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

      (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 on microfilm, microfiche, or other system which 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.

  (6) 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, and if for a controlled substance, the address and DEA registration number of the practitioner;

      (iv) name and strength of the drug prescribed;

      (v) quantity prescribed;

      (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; and

      (viii) date of issuance.

    (B) All original electronic prescription drug orders shall bear:

      (i) name of the patient, 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, and if for a controlled substance, the address and DEA registration number of the practitioner;

      (iv) name and strength of the drug prescribed;

      (v) quantity prescribed;

      (vi) directions for use;

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

      (viii) date of issuance;

      (ix) a statement which indicates that the prescription has been electronically transmitted (e.g., Faxed to or electronically transmitted to);

      (x) name, address, and electronic access number of the pharmacy to which the prescription was transmitted;

      (xi) telephone number of the prescribing practitioner;

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

      (xiii) if transmitted by a designated agent, the full name of the designated agent.

    (C) All original written prescriptions carried out or signed by an advanced practice nurse or physician assistant in accordance with Subtitle B, Chapter 157, Occupations Code, shall bear:

      (i) name and address of the patient;

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

      (iii) name, identification number, original signature and if the prescription is for a controlled substance, the DEA number of the advanced practice nurse or physician assistant;

      (iv) address and telephone number of the clinic at which the prescription drug order was carried out or signed;

      (v) name, strength, and quantity of the drug;

      (vi) directions for use;

      (vii) indications for use, if appropriate;

      (viii) date of issuance; and

      (ix) number of refills authorized.

    (D) 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) effective January 1, 2009, 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;

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

      (vii) effective June 1, 2010, for each new prescription the initials or identification code of the pharmacist responsible for providing counseling.

  (7) Refills.

    (A) Refills may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order.

    (B) 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.

    (C) 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.

    (D) 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.

    (E) 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 which 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.

    (F) 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 which 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.

(c) Patient medication records.

  (1) A patient medication record system shall be maintained by the pharmacy for patients to whom prescription drug orders are dispensed.

  (2) The patient medication record system shall provide for the immediate retrieval of information for the previous 12 months which is necessary for the dispensing pharmacist to conduct a prospective drug regimen review at the time a prescription drug order is presented for dispensing.

  (3) The pharmacist-in-charge shall assure that a reasonable effort is made to obtain and record in the patient medication record at least the following information:

    (A) full name of the patient for whom the drug is prescribed;

    (B) address and telephone number of the patient;

    (C) patient's age or date of birth;

    (D) patient's gender;

    (E) any known allergies, drug reactions, idiosyncrasies, and chronic conditions or disease states of the patient and the identity of any other drugs currently being used by the patient which may relate to prospective drug regimen review;

    (F) pharmacist's comments relevant to the individual's drug therapy, including any other information unique to the specific patient or drug; and

    (G) a list of all prescription drug orders dispensed (new and refill) to the patient by the pharmacy during the last two years. Such list shall contain the following information:

      (i) date dispensed;

      (ii) name, strength, and quantity of the drug dispensed;

      (iii) prescribing practitioner's name;

      (iv) unique identification number of the prescription; and

Cont'd...

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