Kentucky Laws

Requirements for Licensure and Operations of Medications for Opioid Use Disorder Treatment

Question:

What are the OTP facility requirements?

Answer:
  • Must contain specified number of bathrooms
  • Must contain panic buttons
  • Must have sufficient parking spots
This answer is derived from 1 section of law
Citation:
  • citation 1: see full citation
    Section 8.  Physical Environment.  (1)  Accessibility. An outpatient AODE shall meet requirements for making buildings and facilities accessible to and usable by individuals with physical disabilities in accordance with KRS 198B.260 and 815 KAR 7:120.(2)  Fire safety. An outpatient AODE shall be approved by the State Fire Marshal's office prior to initial licensure or if the AODE changes location.(3)  Physical location and overall environment.(a)  An outpatient AODE shall:1.  Comply with building codes, ordinances, and administrative regulations that are enforced by city, county, or state jurisdictions;2.  Display a sign that can be viewed by the public that contains the facility name, hours of operation, and a street address;3.  Have a publicly listed telephone number;4. Have a dedicated phone number to send and receive faxes with a fax machine that shall be operational twenty-four (24) hours per day or use encrypted electronic messaging technology;5.  Have a reception and waiting area;6.  Provide a restroom for client use; and7.  Have an administrative area.(b)  The condition of the physical location and the overall environment shall be maintained in such a manner that the safety and well-being of clients, personnel, and visitors shall be assured.(4)  Additional requirements for NTPs.(a)  The building used for the NTP shall meet the requirements of 21 C.F.R. 1301.74(j).(b)  The waiting area shall be separated from the dosing area to permit each client privacy and confidentiality at the time of dosing.(c)  The dosing area shall be clean and sanitary and shall contain:1.  A sink;2.  Hot and cold running water; and3.  Pill-counting trays if tablets are being used.(d)  The security and floor plan of the dosing area shall be in accordance with 21 C.F.R. 1301.72.(e)  The facility shall have two (2) restrooms, which shall be accessible to clients with disabilities.(f)  Restrooms available to clients to provide urine specimens shall be:1.  Secure;2.  Clean; and3.  Sanitary.(g)  The building shall be secured by a local security company approved by the DEA and the SNA.(h)  There shall be a minimum of two (2) panic buttons or similar devices for each NTP with:1.  One (1) in the reception area; and2.  One (1) in the dosing area.(i)  There shall be a telephone with an outside line accessible in the dosing area.(j)  Internal security shall meet the requirements of 21 C.F.R. 1301.74(b), (h), (i), (j), (k); 1301.91; 1301.92 and shall be installed only after consultation with the DEA and the SNA.(k)  Parking spaces at the clinic site shall be adequate to accommodate the maximum number of clients expected to be at the clinic site at one (1) time. see full law