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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER CNUCLEAR PHARMACY (CLASS B)
RULE §291.52Definitions

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set forth in the Act, §551.003.

  (1) Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Occupations Code, as amended.

  (2) Accurately as prescribed--Dispensing, delivering, and/or distributing a prescription drug order or radioactive prescription drug order:

    (A) to the correct patient (or agent of the patient) for whom the drug or device was prescribed;

    (B) with the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner; and

    (C) with correct labeling (including directions for use) as ordered by the practitioner. Provided, however, that nothing herein shall prohibit pharmacist substitution if substitution is conducted in strict accordance with applicable laws and rules, including Subchapter A, Chapter 562 of the Act.

  (3) ACPE--Accreditation Council for Pharmacy Education.

  (4) Administer--The direct application of a prescription drug and/or radiopharmaceutical, by injection, inhalation, ingestion, or any other means to the body of a patient by:

    (A) a practitioner, an authorized agent under his supervision, or other person authorized by law; or

    (B) the patient at the direction of a practitioner.

  (5) Airborne particulate cleanliness class--The level of cleanliness specified by the maximum allowable number of particles per cubic meter of air as specified in the International Organization of Standardization (ISO) Classification Air Cleanliness (ISO 14644-1). For example:

    (A) ISO Class 5 (formerly Class 100) is an atmospheric environment that contains less than 3,520 particles 0.5 microns in diameter per cubic meter of air (formerly stated as 100 particles 0.5 microns in diameter per cubic foot of air);

    (B) ISO Class 7 (formerly Class 10,000) is an atmospheric environment that contains less than 352,000 particles 0.5 microns in diameter per cubic meter of air (formerly stated as 10,000 particles 0.5 microns in diameter per cubic foot of air); and

    (C) ISO Class 8 (formerly Class 100,000) is an atmospheric environment that contains less than 3,520,000 particles 0.5 microns in diameter per cubic meter of air (formerly stated as 100,000 particles 0.5 microns in diameter per cubic foot of air).

  (6) Ancillary supplies--Supplies necessary for the administration of compounded sterile radiopharmaceuticals.

  (7) Aseptic processing--The technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing.

  (8) Authentication of product history--Identifying the purchasing source, the intermediate handling, and the ultimate disposition of any component of a radioactive drug.

  (9) Authorized nuclear pharmacist--A pharmacist who:

    (A) has completed the specialized training requirements specified by this subchapter for the preparation and distribution of radiopharmaceuticals; and

    (B) is named on a Texas radioactive material license, issued by the Texas Department of State Health Services, Radiation Control Program.

  (10) Authorized user--Any individual named on a Texas radioactive material license, issued by the Texas Department of State Health Services, Radiation Control Program.

  (11) Automated compounding or drug dispensing device--An automated device that compounds, measures, counts, packages, and/or labels a specified quantity of dosage units for a designated drug product.

  (12) Biological Safety Cabinet, Class II--A ventilated cabinet for personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward HEPA filtered laminar airflow for product protection, and HEPA filtered exhausted air for environmental protection.

  (13) Board--The Texas State Board of Pharmacy.

  (14) Clean room or controlled area--A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.

  (15) Component--Any ingredient intended for use in the compounding of a drug preparation, including those that may not appear in such preparation.

  (16) Compounding--The preparation, mixing, assembling, packaging, or labeling of a drug or device:

    (A) as the result of a practitioner's prescription drug or medication order based on the practitioner-patient-pharmacist relationship in the course of professional practice;

    (B) for administration to a patient by a practitioner as the result of a practitioner's initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice;

    (C) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or

    (D) for or as an incident to research, teaching, or chemical analysis and not for sale or dispensing, except as allowed under §562.154 or Chapter 563 of the Act.

  (17) Controlled substance--A drug, immediate precursor, or other substance listed in Schedules I - V or Penalty Groups 1-4 of the Texas Controlled Substances Act, as amended, or a drug, immediate precursor, or other substance included in Schedule I, II, III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).

  (18) Critical site--Sterile ingredients of compounded sterile preparations and locations on devices and components used to prepare, package, and transfer compounded sterile preparations that provide opportunity for exposure to contamination.

