| (-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
(ii) a pharmacist checks the accuracy of each original
or new prescription drug order and is responsible for the final check
of the order through the automated checking device.
(B) If the final check is accomplished as specified
in subparagraph (A) 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
(A)(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
dispensing process;
(iii) the pharmacy establishes mechanisms and procedures
to test the accuracy of the automated checking device at least monthly;
and
(iv) the pharmacy establishes procedures to ensure
that errors identified by the automated checking device may not be
overridden by a pharmacy technician and must be reviewed and corrected
by a pharmacist.
|
| Source Note: The provisions of this §291.33 adopted to be effective September 14, 1988, 13 TexReg 4306; amended to be effective February 1, 1989, 14 TexReg 453; amended to be effective September 5, 1990, 15 TexReg 4807; amended to be effective January 29, 1992, 17 TexReg 323; amended to be effective January 1, 1993, 17 TexReg 9116; amended to be effective January 4, 1994, 18 TexReg 9853; amended to be effective June 1, 1994, 19 TexReg 3921; amended to be effective December 1, 1994, 19 TexReg 9179; amended to be effective March 21, 1996, 21 TexReg 2227; amended to be effective April 7, 1997, 22 TexReg 3106; amended to be effective March 29, 2000, 25 TexReg 2575; amended to beeffective June 4, 2000, 25 TexReg 4778; amended to be effective August 31, 2000, 25 TexReg 8405; amended to be effective December 27, 2000, 25 TexReg 12690; amended to be effective June 20, 2001, 26 TexReg 4478; amended to be effective December 19, 2001, 26 TexReg 10311; amended to be effective June 1, 2002, 27 TexReg 1736; amended to be effective December 15, 2002, 27 TexReg 11537; amended to be effective June 23, 2003, 28 TexReg 4637; amended to be effective March 4, 2004, 29 TexReg 1951; amended to be effective June 6, 2004, 29 TexReg 5361; amended to be effective June 12, 2005, 30 TexReg 3208; amended to be effective June 11, 2006, 31 TexReg 4629; amended to be effective March 6, 2008, 33 TexReg 1784; amended to be effective September 7, 2008, 33 TexReg 7218; amended to be effective December 14, 2008, 33 TexReg 10027; amended to be effective March 12, 2009, 34 TexReg 1593; amendedto be effective June 7, 2009, 34 TexReg 3391; amended to be effective December 6, 2009, 34 TexReg 8691; amended to be effective May 30, 2010, 35 TexReg 4165; amended to be effective December 8, 2010, 35 TexReg 10690; amended to be effective March 10, 2011, 36 TexReg 1517; amended to be effective September 12, 2011, 36 TexReg 5847; amended to be effective June 7, 2012, 37 TexReg 4046; amended to be effective June 12, 2013, 38 TexReg 3592; amended to be effective December 10, 2013, 38 TexReg 8835; amended to be effective September 11, 2014, 39 TexReg 7094; amended to be effective December 7, 2014, 39 TexReg 9345; amended to be effective December 6, 2015, 40 TexReg 8766; amended to be effective September 11, 2016, 41 TexReg 6697; amended to be effective September 6, 2017, 42 TexReg 4466; amended to be effective June 7, 2018, 43 TexReg 3587; amended to be effective September 16,2018, 43TexReg 5783; amended to be effective March 12, 2019, 44 TexReg 1320; amended to be effective December 10, 2020, 45 TexReg 8852; amended to be effective August 24, 2022, 47 TexReg 4976; amended to be effective December 6, 2022, 47 TexReg 8041; amended to be effective December 4, 2023, 48 TexReg 7049 |
