The purpose of the proposed rule is to update material incorporated by reference in the rule.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.006Drugs and Devices; Labeling Requirements

PURPOSE AND EFFECT: The purpose of the proposed rule is to update material incorporated by reference in the rule.

SUMMARY: The subject area to be addressed in this rule is the adoption and incorporation by reference of federal labeling requirements for prescription drugs and devices.

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, 499.05 FS.

LAW IMPLEMENTED: 499.007 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: Janetta Sampson Operations and Management Consultant Manager, Department of Business and Professional Regulation, 2601 Blair Stone Road, Tallahassee, Florida 32399-1047; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

61N-1.006 Drugs and Devices; Labeling Requirements.

(1) The department adopts and incorporates by reference the labeling requirements for prescription drugs and over-the-counter drugs as set forth in the federal act at 21 U.S.C. ss. 301 et seq. and in Title 21 Code of Federal Regulations Parts 1-1299 (as of 2/10/21 10/1/03).

(a) through (c) No change.

(2) The department adopts and incorporates by reference the labeling requirements for medical devices as set forth in the federal act at 21 U.S.C. ss. 301 et seq. and in Title 21 Code of Federal Regulations Parts 800- 898 895 (as of 4/26/2110/1/03), incorporated by reference in paragraph (1) of this rule.

Rulemaking Authority 499.01, 499.05 FS. Law Implemented 499.01, 499.007 FS. History–New 1-1-77, Amended 12-12-82, 7-8-84, Formerly 10D-45.39, Amended 11-26-86, 7-1-96, Formerly 10D-45.039, Amended 1-26-99, 4-17-01, 1-1-04, Formerly 64F-12.006, Amended _____.

 

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

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Julie I. Brown, Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: May 24, 2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: March 11, 2021