1. (a) Pharmacists-in-Charge.

   1. (1) General.

      1. (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.
      2. (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.
      3. (C) An authorized nuclear pharmacist may be pharmacist-in-charge for no more than one nuclear pharmacy at any one given time.

   2. (2) Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following:

      1. (A) ensuring that radiopharmaceuticals are dispensed and delivered safely and accurately as prescribed;
      2. (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;
      3. (C) establishing policies for procurement of drugs and devices and storage of all pharmaceutical materials including radiopharmaceuticals, components used in the compounding of radiopharmaceuticals, and drug delivery devices;
      4. (D) developing a system for the disposal and distribution of drugs from the Class B pharmacy;
      5. (E) developing a system for the compounding, sterility assurance, and quality control of sterile radiopharmaceuticals;
      6. (F) 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;
      7. (G) developing a system to assure the maintenance of effective controls against the theft or diversion of prescription drugs, and records for such drugs;
      8. (H) 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
      9. (I) legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy.

2. (b) Authorized nuclear pharmacists.

   1. (1) General.

      1. (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.

      2. (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:

         1. (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 Bureau of Radiation Control, Texas Department of Health;
         2. (ii) be a pharmacist licensed by the board to practice pharmacy in Texas; and

         3. (iii) submit to the board either:

            1. (I) written certification that he or she has current board certification as a nuclear pharmacist by the Board of Pharmaceutical Specialties; or

            2. (II) written certification signed by 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 Bureau of Radiation Control, Texas Department of Health 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 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 dose calibrators, 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 mistakes in the administration of radioactive material; and

               (-5-) using procedures to prevent or minimize contamination and using proper decontamination procedures.

      3. (C) The board may issue a letter of notification that the evidence submitted by the pharmacist meets the requirements of subparagraph (B)(i) - (iii) of this paragraph and has been accepted by the board and that, based thereon, the pharmacist is recognized as an authorized nuclear pharmacist.

      4. (D) Authorized nuclear pharmacists are solely responsible for the direct supervision of pharmacy technicians and for delegating nuclear pharmacy techniques and additional duties, other than those listed in paragraph (2) of this subsection, to pharmacy technicians. Each authorized nuclear pharmacist:

         1. (i) shall verify the accuracy of all acts, tasks, or functions performed by pharmacy technicians; and
         2. (ii) shall be responsible for any delegated act performed by pharmacy technicians under his or her supervision.
      5. (E) 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.
      6. (F) The dispensing pharmacist shall ensure that the drug is dispensed and delivered safely and accurately as prescribed.

   2. (2) Duties. Duties which may only be performed by an authorized nuclear pharmacist are as follows:

      1. (A) receiving verbal therapeutic prescription drug orders and reducing these orders to writing, either manually or electronically;
      2. (B) receiving verbal, diagnostic prescription drug orders in instances where patient specificity is required for patient safety (e.g., radiolabeled blood products, radiolabeled antibiodies) and reducing these orders to writing, either manually or electronically;
      3. (C) interpreting and evaluating radioactive prescription drug orders;
      4. (D) selection of drug products; and
      5. (E) 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.

3. (c) Pharmacy Technicians.

   1. (1) General.

      1. (A) On June 1, 2004, all persons employed as pharmacy technicians must be either registered pharmacy technicians or pharmacy technician trainees as follows.

         1. (i) All persons who have passed the required pharmacy technician certification examination must be registered with the board under the provisions this section.
         2. (ii) All persons who have not taken and passed the required pharmacy certification examination shall be designated pharmacy technician trainees under the provisions of §297.5 of this title (relating to Pharmacy Technician Trainees).
      2. (B) Between January 1, 2004, and May 31, 2004, all persons employed as pharmacy technicians who are qualified for registration by the board shall register according to the schedule designated by the board. Between January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled time for registration and persons who have applied for registration, but the registration has not been completed shall comply with the rules in effect prior to January 1, 2004, relating to requirements and duties for certified pharmacy technicians.
      3. (C) All pharmacy technicians shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician Training).

   2. (2) Duties.

      1. (A) General. Pharmacy technicians may perform any nuclear pharmacy technique delegated by an authorized nuclear pharmacist which is associated with the preparation and distribution of radiopharmaceuticals other than those duties listed in subsection (b)(2) of this section provided:

         1. (i) an authorized nuclear pharmacist conducts in-process and final checks; and
         2. (ii) pharmacy technicians are under the direct supervision of and responsible to an authorized nuclear pharmacist.
      2. (B) Labeling. Only registered pharmacy technicians may affix a label to a prescription container.

   3. (3) Ratio of authorized nuclear pharmacist to pharmacy technicians.

      1. (A) The ratio of authorized nuclear pharmacists to pharmacy technicians may not exceed 1:2, provided that only one pharmacy technician may be engaged in the compounding of a sterile radiopharmaceutical.
      2. (B) The ratio of authorized nuclear pharmacists to pharmacy technicians may be 1:3 provided that at least one of the three technicians is a registered pharmacy technician and only one may be engaged in the compounding of a sterile radiopharmaceutical.

