22 Tex. Admin. Code § 291.31 – Definitions

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:
1. (A) to the correct patient (or agent of the patient) for whom the drug or device was prescribed;
2. (B) with the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner; and
3. (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 Chapters 562 and 563 of the Texas Pharmacy Act.
(2) Act--The Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Occupations Code, as amended.
(3) Advanced practice nurse--A registered nurse approved by the Texas State Board of Nurse Examiners to practice as an advanced practice nurse on the basis of completion of an advanced education program. The term includes a nurse practitioner, a nurse midwife, a nurse anesthetist, and a clinical nurse specialist.
(4) Automated compounding or counting device--An automated device that compounds, measures, counts, and/or packages a specified quantity of dosage units of a designated drug product.
(5) Automated pharmacy dispensing systems--a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, dispensing, and distribution of medications, and which collects, controls, and maintains all transaction information. "Automated pharmacy dispensing systems" does not mean "Automated compounding or counting devices" or "Automated medication supply devices."
(6) Board--The Texas State Board of Pharmacy.
(7) Carrying out or signing a prescription drug order--The completion of a prescription drug order presigned by the delegating physician, or the signing of a prescription by an advanced practice nurse or physician assistant after the person has been designated with the Texas Medical Board by the delegating physician as a person delegated to sign a prescription. The following information shall be provided on each prescription:
1. (A) patient's name and address;
2. (B) name, strength, and quantity of the drug to be dispensed;
3. (C) directions for use;
4. (D) the intended use of the drug, if appropriate;
5. (E) the name, address, and telephone number of the physician;
6. (F) the name, address, telephone number, identification number, and if the prescription is for a controlled substance, the DEA number of the advanced practice nurse or physician assistant completing the prescription drug order;
7. (G) the date; and
8. (H) the number of refills permitted.
(8) 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.
(9) 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 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).
(10) Dangerous drug--A drug or device that:
1. (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
2. (B) bears or is required to bear the legend:
  1. (i) "Caution: federal law prohibits dispensing without prescription" or "Rx only" or another legend that complies with federal law; or
  2. (ii) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian."
(11) 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).
(12) 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.
(13) Designated agent--
1. (A) a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner to communicate prescription drug orders to a pharmacist;
2. (B) a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom the practitioner communicates a prescription drug order;
3. (C) an advanced practice nurse or physician assistant authorized by a practitioner to carry out or sign a prescription drug order for dangerous drugs under Chapter 157 of the Medical Practice Act (Subtitle B, Occupations Code); or
4. (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 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).
(14) 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.
(15) Dispensing pharmacist--The pharmacist responsible for the final check of the dispensed prescription before delivery to the patient.
(16) Distribute--The delivery of a prescription drug or device other than by administering or dispensing.
(17) Downtime--Period of time during which a data processing system is not operable.
(18) Drug regimen review--An evaluation of prescription drug orders and patient medication records for:
1. (A) known allergies;
2. (B) rational therapy-contraindications;
3. (C) reasonable dose and route of administration;
4. (D) reasonable directions for use;
5. (E) duplication of therapy;
6. (F) drug-drug interactions;
7. (G) drug-food interactions;
8. (H) drug-disease interactions;
9. (I) adverse drug reactions; and
10. (J) proper utilization, including overutilization or underutilization.
(19) Electronic prescription drug order--A prescription drug order which is transmitted by an electronic device to the receiver (pharmacy).
(20) 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:
1. (A) maintain a permanent list of the unique security codes assigned to persons authorized to use the data processing system; and
2. (B) have an ongoing security program which is capable of identifying misuse and/or unauthorized use of electronic signatures.
(21) 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.
(22) Hard copy--A physical document that is readable without the use of a special device (i.e., cathode ray tube (CRT), microfiche reader, etc.).
(23) Hot water-The temperature of water from the pharmacy's sink maintained at a minimum of 105 degrees F (41 degrees C).
(24) Medical Practice Act--The Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.
(25) Medication order--A written order from a practitioner or a verbal order from a practitioner or his authorized agent for administration of a drug or device.
