The Board proposes the rule amendment to update language regarding maintaining and destruction of records and to incorporate revised form DEA-41.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-28.303Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing Homes)

PURPOSE AND EFFECT: The Board proposes the rule amendment to update language regarding maintaining and destruction of records and to incorporate revised form DEA-41.

SUMMARY: Language regarding maintaining and destruction of records will be updated and revised form DEA-41 will be incorporated in the rule.

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 Committee meetings and Board meetings, 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, 465.018 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: Jessica Sapp, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-28.303 Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing Homes).

(1) No change.

(2) Permittees are required to complete a United States Drug Enforcement Administration (D.E.A.) Form DEA-41 “Registrants Record of Controlled Substances Destroyed Inventory of Drugs Surrendered” (Expiration Date 01/31/2024 effective 8/31/2014), herein incorporated by reference, available at http://www.flrules.org/Gateway/reference.asp?No=Ref- 03998 or http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/. This form, at the time of destruction, shall be witnessed and signed by the prescription department manager or the consultant pharmacist of record and D.E.A. agent, or a Department inspector. This method of destruction requires that a copy of the completed and witnessed Form DEA 41 be mailed to the D.E.A. office in his/her area within one (1) business day after the destruction.

(3) Another method of destruction shall be conducted by at least two persons: One will be the prescription department manager or the consultant pharmacist of record. The other will be one of the following: medical director or his/her physician designee, director of nursing or his/her licensed nurse designee, or a sworn law enforcement officer. These persons shall serve as the witnesses for the Form DEA-41 and the destruction. This method of destruction requires that a copy of the completed and witnessed Form DEA-41 be mailed to the D.E.A. office in the permittee’s area within one (1) business day after destruction.

(4) through (5) No change.

(6) All records shall be maintained as required by section 465.022, F.S.

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.018 FS. History–New 4-21-87, Formerly 21S-19.003, Amended 7-31-91, Formerly 21S-28.303, 61F10-28.303, Amended 1-30-96, Formerly 59X-28.303, Amended 2-5-07, 10-27-09, 2-1-12, 4-20-14,                   .

 

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 20, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 11, 2023