7560779, 64B16-28.101 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 7560779

Notice of Development of Rulemaking

Department:

DEPARTMENT OF HEALTH

Division:

Board of Pharmacy

Chapter:

GENERAL REQUIREMENTS - PERMITS

Overview

RULE:

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; Commencement of Operations
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64B16-28.110	Outdated Pharmaceuticals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64B16-28.114	Prescription Refills (Repealed)
64B16-28.118	Unit Dose and Customized Patient Medication Package Returns
64B16-28.1191	Unclaimed Prescriptions
64B16-28.120	All Permits - Storage of Legend Drugs; Prepackaging
64B16-28.140	Record Maintenance Systems for All Pharmacy Permits
64B16-28.141	Requirements for an Automated Pharmacy System in a Community Pharmacy (Repealed)
64B16-28.150	Record Maintenance Systems for Institutional and Animal Shelter Permits (Repealed)
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 Class I Pharmacies (Nursing Homes)
64B16-28.303	Destruction of Controlled Substances All Permittees (Excluding Institutional Class I 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64B16-28.404	Regulation of Daily Operating Hours (Repealed)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; Exceptions for Prescription Drug Processing Only Pharmacies
64B16-28.501	Consultant Pharmacist of Record; Initial Designation; Change
64B16-28.502	Class I, Class II and Class III Institutional Permit - Labels and Labeling of Medicinal Drugs for Inpatients of a Nursing Home
64B16-28.503	Transmission of Starter Dose Prescriptions for Patients in Class I or Modified II B Institutional Facilities
64B16-28.602	Institutional Class II Class III Dispensing
64B16-28.6021	Institutional Class II and Class III Pharmacy - Emergency Department Dispensing
64B16-28.603	Class II and Class III Institutional Pharmacy Operating Hours
64B16-28.604	Class II and Class III Institutional Pharmacy Department Security
64B16-28.605	Class II and Class III Institutional Pharmacies – Automated Distribution and Packaging
64B16-28.606	Remote Medication Order Processing for Class II or Class III Institutional Pharmacies or Special Pharmacy Permits Servicing Class I, Class II, Modified Class II, Class III, and Special ALF Permitted Facilities
64B16-28.607	Automated Pharmacy System – Long-Term Care, Hospice, and 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) (Repealed)
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:

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:

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.

RULEMAKING 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:

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.

PRINT PUBLISH DATE:

8/28/2009 Vol. 35/34

RELATED STATUTES
AND LAWS:

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., 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.

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://flrules.org/gateway/ruleno.asp?id=64B16-28.101&PDate=8/28/2009&Section=1

REFERENCE MATERIALS:

No reference(s).

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