(a) Purpose.
(1) The purpose of this section is to provide standards
for a centralized prescription drug or medication order processing
pharmacy.
(2) Any facility established for the primary purpose
of processing prescription drug or medication drug orders shall be
licensed as a Class G pharmacy under the Act. A Class G pharmacy shall
not store bulk drugs or dispense a prescription drug order. Nothing
in this subsection shall prohibit an individual pharmacist employee,
individual pharmacy technician employee, or individual pharmacy technician
trainee employee who is licensed in Texas from remotely accessing
the pharmacy's electronic database from a location other than a licensed
pharmacy in order to process prescription or medication drug orders,
provided the pharmacy establishes controls to protect the privacy
and security of confidential records, and the Texas-licensed pharmacist,
pharmacy technician, or pharmacy technician trainee does not engage
in the receiving of written prescription or medication orders or the
maintenance of prescription or medication drug orders at the non-licensed
remote location.
(b) Definitions. The following words and terms, when
used in this section, shall have the following meanings, unless the
context clearly indicates otherwise. Any term not defined in this
section shall have the definition set out in the Act.
(1) Centralized prescription drug or medication order
processing--The processing of prescription drug or medication orders
by a Class G pharmacy on behalf of another pharmacy, a health care
provider, or a payor. Centralized prescription drug or medication
order processing does not include the dispensing of a prescription
drug but includes any of the following:
(A) receiving, interpreting, or clarifying prescription
drug or medication orders;
(B) data entering and transferring of prescription
drug or medication order information;
(C) performing drug regimen review;
(D) obtaining refill and substitution authorizations;
(E) verifying accurate prescription data entry;
(F) interpreting clinical data for prior authorization
for dispensing;
(G) performing therapeutic interventions; and
(H) providing drug information concerning a patient's
prescription.
(2) Full-time pharmacist--A pharmacist who works in
a pharmacy from 30 to 40 hours per week or, if the pharmacy is open
less than 60 hours per week, one-half of the time the pharmacy is
open.
(c) Personnel.
(1) Pharmacist-in-charge.
(A) General. Each Class G pharmacy shall have one pharmacist-in-charge
who is employed on a full-time basis, who may be the pharmacist-in-charge
for only one such pharmacy.
(B) Responsibilities. The pharmacist-in-charge shall
have responsibility for the practice of pharmacy at the pharmacy for
which he or she is the pharmacist-in-charge. The pharmacist-in-charge
may advise the owner on administrative or operational concerns. The
pharmacist-in-charge shall have responsibility for, at a minimum,
the following:
(i) educating and training pharmacy technicians and
pharmacy technician trainees;
(ii) maintaining records of all transactions of the
Class G pharmacy required by applicable state and federal laws and
regulations;
(iii) adhering to policies and procedures regarding
the maintenance of records in a data processing system such that the
data processing system is in compliance with Class G pharmacy requirements;
and
(iv) legally operating the pharmacy, including meeting
all inspection and other requirements of all state and federal laws
or regulations governing the practice of pharmacy.
(2) Owner. The owner of a Class G pharmacy shall have
responsibility for all administrative and operational functions of
the pharmacy. The pharmacist-in-charge may advise the owner on administrative
and operational concerns. The owner shall have responsibility for,
at a minimum, the following, and if the owner is not a Texas licensed
pharmacist, the owner shall consult with the pharmacist-in-charge
or another Texas licensed pharmacist:
(A) providing the pharmacy with the necessary equipment
and resources commensurate with its level and type of practice; and
(B) establishing policies and procedures regarding
maintenance, storage, and retrieval of records in a data processing
system such that the system is in compliance with state and federal
requirements.
(3) Pharmacists.
(A) General.
(i) The pharmacist-in-charge shall be assisted by a
sufficient number of additional licensed pharmacists as may be required
to operate the Class G pharmacy competently, safely, and adequately
to meet the needs of the patients of the pharmacy.
(ii) All pharmacists shall assist the pharmacist-in-charge
in meeting his or her responsibilities.
(iii) Pharmacists are solely responsible for the direct
supervision of pharmacy technicians and pharmacy technician trainees
and for designating and delegating duties, other than those listed
in subparagraph (B) of this paragraph, to pharmacy technicians and
pharmacy technician trainees. Each pharmacist shall be responsible
for any delegated act performed by pharmacy technicians and pharmacy
technician trainees under his or her supervision.
(iv) Pharmacists shall directly supervise pharmacy
technicians and pharmacy technician trainees who are entering prescription
data into the pharmacy's data processing system by one of the following
methods.
(I) Physically present supervision. A pharmacist shall
be physically present to directly supervise a pharmacy technician
or pharmacy technician trainee who is entering prescription order
or medication order data into the data processing system. Each prescription
or medication order entered into the data processing system shall
be verified at the time of data entry.
(II) Electronic supervision. A pharmacist may electronically
supervise a pharmacy technician or pharmacy technician trainee who
is entering prescription order or medication order data into the data
processing system provided the pharmacist:
(-a-) has the ability to immediately communicate directly
with the technician/trainee;
(-b-) has immediate access to any original document
containing prescription or medication order information or other information
related to the dispensing of the prescription or medication order.
Such access may be through imaging technology provided the pharmacist
has the ability to review the original, hardcopy documents if needed
for clarification; and
(-c-) verifies the accuracy of the data entered information
prior to the release of the information to the system for storage.
(III) Electronic verification of data entry by pharmacy
technicians or pharmacy technician trainees. A pharmacist may electronically
verify the data entry of prescription information into a data processing
system provided:
(-a-) the pharmacist has the ability to immediately
communicate directly with the technician/trainee;
(-b-) the pharmacist electronically conducting the
verification is either a:
(-1-) Texas licensed pharmacist; or
(-2-) pharmacist employed by a Class E pharmacy that
has the same owner as the Class G pharmacy where the pharmacy technicians/trainees
are located, or that has entered into a written contract or agreement
with the Class G pharmacy which outlines the services to be provided
and the responsibilities and accountabilities of each pharmacy in
compliance with federal and state laws and regulations;
(-c-) the pharmacy establishes controls to protect
the privacy and security of confidential records; and
(-d-) the pharmacy keeps permanent records of prescriptions
electronically verified for a period of two years.
(v) All pharmacists while on duty, shall be responsible
for complying with all state and federal laws or rules governing the
practice of pharmacy.
(B) Duties. Duties which may only be performed by a
pharmacist are as follows:
(i) receiving oral prescription drug or medication
orders for controlled substances and reducing these orders to writing,
either manually or electronically;
(ii) interpreting prescription drug or medication orders;
(iii) selecting drug products;
(iv) verifying the data entry of the prescription drug
or medication order information at the time of data entry prior to
the release of the information to a Class A, Class C, or Class E pharmacy
for dispensing;
(v) communicating to the patient or patient's agent
information about the prescription drug or device which in the exercise
of the pharmacist's professional judgment, the pharmacist deems significant,
as specified in §291.33(c) of this title (relating to Operational
Standards);
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