The board proposes the rule amendment to change the destruction of controlled substances process making it easier to properly dispose of such substances while ensuring that one of the persons signing for the destruction always is either the ...

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

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

PURPOSE AND EFFECT: The board proposes the rule amendment to change the destruction of controlled substances process making it easier to properly dispose of such substances while ensuring that one of the persons signing for the destruction always is either the prescription department manager or the consultant pharmacist of record, and that a copy of destruction records is timely sent to the DEA.

SUMMARY: The proposed rule amendments are necessary to amend the destruction of controlled substances procedure for Class II institutional pharmacies, requiring one of the two signatures to be the prescription department manager or the consultant pharmacist of record, and to clarify that a copy of the destruction documents be mailed to the DEA within one business day.

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, 465.018 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: Tammy Collins, Acting Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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

(1) Controlled substances that cannot be retained as usable shall be securely stored in the pharmacy/prescription department of the permittee pharmacy until destroyed.

(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 requires 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 the D.E.A. office in his/her area within one (1) business day after the destruction D.E.A. immediately after 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 D.E.A Form 41 and the destruction. This method of destruction requires that a copy of the completed and witnessed D.E.A. Form 41 be mailed to the D.E.A.office in the permittee’s area within one (1) business day after destruction who are either a licensed pharmacist, physician or nurse, or 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) In lieu of destruction on the premises as outlined in (2) and (3) above, controlled substances may also be shipped to reverse distributors for destruction in conformity with federal guidelines.

(5) For patient specific controlled substance prescriptions in a Modified Institutional Class II B, please refer to the language in subsection 64B16-28.301(2), F.A.C.

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,___________.

 

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 4, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: January 16, 2014