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RULE §291.31Definitions

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

  (1) Accurately as prescribed--Dispensing, delivering, and/or distributing a 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 Chapter 562 of the Texas Pharmacy Act.

  (2) Act--The Texas Pharmacy Act, Chapters 551 - 569, Occupations Code, as amended.

  (3) Advanced practice registered nurse--A registered nurse licensed by the Texas Board of Nursing to practice as an advanced practice registered nurse on the basis of completion of an advanced education program. The term includes nurse practitioner, nurse midwife, nurse anesthetist, and clinical nurse specialist. The term is synonymous with advanced nurse practitioner and advanced practice nurse.

  (4) Automated checking device--A device that confirms that the correct drug and strength has been labeled with the correct label for the correct patient prior to delivery of the drug to the patient.

  (5) Automated counting device--An automated device that is loaded with bulk drugs and counts and/or packages (i.e., fills a vial or other container) a specified quantity of dosage units of a designated drug product.

  (6) Automated pharmacy dispensing system--A system that automatically performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, and labeling for dispensing and delivery of medications, and that collects, controls, and maintains all transaction information. "Automated pharmacy dispensing system" does not mean "Automated compounding or counting device" or "Automated medication supply device."

  (7) Beyond use date--The date beyond which a product should not be used.

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

  (9) Confidential record--Any health-related record that contains information that identifies an individual and that is maintained by a pharmacy or pharmacist, such as a patient medication record, prescription drug order, or medication order.

  (10) 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 (Chapter 481, Health and Safety Code), or a drug, immediate precursor, or other substance included in Schedules I, II, III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).

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

    (A) is not included in Penalty Groups 1 - 4 of the Texas Controlled Substances Act, as amended, (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."

  (12) 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).

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

  (14) Designated agent--

    (A) a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner to communicate prescription drug orders to a pharmacist;

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

    (C) an advanced practice registered nurse or physician assistant authorized by a practitioner to prescribe or order drugs or devices under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations Code); or

    (D) a person who is a licensed vocational nurse or has an education equivalent to or greater than that required for a licensed vocational nurse designated by the practitioner to communicate prescriptions for an advanced practice registered nurse or physician assistant authorized by the practitioner to sign prescription drug orders under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations Code).

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

  (16) Dispensing error--An action committed by a pharmacist or other pharmacy personnel that causes the patient or patient's agent to take possession of a dispensed prescription drug and an individual subsequently discovers that the patient has received an incorrect drug product, which includes incorrect strength, incorrect dosage form, and/or incorrect directions for use.

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

  (18) Distribute--The delivery of a prescription drug or device other than by administering or dispensing.

  (19) Downtime--Period of time during which a data processing system is not operable.

  (20) Drug regimen review--An evaluation of prescription drug orders and patient medication records for:

    (A) known allergies;

    (B) rational therapy-contraindications;

    (C) reasonable dose and route of administration;

    (D) reasonable directions for use;

    (E) duplication of therapy;

    (F) drug-drug interactions;

    (G) drug-food interactions;

    (H) drug-disease interactions;

    (I) adverse drug reactions; and

    (J) proper utilization, including overutilization or underutilization.

  (21) Electronic prescription drug order--A prescription drug order that is generated on an electronic application and transmitted as an electronic data file.

  (22) Electronic signature--A unique security code or other identifier which specifically identifies the person entering information into a data processing system. A facility which utilizes electronic signatures must:

    (A) maintain a permanent list of the unique security codes assigned to persons authorized to use the data processing system; and

    (B) have an ongoing security program which is capable of identifying misuse and/or unauthorized use of electronic signatures.

  (23) Electronic verification process--an electronic verification, bar code verification, weight verification, radio frequency identification (RFID), or similar electronic process or system that accurately verifies that medication has been properly dispensed and labeled by, or loaded into, an automated pharmacy dispensing system.

  (24) Full-time pharmacist--A pharmacist who works in a pharmacy from 30 to 40 hours per week or, if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open.

  (25) Hard copy--A physical document that is readable without the use of a special device.

  (26) Hot water--The temperature of water from the pharmacy's sink maintained at a minimum of 105 degrees F (41 degrees C).

  (27) Medical Practice Act--The Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.

  (28) Medication order--A written order from a practitioner or an oral order from a practitioner or his authorized agent for administration of a drug or device.

  (29) New prescription drug order--A prescription drug order that has not been dispensed to the patient in the same strength and dosage form by this pharmacy within the last year.

  (30) Original prescription--The:

    (A) original written prescription drug order; or


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