The proposed rulemaking amends Rule 61N-1.018, F.A.C., to update and revise the Division’s fee rule to remove reference to “cosmetic product registration fees” pursuant to Ch. 2017-051, Laws of Florida (2017); to allow for biennial renewal of ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.018Fees

PURPOSE AND EFFECT: The proposed rulemaking amends Rule 61N-1.018, F.A.C., to update and revise the Division’s fee rule to remove reference to “cosmetic product registration fees” pursuant to Ch. 2017-051, Laws of Florida (2017); to allow for biennial renewal of Prescription Drug Wholesale Distributor and Out-of-State Prescription Drug Wholesale Distributor permits; to adopt fees for Non-resident Prescription Drug Repackager permits; to amend bonding requirements for Prescription Drug Wholesale Distributor and Out-of-State Prescription Drug Wholesale Distributor permits receiving $10 million or less in annual receipts; and conform statutory cross references.

SUMMARY: Fees for cosmetic product registration; fees for Prescription Drug Wholesale Distributor and Out-of-State Prescription Drug Wholesale Distributor permits; fees for Non-resident Prescription Drug Repackager permits; bond requirements for Prescription Drug Wholesale Distributor or Out-of-State Prescription Drug Wholesale permits; and statutory cross references for bonding requirements.

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 FS.

LAW IMPLEMENTED: 499.002, 499.01, 499.012, 499.015, 499.04, 499.041, 499.05 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, Operations Review Specialist, Division of Drugs, Devices and Cosmetics, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047; 850-717-1802; [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 (including virtual)	$1500
	Prescription Drug Repackager	$1500
	Device Manufacturer	$1200
	Cosmetic Manufacturer	$800
	Over-the Counter Drug Manufacturer	$800
	Medical Gas Manufacturer	$1000
	Non-resident Prescription Drug Manufacturer (including virtual)	$1000
	Non-resident Prescription Drug Repackager	$1500

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
	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)	$1600 $800
Out-of-State Prescription Drug Wholesale Distributor	$1600 $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	$600
	Restricted Prescription Drug Distributor – Blood Establishment	$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 with more than $10 million in annual gross receipts during the previous tax year, as set forth in Section 499.012(8)(m), 499.01(2)(d),(e), F.S.	$100,000
	(d) Bond/Security: Prescription Drug Wholesale Distributor or Out-of-State                                    Prescription Drug Wholesale Distributor with $10 million or less in annual gross receipts during the previous tax year, as set forth in Section 499.012(8)(m), F.S.	$25,000
	(e)(d) Bond/Security: Limited Prescription Drug Veterinary Wholesale, as set forth in Section 499.01(2) (m)(l), F.S.	$20,000
	(f)(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.

	(g)(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.
	(h)(g) Listed Identical Products	$15
	(i) (h) Free Sale Certificate	$25
	Signature of Free Sale Certificate copy (requested concurrently)	$2
	(j) (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, 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 6-3-15, _________________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Drew F. Winters, Division Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Jonathan Zachem, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 26, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 26, 2017