Specify fee for 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: Specify fee for Restricted RX Drug Distributor- Blood Establishment permit.

SUBJECT AREA TO BE ADDRESSED: Rule 61N-1.018 Fees.

RULEMAKING AUTHORITY: 499.01, 499.04, 499.05 FS.

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

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT IS: Dinah Greene, Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Tallahassee, FL 32399

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT 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) Annual fees for a WHOLESALE DISTRIBUTOR permit that is issued on an ANNUAL basis are as follows:

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

(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 Restricted Prescription Drug Distributor – Blood Establishment	$600 $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

(4) Miscellaneous OTHER fees are as follows:

		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 or Out-of-State Prescription Drug Wholesale Distributor,	$100,000
	as set forth in Section 499.01(2)(d), (e), F.S.
	(d) Bond/Security: Limited Prescription Drug Veterinary Wholesale, as set forth in Section 499.01(2)(l), F.S.	$20,000
	(e) Change of Address:
	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 permit.
	(f) Product Registration (for each 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, F.S.

Rulemaking Authority 499.01, 499.04, 499.05 FS. Law Implemented 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, Amended_________.