SECTION 291.91. Definitions

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