The Board proposes the rule amendment to update the proper procedures for outdated pharmaceuticals.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.110Outdated Pharmaceuticals

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the proper procedures for outdated pharmaceuticals.

SUMMARY: The proper procedures for outdated pharmaceuticals will be updated.

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.

During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

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: 465.005, 465.022 FS.

LAW IMPLEMENTED: 465.022 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: Jennifer Wenhold, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.110 Outdated Pharmaceuticals.

Under no circumstances may prescription drugs, pharmaceuticals or devices which bear upon the container an expiration or beyond use date which has been reached be sold or dispensed to the public. Accordingly, Persons qualified to do so shall examine the stock of the prescription department of each pharmacy at a minimum interval of four months, and shall remove all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs and pharmaceuticals shall be removed or quarantined from active stock. , or pharmaceuticals which bear upon the container an expiration date which date has been reached, and under no circumstances will pharmaceuticals or devices which bear upon the container an expiration date which has been reached be sold or dispensed to the public.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.023(1)(c), 499.006(9), 499.0121(5) FS. History–New 5-19-72, Repromulgated 12-18-74, Formerly 21S-1.17, 21S-1.017, 21S-28.110, 61F10-28.110, 59X-28.110, Amended, ____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 12, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 14, 2019