Notice of Proposed Rule

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 Section 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, 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, ________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston, R.Ph.
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