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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER BCOMMUNITY PHARMACY (CLASS A)
RULE §291.34Records

    (C) A pharmacist may not dispense a facsimile prescription drug order for a dangerous drug or controlled substance issued by a practitioner licensed in the Dominion of Canada or the United Mexican States unless the practitioner is also licensed in Texas.

  (6) Original prescription drug order records.

    (A) Original prescriptions may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order including clarifications to the order given to the pharmacist by the practitioner or the practitioner's agent and recorded on the prescription.

    (B) Original prescriptions shall be maintained by the pharmacy in numerical order and remain legible for a period of two years from the date of filling or the date of the last refill dispensed.

    (C) If an original prescription drug order is changed, such prescription order shall be invalid and of no further force and effect; if additional drugs are to be dispensed, a new prescription drug order with a new and separate number is required. However, an original prescription drug order for a dangerous drug may be changed in accordance with paragraph (10) of this subsection relating to accelerated refills.

    (D) Original prescriptions shall be maintained in three separate files as follows:

      (i) prescriptions for controlled substances listed in Schedule II;

      (ii) prescriptions for controlled substances listed in Schedules III-V; and

      (iii) prescriptions for dangerous drugs and nonprescription drugs.

    (E) Original prescription records other than prescriptions for Schedule II controlled substances may be stored in a system that is capable of producing a direct image of the original prescription record, e.g., digitalized imaging system. If original prescription records are stored in a direct imaging system, the following is applicable:

      (i) the record of refills recorded on the original prescription must also be stored in this system;

      (ii) the original prescription records must be maintained in numerical order and separated in three files as specified in subparagraph (D) of this paragraph; and

      (iii) the pharmacy must provide immediate access to equipment necessary to render the records easily readable.

  (7) Prescription drug order information.

    (A) All original prescriptions shall bear:

      (i) name of the patient, or if such drug is for an animal, the species of such animal and the name of the owner;

      (ii) address of the patient, provided, however, a prescription for a dangerous drug is not required to bear the address of the patient if such address is readily retrievable on another appropriate, uniformly maintained pharmacy record, such as medication records;

      (iii) name, address and telephone number of the practitioner at the practitioner's usual place of business, legibly printed or stamped and if for a controlled substance, the DEA registration number of the practitioner;

      (iv) name and strength of the drug prescribed;

      (v) quantity prescribed numerically and if for a controlled substance:

        (I) numerically, followed by the number written as a word, if the prescription is written;

        (II) numerically, if the prescription is electronic; or

        (III) if the prescription is communicated orally or telephonically, as transcribed by the receiving pharmacist;

      (vi) directions for use;

      (vii) intended use for the drug unless the practitioner determines the furnishing of this information is not in the best interest of the patient;

      (viii) date of issuance;

      (ix) if a faxed prescription:

        (I) a statement that indicates that the prescription has been faxed (e.g., Faxed to); and

        (II) if transmitted by a designated agent, the name of the designated agent;

      (x) if electronically transmitted:

        (I) the date the prescription drug order was electronically transmitted to the pharmacy, if different from the date of issuance of the prescription; and

        (II) if transmitted by a designated agent, the name of the designated agent; and

      (xi) if issued by an advanced practice nurse or physician assistant in accordance with Subtitle B, Chapter 157, Occupations Code the:

        (I) name, address, telephone number, and if the prescription is for a controlled substance, the DEA number of the supervising practitioner; and

        (II) address and telephone number of the clinic where the prescription drug order was carried out or signed.

    (B) At the time of dispensing, a pharmacist is responsible for documenting the following information on either the original hard copy prescription or in the pharmacy's data processing system:

      (i) unique identification number of the prescription drug order;

      (ii) initials or identification code of the dispensing pharmacist;

      (iii) initials or identification code of the pharmacy technician or pharmacy technician trainee performing data entry of the prescription, if applicable;

      (iv) quantity dispensed, if different from the quantity prescribed;

      (v) date of dispensing, if different from the date of issuance; and

      (vi) brand name or manufacturer of the drug or biological product actually dispensed, if the drug was prescribed by generic name or interchangeable biological name or if a drug or interchangeable biological product other than the one prescribed was dispensed pursuant to the provisions of the Act, Chapters 562 and 563.

