To create a new rule to provide language and incorporate by reference, the Application for Permit as a Limited Prescription Drug Veterinary Wholesale Distributor.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.007Application for Limited Prescription Drug Veterinary Wholesale Distributor Permit

PURPOSE AND EFFECT: To create a new rule to provide language and incorporate by reference, the Application for Permit as a Limited Prescription Drug Veterinary Wholesale Distributor.

SUMMARY: The proposed rulemaking creates and incorporates by reference the Division of Drugs, Devices, and Cosmetics’ Application for Permit as a Limited Prescription Drug Veterinary Wholesale Distributor, within the text of Proposed Rule 61N-2.007, 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, 499.041(2)(g), 499.05, 559.79, F.S.

LAW IMPLEMENTED: 499.01(2)(m), 499.012, 499.0121, 499.04(2)(g), 499.05, 499.051, 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: 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-2.007 Application for Limited Prescription Drug Veterinary Wholesale Distributor Permit.

A Limited Prescription Drug Veterinary Wholesale Distributor Permit is required for any person that engages in the distribution in or into this state of veterinary prescription drugs and prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act, and under the conditions set forth in Section 499.01(2)(m)1-8, F.S., unless such person is engaging in the activities of and permitted as a prescription drug manufacturer, nonresident prescription drug manufacturer, prescription drug wholesale distributor, or out-of-state prescription drug wholesale distributor. Applicants wishing to obtain a Limited Prescription Drug Veterinary Wholesale Distributor Permit shall submit a complete application to the Department on form DBPR-DDC-219, Application for Permit as a Limited Prescription Drug Veterinary Wholesale Distributor, effective November 2019, incorporated herein by reference, https://www.flrules.org/gateway/reference.asp?no=Ref-XXXXX, together with the appropriate fees. A copy of Form DBPR-DDC-219, Application for Permit as a Limited Prescription Drug Veterinary Wholesale Distributor, 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, 499.041(2)(g), 499.05,  559.79 F.S. Law Implemented 499.01(2)(m), 499.012, 499.0121, 499.04(2)(g),  499.05, 499.051,  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 29, 2019

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