The Program intends through this rule promulgation to raise permit fees in this section to the maximum allowed by Section 499.041 F.S., in order to comply with the funding requirements of Section 499.04 F.S. The proposed rule will also provide the ...

 

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 raise permit fees in this section to the maximum allowed by Section 499.041 F.S., in order to comply with the funding requirements of Section 499.04 F.S. The proposed rule will also provide the fee for the limited prescription drug veterinary wholesaler permit authorized by Florida Laws section 2006-92. The proposed rule will clarify the circumstances when a reinspection fee for a new permit application will be assessed.
SUMMARY: The rule implements the fee for the limited prescription drug veterinary wholesaler permit, while raising the permit fees authorized under Chapter 499, Florida Statutes. The rule clarifies the circumstances where a re-inspection fee may be imposed for a new permit application.
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 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’s permit are as follows:

Permit Biennial Fee

Prescription Drug Manufacturer$1500 $1300

Prescription Drug Repackager$1500 $1300

Device Manufacturer$1200 $1000

Cosmetic Manufacturer$800  $600

Over-the Counter Drug Manufacturer$800 $600

Compressed Medical Gas Manufacturer$1000 $900

Non-resident Prescription Drug Manufacturer$1500 $850

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

PermitBiennial Fee

Compressed Medical Gas Wholesaler$600 $500

Retail Pharmacy Wholesaler$100

Freight Forwarder$600 $250

Veterinary Prescription Drug Wholesaler$1000

Limited Prescription Drug Veterinary Wholesaler$1000.

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

Prescription Drug Wholesaler (including
Broker Only)$800

Out-of-State Prescription Drug Wholesaler$800 $700

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

PermitBiennial Fee

Complimentary Drug Distributor$500

Veterinary Legend Drug Retail Establishment$600 $500

Medical Oxygen Retail Establishment$600 $500

Restricted Rx Drug Distributor – Health
Care Entity$600 $500

Restricted Rx Drug Distributor – Charitable
Organization$600 $400

Restricted Rx Drug Distributor – Reverse
Distributor$600 $500

Restricted Rx Drug Distributor – Destruction$600 $500

Restricted Rx Drug Distributor – Government
Programs$600 $400

Restricted Rx Drug Distributor – Institutional
Research$600 $400

(4) Miscellaneous other fees are as follows:

Description of other service feesFee

Certification as Designated Representative$150

Initial Application/On-site Inspection$150

(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.

Prescription Drug Wholesaler Bond/Security or Out-of-State Prescription Drug

Wholesaler Bond/Security, as set forth in
Section 499.012(2), F.S.$100,000

Limited Prescription Drug Veterinary
Wholesaler Bond/Security, as set
forth in Section 499.012(2)(h), F.S.,$20, 000

Change of Address Fee:

A relocation fee of $100 must be paid for each permitted person 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 all other permits.

Product Registration (per drug or cosmetic product registered) $30 20*

* The registration fee for a drug or cosmetic product being amended to an existing product registration that has 12 months or less until it expires is              $15 10

Listed Identical Products$15 -0-

Free Sale Certificate$25

Signature copy (requested concurrently$2

Delinquent Establishment Permit Renewal (per permit)$100

(5) The department shall assess other fees as provided in 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.________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Rebecca Poston
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 26, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: March 23, 2007