Current through Reg. 50, No. 187; September 24, 2024
(1) Definitions. The following definitions
shall be applicable for purposes of this rule:
(a) "Automated filling system" means an
automated system used within a pharmacy to assist in filling a prescription
drug order by selecting, labeling, filling, or sealing medication for
dispensing. An "automated filling system" shall not include automated devices
used solely to count medication, vacuum tube drug delivery systems, or systems
governed by Rule 64B16-28.606 or
64B16-28.607, F.A.C.
(b) "Electronic verification process" means
an electronic verification, bar code verification, weight verification, radio
frequency identification (RFID), or similar electronic process or system that
accurately verifies medication has been properly prepared for dispensing by an
automated filling system.
(c)
"Manufacturer Unit of Use Package" means a drug dispensed in the manufacturer's
original and sealed packaging, or in the original and sealed packaging of a
repackager.
(d) "Repackager" means
a repackager registered with the United States Food and Drug Administration
(FDA), as defined by Section
499.003(50),
F.S.
(e) "Prepacked" means any drug
that has been removed from the original packaging of the manufacturer or an FDA
Repackager and is placed in a container for use in an automated filling system,
as referenced by Section
499.003(42),
F.S.
(f) "System drug identifier
database" means the database or other system which positively identifies the
drug to be dispensed by the automated filling system.
(2) The system drug identifier database shall
be maintained by a pharmacist and shall not be delegated.
(3) Medication Stocking. Automated filling
systems (hereinafter "system") may be stocked or restocked by a pharmacist,
pharmacy intern, or registered pharmacy technician under the supervision of a
pharmacist, as each are defined by subsection
64B16-27.1001(7),
F.A.C.
(4) Verification. Except as
provided herein, a licensed pharmacist must verify the accuracy of the final
contents of any medication filled or packaged by a system, and any label
affixed thereto, prior to dispensing, as defined by subsection
64B16-27.1001(3),
F.A.C.
(5) The pharmacist
verification requirements of subsection (4), shall be deemed satisfied if:
(a) The pharmacy establishes and follows a
policy and procedure manual that complies with subsection (6), of this
rule;
(b) The system is fully
automated from the time the medication is stocked into the machine until a
completed, labeled and sealed prescription is produced by the system that is
ready for dispensing to the patient. No manual intervention with the medication
may occur after the medication is stocked into the system. For purposes of this
section, manual intervention shall not include preparing a finished
prescription for mailing, delivery, or storage;
(c) A pharmacist must perform a prospective
drug review and verify the accuracy of the prescription information used by or
entered into the system for a specific patient prior to initiation of the
automatic fill process. The name, initials or identification codes(s) of the
verifying pharmacist shall be recorded in the pharmacy's records and maintained
for four (4) years after dispensing, or longer if required by applicable
law;
(d) All medication Prepacked
by the pharmacy must be verified by a pharmacist pursuant to subsection
64B16-27.1001(3),
F.A.C.
(e) A pharmacist verifies
the correct medication, either the Manufacturer Unit of Use Package, Repacked,
or Prepacked container, was properly filled and stocked in the system.
Alternatively, an electronic verification process may be used to verify a
Manufacturer Unit of Use Package, repackaged, or prepacked
containers;
(f) The medication to
be dispensed is selected, filled, labeled, or sealed in the prescription
container by the system or dispensed by the system in a Manufacturer's Unit of
Use Package, repacked, or prepacked container;
(g) An electronic verification process is
used to verify the proper prescription label has been affixed to the correct
medication, prepackaged medication or Manufacturer Unit of Use Package for the
correct patient; and,
(h) An audit
trail is maintained for the prescription from the beginning of the system to
the dispensing from the system, and maintain for four (4)
years.
(6) The pharmacist
verification requirements of subsection (4), shall be deemed satisfied for a
system that is not fully automated when all or part of the system is used for
Manufacturer Unit of Use Packages if:
(a) The
system utilizes an Electronic Verification Process to verify that the correct
drug matches the correct prescription label;
(b) The Electronic Verification Process
activities are undertaken by a pharmacist, pharmacy intern, or registered
pharmacy technician under the supervision of a pharmacist, as each are defined
by subsection 64B16-27.1001(7),
F.A.C., and consistent with Section
64B16-27.4001, F.A.C.;
and,
(c) An audit trail is
maintained for the prescription from the beginning of the system to the
dispensing from the system, and maintained for four (4)
years.
(7) Policies and
Procedures. Pharmacies verifying prescriptions pursuant to subsection (5) or
(6), of this rule, shall establish and follow written policies and procedures
to ensure the proper, safe, and secure functioning of the system. Policies and
procedures shall be reviewed annually by the prescription department manager or
consultant pharmacist of record and shall be maintained in the pharmacy's
records for a minimum of four (4) years. The required annual review shall be
documented in the pharmacy's records and made available upon request. At a
minimum, the pharmacy shall establish and follow policies and procedures for:
(a) Maintaining the system and any
accompanying electronic verification process in good working order;
(b) Ensuring the integrity of the system drug
identifier database and identification of persons responsible for database
entries;
(c) Ensuring accurate
filling, stocking, and verification of the system, as applicable;
(d) Ensuring sanitary operations of the
system and preventing cross-contamination of cells, cartridges, containers,
cassettes, or packages;
(e) Testing
the accuracy of the system and any accompanying electronic verification
process. At a minimum, the system and electronic verification process shall be
tested before the first use of the system or restarting the system and upon any
modification to the system or electronic verification process that changes or
alters the filling or electronic verification process;
(f) Training persons authorized to access,
stock, restock, or utilize the system in equipment use and operations, as
applicable;
(g) Conducting routine
and preventive maintenance and, if applicable, calibration;
(h) Removing expired, adulterated, misbranded
or recalled drugs;
(i) Preventing
unauthorized access to the system, including assigning, discontinuing or
changing security access;
(j)
Identifying and recording persons responsible for stocking, and filling the
system;
(k) Ensuring compliance
with state and federal law, including, all applicable labeling, storage, and
security requirements;
(l)
Maintaining an ongoing quality assurance program that monitors performance of
the system and any electronic verification process to ensure proper and
accurate functioning, including tracking and documenting of automated filling
system errors that are not corrected prior to dispensing to the patient. Such
documentation shall be maintained for four (4) years and produced to the Board
upon request.
(8)
Recordkeeping. Except as otherwise provided herein, records required by this
rule shall be maintained in the pharmacy's records electronically or in writing
for a minimum of four (4) years, or longer if required under applicable law. If
the verification requirements of paragraph (5)(d), of this rule, are completed
by a pharmacist, the name, initials or identification code(s) of the verifying
pharmacist shall be recorded in the pharmacy's records and maintained for four
(4) years after dispensing. Records shall be made available for inspection and
produced to the Board or the Board's authorized designee upon
request.
Rulemaking Authority 465.005, 465.0155, 465.022(1) FS. Law
Implemented 465.003(17), 465.0155, 465.022(1)
FS.
New 3-24-14, Amended
11-5-17.
