13821935, 61N-1.018 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 13821935

Notice of Development of Rulemaking

Department:

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Division:

Drugs, Devices and Cosmetics

Chapter:

REGULATIONS FOR DRUGS, DEVICES AND COSMETICS

Overview

RULE:

61N-1.018

Fees

PURPOSE:

Specify fee for Restricted RX Drug Distributor-Blood Establisment permit; and for device product registration.

SUBJECT:

(3) Biennial fees for OTHER permits are as follows:
Biennial Fee
Complimentary Drug Distributor	$500
Veterinary Prescription Drug Retail Establishment $600
Medical Oxygen Retail Establishment $600
Restricted Prescription Drug Distributor-Blood Establishment	$600
Restricted Prescription Drug Distributor – Health Care Entity	$600
Restricted Prescription Drug Distributor – Charitable Organization	$600
Restricted Prescription Drug Distributor – Reverse Distributor	$600
Restricted Prescription Drug Distributor – Destruction	$600
Restricted Prescription Drug Distributor – Government Programs	$600
Restricted Prescription Drug Distributor – Institutional Research	$600
Third Party Logistics Provider	$600
Health Care Clinic Establishment	$255
(f) Product Registration (for each drug, device or cosmetic product registered)	$30*
* The registration fee for a prescription drug, device or cosmetic product being amended to an existing product registration that has 12 months or less until it expires is $15.

RULEMAKING AUTHORITY:

499.01, 499.04, 499.05 FS

LAW:

499.01, 499.012, 499.015, 499.04, 499.041, 499.05, 499.028 FS. History–New 7-1-96, Formerly 10D-45.0544, Amended 4-17-01, 7-6-03, 1-1-04, 9-13-04, 2-14-06, 9-5-07, 3-10-09, Formerly 64F-12.018.

PRINT PUBLISH DATE:

11/15/2013 Vol. 39/223

RELATED STATUTES
AND LAWS:

499.01, 499.04, 499.05 FS, 499.01, 499.012, 499.015, 499.04, 499.041, 499.05, 499.028 FS. History–New 7-1-96, Formerly 10D-45.0544, Amended 4-17-01, 7-6-03, 1-1-04, 9-13-04, 2-14-06, 9-5-07, 3-10-09, Formerly 64F-12.018.

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-1.018&PDate=11/15/2013&Section=1

REFERENCE MATERIALS:

No reference(s).

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