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

   1. (1) Designated agent or authorized agent--An individual under the supervision of a practitioner, designated in writing by the practitioner, and for whom the practitioner assumes responsibility, who communicates the practitioner's instructions to the pharmacist. The written designation of an agent authorized to communicate prescriptions shall be maintained in the usual place of business of the practitioner and shall be available for inspection by investigators for the Texas State Board of Medical Examiners, the State Board of Dental Examiners, the State Board of Veterinary Medical Examiners, or the Department of Public Safety.

   2. (2) Emergency rule--For the purpose of authorizing an oral prescription for a Schedule II substance, the term "emergency situation" means those situations in which the prescribing practitioner determines that:

      1. (A) immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user;
      2. (B) no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II; and
      3. (C) it is not reasonably possible for the prescribing practitioner to provide a written prescription to a pharmacist prior to the dispensing.

   3. (3) 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 center--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.

   4. (4) Institutional practitioner--

      1. (A) An individual who meets each of the following qualifications:

         1. (i) not yet licensed by the appropriate state professional licensing board;
         2. (ii) enrolled in a bona fide professional training program;
         3. (iii) in a base hospital or institutional training facility registered by the Federal Drug Enforcement Administration; and
         4. (iv) authorized by the base hospital or training institution to administer, dispense, or prescribe controlled substances.
      2. (B) Institutional practitioner shall be limited to interns, residents, fellows, or their equivalent.
   5. (5) Medical purpose--The utilization of controlled substances for the purpose of relieving or curing mental or physical diseases or infirmities.
   6. (6) Possession--The actual care, custody, control, or management.
   7. (7) Prescribe--A direction or authorization, by prescription, permitting an ultimate user lawfully to obtain controlled substances from any person authorized by law to dispense such substances.
   8. (8) Triplicate prescription--The official Texas Department of Public Safety prescription form utilized to administer, dispense, prescribe, or deliver a Schedule II narcotic and/or Schedule II-N nonnarcotic controlled substance to an ultimate user.
   9. (9) Ultimate user--A person who has lawfully obtained and possesses a controlled substance for his own use or for the use of a member of his household or for administering to an animal owned by him or a member of his 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 Triplicate Prescription Section, Texas Department of Public Safety, P.O. Box 4087, Austin, Texas 78773.

3. (c) Purpose of issuing triplicate prescriptions.

   1. (1) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription not issued in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Texas Controlled Substances Act, §481.074, and the person knowingly filling such a purported prescription, as well as the person issuing it, may be subject to the penalties provided for violation of the provisions of law or rules relating to controlled substances.
   2. (2) Prescriptions for Schedule II controlled substances shall be issued on the triplicate prescription form only and may not be refilled.

4. (d) Emergency dispensing of Schedule II controlled substances. No controlled substance in Schedule II may be administered, dispensed, prescribed, or delivered without the written prescription of a practitioner on a triplicate prescription form, except that in emergency situations, as defined as follows:

   1. (1) Schedule II controlled substances may be dispensed upon oral or telephonically communicated prescription of a practitioner or a practitioner's designated agent reduced promptly to writing by the pharmacy and filed by the pharmacy. Within 72 hours after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written triplicate prescription, with the "Check if Emergency" block marked and indicating the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to other requirements of the Code of Federal Regulations, Title 21, Chapter 2, Part 1306.05, the prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The federal regulation will be deemed satisfied by marking the block at the bottom of the triplicate prescription form indicating "Check if Emergency" and filling in "Date Issued" space at top of form;
   2. (2) the written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the 72-hour period. Upon receipt, the dispensing pharmacist shall attach Copy 2 of the triplicate prescription to the oral emergency prescription which has earlier been reduced to writing;
   3. (3) the dispensing pharmacist shall send Copy 1 of the triplicate prescription to the Department of Public Safety within 30 days from the date the prescription is filled. Copy 2 of the triplicate prescription, along with the copy of the oral emergency prescription, will be retained by the pharmacy for two years for inspection purposes. No prescription for a Schedule II controlled substance may be refilled.

5. (e) Partial dispensing of Schedule II controlled substances.

   1. (1) If unable to supply the full quantity called for in a written or emergency oral prescription for a Schedule II controlled substance, the pharmacist may partially dispense the prescription and complete the prescription under the following conditions.

      1. (A) The pharmacist notes the initial partial quantity dispensed on the face of the written prescription or emergency oral prescription.
      2. (B) The remaining portion of the prescription is dispensed within 72 hours of the first partial dispensing. No further quantity may be dispensed beyond 72 hours without a new prescription.
      3. (C) If the remaining portion of the prescription is not or cannot be dispensed within the 72-hour period, the pharmacist shall notify the prescribing practitioner.

   2. (2) A pharmacist may dispense a prescription for a Schedule II controlled substance in partial quantities to include individual dosage units, for a patient in a long-term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness under the following conditions.

      1. (A) The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Texas Controlled Substances Act.
      2. (B) If there is any question about whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient.

