CS/CS/HB 59 — Automated Pharmacy Systems
by Health and Human Services Committee; Health Quality Subcommittee; and Rep. Willhite and others (CS/CS/SB 708 by Rules Committee; Health Policy Committee; and Senator Hutson)
This summary is provided for information only and does not represent the opinion of any Senator, Senate Officer, or Senate Office.
Prepared by: Health Policy Committee (HP)
The bill expands current law to permit a licensed community pharmacy to provide outpatient pharmacy services for the dispensing of medicinal drugs through the use of an automated pharmacy system (APS) that need not be located at the same location as the community pharmacy if:
- The APS is under the supervision and control of the community pharmacy;
- The APS is housed in an indoor environment area and in a location to increase patients’ access to their prescriptions, including, but not limited to:
- Medical facilities;
- Places of business where essential goods and commodities are sold;
- Large employer workplaces; or
- Locations where access to a community pharmacy is limited
- The community pharmacy providing services through the APS notifies the Board of Pharmacy (BOP) of the location of the APS and any changes in such location;
- The APS has a mechanism that provides live, real time patient counseling by a pharmacist licensed in Florida, before the dispensing of any medicinal drug;
- The APS does not contain or dispense any controlled substance;
- The community pharmacy maintains a record of the drugs dispensed, including the identity of the pharmacist responsible for verifying the accuracy of the dosage and directions and providing patient counseling;
- The APS ensures confidentiality of personal health information; and
- The community pharmacy maintains written policies and procedures to ensure the proper, safe, and secure functioning of the APS.
A community pharmacy using an APS must annually review the policies and procedures and maintain a record of such policies and procedures for at least four years. The annual review must be documented in the community pharmacy's records and must be made available to the BOP upon request. The policies and procedures must address numerous issues relating to the operation, maintenance, filling, stocking, restocking, testing, and security of an APS, as well as the training of persons authorized to access the APS. The bill requires a community pharmacy to maintain an ongoing quality assurance program for the performance of its APS.
The bill requires that medicinal drugs stored in bulk or unit of use in an APS used for outpatient dispensing are part of the inventory of the pharmacy providing such outpatient dispensing with the APS.
The bill deletes the current-law requirement for the BOP to adopt rules governing a pharmacy’s use of an APS and instead authorizes the BOP to adopt such rules.
If approved by the Governor, these provisions take effect July 1, 2020.
Vote: Senate 27-12; House 115-1