22 Tex. Admin. Code § 291.92 - Personnel
(a) Pharmacist-in-charge.
(1) General.
(A) Each Class D pharmacy shall have one
pharmacist-in-charge who is employed or under written agreement, at least on a
part-time basis, but may be employed on a full-time basis if desired, and who
may be pharmacist-in-charge of more than one clinic pharmacy.
(B) A written agreement shall exist between
the clinic and the pharmacist-in-charge, and a copy of the written agreement
shall be made available to the board upon request.
(2) Responsibilities. The
pharmacist-in-charge shall have at a minimum, the responsibility for the
following:
(A) continuous supervision of
registered nurses, licensed vocational nurses, physician assistants, pharmacy
technicians, pharmacy technician trainees, and assistants carrying out the
pharmacy related aspects of provision;
(B) documented periodic on-site visits as
specified in §
291.93(h) and
§
291.94(b) of
this title (relating to Operational Standards and Records), either personally
or by the consultant pharmacist or staff pharmacist, to insure that the clinic
is following set policies and procedures; documentation shall be as specified
in §
291.94(b) of
this title;
(C) development of a
formulary for the clinic, in conjunction with the clinic's pharmacy and
therapeutics committee, consisting of drugs and/or devices needed to meet the
objectives of the clinic;
(D)
procurement and storage of drugs and/or devices, but he or she may receive
input from other appropriate staff of the clinic;
(E) determining specifications of all drugs
and/or devices procured by the clinic;
(F) maintenance of records of all
transactions of the pharmacy as may be required by applicable law and as may be
necessary to maintain accurate control over and accountability for all drugs
and/or devices;
(G) development and
at least annual review of a policy and procedure manual for the pharmacy in
conjunction with the clinic's pharmacy and therapeutics committee;
(H) meeting inspection and other requirements
of the Texas Pharmacy Act and these sections;
(I) dispensing of prescription orders;
and
(J) conducting inservice
training at least annually for supportive personnel who provide drugs; such
training shall be related to actions, contraindications, adverse reactions, and
pharmacology of drugs contained in the formulary.
(b) Consultant pharmacist.
(1) The consultant pharmacist may be the
pharmacist-in-charge.
(2) The
consultant pharmacist may be retained by more than one clinic.
(c) Staff pharmacists.
(1) The pharmacist-in-charge may be assisted
by a sufficient number of additional pharmacists as may be required to operate
the clinic pharmacy competently, safely, and adequately to meet the needs of
the patients of the clinic.
(2)
Staff pharmacists and/or the consultant pharmacist shall assist the
pharmacist-in-charge in meeting the responsibilities as outlined in subsection
(a)(2) of this section and in ordering, supervising, and accounting for drugs
and/or devices.
(3) Staff
pharmacists and/or the consultant pharmacist shall be responsible for any
delegated act performed by supportive personnel under his or her
supervision.
(d)
Supportive personnel.
(1) Qualifications.
(A) Supportive personnel shall possess
education and training necessary to carry out their responsibilities.
(B) Supportive personnel shall be qualified
to perform the pharmacy tasks assigned to them.
(2) Duties. Duties may include:
(A) prepackaging and labeling unit of use
packages, under the direct supervision of a pharmacist with the pharmacist
conducting in-process and final checks and affixing his or her signature to the
appropriate quality control records;
(B) maintaining inventories of drugs and/or
devices; and
(C) maintaining
pharmacy records.
(3)
Absence of the pharmacist. The pharmacist-in-charge shall designate from among
the supportive personnel a person to supervise the day-to-day pharmacy-related
operations of the clinic.
(e) Owner. The owner of a Class D 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) establishment of policies for
procurement of prescription drugs and devices and other products provided or
dispensed from the Class D pharmacy;
(2) establishment and maintenance of
effective controls against the theft or diversion of prescription
drugs;
(3) providing the pharmacy
with the necessary equipment and resources commensurate with its level and type
of practice; and
(4) establishment
of 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.
Notes
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