  (8) Refills.

    (A) General information.

      (i) Refills may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order except as authorized in paragraph (10) of this subsection relating to accelerated refills.

      (ii) If there are no refill instructions on the original prescription drug order (which shall be interpreted as no refills authorized) or if all refills authorized on the original prescription drug order have been dispensed, authorization from the prescribing practitioner shall be obtained prior to dispensing any refills and documented as specified in subsection (l) of this section.

    (B) Refills of prescription drug orders for dangerous drugs or nonprescription drugs.

      (i) Prescription drug orders for dangerous drugs or nonprescription drugs may not be refilled after one year from the date of issuance of the original prescription drug order.

      (ii) If one year has expired from the date of issuance of an original prescription drug order for a dangerous drug or nonprescription drug, authorization shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of the drug.

    (C) Refills of prescription drug orders for Schedules III-V controlled substances.

      (i) Prescription drug orders for Schedules III-V controlled substances may not be refilled more than five times or after six months from the date of issuance of the original prescription drug order, whichever occurs first.

      (ii) If a prescription drug order for a Schedule III, IV, or V controlled substance has been refilled a total of five times or if six months have expired from the date of issuance of the original prescription drug order, whichever occurs first, a new and separate prescription drug order shall be obtained from the prescribing practitioner prior to dispensing any additional quantities of controlled substances.

    (D) Pharmacist unable to contact prescribing practitioner. If a pharmacist is unable to contact the prescribing practitioner after a reasonable effort, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:

      (i) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;

      (ii) the quantity of prescription drug dispensed does not exceed a 72-hour supply;

      (iii) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;

      (iv) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;

      (v) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection;

      (vi) the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title; and

      (vii) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:

        (I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy that contains the essential information;

        (II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;

        (III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and

        (IV) the pharmacist complies with the requirements of clauses (ii) - (vi) of this subparagraph.

    (E) Natural or manmade disasters. If a natural or manmade disaster has occurred that prohibits the pharmacist from being able to contact the practitioner, a pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided:

      (i) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering;

      (ii) the quantity of prescription drug dispensed does not exceed a 30-day supply;

      (iii) the governor has declared a state of disaster;

      (iv) the board, through the executive director, has notified pharmacies that pharmacists may dispense up to a 30-day supply of prescription drugs;

      (v) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills;

      (vi) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time;

      (vii) the pharmacist maintains a record of the emergency refill containing the information required to be maintained on a prescription as specified in this subsection;

      (viii) the pharmacist affixes a label to the dispensing container as specified in §291.33(c)(7) of this title; and

      (ix) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his professional judgment in refilling the prescription provided:

        (I) the patient has the prescription container, label, receipt or other documentation from the other pharmacy that contains the essential information;

        (II) after a reasonable effort, the pharmacist is unable to contact the other pharmacy to transfer the remaining prescription refills or there are no refills remaining on the prescription;

        (III) the pharmacist, in his professional judgment, determines that such a request for an emergency refill is appropriate and meets the requirements of clause (i) of this subparagraph; and

        (IV) the pharmacist complies with the requirements of clauses (ii) - (viii) of this subparagraph.

    (F) Auto-Refill Programs. A pharmacy may use a program that automatically refills prescriptions that have existing refills available in order to improve patient compliance with and adherence to prescribed medication therapy. The following is applicable in order to enroll patients into an auto-refill program.

      (i) Notice of the availability of an auto-refill program shall be given to the patient or patient's agent, and the patient or patient's agent must affirmatively indicate that they wish to enroll in such a program and the pharmacy shall document such indication.

      (ii) The patients or patient's agent shall have the option to withdraw from such a program at any time.

      (iii) Auto-refill programs may be used for refills of dangerous drugs, and schedule IV and V controlled substances. Schedule II and III controlled substances may not be dispensed by an auto-refill program.

Cont'd...

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