| (B) the devices may be loaded with bulk drugs only
by a pharmacist or by pharmacy technicians or pharmacy technician
trainees under the direction and direct supervision of a pharmacist;
(C) the label of an automated counting device container
containing a bulk drug shall indicate the brand name and strength
of the drug; or if no brand name, then the generic name, strength,
and name of the manufacturer or distributor;
(D) records of loading bulk drugs into an automated
counting device shall be maintained to show:
(i) name of the drug, strength, and dosage form;
(ii) manufacturer or distributor;
(iii) manufacturer's lot number;
(iv) expiration date;
(v) date of loading;
(vi) name, initials, or electronic signature of the
person loading the automated counting device; and
(vii) name, initials, or electronic signature of the
responsible pharmacist; and
(E) the automated counting device shall not be used
until a pharmacist verifies that the system is properly loaded and
affixes his or her name, initials, or electronic signature to the
record as specified in subparagraph (D) of this paragraph.
(2) Automated pharmacy dispensing systems.
(A) Authority to use automated pharmacy dispensing
systems. A pharmacy may use an automated pharmacy dispensing system
to fill prescription drug orders provided that:
(i) the pharmacist-in-charge is responsible for the
supervision of the operation of the system;
(ii) the automated pharmacy dispensing system has been
tested by the pharmacy and found to dispense accurately. The pharmacy
shall make the results of such testing available to the board upon
request; and
(iii) the pharmacy will make the automated pharmacy
dispensing system available for inspection by the board for the purpose
of validating the accuracy of the system.
(B) Automated pharmacy dispensing systems may be stocked
or loaded by a pharmacist or by a pharmacy technician or pharmacy
technician trainee under the supervision of a pharmacist.
(C) Quality assurance program. A pharmacy which uses
an automated pharmacy dispensing system to fill prescription drug
orders shall operate according to a quality assurance program of the
automated pharmacy dispensing system which:
(i) requires continuous monitoring of the automated
pharmacy dispensing system; and
(ii) establishes mechanisms and procedures to test
the accuracy of the automated pharmacy dispensing system at least
every twelve months and whenever any upgrade or change is made to
the system and documents each such activity.
(D) Policies and procedures of operation.
(i) When an automated pharmacy dispensing system is
used to fill prescription drug orders, it shall be operated according
to written policies and procedures of operation. The policies and
procedures of operation shall:
(I) provide for a pharmacist's review, approval, and
accountability for the transmission of each original or new prescription
drug order to the automated pharmacy dispensing system before the
transmission is made;
(II) provide for access to the automated pharmacy dispensing
system for stocking and retrieval of medications which is limited
to licensed healthcare professionals or pharmacy technicians acting
under the supervision of a pharmacist;
(III) require that a pharmacist checks, verifies, and
documents that the correct medication and strength of bulk drugs,
prepackaged containers, or manufacturer's unit of use packages were
properly stocked, filled, and loaded in the automated pharmacy dispensing
system prior to initiating the fill process; alternatively, an electronic
verification system may be used for verification of manufacturer's
unit of use packages or prepacked medication previously verified by
a pharmacist;
(IV) provide for an accountability record to be maintained
that documents all transactions relative to stocking and removing
medications from the automated pharmacy dispensing system;
(V) require a prospective drug regimen review is conducted
as specified in subsection (c)(2) of this section; and
(VI) establish and make provisions for documentation
of a preventative maintenance program for the automated pharmacy dispensing
system.
(ii) A pharmacy that uses an automated pharmacy dispensing
system to fill prescription drug orders shall, at least annually,
review its written policies and procedures, revise them if necessary,
and document the review.
(E) Recovery Plan. A pharmacy that uses an automated
pharmacy dispensing system to fill prescription drug orders shall
maintain a written plan for recovery from a disaster or any other
situation which interrupts the ability of the automated pharmacy dispensing
system to provide services necessary for the operation of the pharmacy.
The written plan for recovery shall include:
(i) planning and preparation for maintaining pharmacy
services when an automated pharmacy dispensing system is experiencing
downtime;
(ii) procedures for response when an automated pharmacy
dispensing system is experiencing downtime; and
(iii) procedures for the maintenance and testing of
the written plan for recovery.
(F) Final check of prescriptions dispensed using an
automated pharmacy dispensing system. For the purpose of §291.32(c)(2)(D)
of this title (relating to Personnel), a pharmacist must perform the
final check of all prescriptions prior to delivery to the patient
to ensure that the prescription is dispensed accurately as prescribed.
(i) This final check shall be considered accomplished
if:
(I) a check of the final product is conducted by a
pharmacist after the automated pharmacy dispensing system has completed
the prescription and prior to delivery to the patient; or
(II) the following checks are conducted:
(-a-) if the automated pharmacy dispensing system contains
bulk stock drugs, a pharmacist verifies that those drugs have been
accurately stocked as specified in subparagraph (D)(i)(III) of this
paragraph;
(-b-) if the automated pharmacy dispensing system contains
manufacturer's unit of use packages or prepackaged medication previously
verified by a pharmacist, an electronic verification system has confirmed
that the medications have been accurately stocked as specified in
subparagraph (D)(i)(III) of this paragraph;
(-c-) a pharmacist checks the accuracy of the data
entry of each original or new prescription drug order entered into
the automated pharmacy dispensing system; and
(-d-) an electronic verification process is used to
verify the proper prescription label has been affixed to the correct
medication container, prepackaged medication, or manufacturer unit
of use package for the correct patient.
(ii) If the final check is accomplished as specified
in clause (i)(II) of this subparagraph, the following additional requirements
must be met:
(I) the dispensing process must be fully automated
from the time the pharmacist releases the prescription to the automated
pharmacy dispensing system until a completed, labeled prescription
ready for delivery to the patient is produced;
(II) the pharmacy has conducted initial testing and
has a continuous quality assurance program which documents that the
automated pharmacy dispensing system dispenses accurately as specified
in subparagraph (C) of this paragraph;
(III) the automated pharmacy dispensing system documents
and maintains:
(-a-) the name(s), initials, or identification code(s)
of each pharmacist responsible for the checks outlined in clause (i)(II)
of this subparagraph; and
(-b-) the name(s), initials, or identification code(s)
and specific activity(ies) of each pharmacist, pharmacy technician,
or pharmacy technician trainee who performs any other portion of the
dispensing process; and
(IV) the pharmacy establishes mechanisms and procedures
to test the accuracy of the automated pharmacy dispensing system at
least every month rather than every twelve months as specified in
subparagraph (C) of this paragraph.
(3) Automated checking device.
(A) For the purpose of §291.32(c)(2)(D) of this
title, the final check of a dispensed prescription shall be considered
accomplished using an automated checking device provided a check of
the final product is conducted by a pharmacist prior to delivery to
the patient or the following checks are performed:
(i) the drug used to fill the order is checked through
the use of an automated checking device which verifies that the drug
is labeled and packaged accurately; and
Cont'd... |