  (19) Dangerous drug--A drug or device that:

    (A) is not included in Penalty Group 1, 2, 3, or 4, Chapter 481, Health and Safety Code, and is unsafe for self-medication; or

    (B) bears or is required to bear the legend:

      (i) "Caution: federal law prohibits dispensing without prescription" or "Rx only" or another legend that complies with federal law; or

      (ii) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian."

  (20) Data communication device--An electronic device that receives electronic information from one source and transmits or routes it to another (e.g., bridge, router, switch, or gateway).

  (21) Deliver or delivery--The actual, constructive, or attempted transfer of a prescription drug or device, radiopharmaceutical, or controlled substance from one person to another, whether or not for a consideration.

  (22) Designated agent--

    (A) an individual, including a licensed nurse, physician assistant, or pharmacist:

      (i) who is designated by a practitioner and authorized to communicate a prescription drug order to a pharmacist; and

      (ii) for whom the practitioner assumes legal responsibility;

    (B) a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom a practitioner communicates a prescription drug order; or

    (C) a registered nurse or physician assistant authorized by a practitioner to administer a prescription drug order for a dangerous drug under Subchapter B, Chapter 157 (Occupations Code).

  (23) Device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related articles, including any component parts or accessory that is required under federal or state law to be ordered or prescribed by a practitioner.

  (24) Diagnostic prescription drug order--A radioactive prescription drug order issued for a diagnostic purpose.

  (25) Dispense--Preparing, packaging, compounding, or labeling for delivery a prescription drug or device, or a radiopharmaceutical in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.

  (26) Dispensing pharmacist--The authorized nuclear pharmacist responsible for the final check of the dispensed prescription before delivery to the patient.

  (27) Distribute--The delivering of a prescription drug or device, or a radiopharmaceutical other than by administering or dispensing.

  (28) Electronic radioactive prescription drug order--A radioactive prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).

  (29) Internal test assessment--Validation of tests for quality control necessary to insure the integrity of the test.

  (30) Nuclear pharmacy technique--The mechanical ability required to perform the nonjudgmental, technical aspects of preparing and dispensing radiopharmaceuticals.

  (31) Original prescription--The:

    (A) original written radioactive prescription drug orders; or

    (B) original verbal or electronic radioactive prescription drug orders maintained either manually or electronically by the pharmacist.

  (32) Pharmacist-in-charge--The pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy.

  (33) Pharmacy technician--An individual whose responsibility in a pharmacy is to provide technical services that do not require professional judgment regarding preparing and distributing drugs and who works under the direct supervision of and is responsible to a pharmacist.

  (34) Pharmacy technician trainee--An individual who is registered with the board as a pharmacy technician trainee and is authorized to participate in a pharmacy's technician training program.

  (35) Process validation--Documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

  (36) Quality assurance--The set of activities used to ensure that the process used in the preparation of sterile radiopharmaceuticals lead to preparations that meet predetermined standards of quality.

  (37) Radiopharmaceutical--A prescription drug or device that exhibits spontaneous disintegration of unstable nuclei with the emission of a nuclear particle(s) or photon(s), including any nonradioactive reagent kit or nuclide generator that is intended to be used in preparation of any such substance.

  (38) Radioactive drug quality control--The set of testing activities used to determine that the ingredients, components (e.g., containers), and final radiopharmaceutical prepared meets predetermined requirements with respect to identity, purity, non-pyrogenicity, and sterility and the interpretation of the resulting data in order to determine the feasibility for use in humans and animals including internal test assessment, authentication of product history, and the keeping of mandatory records.

  (39) Radioactive drug service--The act of distributing radiopharmaceuticals; the participation in radiopharmaceutical selection and the performance of radiopharmaceutical drug reviews.

  (40) Radioactive prescription drug order--An order from a practitioner or a practitioner's designated agent for a radiopharmaceutical to be dispensed.

  (41) Sterile radiopharmaceutical--A dosage form of a radiopharmaceutical free from living micro-organisms.

  (42) Therapeutic prescription drug order--A radioactive prescription drug order issued for a specific patient for a therapeutic purpose.

  (43) Ultimate user--A person who has obtained and possesses a prescription drug or radiopharmaceutical for administration to a patient by a practitioner.


Source Note: The provisions of this §291.52 adopted to be effective March 19, 1998, 23 TexReg 2815; amended to be effective September 16, 1999, 24 TexReg 7259; amended to be effective June 1, 2002, 27 TexReg 1781; 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

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