The Board proposes the rule amendment and for a substantial re-write and reorganization of the Chapter; and to review the existing language in the rules to determine whether changes are necessary.

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO: RULE TITLE
64B16-28.101: Prescription Area Accessible to Inspection
64B16-28.102: Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment
64B16-28.1035: Patient Consultation Area
64B16-28.108: All Permits - Labels and Labeling of Medicinal Drugs
64B16-28.1081: Regulation of Daily Operating Hours
64B16-28.109: Prescription Department; Padlock; Sign: "Prescription Department Closed."
64B16-28.110: Outdated Pharmaceuticals
64B16-28.113: Permits; Single Entity; Single Location
64B16-28.114: Prescription Refills
64B16-28.118: Unit Dose and Customized Patient Medication Package Returns by In-patients
64B16-28.1191: Unclaimed Prescriptions
64B16-28.120: All Permits - Storage of Legend Drugs; Prepackaging
64B16-28.140: Record Maintenance Systems for Community, Special-Limited Community, Special-Closed Systems, Special-Parenteral/Enteral, and Nuclear Permits
64B16-28.141: Requirements for an Automated Pharmacy System in a Community Pharmacy
64B16-28.150: Record Maintenance Systems for Institutional Pharmacies – Nursing Homes
64B16-28.202: Closing of a Pharmacy; Transfer of Prescription Files
64B16-28.2021: Change of Ownership
64B16-28.203: Transfer of Medicinal Drugs; Change of Ownership; Closing of a Pharmacy
64B16-28.301: Destruction of Controlled Substances - Institutional Pharmacies
64B16-28.303: Destruction of Controlled Substances All Permittees (excluding Nursing Homes)
64B16-28.404: Regulation of Daily Operating Hours (Repealed)
64B16-28.405: Remote Medication Order Processing for Community Pharmacies
64B16-28.450: Centralized Prescription Filling, Delivering and Returning
64B16-28.451: Pharmacy Common Database
64B16-28.501: Institutional Permit - Consultant Pharmacist of Record
64B16-28.502: Labels and Labeling of Medicinal Drugs Institutional Permit I. (Nursing Homes)
64B16-28.503: Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities
64B16-28.602: Class II Institutional Dispensing
64B16-28.6021: Class II Institutional Pharmacy - Emergency Department Dispensing
64B16-28.603: Class II Institutional Pharmacy Operating Hours
64B16-28.604: Class II Institutional Pharmacy Department Security
64B16-28.605: Class II Institutional Pharmacies – Automated Distribution and Packaging
64B16-28.606: Remote Medication Order Processing for Class II Institutional Pharmacies
64B16-28.607: Automated Pharmacy System – Long-Term Care, Hospice or Prison
64B16-28.702: Modified Class II Institutional Pharmacies
64B16-28.800: Special Pharmacies
64B16-28.810: Special Pharmacy - Limited Community Permit
64B16-28.820: Sterile Products and Special Parenteral/Enteral Compounding
64B16-28.830: Special - Closed System Pharmacy
64B16-28.840: Special - Non Resident (Mail Service)
64B16-28.850: Special Pharmacy - ESRD
64B16-28.860: Special Pharmacy - Parenteral/Enteral Extended Scope Permit
64B16-28.870: Special-ALF
64B16-28.900: Definitions - Nuclear Pharmacy
64B16-28.901: Nuclear Pharmacy - General Requirements
64B16-28.902: Nuclear Pharmacy - Minimum Requirements
PURPOSE AND EFFECT: The Board proposes the rule amendment and for a substantial re-write and reorganization of the Chapter; and to review the existing language in the rules to determine whether changes are necessary.
SUBJECT AREA TO BE ADDRESSED: Prescription Area Accessible to Inspection; Sink and Running Water, Sufficient Space, Refrigeration, Sanitation, Equipment; Patient Consultation Area; All Permits – Labels and Labeling of Medicinal Drugs; Regulation of Daily Operating Hours; Prescription Department; Padlock; Sign: “Prescription Department Closed.” Permits; Single Entity; Single Location; Prescription Refills; Unit Dose and Customized Patient Medication Package Returns by In-patients; Unclaimed Prescriptions; All Permits – Storage of Legend Drugs; Prepackaging; Record Maintenance Systems for a Community, Special-Limited Community Special-Closed Systems, Special-Parenteral/Enteral, and Nuclear Permits; Requirements for an Automated Pharmacy System in a Community Pharmacy; Closing of a Pharmacy; Transfer of Prescription Files; Change of Ownership; Transfer of Medicinal Drugs; Change of Ownership; Closing of a Pharmacy; Destruction of Controlled Substances – Institutional Pharmacies; Destruction of Controlled Substances All Permittees (excluding Nursing Homes); Centralized Prescription Filling, Delivering and Returning; Pharmacy Common Database; Institutional Permit – Consultant Pharmacist of Record; Labels and Labeling of Medicinal Drugs Institutional Permit I (Nursing Homes); Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities; Class II Institutional Pharmacies; Class II Institutional Pharmacy – Emergency Department Dispensing; Class II Institutional Pharmacy Operating Hours; Class II Institutional Pharmacy Department Security; Class II Institutional Pharmacies – Automated Distribution and Packaging; Remote Medication Order Processing for Class II Institutional Pharmacies; Automated Pharmacy System – Long Term Care, Hospice or Prison; Modified Class II Institutional Pharmacies Special Pharmacies; Special Pharmacy – Limited Community Permit; Sterile Products and Special Parenteral/Enteral Compounding; Special – Closed System Pharmacy; Special – Non Resident (Mail Service); Special Pharmacy – ESRD; Special Pharmacy – Parenteral/Enteral Extended Scope Permit; Special-ALF; Definitions – Nuclear Pharmacy; Nuclear Pharmacy – General Requirements; Nuclear Pharmacy – Minimum Requirements.
SPECIFIC AUTHORITY: 465.005, 465.007, 465.0125, 465.0155, 465.0156, 465.016(1), 465.019(4), 465.022, 465.022(1)(a), (g), 465.0255, 465.0265, 893.04 FS.
LAW IMPLEMENTED: 465.003(10)(a), (11)(a), (14), (16), 465.007, 465.0125, 465.014, 465.016(1)(l), 465.017, 465.018, 465.019(2)(b), (c), (4), 465.019, 465.0126, 465.0156, 465.0193, 465.0196, 465.022(1), (1)(e), (1)(g), (7), 465.022, 465.0235, 465.026, 465.0265, 465.0266, 893.07 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Rebecca Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.