The Board proposes the rule amendment to provide an easier method for destruction of controlled substances.

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO.: RULE TITLE:
64B16-28.303: Destruction of Controlled Substances All Permittees (excluding Nursing Homes)

PURPOSE AND EFFECT: The Board proposes the rule amendment to provide an easier method for destruction of controlled substances.

SUMMARY: New language will provide for an easier method for destruction of controlled substances.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST AND LEGISLATIVE RATIFICATION:

During discussion of the economic impact of the rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Cost (SERC) was not necessary and that the rule amendment will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time. The Board has determined that this rule will not have an adverse impact on small business, or likely increase regulatory costs in excess of $200,000 in the aggregate within 1 year after implementation of the rule. Any person who wishes to provide information regarding the statement of estimated costs, or to provide a proposal for a lower regulatory cost 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 FAW.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Mark Whitten, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64B16-28.303 Destruction of Controlled Substances All Permittees (excluding Nursing Homes).

(1) No change.

(2) Permittees are required to complete a United States Drug Enforcement Administration (D.E.A.) Form 41. 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 does not require prior approval from D.E.A., but does require that a copy of the completed and witnessed D.E.A. Form 41 be mailed to D.E.A. immediately after destruction.

(3) Another method of destruction shall be conducted by at least two persons who are either a licensed pharmacist, physician or nurse, or requires the prescription department manager for the permit, one other pharmacist, and a sworn law enforcement officer or any combination thereof, to serve as the witnesses. A copy of the completed D.E.A. Form 41 and a letter providing the proposed date of destruction, the proposed method of destruction and the names and titles of the proposed witnesses must be received by D.E.A. at least two weeks prior to the proposed date of destruction which shall constitute a request for destruction. The drugs may not be destroyed until D.E.A. grants approval of the request for destruction. A copy of the completed and witnessed D.E.A. Form 41 shall be mailed to D.E.A. immediately after destruction.

(4) No change.

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, _________.

 

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: February 8, 2011

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: September 30, 2011