4. (d) Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile radiopharmaceuticals.

   1. (1) General.

      1. (A) All pharmacy personnel preparing sterile radiopharmaceuticals shall receive didactic and experiential training and competency evaluation through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge and described in the policy and procedure or training manual. Such training shall include instruction and experience in the following areas:

         1. (i) aseptic technique;
         2. (ii) critical area contamination factors;
         3. (iii) environmental monitoring;
         4. (iv) facilities;
         5. (v) equipment and supplies;
         6. (vi) sterile pharmaceutical and radiopharmaceutical calculations and terminology;
         7. (vii) sterile radiopharmaceutical compounding documentation;
         8. (viii) quality assurance procedures;
         9. (ix) aseptic preparation procedures including proper gowning and gloving technique;
         10. (x) handling of hazardous drugs, if applicable; and
         11. (xi) general conduct in the controlled area.
      2. (B) The aseptic technique of each person compounding or responsible for the direct supervision of personnel compounding sterile radiopharmaceuticals shall be observed, evaluated, and documented as satisfactory through written or practical tests and process validation.

      3. (C) Although process validation may be incorporated into the experiential portion of a training program, process validation must be conducted at each pharmacy where an individual compounds sterile radiopharmaceuticals. No product intended for patient use shall be compounded by an individual until the on-site process validation test indicates that the individual can competently perform aseptic procedures, except that an authorized nuclear pharmacist may temporarily compound sterile radiopharmaceuticals and supervise pharmacy technicians compounding sterile radiopharmaceuticals without process validation provided the authorized nuclear pharmacist:

         1. (i) has completed a recognized course in an accredited college of pharmacy or a course sponsored by an American Council on Pharmaceutical Education approved provider which provides 20 hours of instruction and experience in the areas listed in this paragraph; and
         2. (ii) completes the on-site process validation within seven days of commencing work at the pharmacy.
      4. (D) Process validation procedures for assessing the preparation of specific types of sterile radiopharmaceuticals shall be representative of all types of manipulations, products, and batch sizes that personnel preparing that type of radioradiopharmaceutical are likely to encounter.

      5. (E) The pharmacist-in-charge shall assure continuing competency of pharmacy personnel through in-service education, training, and process validation to supplement initial training. Personnel competency shall be evaluated:

         1. (i) during orientation and training prior to the regular performance of those tasks;
         2. (ii) whenever the quality assurance program yields an unacceptable result;
         3. (iii) whenever unacceptable techniques are observed; and
         4. (iv) at least on an annual basis.

   2. (2) Pharmacists.

      1. (A) All pharmacists who compound sterile radiopharmaceuticals or supervise pharmacy technicians compounding sterile radiopharmaceuticals shall:

         1. (i) effective January 1, 2000, complete a recognized course in an accredited college of pharmacy or a course sponsored by an American Council on Pharmaceutical Education approved provider which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; and

         2. (ii) possess knowledge about:

            1. (I) aseptic processing;
            2. (II) quality control as related to environmental, component, and end-product testing;
            3. (III) chemical, pharmaceutical, and clinical properties of drugs;
            4. (IV) container, equipment, and closure system selection; and
            5. (V) sterilization techniques.
      2. (B) Pharmacists shall discontinue preparation of sterile radiopharmaceuticals if the training specified in subparagraph (A) of this paragraph is not completed by January 1, 2000.
      3. (C) The required experiential portion of the training programs specified in this paragraph must be supervised by an individual who has already completed training in the compounding of sterile pharmaceuticals.

   3. (3) Pharmacy technicians. In addition to the qualifications and training outlined in subsection (c) of this section, all pharmacy technicians who compound sterile radiopharmaceuticals shall:

      1. (A) have a high school or equivalent education;
      2. (B) complete through a single course, a structured on-the-job didactic and experiential training program at this pharmacy which provides 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may not be transferred to another pharmacy unless the pharmacies are under common ownership and control and use a common training program;
      3. (C) acquire the required experiential portion of the training programs specified in this paragraph under the supervision of an individual who has already completed training in the compounding of sterile pharmaceuticals.
      4. (D) effective January 1, 2001, be certified pharmacy technicians.
      5. (E) on January 1, 2001, discontinue preparation of sterile pharmaceuticals if the technician has not taken and passed the National Pharmacy Technician Certification Exam or other examination approved during an open meeting by the Board. Such pharmacy technicians may continue to compound sterile pharmaceuticals during the interim between the effective date of these rules and January 1, 2001, if they maintain documentation of completion of the training specified in subparagraph (B) of this paragraph.

   4. (4) Documentation of Training. A written record of initial and in-service training and the results of written or practical testing and process validation of pharmacy personnel shall be maintained and contain the following information:

      1. (A) name of the person receiving the training or completing the testing or process validation;
      2. (B) date(s) of the training, testing, or process validation;
      3. (C) general description of the topics covered in the training or testing or of the process validated;
      4. (D) name of the person supervising the training, testing, or process validation; and
      5. (E) signature (first initial and last name or full signature) of the person receiving the training or completing the testing or process validation and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training, testing, or process validation of personnel.

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.