The purpose and effect of the proposed rule amendment is to update and revise Rule 61N-2.033, F.A.C. in accordance with HB 1335 (ch. 2024-178) and to incorporate a new form by reference.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.033Application for Certification as a Designated Representative

PURPOSE AND EFFECT: The purpose and effect of the proposed rule amendment is to update and revise Rule 61N-2.033, F.A.C. in accordance with HB 1335 (ch. 2024-178) and to incorporate a new form by reference.

SUMMARY: The proposed rulemaking amends Rule 61N-2.033, F.A.C., in order to update and revise the rule to incorporate a new form by reference.

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:

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, 499.012, 499.0121, 499.04, 499.041, 499.05, F.S.

LAW IMPLEMENTED: 499.01, 499.012, 499.0121, 499.015, 499.04, 499.041, 499.05, 559.79, F.S.

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: Susan Hartmann Swartz, Rules Attorney, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, Florida 32399-2202, Tel. [phone], Email [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-2.033 Application for Certification as a Designated Representative.

Certification as a Designated Representative is required for any natural person who is designated by a prescription drug wholesale distributor or out-of-state prescription drug wholesale distributor to act as their designated representative pursuant to Section 499.012(15), F.S. An applicant wishing to obtain certification as a designated representative as required under Section 499.012(15), F.S., shall submit a complete application to the department on Form DBPR-DDC-226, Application for Certification as a Designated Representative, effective October, 2024 January 2018, incorporated herein by reference, (new DOS link)  http://www.flrules.org/Gateway/reference.asp?No=Ref-09256, together with the appropriate fees. A copy of Form DBPR-DDC-226, Application for Certification as a Designated Representative, can be obtained at https://www.myfloridalicense.com or by contacting the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics at 2601 Blair Stone Road, Tallahassee, Florida 32399-1047, [phone].

Rulemaking Authority 499.01, 499.012, 499.0121, 499.04, 499.041, 499.05, FS. 499.01, 499.012, 499.0121, 499.015, 499.04, 499.041, 499.05, 559.79 FS. History‒New 4-12-18, Amended ____________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Susan Hartmann Swartz

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Melanie S. Griffin

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 16, 2024

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 28, 2024