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 ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.017Certificates of Free Sale

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, 499.015 FS.

LAW IMPLEMENTED: 499.015, 499.04, 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-1.017 Certificates of Free Sale.

(1) A written request for a certificate of free sale must be submitted to the department by the Florida permitted manufacturer of the drug or cosmetic indicating the name and address of the company to be designated on the free sale certificate as the distributor or manufacturer or both; the name, address, and product registration number of the company who has registered the product; the specific name of the product(s) to be included in the certificate; the product label if a current label is not on file with the department; and the appropriate fee as provided in Rule 61N-1.018, F.A.C.

(2) A maximum of 30 product names can be included on one certificate of free sale.

Rulemaking Authority 499.05, 499.015 FS. Law Implemented 499.015, 499.04, 499.05 FS. History–New 7-1-96, Formerly 10D-45.0543, Amended 4-17-01, Formerly 64F-12.017,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