      3. (C) For each partial dispensing, the dispensing pharmacist shall record on the back of Copy 1 and Copy 2 of the prescription the:

         1. (i) date of the partial dispensing;
         2. (ii) quantity dispensed;
         3. (iii) remaining quantity authorized to be dispensed; and
         4. (iv) identification of the dispensing pharmacist.
      4. (D) Prior to any subsequent partial dispensing the pharmacist must determine that the additional partial dispensing is necessary.
      5. (E) The total quantity of the Schedule II controlled substances dispensed in all partial dispensings must not exceed the total quantity prescribed.
      6. (F) Schedule II prescriptions for patients in a long-term care facility or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 30 days from the issue date unless sooner terminated by discontinuance of the medication.

6. (f) Exceptions to use of triplicate prescriptions.

   1. (1) A medication order written for a patient who is admitted to a hospital at the time the medication order is written and filled is not required to be on a triplicate prescription.

      1. (A) Medication order, as used in this subsection, will mean a drug order issued for administration to a patient admitted to a hospital.

      2. (B) Admitted to a hospital, as used in this subsection, will include the following:

         1. (i) general hospitals, special hospitals, ambulatory surgical centers, and surgical duties in dental schools;
         2. (ii) hospital clinics and emergency room admittance, if the clinic and/or emergency room is under the control, direction, and administration as an integral part of the general or special hospital.

   2. (2) A prescription written and filled for a patient who is admitted to a hospital at the time the prescription is written and filled is not required to be on a triplicate prescription; however, such prescription shall comply with the requirements of the Texas Pharmacy Act, Texas Civil Statutes, Article 4542a-1, §40(g).

      1. (A) Schedule II controlled substances may be dispensed by a practitioner or pharmacy of the hospital to a patient who has been admitted to a hospital and who will require an emergency quantity of controlled substances upon release from the hospital. These Schedule II controlled substances may only be dispensed to a patient while such patient is still admitted to and a resident of the hospital.
      2. (B) The amount of Schedule II controlled substances dispensed under this subsection may only be the amount needed for proper treatment of the patient until access to a pharmacy other than the hospital pharmacy is possible, but in no event may exceed a seven-day supply. However, when an emergency supply is dispensed from the emergency room of the hospital, the amount dispensed may not exceed a 72-hour supply.
      3. (C) The Schedule II controlled substances dispensed under the situations outlined in subparagraph (B) of this paragraph must be in a properly labeled container.

7. (g) Pharmacist responsibilities.

   1. (1) Upon receipt of Copy 1 and Copy 2 of a properly completed triplicate prescription from a practitioner, each dispensing pharmacist shall utilize the "Pharmacy Use Only" section and record the following.

      1. (A) Pharmacy name, address, area code/telephone number, and Drug Enforcement Administration number. This information may be printed, typed, or rubber stamped, or the pharmacist may use a label that is securely affixed in this area.
      2. (B) The dispensing pharmacist's signature shall be entered in a space located directly below the pharmacy information.
      3. (C) Enter in the spaces provided the date filled and the pharmacy prescription number.
      4. (D) Ensure that the drug prescribed and/or its substitute is legible on Copy 1 and Copy 2 of the triplicate prescription.
   2. (2) No Schedule II prescription may be dispensed after the end of the seventh day following the date of issuance.

   3. (3) A pharmacist may dispense a prescription that is orally or telephonically communicated by a practitioner or his designated agent for a Schedule II controlled substance in "emergency situations," as defined by subsection (a)(2) of this section.

      1. (A) In such emergency situations the dispensing pharmacist shall reduce promptly to writing the following:

         1. (i) name, address, and Federal Drug Enforcement Administration number of the dispensing practitioner;
         2. (ii) drug prescribed, the dosage, and instructions for use;
         3. (iii) name, address, and age of the person for whom the controlled substance is prescribed (or if an animal, the species and owner's name and address).
      2. (B) The pharmacist shall file the recorded information as set out in subsection (d) of this section in the pharmacy's Schedule II prescription files.
      3. (C) Within the 72 hours from the time the emergency oral or telephonic communication was received, the practitioner must provide the dispensing pharmacy with the triplicate prescription corresponding to the oral prescription order. If such triplicate prescription is not provided, the pharmacist shall contact the Department of Public Safety and the Drug Enforcement Administration.
      4. (D) The practitioner is required to place the date issued on the triplicate prescription and such date shall be the date the practitioner or his designated agent communicated the emergency oral or telephonic prescription to the pharmacy.
      5. (E) The practitioner shall check the block at the bottom of the triplicate prescription which indicates the prescription is an emergency order. If the practitioner fails to check such block, the pharmacist should do so.
      6. (F) The pharmacist shall attach Copy 2 to the oral emergency prescription which was reduced to writing upon receipt from the practitioner or practitioner's designated agent.
   4. (4) Within 30 days from the date a pharmacist fills a triplicate prescription or no later than the 30th day after completion of a prescription dispensed under subsection (e)(2) of this section, the pharmacy is required to mail Copy 1 of the form to the Texas Department of Public Safety, Triplicate Prescription Section, P.O. Box 4087, Austin, Texas 78773.
   5. (5) Should a prescription be written on a triplicate prescription by a practitioner for a controlled substance other than a Schedule II, the pharmacist may dispense the prescription but shall mark the prescription in such way as to clearly indicate that the drug dispensed is not a Schedule II controlled substance.

Source Note:The provisions of this §291.35 adopted to be effective November 5, 1982, 7 TexReg 3830; amended to be effective September 5, 1990, 15 TexReg 4807; amended to be effective January 1, 1993, 17 TexReg 9116; amended to be effective June 1, 1994, 19 TexReg 3921.