| (E) A distributing pharmacist shall be responsible
for and ensure that the drug is prepared for distribution safely,
and accurately as prescribed unless the pharmacy's data processing
system can record the identity of each pharmacist involved in a specific
portion of the preparation of medication orders for distribution,
in which case each pharmacist involved in the preparation of medication
orders shall be responsible for and ensure that the portion of the
process the pharmacist is performing results in the safe and accurate
distribution and delivery of the drug as ordered. The preparation
and distribution process for medication orders shall include, but
not be limited to, drug regimen review, and verification of accurate
medication order data entry, preparation, and distribution, and performance
of the final check of the prepared medication.
(2) Duties. Duties of the pharmacist-in-charge and
all other pharmacists shall include, but need not be limited to the
following:
(A) providing those acts or services necessary to provide
pharmaceutical care;
(B) receiving, interpreting, and evaluating prescription
drug orders, and reducing verbal medication orders to writing either
manually or electronically;
(C) participating in drug and/or device selection as
authorized by law, drug and/or device supplier selection, drug administration,
drug regimen review, or drug or drug-related research;
(D) performing a specific act of drug therapy management
for a patient delegated to a pharmacist by a written protocol from
a physician licensed in this state in compliance with the Medical
Practice Act Subtitle B, Chapter 157, Occupations Code;
(E) accepting the responsibility for:
(i) distributing prescription drugs and devices with
drug components pursuant to medication orders;
(ii) compounding and labeling of prescription drugs
and devices with drug components;
(iii) proper and safe storage of prescription drugs
and devices with drug components; and
(iv) maintaining proper records for prescription drugs
and devices with drug components.
(3) Special requirements for compounding. All pharmacists
engaged in compounding non-sterile preparations shall meet the training
requirements specified in §291.131 of this title (relating to
Pharmacies Compounding Non-sterile Preparations).
(e) Pharmacy technicians and pharmacy technician trainees.
(1) General.
(A) All pharmacy technicians and pharmacy technician
trainees shall meet the training requirements specified in §297.6
of this title (relating to Pharmacy Technician and Pharmacy Technician
Trainee Training).
(B) A pharmacy technician performing the duties specified
in paragraph (2)(C) of this subsection shall complete training regarding:
(i) procedures for one pharmacy technician to verify
the accuracy of actions performed by another pharmacy technician including
required documentation; and
(ii) the duties that may be performed by one pharmacy
technician and checked by another pharmacy technician.
(C) In addition to the training requirements specified
in subparagraph (A) of this paragraph, pharmacy technicians working
in a rural hospital and performing the duties specified in paragraph
(2)(D)(ii) of this subsection shall complete the following. Training
on the:
(i) procedures for verification of the accuracy of
actions performed by pharmacy technicians including required documentation;
(ii) duties which may and may not be performed by pharmacy
technicians in the absence of a pharmacist; and
(iii) pharmacy technician's role in preventing dispensing
and distribution errors.
(2) Duties. Duties may include, but need not be limited
to, the following functions under the supervision of and responsible
to a pharmacist:
(A) Facilities with 101 beds or more. The following
functions must be performed under the physically present supervision
of a pharmacist:
(i) pre-packing and labeling unit and multiple dose
packages, provided a pharmacist supervises and conducts a final check
and affixes his or her name, initials or electronic signature to the
appropriate quality control records prior to distribution;
(ii) preparing, packaging, compounding, or labeling
prescription drugs pursuant to medication orders, provided a pharmacist
supervises and checks the preparation prior to distribution;
(iii) bulk compounding or batch preparation provided
a pharmacist supervises and conducts in-process and final checks and
affixes his or her name, initials, or electronic signature to the
appropriate quality control records prior to distribution;
(iv) distributing routine orders for stock supplies
to patient care areas;
(v) entering medication order and drug distribution
information into a data processing system, provided judgmental decisions
are not required and a pharmacist checks the accuracy of the information
entered into the system prior to releasing the order;
(vi) loading unlabeled drugs into an automated compounding
or counting device provided a pharmacist supervises, verifies that
the system was properly loaded prior to use, and affixes his or her
name, initials or electronic signature to the appropriate quality
control records;
(vii) accessing automated medication supply systems
after proper training on the use of the automated medication supply
system and demonstration of comprehensive knowledge of the written
policies and procedures for its operation; and
(viii) compounding non-sterile preparations pursuant
to medication orders provided the pharmacy technicians or pharmacy
technician trainees have completed the training specified in §291.131
of this title.
(B) Facilities with 100 beds or less.
(i) Physically present supervision. The following functions
must be performed under the physically present supervision of a pharmacist
unless the pharmacy meets the requirements for a rural hospital and
has been approved by the board to allow pharmacy technicians to perform
the duties specified in §562.1011 of the Texas Pharmacy Act and
subparagraph (D)(ii) of this paragraph:
(I) pre-packing and labeling unit and multiple dose
packages, provided a pharmacist supervises and conducts a final check
and affixes his or her name, initials or electronic signature to the
appropriate quality control records prior to distribution;
(II) bulk compounding or batch preparation provided
a pharmacist supervises and conducts in-process and final checks and
affixes his or her name, initials, or electronic signature to the
appropriate quality control records prior to distribution;
(III) loading unlabeled drugs into an automated compounding
or counting device provided a pharmacist supervises, verifies that
the system was properly loaded prior to use, and affixes his or her
name, initials, or electronic signature to the appropriate quality
control records; and
(IV) compounding medium-risk and high-risk sterile
preparations pursuant to medication orders provided the pharmacy technicians
or pharmacy technician trainees:
(-a-) have completed the training specified in §291.133
of this title (relating to Pharmacies Compounding Sterile Preparations);
and
(-b-) are supervised by a pharmacist who has completed
the training specified in §291.133 of this title and who conducts
in-process and final checks, and affixes his or her name, initials,
or electronic signature to the label or if batch prepared, to the
appropriate quality control records. (The name, initials, or electronic
signature are not required on the label if it is maintained in a permanent
record of the pharmacy.)
(ii) Electronic supervision or physically present supervision.
The following functions may be performed under the electronic supervision
or physically present supervision of a pharmacist:
(I) preparing, packaging, or labeling prescription
drugs pursuant to medication orders, provided a pharmacist checks
the preparation prior to distribution;
(II) distributing routine orders for stock supplies
to patient care areas;
(III) entering medication order and drug distribution
information into a data processing system, provided judgmental decisions
are not required and a pharmacist checks the accuracy of the information
entered into the system prior to releasing the order;
(IV) accessing automated medication supply systems
after proper training on the use of the automated medication supply
system and demonstration of comprehensive knowledge of the written
policies and procedures for its operation;
(V) compounding non-sterile preparations pursuant to
medication orders provided the pharmacy technicians or pharmacy technician
trainees have completed the training specified in §291.131 of
this title; and
Cont'd... |
