The purpose and effect of the proposed rule is to correct the title of two medical gas related permits and to set forth the biennial licensure fees for the Restricted Rx Drug Distributor – Blood Establishment permit.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.018Fees

PURPOSE AND EFFECT: The purpose and effect of the proposed rule is to correct the title of two medical gas related permits and to set forth the biennial licensure fees for the Restricted Rx Drug Distributor – Blood Establishment permit.

SUMMARY: The proposed rule amends the title of two medical gas related permits and sets forth the biennial licensing fees for the Restricted Rx Drug Distributor – Blood Establishment permit.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The economic review conducted by the agency.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 499.01, 499.04, 499.05, 499.831, 499.832 FS.

LAW IMPLEMENTED: 499.01, 499.012, 499.015, 499.04, 499.041, 499.05, 499.028, 499.831, 499.832 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dinah Greene, Government Operations Consultant II, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, [phone], [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.018 Fees.

(1) Biennial fees for a MANUFACTURER or REPACKAGER permit are as follows:

		Biennial Fee
	Prescription Drug Manufacturer	$1500
	Prescription Drug Repackager	$1500
	Device Manufacturer	$1200
	Cosmetic Manufacturer	$800
	Over-the Counter Drug Manufacturer	$800
	Compressed Medical Gas Manufacturer	$1000
	Non-resident Prescription Drug Manufacturer	$1000

No manufacturer shall be required to pay more than one fee per establishment to obtain an additional manufacturing permit; but the manufacturer must pay the highest fee applicable to the operations in each establishment.

(2)(a) Biennial fees for a WHOLESALE DISTRIBUTOR or FREIGHT FORWARDER permit that is issued on a BIENNIAL basis are as follows:

		Biennial Fee
	Compressed Medical Gas Wholesale Distributor	$600
	Retail Pharmacy Drug Wholesale Distributor	$100
	Freight Forwarder	$600
	Veterinary Prescription Drug Wholesale Distributor	$1000
	Limited Prescription Drug Veterinary Wholesale Distributor	$1000

(b) No change.

(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 Restricted Prescription Drug Distributor – Health Care Entity	$600 $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

(4) through (5) No change.

Rulemaking Authority 499.01, 499.04, 499.05, 499.831, 499.832 FS. Law Implemented 499.01, 499.012, 499.015, 499.04, 499.041, 499.05, 499.028, 499.831, 499.832 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, Amended _______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Reginald D. Dixon, Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ken Lawson, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 16, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: April 17, 2014