15234449, 64B16-28.905 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 15234449

Notice of Development of Rulemaking

Department:

DEPARTMENT OF HEALTH

Division:

Board of Pharmacy

Chapter:

GENERAL REQUIREMENTS - PERMITS

Overview

RULE:

64B16-28.905

Nonresident Sterile Compounding Permit Inspections; Approved Inspection Entities (Transferred)

PURPOSE:

The Board proposes the rule promulgation to set the parameters for required inspections, acceptable circumstances for a current inspection; determining how, when, and under what circumstances an inspection must be conducted; and to adopt rules for evaluating and approving entities that may perform an inspection in lieu of an onsite inspection by the department. The rule promulgation is to implement Ch. 2014-148, Laws of Florida (HB 323).

SUBJECT:

Non Resident Pharmacies Inspections for Obtaining Nonresident Sterile Compounding Permits.

RULEMAKING AUTHORITY:

465.0158 FS.

LAW:

465.0158 FS.

PRINT PUBLISH DATE:

10/31/2014 Vol. 40/213

RELATED STATUTES
AND LAWS:

465.0158 FS., 465.0158 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=64B16-28.905&PDate=10/31/2014&Section=1

REFERENCE MATERIALS:

No reference(s).

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