The Division proposes the rule amendment to specify record keeping requirements.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.012Records of Drugs, Cosmetics and Devices

PURPOSE AND EFFECT: The Division proposes the rule amendment to specify record keeping requirements.

SUMMARY: The proposed amendment sets forth the records which must be created and maintained by entities in Florida engaging in the possession of limited quantities of prescription drugs, obtained from non-Florida licensed sources, for the purpose of research and development.

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, 499.0121 FS.

LAW IMPLEMENTED: 499.01, 499.012, 499.0121, 499.01212, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.066, 499.067 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-1.012 Records of Drugs, Cosmetics and Devices.

(1) through (16) No change.

(17) For purposes of prescription drugs obtained in “limited quantities” for research and development (“R&D”) purposes under Section 499.01(3) and (4)(b), F.S. and Rule 61N-1.001(2)(n), F.A.C., the records required pursuant to Section 499.0121(6), F.S., must identify the R&D requirements, acquisition schedule and use of each drug acquired relative to anticipated and ongoing R&D activities. These records must be created in advance of or within 30 calendar days of the particular R&D activities, and are subject to inspection under 499.051, F.S. Non-clinical/pre-clinical R&D quantities must be updated annually, and clinical quantities must be updated semiannually. The researcher must maintain all other records required under Chapter 499, including, without limitations, Section 499.01(3) or (4)(b), and applicable federal laws.

Rulemaking Authority 499.003, 499.01(2)(g), 499.05, 499.0121 FS. Law Implemented 499.01, 499.003, 499.012, 499.0121, 499.01212, 499.028, 499.04, 499.041, 499.05, 499.051, 499.052, 499.06, 499.063, 499.064, 499.066, 499.067 FS. History–New 1-1-77, Amended 12-12-82, 7-8-84, 1-30-85, Formerly 10D-45.53, Amended 11-26-86, 2-4-93, 7-1-96, Formerly 10D-45.053, Amended 1-26-99, 4-17-01, 10-7-03, 1-1-04, 6-15-04, 8-2-04, 1-19-06, 8-6-06, Formerly 64F-12.012, Amended 3-4-13, Amended ___________.

 

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: July 31, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 17, 2013