| (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).
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