of prescription opioid analgesics, an expanded toxicology panel that includes these opioids shall be administered. Additional testing shall be based on individual needs and local drug use patterns and trends.

(C) Random drug testing of each individual in maintenance treatment shall be conducted at least eight (8) times during a twelve- (12-) month period.

(D) Individuals engaged in long-term detoxification treatment (medical withdrawal) shall receive an initial drug test and a monthly random test.

(E) Individuals engaged in short-term detoxification treatment (medical withdrawal) shall have at least one (1) initial drug test.

(12) Unsupervised Approved Use (Take-Home) of Medication. The medical director shall ensure policies and procedures for approval of take-home methadone do not create barriers to individuals in maintenance treatment. The dispensing restrictions set forth in this section of this rule do not apply to buprenorphine and buprenorphine products.

(A) Any individual in comprehensive maintenance treatment may receive a single take-home dose of methadone for a day the program is closed for business, including Sundays and state and federal holidays.

(B) Decisions on dispensing methadone to individuals for unsupervised use, beyond that set forth in this rule, shall be determined by the medical director. In determining which individuals may be approved for unsupervised use, the medical director shall consider the following:

1. Absence of recent misuse of drugs (opioid or non-narcotic), including alcohol;

2. Regularity of program attendance;

3. Absence of serious behavioral issues at the program;

4. Absence of known recent involvement in the justice system, such as drug dealing;

5. Stability of the individual's home environment and social relationships;

6. Length of time in comprehensive maintenance treatment;

7. Assurance that take-home medication can be safely stored within the individual's home; and

8. Whether the rehabilitative benefit the individual derives from decreasing the frequency of program attendance outweighs the potential risks of diversion.

(C) Determinations for unsupervised use of methadone and the basis for such determinations, consistent with the criteria outlined in paragraphs (12)(B)1. to 8. of this rule, shall be documented in the individual record.

(D) Take-home doses dispensed to individuals beyond that specified in subsection (12)(A) of this rule, shall be subject to the following:

1. During the first ninety (90) days of treatment, the take-home supply is limited to one (1) dose each week and the individual must ingest all other doses under appropriate supervision at the program;

2. In the second ninety (90) days of treatment, the take-home supply is limited to two (2) doses per week;

3. In the third ninety (90) days of treatment, the take-home supply is limited to three (3) doses per week;

4. In the remaining months of the first year of treatment, the individual is limited to a maximum six- (6-) day supply of take-home medication;

5. After one (1) year of continuous treatment, the individual may receive a maximum two- (2-) week supply of take-home medication; and

6. After two (2) years of continuous treatment, the individual may receive a maximum one- (1-) month supply of take-home medication and he/she must make monthly visits to the program.

(E) Individuals in short-term detoxification treatment or interim maintenance treatment shall not receive methadone for unsupervised or take-home use.

(F) OTPs must implement written procedures to identify theft or diversion of take-home medications, including labeling containers with the OTP's name, address, and telephone number. Programs must also ensure take-home supplies are packaged in a manner designed to reduce the risk of accidental ingestion, including use of child-proof containers.

(G) Program staff shall educate individuals about safe transportation and storage of methadone, as well as emergency procedures in case of accidental ingestion.

(H) Individuals approved for take-home doses of methadone must have a lock box for safe transportation and home storage.

(I) OTPs shall implement written policies and procedures that address the responsibilities of individuals who are approved for takehome doses of methadone, including methods to assure appropriate use and storage of the medication.

(J) Staff shall regularly monitor each individual's use of take-home medication to ensure security of the medication and prevent diversion. When determined necessary, the medical director and staff may review an individual's unsupervised use and may deny or rescind take-home privileges. Such action shall be documented in the individual record, including the rationale for denial or rescission of unsupervised use.

(K) The time in treatment requirements outlined in paragraphs (12)(D)1. to 6. of this rule are minimum reference points after which an individual may be considered for take-home medication privileges. The time references do not mean an individual in treatment for a particular time has a specific right for approval of take-home medication.

(L) Any deviation from the regulations for unsupervised use of methadone as specified in this rule requires prior approval from the state opioid treatment authority (SOTA), or his/her designee, and/or SAMHSA.

1. The Exception Request and Record of Justification form SMA-168 must be submitted to the SOTA/designee and/or SAMHSA as specified in section (24) of this rule. Justification for an exception may include, but is not limited to, transportation hardships, employment, vacation, medical or family emergencies, or other unexpected circumstances.

(13) Guest Medication. Individuals who travel, but do not meet the criteria for take-home medication as specified in section (12) of this rule, should be considered for guest medication in accordance with the 2020 Guidelines for Guest Medications hereby incorporated by reference and made a part of this rule, as published by the American Association for the Treatment of Opioid Dependence, 225 Varick St., Suite 402, New York, NY 10014, (212) 566-5555. This rule does not incorporate any subsequent amendments or additions to this publication.

(A) Guest medication provides a mechanism for individuals to travel from their home program for business, pleasure, or family emergencies. It also provides an option for individuals who need to travel for a period of time that exceeds the amount of eligible takehome doses to do so within regulatory requirements.

