SECTION 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.

Source Note: The provisions of this §291.53 adopted to be effective March 19, 1998, 23 TexReg 2815; amended to be effective September 16, 1999, 24 TexReg 7259; amended to be effective September 12, 2001, 26 TexReg 6920; amended to be effective March 4, 2004, 29 TexReg 1999; amended to be effective June 6, 2004, 29 TexReg 5362; amended to be effective September 14, 2010, 35 TexReg 8357; amended to be effective June 7, 2012, 37 TexReg 4047; amended to be effective March 26, 2014, 39 TexReg 2080; amended to be effective September 14, 2015, 40 TexReg 6110; amended to be effective December 6, 2015, 40 TexReg 8766; amended to be effective December 10, 2020, 45 TexReg 8854