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

   1. (1) Act--The Texas Controlled Substances Act (Act), the Health and Safety Code, Chapter 481.

   2. (2) Administer--To directly apply a controlled substance whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by:

      1. (A) a practitioner (or in his presence, by his authorized agent); or
      2. (B) the patient or research subject at the direction and in the presence of a practitioner.
   3. (3) Agent--An authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser. It does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman when acting in the usual and lawful course of his employment.
   4. (4) At cost--The fee charged each prescribing practitioner for actual cost of the triplicate prescription form which is the average rate for printing, processing, mailing containers, binders, and cost of mailing 100 forms per package.

   5. (5) Concurring practitioner--A physician, dentist, veterinarian, or podiatrist who is a registrant as defined by the Act, §481.002(44), and who:

      1. (A) examines the patient of another physician, dentist, veterinarian, or podiatrist who is not a registrant as defined by the Act, §481.002(44), but is currently licensed by the appropriate state licensing board;
      2. (B) concurs with the diagnosis and proposed treatment made by the other; and
      3. (C) dispenses or prescribes the proper controlled substance to the patient acting in the usual course of professional practice.
   6. (6) Controlled substance--A substance, including a drug and an immediate precursor, listed in Schedules I-V or Penalty Groups 1-4 of the Act.

   7. (7) Counterfeit/simulated controlled substance--

      1. (A) a substance that is purported to be a controlled substance but is chemically different from the controlled substance it is purported to be; or
      2. (B) a controlled substance which, or the container or labeling of which, without authorization bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person who in fact manufactured, distributed, or dispensed the substance.
   8. (8) Deliver--To transfer, actually or constructively, to another a controlled substance, counterfeit substance, or drug paraphernalia, regardless of whether there is an agency relationship. The term includes offering to sell a controlled substance, counterfeit substance, or drug paraphernalia.
   9. (9) Delivery or drug transaction--The act of delivering.
   10. (10) Department--The Texas Department of Public Safety.
   11. (11) Designated agent--An individual designated under the Act, §481.073, to communicate a practitioner's instructions to a pharmacist.
   12. (12) Director--The director of the department or an employee of the department designated by the director.
   13. (13) Dispense--The delivery of a controlled substance in the course of professional practice or research, by a practitioner or person acting under the lawful order of a practitioner, to an ultimate user or research subject. The term includes the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for delivery.
   14. (14) Dispenser--A practitioner, institutional practitioner, pharmacist, or pharmacy that dispenses a controlled substance.
   15. (15) Distribute--To deliver a controlled substance other than by administering or dispensing the substance.
   16. (16) Distributor--A person who distributes.

   17. (17) Drug--A substance, other than a device or a component, part, or accessory of a device that is:

       1. (A) recognized as a drug in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or a supplement to either pharmacopoeia or the formulary;
       2. (B) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;
       3. (C) intended to affect the structure or function of the body of man or animals but is not food; or
       4. (D) intended for use as a component of a substance described in subparagraphs (A)-(C) of this paragraph.
   18. (18) Drug Enforcement Administration--The Drug Enforcement Administration of the United States Department of Justice or its successor agency.
   19. (19) Federal Controlled Substances Act--The Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 United States Code §801 et seq.) or its successor statute.

   20. (20) Hospital--

       1. (A) General hospital--Any establishment offering services, facilities, and beds for use beyond 24 hours for two or more nonrelated individuals requiring diagnosis, treatment, or care for illness, injury, deformity, abnormality, or pregnancy, and regularly maintaining at least clinical laboratory services, diagnostic x-ray services, treatment facilities which would include surgery and/or obstetrical care, and other definitive medical or surgical treatment of similar extent.
       2. (B) Special hospital--Any establishment offering services, facilities, and beds for use beyond 24 hours for two or more nonrelated individuals who are regularly admitted, treated, and discharged and require services more intensive than room, board, personal services, and general nursing care and which has clinical laboratory facilities, diagnostic x-ray facilities, treatment facilities, and/or other definitive medical treatment and has a medical house staff in regular attendance, and maintains records of the clinical work performed for each patient.
       3. (C) Ambulatory surgical centers (if licensed)--Approved surgical centers licensed by the state hospital licensing board and approved by Medicaid to do day surgery when patient is not admitted beyond a 24-hour period.

   21. (21) Institutional practitioner--An intern, resident physician, fellow, or person in an equivalent professional position who:

       1. (A) is not licensed by the appropriate state professional licensing board;
       2. (B) enrolled in a bona fide professional training program in a base hospital or institutional training facility registered by the Drug Enforcement Administration; and
       3. (C) is authorized by the base hospital or institutional training facility to administer, dispense, or prescribe controlled substances.
   22. (22) Lawful possession--The possession of a controlled substance that has been obtained in accordance with state or federal law.
   23. (23) Long-term care facility--An establishment licensed by the Texas Department of Health, Bureau of Long-term Care, which maintains emergency medical kits and furnishes (in single or multiple facilities) food and shelter to four or more persons unrelated to the proprietor and, in addition, provides minor treatment under the direction and supervision of a physician licensed by the Texas State Board of Medical Examiners or services which meet some need beyond the basic provisions of food, shelter, and laundry.

