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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER ECLINIC PHARMACY (CLASS D)
RULE §291.91Definitions

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

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

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

    (A) a practitioner or an authorized agent under his supervision; or

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

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

  (4) Clinic--A facility/location other than a physician's office, where limited types of dangerous drugs or devices restricted to those listed in and approved for the clinic's formulary are stored, administered, provided, or dispensed to outpatients.

  (5) Consultant pharmacist--A pharmacist retained by a clinic on a routine basis to consult with the clinic in areas that pertain to the practice of pharmacy.

  (6) Continuous supervision--Supervision provided by the pharmacist-in-charge, consultant pharmacist, and/or staff pharmacist, and consists of on-site and telephone supervision, routine inspection, and a policy and procedure manual.

  (7) 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).

  (8) Dangerous drug--Any drug or device that is not included in Penalty Groups 1-4 of the Controlled Substances Act and that is unsafe for self-medication or any drug or device that bears or is required to bear the legend:

    (A) "Caution: federal law prohibits dispensing without prescription" or "Rx only";

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

  (9) 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.

  (10) Indigent--Person who meets or falls below 185% of federal poverty income guidelines as established from time to time by the United States Department of Health and Human Services.

  (11) Limited type of device--An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a practitioner, that is contained in the clinic formulary and is to be administered, dispensed, or provided according to the objectives of the clinic.

  (12) Limited type of drug--A dangerous drug contained in the clinic formulary, and to be administered, dispensed, or provided according to the objectives of the clinic.

  (13) Outpatient--An ambulatory patient who comes to a clinic to receive services related to the objectives of the clinic and departs the same day.

  (14) Pharmacist--A person licensed by the board to practice pharmacy.

  (15) Pharmacist-in-charge--The pharmacist designated on a pharmacy license as the pharmacist who is responsible for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy.

  (16) Practitioner--

    (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 the Act;

    (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;

    (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

    (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.

  (17) Prepackaging--A method of packaging a drug product into a single container which contains more than one dosage unit and usually contains sufficient quantity of medication for one normal course of therapy.

  (18) Provide--To supply one or more units of use of a nonprescription drug or dangerous drug to a patient.

  (19) Standing delegation order--Written orders from a physician and designed for a patient population with specific diseases, disorders, health problems, or sets of symptoms, which provide authority for and a plan for use with patients presenting themselves prior to being examined or evaluated by a physician to assure that such acts are carried out correctly and are distinct from specific orders written for a particular patient.

  (20) Standing medical order--Written orders from a physician or the medical staff of an institution for patients which have been examined or evaluated by a physician and which are used as a guide in preparation for and carrying out medical and/or surgical procedures.

  (21) Supportive personnel--Individuals under the supervision of a pharmacist-in-charge, designated by the pharmacist-in-charge, and for whom the pharmacist-in-charge assumes legal responsibility, who function and perform under the instructions of the pharmacist-in-charge.

  (22) Texas Controlled Substances Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended.

  (23) Unit of use--A sufficient quantity of a drug product for one normal course of therapy.


Source Note: The provisions of this §291.91 adopted to be effective January 7, 1987, 11 TexReg 5128; amended to be effective January 29, 1992, 17 TexReg 324; amended to be effective March 12, 2003, 28 TexReg 2082; amended to be effective September 7, 2008, 33 TexReg 7242; amended to be effective July 11, 2011, 36 TexReg 4412

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