(B) Individuals shall be on a stable dose of methadone and not be scheduled for a dose increase or decrease during guest medication.

(C) Individuals approved for guest medication must be medically and psychiatrically stable.

(14) Continuity of Care. The program shall implement written policies and procedures to address continuity of care for individuals who are unable to participate in regularly scheduled visits for observed ingestion of medication due to illness, pregnancy, participation in residential treatment, incarceration, lack of transportation, or other situations.

(A) A chain-of-custody process shall be implemented to document the transportation, delivery, administration, and observation of medication when an individual is unable to report to the program as required.

(15) Diversion Control. OTPs shall maintain and implement a writ-ten diversion control plan as part of its performance improvement process. The plan shall contain specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use. Medical and administrative staff of the program shall be assigned to implement the diversion control measures and functions described in the diversion control plan.

(16) Interim Maintenance Treatment. The program sponsor of a public or private OTP may place an individual who is eligible for admission to comprehensive maintenance treatment into interim maintenance treatment, if he/she cannot be placed in a public or nonprofit private comprehensive OTP within a reasonable geographic area within fourteen (14) days of the individual's application for admission to comprehensive maintenance treatment.

(A) An initial and at least two (2) other urine screens shall be taken from an individual engaged in interim treatment during the maximum one hundred twenty (120) days permitted for such treatment.

(B) The OTP shall maintain and implement written policies and procedures for transferring individuals from interim maintenance to comprehensive maintenance treatment.

1. The transfer criteria shall include, at a minimum, a preference for admitting women who are pregnant into interim maintenance treatment and criteria for transferring individuals from interim maintenance to comprehensive maintenance treatment.

(C) Interim maintenance treatment shall be provided in a manner consistent with all applicable federal and state laws, including sections 1923, 1927(a), and 1976 of the Public Health Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-11).

(D) The program shall notify the SOTA when an individual begins interim maintenance treatment, when he/she leaves interim maintenance treatment, and before the date of mandatory transfer to comprehensive maintenance treatment, documenting all notifications in the individual record.

(E) SAMHSA may revoke the interim maintenance authorization for a program that fails to comply with the provisions of this section of this rule.

(F) SAMHSA will consider revoking the interim maintenance authorization of a program if the state in which the program operates is not in compliance with the provisions of 42 CFR section 8.11(g).

(G) All requirements for comprehensive maintenance treatment apply to interim maintenance treatment with the following exceptions:

1. The opioid agonist treatment medication is required to be administered daily under observation;

2. Unsupervised (take-home) use is not allowed;

3. An initial treatment plan and periodic treatment plan reviews are not required;

4. A primary counselor is not required to be assigned to the individual;

5. Interim maintenance treatment shall not be provided for longer than one hundred twenty (120) days in any twelve- (12-) month period; and

6. The rehabilitative, educational, and other counseling services specified in section (4) of this rule are not required to be provided to the individual.

(17) Medically Supervised Withdrawal. The program shall maintain and implement written policies and procedures to ensure individuals are admitted to shortor long-term detoxification treatment (as defined in 42 CFR section 8.2.) by qualified staff, such as the program physician, who determines such treatment is appropriate by applying established diagnostic criteria. Medically supervised withdrawal may be voluntary or involuntary, as specified in sections (18) and (20) of this rule.

(A) The individual's treatment plan and continuing recovery plan shall include a strategy to transition to another form of medication, if needed. Review of the risks and benefits of withdrawal from maintenance therapy shall be provided, and informed written consent shall be obtained from individuals who voluntarily choose this treatment option.

(B) Individuals shall be educated about the risks of a recurrence of symptoms and potential for fatal overdose following medically supervised withdrawal, and be offered relapse prevention services that includes counseling, naloxone, and opioid antagonist therapy.

(C) OTPs shall offer a variety of supportive options as part of the transition from opioid agonist therapy, such as increased counseling sessions prior to discharge, and individuals shall be encouraged to attend a twelve- (12-) step or other mutual-help program sensitive to the needs of individuals receiving treatment with medication.

(D) Individuals with two (2) or more unsuccessful detoxification episodes within a twelve- (12-) month period must be assessed by the program physician for other forms of treatment. A program shall not admit an individual for more than two (2) detoxification episodes in one (1) year.

(18) Voluntary Medically Supervised Withdrawal. Voluntary medically supervised withdrawal may be initiated by the person served or the program physician in collaboration with the individual as part of individualized treatment planning.

(A) As deemed clinically appropriate, women shall have a pregnancy test and the results reviewed prior to initiation of medically supervised withdrawal.

(B) For women who are pregnant, the physician shall not initiate withdrawal before fourteen (14) weeks or after thirty-two (32) weeks of pregnancy.

(C) If an individual experiences intolerable withdrawal symptoms or actual or potential return to use, the physician shall consider stop-ping the withdrawal process and restoring the individual to a previously effective dose. In collaboration with the individual served, the physician shall determine if an additional period of maintenance is necessary before further medically supervised withdrawal is attempted.

(D) Regardless of whether medically supervised withdrawal is conducted with or against medical advice (AMA), careful review of the risks and benefits of withdrawal from maintenance treatment must be provided to the individual and informed written consent obtained from those who choose to initiate medically supervised withdrawal.

