| (VII) establish and make provisions for documentation
of a preventative maintenance program for the automated medication
supply system.
(ii) A pharmacy which uses an automated medication
supply system to fill medication orders shall, at least annually,
review its written policies and procedures, revise them if necessary,
and document the review.
(D) Automated medication supply systems used for storage
and recordkeeping of medications located outside of the pharmacy department
(e.g., Pyxis). A pharmacy technician or pharmacy technician trainee
may restock an automated medication supply system located outside
of the pharmacy department with prescription drugs provided:
(i) prior to distribution of the prescription drugs
a pharmacist verifies that the prescription drugs pulled to stock
the automated supply system match the list of prescription drugs generated
by the automated medication supply system except as specified in §291.73(e)(2)(C)(ii)
of this title; or
(ii) all of the following occur:
(I) the prescription drugs to restock the system are
labeled and verified with a machine readable product identifier, such
as a barcode;
(II) either:
(-a-) the drugs are in tamper evident product packaging,
packaged by an FDA registered repackager or manufacturer, that is
shipped to the pharmacy; or
(-b-) if any manipulation of the product occurs in
the pharmacy prior to restocking, such as repackaging or extemporaneous
compounding, the product must be checked by a pharmacist; and
(III) quality assurance audits are conducted according
to established policies and procedures to ensure accuracy of the process.
(E) Recovery Plan. A pharmacy which uses an automated
medication supply system to store or distribute medications for administration
pursuant to medication orders shall maintain a written plan for recovery
from a disaster or any other situation which interrupts the ability
of the automated medication supply 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 medication supply system is experiencing
downtime;
(ii) procedures for response when an automated medication
supply system is experiencing downtime;
(iii) procedures for the maintenance and testing of
the written plan for recovery; and
(iv) procedures for notification of the Board and other
appropriate agencies whenever an automated medication supply system
experiences downtime for more than two days of operation or a period
of time which significantly limits the pharmacy's ability to provide
pharmacy services.
(3) Verification of medication orders prepared by the
pharmacy department through the use of an automated medication supply
system. A pharmacist must check drugs prepared pursuant to medication
orders to ensure that the drug is prepared for distribution accurately
as prescribed. This paragraph does not apply to automated medication
supply systems used for storage and recordkeeping of medications located
outside of the pharmacy department.
(A) This check shall be considered accomplished if:
(i) a check of the final product is conducted by a
pharmacist after the automated system has completed preparation of
the medication order and prior to delivery to the patient; or
(ii) the following checks are conducted by a pharmacist:
(I) if the automated medication supply system contains
unlabeled stock drugs, a pharmacist verifies that those drugs have
been accurately stocked; and
(II) a pharmacist checks the accuracy of the data entry
of each original or new medication order entered into the automated
medication supply system before the order is filled.
(B) If the final check is accomplished as specified
in subparagraph (A)(ii) of this paragraph, the following additional
requirements must be met.
(i) The medication order preparation process must be
fully automated from the time the pharmacist releases the medication
order to the automated system until a completed medication order,
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 medication supply system dispenses accurately as specified
in paragraph (2)(A) and (B) of this subsection.
(iii) The automated medication supply system documents
and maintains:
(I) the name(s), initials, or identification code(s)
of each pharmacist responsible for the checks outlined in subparagraph
(A)(ii) of this paragraph; and
(II) the name(s), initials, or identification code(s)
and specific activity(ies) of each pharmacist or pharmacy technician
or pharmacy technician trainee who performs any other portion of the
medication order preparation process.
(iv) The pharmacy establishes mechanisms and procedures
to test the accuracy of the automated medication supply system at
least every month rather than every six months as specified in paragraph
(2)(B) of this subsection.
(4) Automated checking device.
(A) For the purpose of this subsection, an automated
checking device is a fully automated device which confirms, after
a drug is prepared for distribution but prior to delivery to the patient,
that the correct drug and strength has been labeled with the correct
label for the correct patient.
