The Division proposes the rule amendment to specify certain storage requirements.

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

RULE NO.:RULE TITLE:

61N-1.013Prescription Drugs; Receipt, Storage and Security

PURPOSE AND EFFECT: The Division proposes the rule amendment to specify certain storage requirements.

SUMMARY: The proposed amendment sets forth the storage requirements for entities in Florida who obtain prescription drugs obtained from non-Florida licensed sources and use said drugs for 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: 499.0121(1), 499.05 FS.

LAW IMPLEMENTED: 499.006, 499.007, 499.01, 499.0121, 499.028(6), 499.052 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-1.013 Prescription Drugs; Receipt, Storage and Security.

(1) No change.

(2) No change.

(3)(a) through (c) No change.

(d) Facility requirements for the storage and handling of prescription drugs.

1. through 2. No change.

3. 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., must be physically segregated from all other products intended for manufacturing, compounding, dispensing, or administration. In a manufacturer’s establishment, these drugs must also be stored and maintained in a separate and clearly designated area.

(4) through (7) No change.

Rulemaking Authority 499.0121(1), 499.05 FS. Law Implemented 499.004, 499.006, 499.007, 499.01, 499.0121, 499.028(6), 499.052 FS. History–New 7-8-84, Amended 1-30-85, Formerly 10D-45.535, Amended 11-26-86, 7-1-96, Formerly 10D-45.0535, Amended 1-26-99, 4-17-01, 1-1-04, 1-19-06, 11-18-07, Formerly 64F-12.013, Amended ____________.

 

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

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: July 21, 2015

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