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

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.022Application for Restricted Prescription Drug Distributor – Health Care Entity Permit

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

SUMMARY: The proposed rulemaking creates and incorporates by reference the Division of Drugs, Devices, and Cosmetics’ Application for Permit as a Restricted Prescription Drug Distributor – Health Care Entity, within the text of Proposed Rule 61N-2.022, 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, 499.041 F.S.

LAW IMPLEMENTED: 499.01, 499.012, 499.0121, 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: Stephanie Prine, Government Operations Consultant, III, 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-2.022 Application for Permit as a Restricted Prescription Drug Distributor – Health Care Entity.

A Restricted Prescription Drug Distributor – Health Care Entity Permit is required for a hospital or health care entity for the limited purpose of transferring prescription drugs among hospitals or other health care entities that are either: (1) under common control; or (2) members of a group purchasing organization; or (3) a warehouse or purchasing depot of a university to transfer prescription drugs to practitioner or non-practitioner researchers for university sponsored research conducted in accordance with Section 1004.22, F.S. An applicant wishing to obtain a Restricted Prescription Drug Distributor – Health Care Entity Permit shall submit a complete application to the department on Form DBPR-DDC-207, Application for Permit as a Restricted Prescription Drug Distributor – Health Care Entity, effective September 2019, incorporated herein by reference, http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX, together with the appropriate fees. A copy of Form DBPR-DDC-207, Application for Permit as a Restricted Prescription Drug Distributor – Health Care Entity, 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, 499.041 F.S. Law Implemented 499.01, 499.012, 499.0121, 499.041, 499.05, 559.79 F.S. History‒New__________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Walter Copeland, Division Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Halsey Beshears, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 9, 2019

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