To adopt and incorporate necessary changes to Division rules reflecting the removal of the Division’s authority to require registration and issue certificates of free sale for cosmetic products manufactured in Florida as amended by Ch. 2017-051, ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-2.002Application for Cosmetic Manufacturer Permit

PURPOSE AND EFFECT: To adopt and incorporate necessary changes to Division rules reflecting the removal of the Division’s authority to require registration and issue certificates of free sale for cosmetic products manufactured in Florida as amended by Ch. 2017-051, Laws of Florida (2017).

SUMMARY: Division’s authority to require registration and issue certificates of free sale for cosmetic products manufactured in Florida.

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: 499.05, 499.012 FS.

LAW IMPLEMENTED: 499.002, 499.003, 499.01, 499.012, 499.015, 499.05 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; 850-717-1802; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-2.002 Application for Cosmetic Manufacturer Permit.

A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit. A person located in this state, prior to engaging in activity for which a cosmetic manufacturer permit is required, must file with the department a completed application on form number DBPR-DDC-206, Application for Permit as a Cosmetic Manufacturer, effective July 2017, April 2016, adopted and incorporated herein by reference and comply with all the requirements for permitting in Chapter 499, F.S., and Title 61N, F.A.C. This form is available upon request from the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047, [phone], or at http://www.flrules.org/Gateway/reference.asp?No=Ref-06904.

Rulemaking Authority 499.012(3), 499.041(1)(c) FS. Law Implemented 499.01, 499.012, 499.0121, 499.015, 499.04, 499.041, 499.005(6), 499.0051(13), 499.051(1), 559.79 FS. History‒New 6-9-16,Amended              .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Drew F. Winters, Director

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 26, 2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: July 18, 2017