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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER FNON-RESIDENT PHARMACY (CLASS E)
RULE §291.104Operational Standards

    (E) The pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container in both English and Spanish the local and toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)."

    (F) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., nursing homes).

    (G) Upon delivery of a refill prescription, a pharmacist shall ensure that the patient or patient's agent is offered information about the refilled prescription and that a pharmacist is available to discuss the patient's prescription and provide information.

    (H) Nothing in this subparagraph shall be construed as requiring a pharmacist to provide consultation when a patient or patient's agent refuses such consultation. The pharmacist shall document such refusal for consultation.

  (4) Labeling. At the time of delivery, the dispensing container shall bear a label that contains the following information:

    (A) the name, physical address, and phone number of the pharmacy;

    (B) if the drug is dispensed in a container other than the manufacturer's original container, the date after which the prescription should not be used or beyond-use-date. Unless otherwise specified by the manufacturer, the beyond-use-date shall be one year from the date the drug is dispensed or the manufacturer's expiration date, whichever is earlier. The beyond-use-date may be placed on the prescription label or on a flag label attached to the bottle. A beyond-use-date is not required on the label of a prescription dispensed to a person at the time of release from prison or jail if the prescription is for not more than a 10-day supply of medication;

    (C) either on the prescription label or the written information accompanying the prescription, the statement, "Do not flush unused medications or pour down a sink or drain." A drug product on a list developed by the Federal Food and Drug Administration of medicines recommended for disposal by flushing is not required to bear this statement; and

    (D) any other information that is required by the pharmacy or drug laws or rules in the state in which the pharmacy is located.

(c) Substitution requirements.

  (1) Unless compliance would violate the pharmacy or drug laws or rules in the state in which the pharmacy is located a pharmacist in a Class E pharmacy may dispense a generically equivalent drug or interchangeable biological product and shall comply with the provisions of §309.3 of this title (relating to Substitution Requirements) and §309.7 of this title (relating to Dispensing Responsibilities).

  (2) The pharmacy must include on the prescription order form completed by the patient or the patient's agent information that clearly and conspicuously:

    (A) states that if a less expensive generically equivalent drug or interchangeable biological product is available for the brand prescribed, the patient or the patient's agent may choose between the generically equivalent drug or interchangeable biological product and the brand prescribed; and

    (B) allows the patient or the patient's agent to indicate the choice of the generically equivalent drug or interchangeable biological product or the brand prescribed.

(d) Therapeutic Drug Interchange. A switch to a drug providing a similar therapeutic response to the one prescribed shall not be made without prior approval of the prescribing practitioner. This subsection does not apply to generic substitution. For generic substitution, see the requirements of subsection (c) of this section.

  (1) The patient shall be notified of the therapeutic drug interchange prior to, or upon delivery, of the dispensed prescription to the patient. Such notification shall include:

    (A) a description of the change;

    (B) the reason for the change;

    (C) whom to notify with questions concerning the change; and

    (D) instructions for return of the drug if not wanted by the patient.

  (2) The pharmacy shall maintain documentation of patient notification of therapeutic drug interchange which shall include:

    (A) the date of the notification;

    (B) the method of notification;

    (C) a description of the change; and

    (D) the reason for the change.

(e) Transfer of Prescription Drug Order Information. Unless compliance would violate the pharmacy or drug laws or rules in the state in which the pharmacy is located, a pharmacist in a Class E pharmacy may not refuse to transfer prescriptions to another pharmacy that is making the transfer request on behalf of the patient. The transfer of original prescription information must be done within four business hours of the request.

(f) Prescriptions for Schedules II - V controlled substances. Unless compliance would violate the pharmacy or drug laws or rules in the state in which the pharmacy is located, a pharmacist in a Class E pharmacy who dispenses a prescription for a Schedules II - V controlled substance for a resident of Texas shall electronically send the prescription information to the Texas State Board of Pharmacy as specified in §315.6 of this title (relating to Pharmacy Responsibility - Electronic Reporting) not later than the next business day after the prescription is dispensed.


Source Note: The provisions of this §291.104 adopted to be effective September 1, 2000, 25 TexReg 2617; amended to be effective December 15, 2002, 27 TexReg 11541; amended to be effective June 23, 2003, 28 TexReg 4638; amended to be effective June 6, 2004, 29 TexReg 5397; amended to be effective June 12, 2005, 30 TexReg 3209; amended to be effective March 6, 2006, 31 TexReg 1441; amended to be effective September 18, 2007, 32 TexReg 6348; amended to be effective June 8, 2008, 33 TexReg 4307; amended to be effective December 6, 2009, 34 TexReg 8703; amended to be effective May 30, 2010, 35 TexReg 4178; amended to be effective September 12, 2011, 36 TexReg 5847; amended tobe effective December 5, 2012, 37 TexReg 9514; amended to be effective December 10, 2013, 38 TexReg 8866; amended to be effective June 11, 2015, 40 TexReg 3646; amended to be effective December 6, 2015, 40 TexReg 8779; amended to be effective September 11, 2016, 41 TexReg 6717; amended to be effective December 6, 2018, 43 TexReg 7784

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