The Program intends through this rule promulgation to add fees for new permits authorized by the Florida Legislature. The rule will also clarify the fee for relocation of an establishment holding multiple permits.

DEPARTMENT OF HEALTH
Division of Family Health Services

RULE NO: RULE TITLE
64F-12.018: Fees
PURPOSE AND EFFECT: The Program intends through this rule promulgation to add fees for new permits authorized by the Florida Legislature. The rule will also clarify the fee for relocation of an establishment holding multiple permits.
SUMMARY: The rule implements the fee for the third party logistics provider permit and the health care clinic establishment permit. It also clarifies the fee for relocation of an establishment that holds multiple permits.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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.
SPECIFIC AUTHORITY: 499.01, 499.012, 499.015, 499.04, 499.041, 499.05 FS.
LAW IMPLEMENTED: 499.01, 499.012, 499.015, 499.04, 499.041, 499.05, 499.028 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, R. Ph., Director, Drugs Devices and Cosmetics Program 4052 Bald Cypress Way, Mail Bin #C-04 Tallahassee, Florida 32399

THE FULL TEXT OF THE PROPOSED RULE IS:

64F-12.018 Fees.

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

 

	Permit	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 wholesaler’s permit that is issued on a BIENNIAL biennial basis are as follows:

 

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

 

(b) Annual fees for a WHOLESALE DISTRIBUTOR wholesaler’s permit that is issued on an ANNUAL basis are as follows:

 

Permit	Annual Fee
Prescription Drug Wholesale Distributor Wholesaler (including Broker Only)	$800
Out-of-State Prescription Drug Wholesale Distributor Wholesaler	$800

 

(3) Biennial fees for OTHER distribution permits are as follows:

 

	Permit	Biennial Fee
	Complimentary Drug Distributor	$500
	Veterinary Prescription Legend Drug Retail Establishment	$600
	Medical Oxygen Retail Establishment	$600
	Restricted Prescription Rx Drug Distributor  Health Care Entity	$600
	Restricted Prescription Rx Drug Distributor  Charitable Organization	$600
	Restricted Prescription Rx Drug Distributor  Reverse Distributor	$600
	Restricted Prescription Rx Drug Distributor  Destruction	$600
	Restricted Prescription Rx Drug Distributor  Government Programs	$600
	Restricted Prescription Rx Drug Distributor  Institutional Research Third Party Logistics Provider Health Care Clinic Establishment	$600 $600 $255

 

(4) Miscellaneous OTHER other fees are as follows:

 

	Description of other service fees	Fee
	(a) Certification as Designated Representative	$150
	(b) Initial Application/On-site Inspection	$150 Non-Refundable
	(The initial application/on-site inspection fee is non-refundable.)
	If the department determines it must re-inspect for an initial application because the applicant does not have security, climate control, a quarantine area, or written policies and procedures, as required by the particular permit for which the applicant is applying; fails to appear for a scheduled inspection; or is otherwise not ready or available for inspection or available to schedule an inspection on or after the date indicated on the application form, an additional on-site inspection fee of $150 is required for each re-inspection.
	(c) Bond/Security: Prescription Drug Wholesale Distributor Wholesaler Bond/Security or Out-of-State Prescription Drug Wholesale Distributor Wholesaler Bond/Security, as set forth in Sections 499.01(2)(d), (e) 499.012(2), F.S.	$100,000
	(d) Bond/Security: Limited Prescription Drug Veterinary Wholesaler Bond/Security, as set fForth in Section 499.01(2)(l) 499.012(2)(h), F.S.	$20,000
	(e) Change of Address Fee:
	A relocation fee of $100 must be paid for each permitted person or establishment relocating for which an on-site inspection is required. If no on-site inspection is required, the relocation fee is $25 per permit. If a permitted person has multiple permits under the same permitted name and address and relocates any or all permitted activities concurrently to the new location, then only one $100 fee is required plus $25 for each additional all other permits.
	(f) Product Registration (for each per drug or cosmetic product registered)	$30*
	*The registration fee for a prescription drug or cosmetic product being amended to an existing product registration that has 12 months or less until it expires is $15.
	(g) Listed Identical Products	$15
	(h) Free Sale Certificate	$25
	Signature of Free Sale Certificate copy (requested concurrently)	$2
	(i) Delinquent Establishment Permit Renewal (per permit)	$100

 

(5) The department shall assess other fees as provided in Chapter 499 Part I Sections 499.001-.081, F.S.

Specific Authority 499.01, 499.012, 499.015, 499.04, 499.041, 499.05 FS. Law Implemented 499.01, 499.012, 499.015, 499.04, 499.041 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,_________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Dr. Ana Viamonte Ros, State Surgeon General
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 3, 2008
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: June 27, 2008