To create a new rule to provide language and incorporate by reference, the Application for Restricted Prescription Drug Distributor – Reverse Distributor Permit.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.024Application for Restricted Rx Drug distributor – Reverse Distributor

PURPOSE AND EFFECT: To create a new rule to provide language and incorporate by reference, the Application for Restricted Prescription Drug Distributor – Reverse Distributor Permit.

SUMMARY: The proposed rulemaking creates and incorporates by reference the Division of Drugs, Devices, and Cosmetics’ Application for Restricted Prescription Drug Distributor – Reverse Distributor Permit within the text of Proposed Rule 61N-2.024, F.A.C.

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, 499.012, 499.05, 559.79 FS.

LAW IMPLEMENTED: 499.01(2)(h), 499.012, 499.03(48)(6), 499.05, 559.79, 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; [phone]; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-2.024 Application for Restricted Prescription Drug Distributor – Reverse Distributor Permit.

A Restricted Prescription Drug Distributor – Reverse Distributor permit is required for any person located in this state who engages in the handling, processing and removal of expired or otherwise adulterated or unsuitable prescription drugs on behalf of licensed pharmacies, practitioners, wholesalers, or other persons authorized to possess prescription drugs, for return to the manufacturer or source of the prescription drug or for destruction.  An applicant wishing to obtain a Restricted Prescription Drug Distributor – Reverse Distributor permit shall file a complete application with the department on form DBPR-DDC-209, Application for Restricted Prescription Drug Distributor – Reverse Distributor permit, effective April 2018, incorporated herein by reference, http://www.flrules.org/Gateway/reference.asp?No=Ref-09283, together with the appropriate fees.  A copy of Form DBPR-DDC-209, Application for Restricted Prescription Drug Distributor-Reverse Distributor permit, 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, 499.05, 559.79 FS. Law Implemented 499.01(2)(h), 499.012,499.003(48)(6),  499.05, 559.79, FS. History‒New ­­­______.

 

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

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 19, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 26, 2016