Fla. Admin. Code Ann. R. 64B16-28.303 - Destruction of Controlled Substances All Permittees (Excluding Institutional Class I 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 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 Section
465.022,
F.S.
Notes
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.018 FS.
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.
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