22 Tex. Admin. Code § 291.53 - Personnel
(a) Pharmacists-in-Charge.
(1) General.
(A) Every nuclear pharmacy shall have an
authorized nuclear pharmacist designated on the nuclear pharmacy license as the
pharmacist-in-charge who shall be responsible for a nuclear pharmacy's
compliance with laws and regulations, both state and federal, pertaining to the
practice of nuclear pharmacy.
(B)
The nuclear pharmacy pharmacist-in-charge shall see that directives from the
board are communicated to the owner(s), management, other pharmacists, and
interns of the nuclear pharmacy.
(C) Each Class B 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 B pharmacy, if the
additional Class B pharmacies are not open to provide pharmacy services
simultaneously; or
(ii) during an
emergency, up to two Class B 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.
(D) The pharmacist-in-charge of a Class B
pharmacy may not serve as the pharmacist-in-charge of a Class A pharmacy or a
Class C pharmacy with 101 beds or more.
(2) Responsibilities. The
pharmacist-in-charge shall have the responsibility for, at a minimum, the
following:
(A) ensuring that
radiopharmaceuticals are dispensed and delivered safely and accurately as
prescribed;
(B) developing a system
to assure that all pharmacy personnel responsible for compounding and/or
supervising the compounding of radiopharmaceuticals within the pharmacy receive
appropriate education and training and competency evaluation;
(C) determining that all pharmacists involved
in compounding sterile radiopharmaceuticals obtain continuing education
appropriate for the type of compounding done by the pharmacist;
(D) supervising a system to assure
appropriate procurement of drugs and devices and storage of all pharmaceutical
materials, including radiopharmaceuticals, components used in the compounding
of radiopharmaceuticals, and drug delivery devices;
(E) assuring that the equipment used in
compounding is properly maintained;
(F) developing a system for the disposal and
distribution of drugs from the Class B pharmacy;
(G) developing a system for bulk compounding
or batch preparation of radiopharmaceuticals;
(H) developing a system for the compounding,
sterility assurance, and quality control of sterile
radiopharmaceuticals;
(I)
maintaining records of all transactions of the Class B pharmacy necessary to
maintain accurate control over and accountability for all pharmaceutical
materials, including radiopharmaceuticals, required by applicable state and
federal laws and rules;
(J)
developing a system to assure the maintenance of effective controls against the
theft or diversion of prescription drugs, and records for such drugs;
(K) assuring that the pharmacy has a system
to dispose of radioactive and cytotoxic waste in a manner so as not to endanger
the public health; and
(L) legally
operating the pharmacy, including meeting all inspection and other requirements
of all state and federal laws or rules governing the practice of
pharmacy.
(b)
Owner. The owner of a Class B 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 B
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) Authorized nuclear pharmacists.
(1) General.
(A) The pharmacist-in-charge shall be
assisted by a sufficient number of additional authorized nuclear pharmacists as
may be required to operate the pharmacy competently, safely, and adequately to
meet the needs of the patients of the pharmacy.
(B) All personnel performing tasks in the
preparation and distribution of radiopharmaceuticals shall be under the direct
supervision of an authorized nuclear pharmacist. General qualifications for an
authorized nuclear pharmacist are the following. A pharmacist shall:
(i) meet minimal standards of training and
experience in the handling of radioactive materials in accordance with the
requirements of the Texas Regulations for Control of Radiation of the Radiation
Control Program, Texas Department of State Health Services;
(ii) be a pharmacist licensed by the board to
practice pharmacy in Texas; and
(iii) submit to the board either:
(I) written certification that he or she has
current board certification as a nuclear pharmacist by the Board of
Pharmaceutical Specialties; or
(II)
written certification signed by a preceptor authorized nuclear pharmacist that
he or she has achieved a level of competency sufficient to independently
operate as an authorized nuclear pharmacist and has satisfactorily completed
700 hours in a structured educational program consisting of both:
(-a-) 200 hours of didactic training in a
program accepted by the Radiation Control Program, Texas Department of State
Health Services, in the following areas:
(-1-) radiation physics and
instrumentation;
(-2-) radiation
protection;
(-3-) mathematics
pertaining to the use and measurement of radioactivity;
(-4-) radiation biology; and
(-5-) chemistry of radioactive material for
medical use; and
(-b-)
500 hours of supervised practical experience in a nuclear pharmacy involving
the following:
(-1-) shipping, receiving, and
performing related radiation surveys;
(-2-) using and performing checks for proper
operation of instruments used to determine the activity of dosages, survey
meters, and, if appropriate, instruments used to measure alpha- or
beta-emitting radionuclides;
(-3-)
calculating, assaying, and safely preparing dosages for patients or human
research subjects;
(-4-) using
administrative controls to avoid adverse medical events in the administration
of radioactive material; and
(-5-)
using procedures to prevent or minimize contamination and using proper
decontamination procedures.
