Section 1140-14-.12 - AUTOMATED DISPENSING SYSTEMS IN LONG-TERM CARE PRACTICE SITESNo prescription drug or device or related material shall be distributed or issued by the use of any automated dispensing device unless the method of operation has been approved and each device licensed by the board to ensure the purity, potency, and integrity of the prescription drug or device or related material, and to protect the prescription drug or device or related material from diversion.
(1) Each pharmacy holding an active license with the Tennessee Board of Pharmacy and using automated dispensing systems shall register each automated dispensing system with the Tennessee Board of Pharmacy. Each pharmacy maintain a list of the physical locations of all automated dispensing machines in its systems, whether such systems are located in the same facility as the licensed pharmacy, or not, and shall be responsible to pay a registration fee, as defined in 1140-01-.10, for each automated dispensing system, which the licensed pharmacy is responsible for and which is located in a long-term care facility.(2) The pharmacist in charge of the long-term care pharmacy practice site shall be designated to be accountable for this automated dispensing system.(a) The filling/stocking of all medications in the automated dispensing system shall be completed by a pharmacist or pharmacy technician under the direct supervision of a pharmacist, except as provided below:1. If the automated dispensing system uses removable cartridges or containers to hold drugs, the prepackaging of the cartridges or containers shall occur at the provider pharmacy unless provided by an FDA approved repackager.2. The prepackaged cartridges, unit dose packages or containers may be sent to the remote site to be loaded into the machine by personnel designated by the pharmacist-in-charge provided: (i) A pharmacist verifies the cartridge or container has been properly filled and labeled;(ii) The individual cartridges, unit dose packages or containers are transported to the remote site in a secure, tamper-evident container; and(iii) The automated dispensing system uses bar-coding, microchip, or other technologies to ensure that the containers are accurately loaded in the automated dispensing system.(iv) All drugs to be stocked in the automated dispensing system shall be delivered to the remote site by the provider pharmacy.(b) A record of medications filled/stocked into an automated dispensing system shall be maintained and shall include identification of the persons filling/stocking and checking for accuracy.(c) All containers of medications stored in the automated dispensing system shall be packaged and labeled in accordance with federal and state laws and regulations.(d) All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations.(e) The automated dispensing system shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated dispensing system, all in accordance with existing state and federal law.(f) The automated dispensing system shall provide a mechanism for securing and accounting for wasted medications or discarded medications in accordance with existing state and federal law.(g) The pharmacist in charge will work collaboratively with healthcare professionals to ensure that appropriate controls and monitors are utilized to provide information that drugs dispensed were for the correct patient and that pilferage is identified and resolved.(3) All persons authorized to have access to these automated systems shall have documentation that they have successfully completed a training program that teaches them to perform the functions they perform with the automated device.(4) Automated dispensing systems shall be used only for the furnishing of drugs and devices and related materials or other products related to the care of patients of that long-term care facility; and(5) At the time of removal of any drug or device or related material from the system, it shall automatically make a record, to be retained by the pharmacy for a minimum of two (2) years, indicating:(a) The date and time of removal of the drug or device or related material;(b) The name, strength, dosage form, and quantity of drugs or devices or related material removed;(c) The identification of the patient for whom the drug or device or related material was ordered; and(d) The identification of the person authorized to remove the drug or device or related material from the device.(6) The pharmacist in charge or designee is responsible for determining how access codes or other methods of access to automated devices are assigned.(7) The facility shall have policies and procedures approved by the pharmacist in charge in coordination with members of the nursing and medical staff for the points outlined in this section for automated dispensing devices.(8) Nothing in this section shall be interpreted to authorize the stocking of controlled substances in automated dispensing systems, except when done in a manner consistent with federal controlled substance rules and regulations.(9) The registration fee for each automated dispensing system shall be determined by the Tennessee Board of Pharmacy and listed in 1140-01-.10. The Board shall maintain a list of registered automated dispensing systems, including physical address and number of systems located at each physical address. Registrations for automated dispensing systems must be renewed every two (2) years.Tenn. Comp. R. & Regs. 1140-14-.12
New rule filed November 22, 2016; effective 2/20/2017.Authority: T.C.A. § 63-10-304.