22 Tex. Admin. Code § 291.153 - Central Prescription Drug or Medication Order Processing Pharmacy (Class G)
(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);
(vi) communicating to the patient or the
patient's agent on his or her request information concerning any prescription
drugs dispensed to the patient by the pharmacy;
(vii) assuring that a reasonable effort is
made to obtain, record, and maintain patient medication records; and
(viii) interpreting patient medication
records and performing drug regimen reviews.
(4) Pharmacy Technicians and Pharmacy
Technician Trainees.
(A) General. 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) Duties.
(i) Pharmacy technicians and pharmacy
technician trainees may not perform any of the duties listed in paragraph
(3)(B) of this subsection.
(ii) A
pharmacist may delegate to pharmacy technicians and pharmacy technician
trainees any nonjudgmental technical duty associated with the preparation and
distribution of prescription drugs provided:
(I) a pharmacist verifies the accuracy of all
acts, tasks, and functions performed by pharmacy technicians and pharmacy
technician trainees; and
(II)
pharmacy technicians and pharmacy technician trainees are under the direct
supervision of and responsible to a pharmacist.
(iii) Pharmacy technicians and pharmacy
technician trainees may perform only nonjudgmental technical duties associated
with the preparation of prescription drugs, as follows:
(I) initiating and receiving refill
authorization requests; and
(II)
entering prescription or medication order data into a data processing
system.
(iv) In addition
to the duties listed above in clause (iii) of this subparagraph, pharmacy
technicians may perform the following nonjudgmental technical duties associated
with the preparation and distribution of prescription drugs:
(I) receiving oral prescription drug or
medication orders for dangerous drugs and reducing these orders to writing,
either manually or electronically; and
(II) transferring or receiving a transfer of
original prescription drug or medication order information for a dangerous drug
on behalf of a patient.
(5) Identification of pharmacy personnel. All
pharmacy personnel shall be identified as follows.
(A) Pharmacy technicians. All pharmacy
technicians shall wear an identification tag or badge that bears the person's
name and identifies him or her as a pharmacy technician, or a certified
pharmacy technician, if the technician maintains current certification with the
Pharmacy Technician Certification Board or any other entity providing an
examination approved by the board.
(B) Pharmacy technician trainees. All
pharmacy technician trainees shall wear an identification tag or badge that
bears the person's name and identifies him or her as a pharmacy technician
trainee.
(C) Pharmacist interns.
All pharmacist interns shall wear an identification tag or badge that bears the
person's name and identifies him or her as a pharmacist intern.
(D) Pharmacists. All pharmacists shall wear
an identification tag or badge that bears the person's name and identifies him
or her as a pharmacist.
(d) Operational Standards.
(1) General requirements.
(A) A Class A, Class C, or Class E Pharmacy
may outsource prescription drug or medication order processing to a Class G
pharmacy provided the pharmacies:
(i) have:
(I) the same owner; or
(II) entered into a written contract or
agreement which outlines the services to be provided and the responsibilities
and accountabilities of each pharmacy in compliance with federal and state laws
and regulations; and
(ii) share a common electronic file or have
appropriate technology to allow access to sufficient information necessary or
required to perform a non-dispensing function.
(B) A Class G pharmacy shall comply with the
provisions applicable to the class of pharmacy contained in §§
291.31-
291.35 of this title (relating to
Definitions, Personnel, Operational Standards, Records, and Official
Prescription Requirements in a Class A (Community) Pharmacy), §§
291.72-
291.75 of this title (relating to
Definitions, Personnel, Operational Standards, and Records in a Class C
(Institutional) Pharmacy), or §§
291.102-
291.105 of this title (relating to
Definitions, Personnel, Operational Standards, and Records in a Class E
(Non-Resident) Pharmacy) to the extent applicable for the specific processing
activity and this section including:
(i)
duties which must be performed by a pharmacist; and
(ii) supervision requirements for pharmacy
technicians and pharmacy technician trainees.
(2) Licensing requirements.