(19) Withdrawal Against Medical Advice (AMA). Individuals who request voluntary medically supervised withdrawal from medication treatment AMA of the physician or program staff, may receive it. Individuals have the right to leave treatment when they choose to do so.

(A) The same services that are available to individuals engaged in voluntary medically supervised withdrawal shall be offered to individuals choosing medically supervised withdrawal AMA.

(B) The program must fully document the issue(s) that caused the individual to seek discharge, steps taken to avoid discharge, and the circumstances of readmission, as applicable.

(C) In the case of a woman who is pregnant, the program must keep the physician or agency providing prenatal care informed, consistent with the privacy standards of 42 CFR section 2.

(20) Involuntary Withdrawal from Treatment (Administrative Withdrawal). Individuals shall be retained in treatment for as long as they can benefit from it and express a desire to continue treatment. Administrative withdrawal is typically involuntary and shall be used only when all other therapeutic options have been exhausted by program staff. OTPs may refer or transfer individuals to a suitable alterative treatment program, as clinically indicated.

(A) Missing scheduled appointments and/or continued drug use shall not be the sole reason for initiating involuntary withdrawal for an individual being served.

(B) If involuntary withdrawal is initiated for an individual, the program shall follow the criteria included in the January, 2015 Federal Guidelines for Opioid Treatment Programs incorporated by reference and made a part of this rule as published by SAMHSA, Center for Substance Abuse Treatment, 1 Choke Cherry Rd., Rockville MD 20857, (877) 726-4727, publication number (SMA) PEP15- FEDGUIDEOTP. This rule does not incorporate any subsequent amendments or additions to this publication.

(21) Medication Storage and Security. The program shall ensure the security of its medication supply and shall account for all medications kept on site at all times.

(A) The program shall meet the requirements of the DEA and BNDD.

(B) The program shall maintain an acceptable security system, and the system shall be checked on a quarterly basis to ensure continued safe operation.

(C) The program shall physically separate the narcotic storage and dispensing area from other parts of the facility used by individuals.

(D) The program shall implement written policies and procedures to ensure positive identification of all individuals before any medication is administered. Verification shall include a minimum of two (2) forms of identification.

(E) The program shall implement written policies and procedures for recording each individual's medication intake and maintaining a daily medication inventory.

(22) Medication Units. Certified OTPs may establish medication units that are authorized to dispense opioid agonist treatment medications for observed ingestion. Services provided at the medication unit must comply with 42 CFR section 8.12.

(A) Prior to establishing a medication unit, the OTP must notify and receive prior approval from the SOTA/designee and SAMHSA by submitting form SMA-162. The required documents include, but are not limited to:

1. A description of how the medication unit will receive its medication supply;

2. An affirmative statement that the medication unit is limited to administering and dispensing the narcotic treatment drug and collecting samples for drug testing or analysis;

3. An affirmative statement that the program sponsor agrees to retain responsibility for individual treatment and care;

4. A diagram and description of the facility to be used as a medication unit;

5. Total number of individuals to be served by the primary OTP and medication unit;

6. Total number of individuals that will be served only at the medication unit;

7. A justification for the need to establish a medication unit; and

8. The name and address of any other active medication unit(s) attached to the primary OTP.

(B) A DEA inspection and approval must be obtained prior to opening a medication unit. A medication unit must have a separate and unique DEA registration.

(C) The OTP must comply with the provisions of 21 CFR part 1300 prior to establishing a mediation unit.

(D) Medication units are not required to be free-standing entities and may be located at a hospital or community pharmacy, for example.

(E) The certified OTP shall be responsible for all operations of an approved medication unit.

(23) Mobile Units. A mobile unit, for the purpose of dispensing opioid agonist treatment medications to individuals for observed ingestion, may be established if approval is granted by the DEA allowing such units to be considered a coincidental activity of the registered OTP. OTPs shall follow all federal, state, and local regulations regarding the operation of a mobile unit.

(24) Exception Requests and Records of Justification. Any deviation from these regulations requires prior approval from the SOTA/designee and/or SAMHSA. Requests must be submitted on the Exception Request and Record of Justification form (SMA-168), SAMHSA, 5600 Fishers Ln., Rockville, MD 20857, (240) 276- 2710.

(A) OTPs shall follow department requirements for submitting form SMA-168 to the SOTA/designee and or/SAMHSA. Failure to submit the completed form and obtain prior approval from the SOTA/designee and/or SAMHSA constitutes a regulatory violation which may jeopardize the OTP's accreditation and certification sta-tus.

(B) SAMHSA and the SOTA/designee must be notified of any change to the OTP sponsor or medical director within three (3) weeks of the change by submitting SAMHSA form SMA-162 in accordance with established procedures.

AUTHORITY: sections 630.655 and 631.102, RSMo 2016. This rule originally filed as 9 CSR 30-3.610. Original rule filed May 13, 1983, effective Sept. 13, 1983. For intervening history, please consult the Code of State Regulations. Rescinded and readopted: Filed May 28, 2021.