The board proposes the rule amendment to update and clarify the procedure for the destruction of controlled substances by Institutional Class I Pharmacies (nursing homes) and to amend the rule title.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.301Destruction of Controlled Substances - Institutional Pharmacies

PURPOSE AND EFFECT: The board proposes the rule amendment to update and clarify the procedure for the destruction of controlled substances by Institutional Class I Pharmacies (nursing homes) and to amend the rule title.

SUMMARY: The proposed rule amendments are necessary to amend the rule title and to update and clarify the procedure for the destruction of controlled substances by Institutional Class I Pharmacies (nursing homes).

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: 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, 465.019 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: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.301 Destruction of Controlled Substances – Institutional Class I Pharmacies (nursing homes).

(1) No change.

(2) A document must be completed showing the name and quantity of the drug, strength and dosage form, patient’s name, prescription number and name of the institution. This documentation, at the time of destruction, shall be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his/her designee, which may include a licensed physician, pharmacists, mid-level practitioner, or nurse, another pharmacist, or a sworn law enforcement officer.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.019, 465.0155 FS. History–New 4-21-87, Formerly 21S-19.001, Amended 7-31-91, Formerly 21S-28.301, 61F10-28.301, Amended 1-30-96, Formerly 59X-28.301, Amended 7-21-09,_________.

 

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: October 9, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 21, 2013