| (a) Pharmacist-in-charge.
(1) General.
(A) Each Class A pharmacy shall have one pharmacist-in-charge
who is employed on a full-time basis and who may be the pharmacist-in-charge
for only one such pharmacy; provided, however, such pharmacist-in-charge
may be the pharmacist-in-charge of:
(i) more than one Class A pharmacy, if the additional
Class A pharmacies are not open to provide pharmacy services simultaneously;
or
(ii) during an emergency, up to two Class A pharmacies
open simultaneously if the pharmacist-in-charge works at least 10
hours per week in each pharmacy for no more than a period of 30 consecutive
days.
(B) The pharmacist-in-charge shall comply with the
provisions of §291.17 of this title (relating to Inventory Requirements).
(C) The pharmacist-in-charge of a Class A pharmacy
may not serve as the pharmacist-in-charge of a Class B pharmacy or
a Class C pharmacy with 101 beds or more.
(2) 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:
(A) educating and training of pharmacy technicians
and pharmacy technician trainees;
(B) supervising a system to assure appropriate procurement
of prescription drugs and devices and other products dispensed from
the Class A pharmacy;
(C) disposing of and distributing drugs from the Class
A pharmacy;
(D) storing all materials, including drugs, chemicals,
and biologicals;
(E) maintaining records of all transactions of the
Class A pharmacy necessary to maintain accurate control over and accountability
for all pharmaceutical materials required by applicable state and
federal laws and sections;
(F) supervising a system to assure maintenance of effective
controls against the theft or diversion of prescription drugs, and
records for such drugs;
(G) 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 A pharmacy requirements;
(H) legally operating the pharmacy, including meeting
all inspection and other requirements of all state and federal laws
or sections governing the practice of pharmacy; and
(I) if the pharmacy uses an automated pharmacy dispensing
system, shall be responsible for the following:
(i) consulting with the owner concerning and adherence
to the policies and procedures for system operation, safety, security,
accuracy and access, patient confidentiality, prevention of unauthorized
access, and malfunction;
(ii) inspecting medications in the automated pharmacy
dispensing system, at least monthly, for expiration date, misbranding,
physical integrity, security, and accountability;
(iii) assigning, discontinuing, or changing personnel
access to the automated pharmacy dispensing system;
(iv) ensuring that pharmacy technicians, pharmacy technician
trainees, and licensed healthcare professionals performing any services
in connection with an automated pharmacy dispensing system have been
properly trained on the use of the system and can demonstrate comprehensive
knowledge of the written policies and procedures for operation of
the system; and
(v) ensuring that the automated pharmacy dispensing
system is stocked accurately and an accountability record is maintained
in accordance with the written policies and procedures of operation.
(b) Owner. The owner of a Class A 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:
(1) establishing policies for procurement of prescription
drugs and devices and other products dispensed from the Class A pharmacy;
(2) establishing policies and procedures for the security
of the prescription department including the maintenance of effective
controls against the theft or diversion of prescription drugs;
(3) if the pharmacy uses an automated pharmacy dispensing
system, reviewing and approving all policies and procedures for system
operation, safety, security, accuracy and access, patient confidentiality,
prevention of unauthorized access, and malfunction;
(4) providing the pharmacy with the necessary equipment
and resources commensurate with its level and type of practice; and
(5) 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.
(c) Pharmacists.
(1) General.
(A) The pharmacist-in-charge shall be assisted by a
sufficient number of additional licensed pharmacists as may be required
to operate the Class A pharmacy competently, safely, and adequately
to meet the needs of the patients of the pharmacy.
(B) All pharmacists shall assist the pharmacist-in-charge
in meeting his or her responsibilities in ordering, dispensing, and
accounting for prescription drugs.
(C) 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 paragraph (2) of this subsection, 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.
(D) 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 data into
the data processing system. Each prescription entered into the data
processing system shall be verified at the time of data entry. If
the pharmacist is not physically present due to a temporary absence
as specified in §291.33(b)(3) of this title (relating to Operational
Standards), on return the pharmacist must:
(I) conduct a drug regimen review for the prescriptions
data entered during this time period as specified in §291.33(c)(2)
of this title; and
(II) verify that prescription data entered during this
time period was entered accurately.
(ii) Electronic supervision. A pharmacist may electronically
supervise a pharmacy technician or pharmacy technician trainee who
is entering prescription data into the data processing system provided
the pharmacist:
(I) has the ability to immediately communicate directly
with the technician/trainee;
(II) has immediate access to any original document
containing prescription information or other information related to
the dispensing of the prescription. Such access may be through imaging
technology provided the pharmacist has the ability to review the original,
hardcopy documents if needed for clarification; and
(III) verifies the accuracy of the data entered information
prior to the release of the information to the system for storage
and/or generation of the prescription label.
(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:
(I) the pharmacist has the ability to immediately communicate
directly with the technician/trainee;
(II) the pharmacist electronically conducting the verification
is either a:
(-a-) Texas licensed pharmacist; or
(-b-) pharmacist employed by a Class E pharmacy that:
(-1-) has the same owner as the Class A pharmacy where
the pharmacy technicians/trainees are located; or
(-2-) has entered into a written contract or agreement
with the Class A 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;
(III) the pharmacy establishes controls to protect
the privacy and security of confidential records; and
Cont'd... |
