17498817, 61N-2.0141 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 17498817

Notice of Development of Rulemaking

Department:

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Division:

Drugs, Devices and Cosmetics

Chapter:

Applications, Forms and Regulations

Overview

RULE:

61N-2.0141

Application for Prescription Drug Manufacturer - Virtual Permit

PURPOSE:

To define terms that are used in Chapter 499, F.S. and Rule 61N, F.A.C. and to adopt and incorporate the division’s permitting application forms into rule.

SUBJECT:

The proposed rule development:  sets the limit on the amount of prescription drugs that may be distributed by a retail pharmacy before that pharmacy is required to be permitted by the division;   establishes the criteria for determining when distributions between commonly owned, End-Stage Renal Dialysis pharmacies is such that it requires a license from the department; and revises the application forms that permit applicants for virtual prescription drug manufacturers and repackagers must submit.

RULEMAKING AUTHORITY:

499.01, 499.012, 499.0121, 499.04, 499.041 FS.

LAW:

499.01, 499.012, 499.0121, 499.015, 499.04, 499.041 FS.

PRINT PUBLISH DATE:

5/5/2016 Vol. 42/88

RELATED STATUTES
AND LAWS:

499.01, 499.012, 499.0121, 499.04, 499.041 FS., 499.01, 499.012, 499.0121, 499.015, 499.04, 499.041 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=61N-2.0141&PDate=5/5/2016&Section=1

REFERENCE MATERIALS:

No reference(s).

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