(B) The final check of a drug prepared pursuant to
a medication order shall be considered accomplished using an automated
checking device provided:
(i) a check of the final product is conducted by a
pharmacist prior to delivery to the patient or the following checks
are performed by a pharmacist:
(I) the prepackaged drug used to fill the order is
checked by a pharmacist who verifies that the drug is labeled and
packaged accurately; and
(II) a pharmacist checks the accuracy of each original
or new medication order.
(ii) the medication order is prepared, labeled, and
made ready for delivery to the patient in compliance with Class C
(Institutional) pharmacy rules; and
(iii) prior to delivery to the patient:
(I) the automated checking device confirms that the
correct drug and strength has been labeled with the correct label
for the correct patient; and
(II) a pharmacist performs all other duties required
to ensure that the medication order has been prepared safely and accurately
as prescribed.
(C) If the final check is accomplished as specified
in subparagraph (B) of this paragraph, the following additional requirements
must be met.
(i) The pharmacy has conducted initial testing of the
automated checking device and has a continuous quality assurance program
which documents that the automated checking device accurately confirms
that the correct drug and strength has been labeled with the correct
label for the correct patient.
(ii) The pharmacy documents and maintains:
(I) the name(s), initials, or identification code(s)
of each pharmacist responsible for the checks outlined in subparagraph
(B)(i) of this paragraph; and
(II) 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
medication order preparation process.
(iii) The pharmacy establishes mechanisms and procedures
to test the accuracy of the automated checking device at least monthly.
|
| Source Note: The provisions of this §291.74 adopted to be effective April 23, 1982, 7 TexReg 1469; amended to be effective November 5, 1982, 7 TexReg 3839; amended to be effective August 30, 1984, 9 TexReg 4450; amended to be effective December 18, 1985, 10 TexReg 4694; amended to be effective July 29, 1987, 12 TexReg 2338; amended to be effective September 14, 1988, 13 TexReg 4318; amended to be effective October 27, 1989, 14 TexReg 5494; amended to be effective September 5, 1990, 15 TexReg 4810; amended to be effective September 27, 1991, 16 TexReg 5071; amended to be effective September 30, 1993, 18 TexReg 6460; amended to be effective March 16, 1995, 20 TexReg 1543;amended to be effective March 21, 1996, 21 TexReg 2242; amended to be effective June 4, 2000, 25 TexReg 4816; amended to be effective August 31, 2000, 25 TexReg 8406; amended to be effective December 27, 2000, 25 TexReg 12728; amended to be effective June 20, 2001, 26 TexReg 4512; amended to be effective December 19, 2001, 26 TexReg 10311; amended to be effective December 15, 2002, 27 TexReg 11541; amended to be effective June 23, 2003, 28 TexReg 4638; amended to be effective June 6, 2004, 29 TexReg 5376; amended to be effective September 11, 2005, 30 TexReg 5366; amended to be effective September 18, 2007, 32 TexReg 6333; amended to be effective March 6, 2008, 33 TexReg 1792; amended to be effective September 7, 2008, 33 TexReg 7241; amended to be effective September 20, 2009, 34 TexReg 6323; amended to be effective March 11, 2010, 35 TexReg 2005; amended to be effective May 30,2010, 35 TexReg 4177; amended to be effective March 10, 2011, 36 TexReg 1528; amended to be effective July 11, 2011, 36 TexReg 4412; amended to be effective December 5, 2012, 37 TexReg 9513; amended to be effective December 10, 2013, 38 TexReg 8847; amended to be effective December 19, 2016, 41 TexReg 9934; amended to be effective January 4, 2018, 42 TexReg 7691; amended to be effective September 16, 2018, 43 TexReg 5784; amended to be effective December 6, 2018, 43 TexReg 7775; amended to be effective December 10, 2020, 45 TexReg 8855; amended to be effective December 4, 2023, 48 TexReg 7060; amended to be effective March 7, 2024, 49 TexReg 1465 |
