Section 64B16-28.607 - Automated Pharmacy System - Long-Term Care, Hospice, and Prison(1) Definitions. (a) "Automated pharmacy system" means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and delivery of a medicinal drug, and which collects, controls, and maintains a record of each transaction.(b) "Provider pharmacy" means a pharmacy that provides pharmacy services by using an automated pharmacy system at a remote site.(c) "Remote site" means a long term care facility or hospice licensed under chapter 400, F.S., or a state correctional institution operated under Chapter 944, F.S., that is not located at the same location as the provider pharmacy, at which pharmacy services are provided using an automated pharmacy system.(d) "Controlled substance" means a substance listed in Chapter 893, F.S., or 21 C.F.R. Part 1308.(2) Provider Pharmacy Requirements. (a) A provider pharmacy may provide pharmacy services to a long term care facility or hospice licensed under Chapter 400 or 429, F.S., or a state correctional institution operated under Chapter 944, F.S., through the use of an automated pharmacy system.(b) An automated pharmacy system shall only be used to provide pharmacy services to an inpatient or a resident of the remote site.(c) Supervision of the automated pharmacy system shall be the responsibility of a Florida pharmacist employed by the provider pharmacy.(d) Every medicinal drug stored in the automated pharmacy system shall be owned by the provider pharmacy.(e) An automated pharmacy system shall be under the supervision of a pharmacist employed by the provider pharmacy. The pharmacist need not be physically present at the remote site if the system is supervised electronically.(f) A provider pharmacy shall have policies and procedures to ensure adequate security.(3) Prescription Department Manager Requirements. (a) The prescription department manager shall ensure that the automated pharmacy system complies with Chapter 893, F.S., and 21 C.F.R., relating to the regulation of controlled substances, for each automated pharmacy system that contains a controlled substance.(b) The prescription department manager shall ensure that the use of an automated pharmacy system does not compromise patient confidentiality.(c) The prescription department manager or a designee shall: 1. Authorize or deny access to the data from an automated pharmacy system or to a drug stored inside the automated pharmacy system.2. Document the training of each person who has access to the data from an automated pharmacy system or to a drug stored inside the automated pharmacy system.(4) Automated Pharmacy System Requirements.(a) A medicinal drug stored in bulk or unit-of-use in an automated pharmacy system is part of the inventory of the provider pharmacy and is not part of the inventory of any other pharmacy permit for the facility.(b) A medicinal drug may be removed from an automated pharmacy system for administration to a patient only after a prescription or order has been received and approved by a pharmacist at the provider pharmacy. This provision does not apply to a medication designated as an emergency medication if the automated pharmacy system is also used as an emergency medication kit in compliance with Section 400.142, F.S., and Rule 59A-4.112, F.A.C.(c) A pharmacist at the provider pharmacy shall control all operations of the automated pharmacy system and approve release of the initial dose of a prescription or order. A subsequent dose from an approved prescription or order may be released without additional approval of a pharmacist. However, any change made in a prescription or order shall require a new approval by a pharmacist to release the drug.(d) A pharmacist at the provider pharmacy shall comply with the patient record requirements in Rule 64B16-27.800, F.A.C., and prospective drug use review requirements in Rule 64B16-27.810, F.A.C., for every medicinal drug delivered through an automated pharmacy system.(e) If the facility where pharmacy services are being provided maintains a medication administration record that includes directions for use of the medication, a unit dose medication may be utilized if the provider pharmacy or the automated pharmacy system identifies and records the dispensing pharmacy, the prescription or order number, the name of the patient, and the name of the prescribing practitioner for each medicinal drug delivered.(f) Stocking or Restocking of an Automated Pharmacy System.1. The stocking or restocking of a medicinal drug in an automated pharmacy system at the remote site shall be completed by a pharmacist or other licensed personnel, except as provided in subparagraph 2., below, of this subsection.2. If the automated pharmacy system uses removable cartridges or containers to store the drug, the stocking or restocking of the cartridges or containers may occur at the provider pharmacy and be sent to the remote site to be loaded by personnel designated by the pharmacist if:a. A pharmacist verifies the cartridge or container has been properly filled and labeled.b. The individual cartridge or container is transported to the remote site in a secure, tamper-evident container.c. The automated pharmacy system uses bar code verification, electronic verification, or similar process to assure that the cartridge or container is accurately loaded into the automated pharmacy system.(g) A medicinal drug that has been removed from the automated pharmacy system shall not be replaced into the system unless a pharmacist has examined the medication, the packaging, and the labeling and determined that reuse of the medication is appropriate.(h) Medication to be returned to the provider pharmacy's stock shall meet the requirements of Rule 64B16-28.118, F.A.C.(5) Security Requirements. (a) If a provider pharmacy intends to store a controlled substance in an automated pharmacy system: 1. It shall maintain a separate DEA registration for each remote site at which a controlled substance is stored, unless the automated pharmacy system is solely used as an emergency kit pursuant to Rule 59A-4.112, F.A.C.2. It may utilize one DEA registration to include multiple automated pharmacy systems located at a single address.(b) A provider pharmacy shall only store a medicinal drug at a remote site within an automated pharmacy system which is locked by a mechanism that prevents access to a drug or to data by unauthorized personnel.(c) Access to the drugs shall be limited to a pharmacist or a registered pharmacy technician employed by the provider pharmacy or licensed personnel in the facility or institution who are authorized to administer medication.(d) An automated pharmacy system that contains a controlled substance shall prohibit simultaneous access to multiple drug entities, drug strengths, or dosage forms of controlled substances.(6) Emergency medication. If an automated pharmacy system is utilized for both a medication ordered for a specific patient and an emergency medication for which the review of a pharmacist is not required:(a) The emergency medication shall be stored separately from other patient medications.(b) The record shall identify the storage location from which the medication was released.(c) The record shall include the name of the medication, the patient, the prescriber, the person who accessed the automated pharmacy system, and the date and time of the release.(7) Record Keeping Requirements. (a) The record of transactions with the automated pharmacy system shall be maintained in a readily retrievable manner.(b) The record shall be available to an authorized agent of the Department of Health or the Board of Pharmacy.(c) The record shall include:1. Name or identification of the patient or resident.2. Name, strength and dosage form of the drug product released.3. Quantity of drug released.4. Date and time of each release of a drug.5. Name of provider pharmacy.6. Prescription number or order number.7. Name of prescribing practitioner.8. Identity of the pharmacist who approved the prescription or order.9. Identity of the person to whom the drug was released.(d) A record of every transaction with the automated pharmacy system shall be maintained for four (4) years.Fla. Admin. Code Ann. R. 64B16-28.607
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.019, 465.022, 465.0235 FS.
New 4-22-07, Amended 1-1-10, Amended by Florida Register Volume 40, Number 127, July 1, 2014 effective 7/14/2014, Amended by Florida Register Volume 45, Number 167, August 27, 2019 effective 9/9/2019, Amended by Florida Register Volume 45, Number 201, October 15, 2019 effective 10/29/2019.New 4-22-07, Amended 1-1-10, 7-14-14, 10-29-19.