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

Effective on Sunday, April 20, 2014
  • 1(1) Controlled substances that cannot be retained as usable shall be securely stored in the pharmacy/prescription department of the permittee pharmacy until destroyed.

    24(2) Permittees are required to complete a United States Drug Enforcement Administration (D.E.A.) Form DEA-41 “Registrants Inventory of Drugs Surrendered” (effective 8/31/2014), herein incorporated by reference, available at 52http://www.flrules.org/Gateway/reference.asp?No=Ref-03998 54or http://www.deadiversion.usdoj.gov/5621cfr_reports57/surrend/. This form, at the time of destruction, shall be witnessed and signed by the prescription department manager 75or the consultant pharmacist of record 81and 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.

    121(3) Another method of destruction 126shall be conducted by at least two persons: 134One 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.

    221(4) In lieu of destruction on the premises as outlined in subsections (2) and (3) above, controlled substances may also be shipped to reverse distributors for destruction in conformity with federal guidelines.

    253(5) For patient specific controlled substance prescriptions in a Modified Institutional Class II B pharmacy, the destruction method in subsection 27364B16-28.301(2), 274F.A.C., must be followed.

    278Rulemaking Authority 280465.005, 281465.022 FS. 283Law Implemented 285465.022, 286465.018 FS. 288History–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.


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