Florida Regulations 64B16-28.303: Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing Homes)
Current as of: 2024 | Check for updates
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(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 DEA-41 “”Registrant Record of Controlled Substances Destroyed”” (Expiration Date 01/31/2024), herein incorporated by reference, available at http://www.flrules.org/Gateway/reference.asp?No=Ref-15213 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.
(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.
(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.
(5) For patient specific controlled substance prescriptions in a Modified Institutional Class II B pharmacy, the destruction method in subsection 64B16-28.301(2), F.A.C., must be followed.
(6) All records shall be maintained as required by Florida Statutes § 465.022
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, 3-20-23.
(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.
(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.
(5) For patient specific controlled substance prescriptions in a Modified Institutional Class II B pharmacy, the destruction method in subsection 64B16-28.301(2), F.A.C., must be followed.
(6) All records shall be maintained as required by Florida Statutes § 465.022
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, 3-20-23.