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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

(a) Licensing requirements.

  (1) A Class E pharmacy shall register with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).

  (2) On initial application, the pharmacy shall follow the procedures specified in §291.1 of this title and then provide the following additional information specified in §560.052(c) and (f) of the Act (relating to Qualifications):

    (A) evidence that the applicant holds a pharmacy license, registration, or permit issued by the state in which the pharmacy is located;

    (B) the name of the owner and pharmacist-in-charge of the pharmacy for service of process;

    (C) evidence of the applicant's ability to provide to the board a record of a prescription drug order dispensed by the applicant to a resident of this state not later than 72 hours after the time the board requests the record;

    (D) an affidavit by the pharmacist-in-charge which states that the pharmacist has read and understands the laws and rules relating to a Class E pharmacy;

    (E) proof of creditworthiness; and

    (F) an inspection report issued not more than two years before the date the license application is received and conducted by the pharmacy licensing board in the state of the pharmacy's physical location.

      (i) A Class E pharmacy may submit an inspection report issued by an entity other than the pharmacy licensing board of the state in which the pharmacy is physically located if the state's licensing board does not conduct inspections as follows:

        (I) an individual approved by the board who is not employed by the pharmacy but acting as a consultant to inspect the pharmacy;

        (II) an agent of the National Association of Boards of Pharmacy;

        (III) an agent of another State Board of Pharmacy; or

        (IV) an agent of an accrediting body, such as the Joint Commission on Accreditation of Healthcare Organizations.

      (ii) The inspection must be substantively equivalent to an inspection conducted by the board.

  (3) On renewal of a license, the pharmacy shall complete the renewal application provided by the board and, as specified in §561.0031 of the Act, provide an inspection report issued not more than three years before the date the renewal application is received and conducted by the pharmacy licensing board in the state of the pharmacy's physical location.

    (A) A Class E pharmacy may submit an inspection report issued by an entity other than the pharmacy licensing board of the state in which the pharmacy is physically located if the state's licensing board does not conduct inspections as follows:

      (i) an individual approved by the board who is not employed by the pharmacy but acting as a consultant to inspect the pharmacy;

      (ii) an agent of the National Association of Boards of Pharmacy;

      (iii) an agent of another State Board of Pharmacy; or

      (iv) an agent of an accrediting body, such as the Joint Commission on Accreditation of Healthcare Organizations.

    (B) The inspection must be substantively equivalent to an inspection conducted by the board.

  (4) A Class E pharmacy which changes ownership shall notify the board within ten days of the change of ownership and apply for a new and separate license as specified in §291.3 of this title (relating to Required Notifications).

  (5) A Class E pharmacy which changes location and/or name shall notify the board of the change as specified in §291.3 of this title.

  (6) A Class E pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within ten days of the change, following the procedures in §291.3 of this title.

  (7) A Class E pharmacy shall notify the board in writing within ten days of closing.

  (8) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.

  (9) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance and renewal of a license and the issuance of an amended license.

  (10) The board may grant an exemption from the licensing requirements of this Act on the application of a pharmacy located in a state of the United States other than this state that restricts its dispensing of prescription drugs or devices to residents of this state to isolated transactions.

  (11) A Class E pharmacy engaged in the centralized dispensing of prescription drug or medication orders or outsourcing of prescription drug order dispensing to a central fill pharmacy shall comply with the provisions of §291.125 of this title (relating to Centralized Prescription Dispensing).

  (12) A Class E pharmacy engaged in central processing of prescription drug or medication orders shall comply with the provisions of §291.123 of this title (relating to Central Prescription or Medication Order Processing).

  (13) A Class E pharmacy engaged in the compounding of non-sterile preparations shall comply with the provisions of §291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations).

  (14) Class E pharmacy personnel shall not compound sterile preparations unless the pharmacy has applied for and obtained a Class E-S pharmacy.

  (15) A Class E pharmacy, which operates as a community type of pharmacy which would otherwise be required to be licensed under the Act §560.051(a)(1) (Community Pharmacy (Class A)), shall comply with the provisions of §291.31 of this title (relating to Definitions), §291.32 of this title (relating to Personnel), §291.33 of this title (relating to Operational Standards), §291.34 of this title (relating to Records), and §291.35 of this title (relating to Official Prescription Requirements), contained in Community Pharmacy (Class A); or which operates as a nuclear type of pharmacy which would otherwise be required to be licensed under the Act §560.051(a)(2) (Nuclear Pharmacy (Class B)), shall comply with the provisions of §291.51 of this title (relating to Purpose), §291.52 of this title (relating to Definitions), §291.53 of this title (relating to Personnel), §291.54 of this title (relating to Operational Standards), and §291.55 of this title (relating to Records), contained in Nuclear Pharmacy (Class B), to the extent such sections are applicable to the operation of the pharmacy.

