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

        (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:

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

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

      (xii) if communicated orally or telephonically:

        (I) the initials or identification code of the transcribing pharmacist; and

        (II) the name of the prescriber or prescriber's agent communicating the prescription information.

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

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

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

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

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

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

      (vi) the 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.

    (C) Prescription drug orders may be utilized as authorized in Title 26, Part 1, Chapter 554 of the Texas Administrative Code.

      (i) A prescription drug order is not required to bear the information specified in subparagraph (A) of this paragraph if the drug is prescribed for administration to an ultimate user who is institutionalized in a licensed health care institution (e.g., nursing home, hospice, hospital). Such prescription drug orders must contain the following information:

        (I) the full name of the patient;

        (II) the date of issuance;

        (III) the name, strength, and dosage form of the drug prescribed;

        (IV) directions for use; and

        (V) the signature(s) required by 26 TAC §554.1506 (relating to Drug Orders).

      (ii) Prescription drug orders for dangerous drugs shall not be dispensed following one year after the date of issuance unless the authorized prescriber renews the prescription drug order.

      (iii) Controlled substances shall not be dispensed pursuant to a prescription drug order under this subparagraph.

  (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 or her professional judgment in refilling a prescription drug order for a drug, other than a Schedule II controlled substance, 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 (relating to Operational Standards); and

      (vii) if the prescription was initially filled at another pharmacy, the pharmacist may exercise his or her 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 or her 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 man-made disasters. If a natural or man-made disaster has occurred that prohibits the pharmacist from being able to contact the practitioner, a pharmacist may exercise his or her professional judgment in refilling a prescription drug order for a drug, other than a Schedule II controlled substance, 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 of Texas 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 or her 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;

Cont'd...

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