Ga. Comp. R. & Regs. R. 480-37-.03 - Minimum Requirements

Minimum Requirements. A pharmacy may use a RAMS provided that:

(a) The pharmacy has a policy and procedure manual at the skilled nursing facility or hospice that includes:
1. The type or name of each RAMS including a serial number or other identifying nomenclature.
2. A method to ensure security of a RAMS to prevent unauthorized access. Such method may include the use of electronic passwords, biometric identification (optic scanning or fingerprint) or other coded identification.
3. A process of filling and stocking a RAMS with drugs; an electronic or hard copy record of medication filled into the system including the product identification, lot number, and expiration date.
4. Documentation of inventory procedures including removal of any discontinued/outdated medications.
5. Compliance with a Continuous Quality Improvement Program.
6. A method to ensure that patient confidentiality is maintained.
(b) No more than a 30-day supply of each individual medication may be stocked in a RAMS at one time.
(c) All drugs in a RAMS must inventoried no less than once every 30 days and documentation must be maintained of the inventories including the removal of any discontinued/out of date medications.
(d) All the registered pharmacists, licensed pharmacy interns or registered pharmacy technicians involved in the process of stocking, entering information into RAMS, or inventorying the RAMS must be identified. No person shall be permitted to perform a function related to the machine that they are not authorized to do in the pharmacy. Specifically, where direct supervision is required in the pharmacy, such supervision must occur in duties related to the RAMS.
(e) Patient confidentiality must be maintained.
(f) The PIC, or a pharmacist designated by the PIC, must be able to revoke, add, or change access to RAMS at any time.
(g) Only a Georgia registered nurse or a Georgia licensed practical nurse may be assigned to access and remove dangerous drugs from a RAMS.
(h) Only a Georgia registered nurse may access and remove controlled substances from a RAMS.
(i) The system ensures that each prescription is dispensed in compliance with the definition of dispense and the practice of the profession of pharmacy.
(j) The system shall maintain a readily retrievable electronic record to identify all pharmacists, pharmacy interns, or registered pharmacy technicians involved in the processing of the prescription order.
(k) A RAMS shall provide the ability to comply with product recalls generated by the manufacturer, distributor, or pharmacy. The system shall have a process in place to isolate affected lot numbers including an intermix of drug product lot numbers.
(l) The stocking or restocking of a dangerous drug or controlled substances shall be completed by:
1. A Georgia licensed pharmacist,
2. A Georgia licensed pharmacy intern/extern under the direct on-site supervision of a Georgia licensed pharmacist, or
3. A Georgia registered pharmacy technician only under the following circumstances:
a. If the remote automated medication system utilizes radio frequency identification or bar coding in the filling process, the pharmacy shall retain an electronic record of the filling activities of the pharmacy technician; or
b. If the remote automated medication system does not utilize radio frequency identification or bar coding in the filling process, a pharmacist shall supervise continuously the filling activities of the pharmacy technician through a two-way audiovisual system.
(m) A RAMS must use at least two separate verifications, such as bar code verification, electronic verification, weight verification, radio frequency identification (RFID) or similar process to ensure that the proper medication is being dispensed from a RAMS.
(o) All medication shall be packaged and labeled in compliance with Board rules and laws for patient specific labeled medication and/or unit of use medication.
(p) The licensed pharmacist responsible for filling, verifying, or loading the RAMS shall be responsible for their individual action.
(q) A prescription drug dispensed by the RAMS pursuant to the requirements of this rule shall be deemed to have been certified by the pharmacist.
(r) A licensed pharmacist may remove discontinued and/or outdated medications from the RAMS and return such medications to the licensed pharmacy for proper disposition. A registered or licensed practical nurse may remove discontinued and/or outdated medications and place them in the designated secured return bin in a RAMS.


Ga. Comp. R. & Regs. R. 480-37-.03
O.C.G.A. ยงยง 26-4-5, 26-4-27, 26-4-28, 26-4-80, 26-4-110.
Original Rule entitled "Minimum Requirements" adopted. F. Feb. 24, 2012; eff. Mar. 15, 2012. Amended: F. Dec. 14, 2021; eff. Jan. 3, 2022.

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