(A) A Class G pharmacy shall register with
the board on a pharmacy license application provided by the board, following
the procedures specified in §
291.1 of this title (relating to
Pharmacy License Application).
(B)
A Class G pharmacy which changes ownership shall notify the board within 10
days of the change of ownership and apply for a new and separate license as
specified in §
291.3 of this title (relating to
Required Notifications).
(C) A
Class G pharmacy which changes location and/or name shall notify the board of
the change within 10 days and file for an amended license as specified in
§
291.3 of this title.
(D) A Class G pharmacy owned by a partnership
or corporation which changes managing officers shall notify the board in
writing of the names of the new managing officers within 10 days of the change,
following the procedures in §
291.3 of this title.
(E) A Class G pharmacy shall notify the board
in writing within 10 days of closing, following the procedures in §
291.5 of this title (relating to
Closing a Pharmacy).
(F) A fee as
specified in §
291.6 of this title (relating to
Pharmacy License Fees) will be charged for issuance and renewal of a license
and the issuance of an amended license.
(G) A separate license is required for each
principal place of business and only one pharmacy license may be issued to a
specific location.
(3)
Environment.
(A) General requirements.
(i) The pharmacy shall be arranged in an
orderly fashion and kept clean. All required equipment shall be in good
operating condition.
(ii) The
pharmacy shall be properly lighted and ventilated.
(iii) The pharmacy is not required to have a
sink exclusive of restroom facilities.
(B) Security.
(i) Each pharmacist while on duty shall be
responsible for the security of the prescription department, including
provisions for effective control against theft or diversion of prescription
drug records.
(ii) Pharmacies shall
employ appropriate measures to ensure that security of prescription drug
records is maintained at all times to prohibit unauthorized access.
(4) Policy and
Procedures. A policy and procedure manual shall be maintained by the Class G
pharmacy and be available for inspection. The manual shall:
(A) outline the responsibilities of each of
the pharmacies;
(B) include a list
of the name, address, telephone numbers, and all license/registration numbers
of the pharmacies involved in centralized prescription drug or medication order
processing; and
(C) include
policies and procedures for:
(i) protecting
the confidentiality and integrity of patient information;
(ii) maintaining appropriate records to
identify the name(s), initials, or identification code(s) and specific
activity(ies) of each pharmacist or pharmacy technician who performed any
processing;
(iii) complying with
federal and state laws and regulations;
(iv) operating a continuous quality
improvement program for pharmacy services designed to objectively and
systematically monitor and evaluate the quality and appropriateness of patient
care, pursue opportunities to improve patient care, and resolve identified
problems; and
(v) annually
reviewing the written policies and procedures and documenting such
review.
(e) Records.
(1) every record required to be kept under
the provisions of this section shall be:
(A)
kept by the pharmacy and be available, for at least two years from the date of
such inventory or record, for inspecting and copying by the board or its
representative and to other authorized local, state, or federal law enforcement
agencies; and
(B) supplied by the
pharmacy within 72 hours, if requested by an authorized agent of the board. If
the pharmacy maintains the records in an electronic format, the requested
records must be provided in a mutually agreeable electronic format if
specifically requested by the board or its representative. Failure to provide
the records set out in this section, either on site or within 72 hours,
constitutes prima facie evidence of failure to keep and maintain records in
violation of the Act.
(2) The pharmacy shall maintain appropriate
records which identify, by prescription drug or medication order, the name(s),
initials, or identification code(s) of each pharmacist, pharmacy technician, or
pharmacy technician trainee who performs a processing function for a
prescription drug or medication order. Such records may be maintained:
(A) separately by each pharmacy and
pharmacist; or
(B) in a common
electronic file as long as the records are maintained in such a manner that the
data processing system can produce a printout which lists the functions
performed by each pharmacy and pharmacist.
(3) In addition, the pharmacy shall comply
with the record keeping requirements applicable to the class of pharmacy to the
extent applicable for the specific processing activity and this
section.
Notes
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