(b) Prescription dispensing and delivery.

  (1) General.

    (A) All prescription drugs and/or devices shall be dispensed and delivered safely and accurately as prescribed.

    (B) The pharmacy shall maintain adequate storage or shipment containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of packaging material and devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process.

    (C) The pharmacy shall utilize a delivery system which is designed to assure that the drugs are delivered to the appropriate patient.

    (D) All pharmacists shall exercise sound professional judgment with respect to the accuracy and authenticity of any prescription drug order they dispense. If the pharmacist questions the accuracy or authenticity of a prescription drug order, he/she shall verify the order with the practitioner prior to dispensing.

    (E) Prior to dispensing a prescription, pharmacists shall determine, in the exercise of sound professional judgment, that the prescription is a valid prescription. A pharmacist may not dispense a prescription drug if the pharmacist knows or should have known that the prescription was issued on the basis of an Internet-based or telephonic consultation without a valid patient-practitioner relationship.

    (F) Subparagraph (E) of this paragraph does not prohibit a pharmacist from dispensing a prescription when a valid patient-practitioner relationship is not present in an emergency situation (e.g. a practitioner taking calls for the patient's regular practitioner).

  (2) Drug regimen review.

    (A) For the purpose of promoting therapeutic appropriateness, a pharmacist shall, prior to or at the time of dispensing a prescription drug order, review the patient's medication record. Such review shall at a minimum identify clinically significant:

      (i) inappropriate drug utilization;

      (ii) therapeutic duplication;

      (iii) drug-disease contraindications;

      (iv) drug-drug interactions;

      (v) incorrect drug dosage or duration of drug treatment;

      (vi) drug-allergy interactions; and

      (vii) clinical abuse/misuse.

    (B) Upon identifying any clinically significant conditions, situations, or items listed in subparagraph (A) of this paragraph, the pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner. The pharmacist shall document such occurrences.

  (3) Patient counseling and provision of drug information.

    (A) To optimize drug therapy, a pharmacist shall communicate to the patient or the patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgment the pharmacist deems significant, such as the following:

      (i) the name and description of the drug or device;

      (ii) dosage form, dosage, route of administration, and duration of drug therapy;

      (iii) special directions and precautions for preparation, administration, and use by the patient;

      (iv) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance and the action required if they occur;

      (v) techniques for self-monitoring of drug therapy;

      (vi) proper storage;

      (vii) refill information; and

      (viii) action to be taken in the event of a missed dose.

    (B) Such communication shall be:

      (i) provided to new and existing patients of a pharmacy with each new prescription drug order. A new prescription drug order is one that has not been dispensed by the pharmacy to the patient in the same dosage and strength within the last year;

      (ii) provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent;

      (iii) communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication; and

      (iv) reinforced with written information. The following is applicable concerning this written information:

        (I) Written information must be in plain language designed for the patient and printed in an easily readable font comparable to but no smaller than ten-point Times Roman. This information may be provided to the patient in an electronic format, such as by e-mail, if the patient or patient's agent requests the information in an electronic format and the pharmacy documents the request.

        (II) When a compounded product is dispensed, information shall be provided for the major active ingredient(s), if available.

        (III) For new drug entities, if no written information is initially available, the pharmacist is not required to provide information until such information is available, provided:

          (-a-) the pharmacist informs the patient or the patient's agent that the product is a new drug entity and written information is not available;

          (-b-) the pharmacist documents the fact that no written information was provided; and

          (-c-) if the prescription is refilled after written information is available, such information is provided to the patient or patient's agent.

        (IV) The written information accompanying the prescription or the prescription label shall contain 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.

    (C) Only a pharmacist may orally provide drug information to a patient or patient's agent and answer questions concerning prescription drugs. Non-pharmacist personnel may not ask questions of a patient or patient's agent which are intended to screen and/or limit interaction with the pharmacist.

    (D) If prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacy shall provide a toll-free telephone line which is answered during normal business hours to enable communication between the patient and a pharmacist.

Cont'd...

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