   24. (24) Manufacture--The production, preparation, propagation, compounding, conversion, or processing of a controlled substance other than marijuana, directly or indirectly by extraction from substances of natural origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes the packaging or repackaging of the substance or labeling or relabeling of its container. However, the term does not include the preparation, compounding, packaging, or labeling of a controlled substance:

       1. (A) by a practitioner as an incident to his administering or dispensing of a controlled substance in the course of professional practice; or
       2. (B) by a practitioner, or by an authorized agent under the supervision of the practitioner, for or as an incident to research, teaching, or chemical analysis and not for delivery.
   25. (25) Medical purpose--The use of a controlled substance for relieving or curing a mental or physical disease or infirmity.
   26. (26) Medication order--An order from a practitioner to dispense a drug to a patient in a hospital for immediate administration while the patient is in the hospital or for emergency use on the patient's release from the hospital.
   27. (27) Official prescription blank--The triplicate prescription form supplied to practitioners at cost by the department for prescribing, administering, dispensing, or delivering Schedule II controlled substances.
   28. (28) Patient--A human for whom or an animal for which a drug is administered, dispensed, delivered, or prescribed by a practitioner.
   29. (29) Person--An individual, corporation, government, business trust, estate, trust, partnership, association, or any other legal entity.
   30. (30) Pharmacist--A person licensed by the Texas State Board of Pharmacy to practice pharmacy and who acts as an agent for a pharmacy.
   31. (31) Pharmacist-in-charge--The pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for the pharmacy's compliance with the Act and other laws relating to pharmacy.
   32. (32) Pharmacist intern--An undergraduate student enrolled in the professional sequence of a college of pharmacy approved by the Texas State Board of Pharmacy and participating in a school-based, board-approved internship program or a graduate of a college of pharmacy who is participating in a board-approved internship.
   33. (33) Pharmacy--A facility licensed by the Texas State Board of Pharmacy where a prescription for a controlled substance is received or processed in accordance with state or federal law.
   34. (34) Physician assistant, assistant, or PA--Refer specifically to a person who is a graduate of a physician assistant training program approved by the Council on Allied Health Education Accreditation of the American Medical Association or a person who has passed the examination given by the national commission on the certification of physician's assistants.
   35. (35) Possession--Actual care, custody, control, or management.

   36. (36) Practitioner--

       1. (A) a physician, dentist, veterinarian, podiatrist, scientific investigator, or other person licensed, registered, or otherwise permitted to distribute, dispense, analyze, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in this state;
       2. (B) a pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in this state; or
       3. (C) a person practicing in and licensed by another state as a physician, dentist, veterinarian, or podiatrist, having a current Drug Enforcement Administration registration number, who may legally prescribe Schedule II, III, IV, or V controlled substances in that state.
   37. (37) Prescribe--The act of a practitioner to authorize a controlled substance to be dispensed to an ultimate user.

   38. (38) Prescription--An order by a practitioner to a pharmacist for a controlled substance for a particular patient that specifies:

       1. (A) the date of issue;
       2. (B) the name and address of the patient or, if the controlled substance is prescribed for an animal, the species of the animal and the name and address of its owner;
       3. (C) the name and quantity of the controlled substance prescribed with the quantity shown numerically followed by the number written as a word if the order is written or, if the order is communicated orally or telephonically, with the quantity given by the practitioner and transcribed by the pharmacist numerically; and
       4. (D) directions for the use of the drug.
   39. (39) Principal place of business--A location where a person manufactures, distributes, dispenses, analyzes, or possesses a controlled substance. The term does not include a location where a practitioner dispenses a controlled substance on an outpatient basis unless the controlled substance is stored at that location.
   40. (40) Processing fee--The fee charged each applicant for registration or reregistration for the costs necessary for processing the application and administration of the Act.
   41. (41) Production--Includes the manufacturing, planting, cultivating, growing, or harvesting of a controlled substance.
   42. (42) Provider pharmacy--A pharmacy that has a signed agreement with a long-term care facility (LTCF) to provide controlled substances and be responsible for obtaining controlled substances registration for an emergency medical kit in the LTCF.
   43. (43) Readily retrievable--The maintenance of records required to be kept by the Act or these rules by automatic data processing or mechanized recordkeeping systems in such a manner that they can be separated from all records in a reasonable time or records maintained in a manner on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.
   44. (44) Registrant--A person who holds a current valid registration.
   45. (45) Registration--The certificate issued by both the department under the Act or by the Drug Enforcement Administration under the Federal Controlled Substance Act authorizing a registrant to distribute, dispense, analyze, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in this state unless the context clearly indicates only the registration of the department or the registration of the Drug Enforcement Administration.
   46. (46) Registration fee--The processing fee.
   47. (47) Substitution--The dispensing of a drug or a brand of drug other than that which is ordered or prescribed.
   48. (48) Supervising physician--A physician licensed by the Texas State Board of Medical Examiners either as a doctor of medicine or doctor of osteopathic medicine who is assuming responsibility and legal liability for the services rendered by the physician assistant and who has been approved by the board to supervise a specific physician assistant.
   49. (49) Triplicate prescription form--An official department prescription form used to administer, dispense, prescribe, or deliver a Schedule II controlled substance to an ultimate user.
   50. (50) Ultimate user--A person who has lawfully obtained and possesses a controlled substance for the person's own use, for the use of a member of the person's household, or for administering to an animal owned by the person or by a member of the person's household.
2. (b) Special instructions. Information and special instruction information regarding procedures under these rules and regulations will be furnished upon request by writing to the Registration Section or Triplicate Prescription Section, Narcotics Service, Texas Department of Public Safety, P.O. Box 4087, Austin, Texas 78773-0001.

Source Note:The provisions of this §13.1 adopted to be effective February 13, 1991, 16 TexReg 568; amended to be effective February 13, 1992, 17 TexReg 859.