Current through Register Vol. 49, No. 6, March 15, 2024
PURPOSE: This rule establishes standards for
automated filling systems.
(1) Definitions. The following definitions
shall be applicable for purposes of this rule:
(A) "Automated filling system"-An automated
system used by 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 governed by
20 CSR
2220-2.800, or automated dispensing and storage
systems governed by
20 CSR
2220-2.900 used to dispense medication directly to a
patient or to an authorized health care practitioner for immediate distribution
or administration to the patient;
(B) "Electronic verification system"-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 dispensed and labeled by, or
loaded into, an automated filling system;
(C) "Manufacturer unit of use package"- A
drug dispensed in the manufacturer's original and sealed packaging, or in the
original and sealed packaging of a repackager, without additional manipulation
or preparation by the pharmacy, except for application of the pharmacy
label;
(D) "Repackager"-A
repackager registered with the United States Food and Drug Administration;
and
(E) "Repacked"-Any drug that
has been removed from the original packaging of the manufacturer or a
repackager's packaging and is placed in a container for use in an automated
filling system.
(2)
Medication Stocking. Automated filling systems (hereinafter "system") may be
stocked or loaded by a pharmacist or by an intern pharmacist or pharmacy
technician under the direct supervision of a pharmacist. Pharmacy repacked
medication, cartridges, or containers shall comply with
20 CSR
2220-2.130.
(3) Verification. Except as provided herein,
a licensed pharmacist shall inspect and verify the accuracy of the final
contents of any medication filled or packaged by an automated filling system,
and any label affixed thereto, prior to dispensing, as required by
20 CSR
2220-2.010(1)(B).
(4) The pharmacist verification requirements
of section (3) shall be deemed satisfied if-
(A) The pharmacy establishes and follows a
policy and procedure manual that complies with section (5) of this
rule;
(B) The filling process is
fully automated from the time the filling process is initiated until a
completed, labeled, and sealed prescription is produced by the automated
filling system that is ready for dispensing to the patient. No manual
intervention with the medication or prescription may occur after the medication
is loaded into the automated filling system. For purposes of this section,
manual intervention shall not include preparing a finished prescription for
mailing, delivery, or storage;
(C)
A pharmacist verifies the accuracy of the prescription information used by or
entered into the automatic filling system for a specific patient prior to
initiation of the automatic fill process. The name, initials, or identification
code(s) of the verifying pharmacist shall be recorded in the pharmacy's records
and maintained for five (5) years after dispensing;
(D) A pharmacist verifies the correct
medication, repacked container, or manufacturer unit of use package was
properly stocked, filled, and loaded in the automated filling system prior to
initiating the fill process. Alternatively, an electronic verification system
may be used for verification of manufacturer unit of use packages or repacked
medication previously verified by a pharmacist;
(E) The medication to be dispensed is filled,
labeled, and sealed in the prescription container by the automated filling
system or dispensed by the system in a manufacturer's unit of use package or a
repacked pharmacy container;
(F) An
electronic verification system is used to verify the proper prescription label
has been affixed to the correct medication, repackaged container, or
manufacturer unit of use package for the correct patient; and
(G) Daily random quality testing is conducted
by a pharmacist on a sample size of prescriptions filled by the automated
filling system. The required sample size shall not be less than two percent
(2%) of the prescriptions filled by the automated system on the date tested or
two percent (2%) of the prescriptions filled by the automated system on the
last day of system operation, as designated in writing by the
pharmacist-in-charge. Proof of compliance with this subsection and random
quality testing date(s) and results shall be documented and maintained in the
pharmacy's records.
(5)
Policies and Procedures. Pharmacies verifying prescriptions pursuant to section
(4) 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 pharmacist-in-charge and shall be
maintained in the pharmacy's records for a minimum of two (2) 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 automated filling system and any accompanying electronic verification
system in good working order;
(B)
Ensuring accurate filling, loading, and stocking of the system;
(C) Ensuring sanitary operations of the
system and preventing cross-contamination of cells, cartridges, containers,
cassettes, or packages;
(D)
Reporting, investigating, and addressing filling errors and system
malfunctions;
(E) Testing the
accuracy of the automated filling system and any accompanying electronic
verification system. At a minimum, the automated filling system and electronic
verification system shall be tested before the first use of the system or
restarting the system and upon any modification to the automated filling system
or electronic verification system that changes or alters the filling or
electronic verification process;
(F) Training persons authorized to access,
stock, restock, or load the automated filling system in equipment use and
operations;
(G) Tracking and
documenting prescription errors related to the automated filling system that
are not corrected prior to dispensing to the patient. Such documentation shall
be maintained for two (2) years and produced to the board upon
request;
(H) Conducting routine and
preventive maintenance and, if applicable, calibration;
(I) Removing expired, adulterated,
misbranded, or recalled drugs;
(J)
Preventing unauthorized access to the system, including, assigning,
discontinuing, or changing security access;
(K) Identifying and recording persons
responsible for stocking, loading, and filling the system;
(L) Ensuring compliance with state and
federal law, including, all applicable labeling, storage, and security
requirements; and
(M) Maintaining
an ongoing quality assurance program that monitors performance of the automatic
fill system and any electronic verification system to ensure proper and
accurate functioning.
(6) 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 two (2) years.
When the verification requirements of subsection (4)(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 five (5) years after dispensing. Records shall be made available for
inspection and produced to the board or the board's authorized designee upon
request.
*Original authority: 338.140, RSMo 1939, amended 1989,
1997, 2011; 338.210, RSMo 1951, amended 2001, 2011 ; 338.250, RSMo 1951,
amended 1990, 1998; and 338.280, RSMo 1951, amended 1971,
1981.