(C) Authorized nuclear pharmacists
are solely responsible for the direct supervision of pharmacy technicians and
pharmacy technician trainees and for delegating nuclear pharmacy techniques and
additional duties, other than those listed in paragraph (3) of this subsection,
to pharmacy technicians and pharmacy technician trainees. Each authorized
nuclear pharmacist shall:
(i) verify the
accuracy of all acts, tasks, or functions performed by pharmacy technicians and
pharmacy technician trainees; and
(ii) be responsible for any delegated act
performed by pharmacy technicians and pharmacy technician trainees under his or
her supervision.
(D) All
authorized nuclear pharmacists while on duty, shall be responsible for
complying with all state and federal laws or rules governing the practice of
pharmacy.
(E) The dispensing
pharmacist shall ensure that the drug is dispensed and delivered safely and
accurately as prescribed.
(2) Special requirements for compounding.
(A) Non-sterile preparations. All pharmacists
engaged in compounding non-sterile preparations, including radioactive
preparations, shall meet the training requirements specified in §
291.131 of this title (relating to
Pharmacies Compounding Non-Sterile Preparations).
(B) Sterile Preparations. All pharmacists
engaged in compounding sterile preparations, including radioactive
preparations, shall meet the training requirements specified in §
291.133 of this title (relating to
Pharmacies Compounding Sterile Preparations).
(3) Duties. Duties which may only be
performed by an authorized nuclear pharmacist are as follows:
(A) receiving oral prescription drug orders
for controlled substances and reducing these orders to writing, either manually
or electronically;
(B) interpreting
and evaluating radioactive prescription drug orders;
(C) selecting drug products; and
(D) performing the final check of the
dispensed prescription before delivery to the patient to ensure that the
radioactive prescription drug order has been dispensed accurately as
prescribed.
(d) Pharmacy Technicians and Pharmacy
Technician Trainees.
(1) 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).
(2) Special requirements for compounding.
(A) Non-sterile preparations. All pharmacy
technicians and pharmacy technician trainees engaged in compounding non-sterile
preparations, including radioactive preparations, shall meet the training
requirements specified in §
291.131 of this title.
(B) Sterile Preparations. All pharmacy
technicians and pharmacy technician trainees engaged in compounding sterile
preparations, including radioactive preparations, shall meet the training
requirements specified in §
291.133 of this title.
(3) Duties.
(A) Pharmacy technicians and pharmacy
technician trainees may not perform any of the duties listed in subsection
(c)(3) of this section.
(B) An
authorized nuclear pharmacist may delegate to pharmacy technicians and pharmacy
technician trainees any nuclear pharmacy technique which is associated with the
preparation and distribution of radiopharmaceuticals provided:
(i) an authorized nuclear 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.
(4) Ratio of authorized nuclear pharmacist to
pharmacy technicians and pharmacy technician trainees.
(A) The ratio of authorized nuclear
pharmacists to pharmacy technicians and pharmacy technician trainees may be
1:6, provided at least three of the six are pharmacy technicians and are
trained in the handling of radioactive materials.
(B) The ratio of authorized nuclear
pharmacists to pharmacy technician trainees may not exceed 1:3.
Notes
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No prior version found.