Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 229 - FOOD AND DRUG › Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS › Section 229.145 - Applications, Fees, Permits

Current through Reg. 49, No. 28; July 12, 2024
(a)
				  Application.
(1) A complete narcotic drug
				  treatment application provided by the department must be submitted to the State
				  Methadone Authority (SMA) to apply for an approved narcotic drug permit to
				  operate a narcotic treatment program (NTP).
(2) A complete application filed in
				  accordance with this subsection for an NTP will be reviewed and evaluated by
				  the department, in accordance with §
											229.281
				  of this title (relating to Processing Permit Application Relating to Food and
				  Drug Operation). An application shall not be considered complete until an
				  application for an NTP has been submitted to the Drug Enforcement
				  Administration (DEA), and to the Substance Abuse and Mental Health Services
				  Administration (SAMHSA). If the program application is denied by the
				  department, the applicant shall have an opportunity for a hearing pursuant to
				  §
											229.147
				  of this title (relating to Denial of Application; Suspension or Revocation of
				  Narcotic Drug Permit).
(3) A person
				  acquiring an NTP currently operating under department approval must submit a
				  new application in accordance with this subsection and an initial fee as
				  required in subsection (b)(1) of this section. A narcotic drug permit will be
				  issued to a new owner or new location and the permit issued to the previous
				  owner or location shall be void and surrendered to the department by certified
				  or registered mail within 24 hours following receipt of the new approved
				  narcotic drug permit.
(4)
				  Individuals who are currently chemical dependent and/or have a history of
				  chemical dependency on any substances that are subjected to abuse within two
				  years of application for a permit, are not eligible for ownership of an
				  NTP.
(5) The number of patients
				  that a clinic is approved to treat is in direct proportion to the number of
				  counselors employed by that clinic. This proportion is a maximum of 50 patients
				  for each counselor. The NTP may exceed the counselor to patient ratio on a
				  temporary basis to permit hiring of new staff when new admissions cause a ratio
				  imbalance or when current staff leave and must be replaced.
(6) Applicants must provide to the department
				  complete information for evaluation of criteria concerning location, funding,
				  compliance history, and competency to operate an NTP.
(A) Scope. The department intends that new
				  NTP locations be established to serve diverse patient populations without
				  singular regard to proximity of location to an existing program(s). The
				  department has established criteria to prevent competition for patients among
				  NTPs in the same area that may result in increased noncompliance with state and
				  federal regulations and compromised patient care.
(B) Criteria. An applicant must affirmatively
				  demonstrate the following:
(i) serviceability
				  of the program at the proposed location by providing the department the
				  following:
(I) a map showing proximity of the
				  proposed NTP to existing programs within a three-mile radius;
(II) a description of how the new program
				  will ensure it will provide treatment services for an underserved population
				  and not duplicate treatment services for existing patients in treatment at an
				  established program in the area;
(III) copies of planned promotional
				  materials, advertisements, and other techniques to publicize the proposed
				  program; and
(IV) procedures that
				  will be used to identify whether a patient is enrolled in another
				  clinic;
(ii) the source
				  and adequacy of financial assets necessary to operate the program;
(iii) if applicable, the compliance history
				  of the applicant, which includes any issues reported to the department by
				  SAMHSA, DEA or any other regulatory agency;
(iv) adequate planning and organizational
				  structure demonstrated by full and complete answers submitted to all questions
				  in the application materials; and
(v) a statement that the applicant has read,
				  understood and agreed to follow all federal and state regulations concerning
				  operation of an NTP.