(26) New prescription drug order--A prescription drug order that:
1. (A) has not been dispensed to the patient in the same strength and dosage form by this pharmacy within the last year;
2. (B) is transferred from another pharmacy; and/or
3. (C) is a discharge prescription drug order. (Note: furlough prescription drug orders are not considered new prescription drug orders.)
(27) Original prescription--The:
1. (A) original written prescription drug order; or
2. (B) original verbal or electronic prescription drug order reduced to writing either manually or electronically by the pharmacist.
(28) Part-time pharmacist--A pharmacist who works less than full-time.
(29) Patient counseling--Communication by the pharmacist of information to the patient or patient's agent in order to improve therapy by ensuring proper use of drugs and devices.
(30) Pharmaceutical care--The provision of drug therapy and other pharmaceutical services intended to assist in the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process.
(31) 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.
(32) Pharmacy technician--An individual who is registered with the board as a pharmacy technician and 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.
(33) 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.
(34) Physician assistant--A physician assistant recognized by the Texas Medical Board as having the specialized education and training required under Subtitle B, Chapter 157, Occupations Code, and issued an identification number by the Texas Medical Board.
(35) Practitioner--
1. (A) a person licensed or registered to prescribe, distribute, administer, or dispense a prescription drug or device in the course of professional practice in this state, including a physician, dentist, podiatrist, or veterinarian but excluding a person licensed under this subtitle;
2. (B) a person licensed by another state, Canada, or the United Mexican States in a health field in which, under the law of this state, a license holder in this state may legally prescribe a dangerous drug;
3. (C) a person practicing in another state and licensed by another state as a physician, dentist, veterinarian, or podiatrist, who has a current federal Drug Enforcement Administration registration number and who may legally prescribe a Schedule II, III, IV, or V controlled substance, as specified under Chapter 481, Health and Safety Code, in that other state; or
4. (D) an advanced practice nurse or physician assistant to whom a physician has delegated the authority to carry out or sign prescription drug orders under §§157.0511, 157.052, 157.053, 157.054, 157.0541, or 157.0542, Occupations Code.
(36) Prepackaging--The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container into a prescription container for dispensing by a pharmacist to the ultimate consumer.
(37) Prescription drug--
1. (A) a substance for which federal or state law requires a prescription before the substance may be legally dispensed to the public;
2. (B) a drug or device that under federal law is required, before being dispensed or delivered, to be labeled with the statement:
  1. (i) "Caution: federal law prohibits dispensing without prescription" or "Rx only" or another legend that complies with federal law; or
  2. (ii) "Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian"; or
3. (C) a drug or device that is required by federal or state statute or regulation to be dispensed on prescription or that is restricted to use by a practitioner only.
(38) Prescription drug order--
1. (A) a written order from a practitioner or a verbal order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or
2. (B) a written order or a verbal order pursuant to Subtitle B, Chapter 157, Occupations Code.
(39) Prospective drug use review--A review of the patient's drug therapy and prescription drug order or medication order prior to dispensing or distributing the drug.
(40) State--One of the 50 United States of America, a U.S. territory, or the District of Columbia.
(41) Texas Controlled Substances Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended.
(42) Written protocol--A physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Texas Medical Board under the Texas Medical Practice Act.

Source Note:The provisions of this §291.31 adopted to be effective November 5, 1982, 7 TexReg 3830; amended to be effective March 31, 1986, 11 TexReg 1349; amended to be effective September 14, 1988, 13 TexReg 4305; amended to be effective September 5, 1990, 15 TexReg 4807; amended to be effective March 18, 1991, 16 TexReg 1365; amended to be effective January 1, 1993, 17 TexReg 9116; amended to be effective June 1, 1994, 19 TexReg 3921; amended to be effective December 1, 1994, 19 TexReg 9179; amended to be effective March 21, 1996, 21 TexReg 2227; amended to be effective April 7, 1997, 22 TexReg 3106; amended to be effective September 16, 1999, 24 TexReg 7227; amendedtobe effectiveMarch 29, 2000, 25 TexReg 2575; amended to be effective March 4, 2004, 29 TexReg 1951; amended to be effective June 6, 2004, 29 TexReg 5361; amended to be effective September 18, 2007, 32 TexReg 6319.