64B16-28.303: Destruction of Controlled Substances All Permittees (excluding Nursing Homes)
PURPOSE AND EFFECT: The Board proposes the rule amendment to clarify requirements.
SUMMARY: Requirements will be clarified.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board determined the proposed rule will not have an impact on small business.
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.
SPECIFIC 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 FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253
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 legibly complete a United States Drug Enforcement Administration legible (D.E.A.) Form 41. This form, at the time of destruction, shall be witnessed and signed by the prescription department manager pharmacist of record and D.E.A. agent inspector, or a Department of Health inspector, or a Health and Rehabilitative Services 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 requires the prescription department manager pharmacist of record for the permit, one other pharmacist, a licensed physician, pharmacist, mid-level practtioner, or nurse, and a sworn law enforcement officer to serve as the witnesses. A copy of the D.EA. 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 Specific 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, ________.