The Division proposes to adopt and incorporate the division’s permitting application forms into rule.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.013Application for Over-the-counter Drug Manufacturer Permit

PURPOSE AND EFFECT: The Division proposes to adopt and incorporate the division’s permitting application forms into rule.

SUMMARY: The proposed rules adopt and incorporate the division’s permitting applications for several permit types.

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: 499.012(3), 499.05, 499.63, 499.701, 499.831, 499.832, 499.834 FS.

LAW IMPLEMENTED: 499.01, 499.012, 499.0121, 499.015, 499.028, 499.04, 499.041, 499.62, 499.63, 499.64, 499.66, 499.67, 499.81, 499.83, 499.831, 499.832, 499.833, 499.834, 499.84, 499.85, 499.86, 499.87, 499.88, 499.89, 499.90, 499.91, 499.92, 499.93, 499.931, 499.94 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, 1940 North Monroe Street Suite 26A, Tallahassee, Florida 32399-1047, [phone], [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-2.013 Application for Over-The-Counter Drug Manufacturer Permit

An over-the-counter drug manufacturer permit is required for any person that engages in the manufacture or repackaging of an over-the-counter drug. A person located in this state, other than a pharmacy operating in compliance with pharmacy practice standards set forth in chapter 465 and the rules promulgated thereunder, engaging in activity for which an over-the-counter drug manufacturer permit is required, must file an application on form number DBPR-DDC-205, Application for Permit as an Over-The-Counter Drug Manufacturer, effective April 2016, adopted and incorporated herein by reference and comply with all the requirements for permitting in Chapter 499, F.S. and Rule 61N, F.A.C.  This form is available upon request from the Division of Drugs, Devices and Cosmetics at 1940 N. Monroe Street, Tallahassee, Florida 32399, [phone], or at http://www.flrules.org/Gateway/reference.asp?No=Ref-06644

Rulemaking Authority 499.012(3) FS. Law Implemented 499.01, 499.012, 499.0121, 499.015, 499.04, 499.041 FS. History‒New ­­­______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Reginald D. Dixon, Director

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ken Lawson, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: March 7, 2016

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