7561264, 64B16-28.108 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 7561264

Notice of Development of Rulemaking

Department:

DEPARTMENT OF HEALTH

Division:

Board of Pharmacy

Chapter:

GENERAL REQUIREMENTS - PERMITS

Overview

RULE:

64B16-28.108	All Permits - Labels and Labeling of Medicinal Drugs
64B16-28.1081	Regulation of Daily Operating Hours; Commencement of Operations
64B16-28.120	All Permits - Storage of Legend Drugs; Prepackaging
64B16-28.502	Class I, Class II and Class III Institutional Permit - Labels and Labeling of Medicinal Drugs for Inpatients of a Nursing Home
64B16-28.602	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
64B16-28.702	Modified Class II Institutional Pharmacies
64B16-28.800	Special Pharmacies
64B16-28.820	Sterile Products and Special Parenteral/Enteral Compounding
64B16-28.870	Special-ALF
64B16-28.902	Nuclear Pharmacy - Minimum Requirements

PURPOSE:

The Board proposes the rule amendment in order to make corrections; for consideration of hour and day requirement; for clarification of language; for consideration of requirements; to add application; to add specific application information; to add application; to clarify language; and to review the existing language in the rules to determine whether other changes are necessary.

SUBJECT:

All Permits – Labels and Labeling of Medicinal Drugs; Regulation of Daily Operating Hours; All Permits – Storage of Legend Drugs; Prepackaging; Labels and Labeling of Medicinal Drugs Institutional Permit I (Nursing Homes); Class II Institutional Pharmacies; Class II Institutional Pharmacy – Emergency Department Dispensing; Class II Institutional Pharmacy Operating Hours; Class II Institutional Pharmacy Department Security; Modified Class II Institutional Pharmacies Special Pharmacies; Sterile Products and Special Parenteral/Enteral Compounding; Special-ALF; Nuclear Pharmacy – Minimum Requirements.

RULEMAKING AUTHORITY:

465.005, 465.007, 465.019(4), 465.022 FS.

LAW:

465.007, 465.018, 465.019(2)(b), (c), (4), 465.0193, 465.0196, 465.022(1), 465.022 FS.

PRINT PUBLISH DATE:

8/28/2009 Vol. 35/34

RELATED STATUTES
AND LAWS:

465.005, 465.007, 465.019(4), 465.022 FS., 465.007, 465.018, 465.019(2)(b), (c), (4), 465.0193, 465.0196, 465.022(1), 465.022 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://www.flrules.org/gateway/ruleno.asp?id=64B16-28.108&PDate=8/28/2009&Section=1

REFERENCE MATERIALS:

No reference(s).

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