SB 708 — Automated Pharmacy Systems

Florida Senate - 2020 CS for CS for SB 708 By the CommitteesCommittee on Rules;Health Policy;

and HealthSenator Policy;Hutson 588-02265-20 2020708c1 A bill to be entitled An act relating to automated pharmacy systems;

and Senator Hutson 595-04241-20 2020708c2 A bill to be entitled An act relating to automated pharmacy systems;

requiring such community pharmacies to adopt, annually review, and maintain a record of, for a specified time period, certain policies and procedures;

authorizing,requiring rather than requiring, the Board of Pharmacy to adopt specified rules;

deleting an obsolete date;

1612 Be It Enacted by the Legislature of the State of Florida:

1814 Section 1. Section 465.0235, Florida Statutes, is amended to read:

465.0235 Automated pharmacy systems used by long-term care facilities, hospices, or state correctional institutionsinstitutions, or for outpatient dispensing.— (1) A pharmacy may provide pharmacy services to a long-term care facility or hospice licensed under chapter 400 or chapter 429 or a state correctional institution operated under chapter 944 through the use of an automated pharmacy system that need not be located at the same location as the pharmacy.

465.003(11),465.003, which is licensed in this state may provide pharmacy services for outpatient dispensing through the use of an automated pharmacy system thatif: need not be located at the same location as the community pharmacy if all of the following criteria are met:

(a) The automated pharmacy system is underlocated inside the supervisioncommunity andpharmacy’s controlpharmacy ofdepartment or is located inside the same establishment as the community pharmacy.

(b) The automated pharmacy system is housedunder inthe ansupervision indoor environment area and incontrol a location that increases patients’ access to their prescriptions, including, but not limited to, medical facilities, places of business where essential goods and commodities are sold, rural areas of the state, large employer workplaces, and locations where access to a community pharmacypharmacy. is limited.

(d) The automated pharmacy system hasis aunder mechanismthe thatsupervision providesand live,control real-timeof patient counseling by a pharmacist, as defined in s.

465.003(10)465.003, and who is licensed in this state,state and is available and accessible for patient counseling before the dispensing of any medicinal drug.

(e) The automated pharmacy system does not contain or dispense any controlled substancesubstances listed in s.

(f) The community pharmacy maintains a record of the medicinal drugs dispenseddispensed, whichincluding includes the identity of the pharmacist responsible for verifying the accuracy of the dosage and directions and providing patient counseling.

(h) The community pharmacy maintains written policies and procedures to ensure the proper, safe, and secure functioning of the automated pharmacy system.

The community pharmacy shall annually review the policies and procedures and maintain a record of them for a minimum of 4 years.

The annual review must be documented in the community pharmacy’s records and must be made available to the board upon request.

The policies and procedures must, at a minimum, address all of the following:

1. Maintaining in good working order the automated pharmacy system and any accompanying electronic verification process.

2. Ensuring the integrity of the automated pharmacy system’s drug identifier database and its ability to identify the person responsible for making database entries.

3. Ensuring the accurate filling, stocking, and verification of the automated pharmacy system.

4. Ensuring sanitary operation of the automated pharmacy system and prevention of cross-contamination of cells, cartridges, containers, cassettes, or packages.

5. Testing the accuracy of the system and any accompanying electronic verification process.

The automated pharmacy system and accompanying electronic verification process must, at a minimum, be tested before the first use of the system, upon restarting the system, and after a modification of the system or electronic verification process which alters the filling or electronic verification process.

6. Training persons authorized to access, stock, restock, or use the system.

7. Conducting routine and preventative maintenance of the automated pharmacy system, including calibration, if applicable.

8. Removing expired, adulterated, misbranded, or recalled drugs from the automated pharmacy system.

9. Preventing unauthorized persons from accessing the automated pharmacy system, including assigning, discontinuing, or modifying security access.

10. Identifying and recording persons responsible for stocking and filling the automated pharmacy system.

11. Ensuring compliance with state and federal law, including, but not limited to, all applicable labeling, storage, and security requirements.

12. Maintaining an ongoing quality assurance program that monitors performance of the automated pharmacy system and any accompanying electronic verification process to ensure proper and accurate functioning, including tracking and documenting system errors.

A community pharmacy must maintain such documentation for a minimum of 4 years and must produce it to the board upon request.

(6)(5) The board may shall adopt rules governing the use of an automated pharmacy systems.systems system by January 1, 2005, which must include specify:

If adopted, such rules system by January 1, 2005, which must include all of the following specify:

and (c) Labeling requirements that permit the use of unit-dose medications if the facility, hospice, or institution maintains medication-administration records that include directions for use of the medication and the automated pharmacy system identifiesidentifies: all of the following: