| (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 §552.1011 of the Texas Pharmacy Act (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; 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, 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
polices 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
(VI) compounding low-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; 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.)
(C) Facilities with an ongoing clinical pharmacy program.
A Class C pharmacy with an ongoing clinical pharmacy program may allow
a pharmacy technician to verify the accuracy of the duties specified
in clause (ii) of this subparagraph when performed by another pharmacy
technician, under the following conditions:
(i) The pharmacy technician:
(I) is a registered pharmacy technician and not a pharmacy
technician trainee; and
(II) meets the training requirements specified in §297.6
of this title and the training requirements specified in paragraph
(1) of this subsection.
(ii) If the requirements of clause (i) of this subparagraph
are met, a pharmacy technician may verify the accuracy of the following
duties performed by another pharmacy technician:
(I) filling medication carts;
(II) distributing routine orders for stock supplies
to patient care areas; and
(III) accessing and restocking 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
(iii) The patient's orders have previously been reviewed
and approved by a pharmacist.
(iv) A pharmacist is on duty in the facility at all
times that the pharmacy is open for pharmacy services.
(D) Rural Hospitals.
(i) A rural hospital may allow a pharmacy technician
to perform the duties specified in clause (ii) of this subparagraph
when a pharmacist is not on duty, if:
(I) the pharmacy technician:
(-a-) is a registered pharmacy technician and not a
pharmacy technician trainee; and
(-b-) meets the training requirements specified in §297.6
of this title and those specified in paragraph (1) of this subsection;
(II) a pharmacist is accessible at all times to respond
to any questions and needs of the pharmacy technician or other hospital
employees, by telephone, answering or paging service, e-mail, or any
other system that makes a pharmacist immediately accessible;
(III) the pharmacy is appropriately staffed to meet
the needs of the pharmacy; and
(IV) a nurse or practitioner at the rural hospital
or a pharmacist through electronic supervision as specified in paragraph
(2)(B)(ii) of this subsection, verifies the accuracy of the actions
of the pharmacy technician.
(ii) If the requirements of clause (i) of this subparagraph
are met, the pharmacy technician may, during the hours that the institutional
pharmacy in the hospital is open, perform the following duties in
the pharmacy without the direct supervision of a pharmacist:
(I) enter medication order and drug distribution information
into a data processing system;
(II) prepare, package, or label a prescription drug
according to a medication order if a licensed nurse or practitioner
verifies the accuracy of the order before administration of the drug
to the patient;
(III) fill a medication cart used in the rural hospital;
(IV) distribute routine orders for stock supplies to
patient care areas; and
(V) access and restock automated medication supply
cabinets.
(3) Procedures.
(A) Pharmacy technicians and pharmacy technician trainees
shall handle medication orders in accordance with standard, written
procedures and guidelines.
Cont'd... |
