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RULE §291.93Operational Standards

    (A) Drug samples of drugs listed on the Class D pharmacy's formulary and supplied by manufacturers shall be properly stored, labeled, provided, or dispensed by the Class D pharmacy in the same manner as prescribed by these sections for dangerous drugs.

    (B) Samples of controlled substances may not be stored, provided, or dispensed in the Class D pharmacy.

  (4) Prepackaging and labeling for provision.

    (A) Drugs may be prepackaged and labeled for provision in the Class D pharmacy. Such prepackaging shall be performed by a pharmacist or supportive personnel under the direct supervision of a pharmacist and shall be for the internal use of the clinic.

    (B) Drugs must be prepackaged in suitable containers.

    (C) The label of the prepackaged unit shall bear:

      (i) the name, address, and telephone number of the clinic;

      (ii) directions for use, which may include incomplete directions for use provided:

        (I) labeling with incomplete directions for use has been authorized by the pharmacy and therapeutics committee;

        (II) precise requirements for completion of the directions for use are developed by the pharmacy and therapeutics committee and maintained in the pharmacy policy and procedure manual; and

        (III) the directions for use are completed by practitioners, pharmacists, or licensed nurses in accordance with the precise requirements developed under subclause (II) of this clause;

      (iii) name and strength of the drug--if generic name, the name of the manufacturer or distributor of the drug;

      (iv) quantity;

      (v) lot number and expiration date; and

      (vi) appropriate ancillary label(s).

    (D) Records of prepackaging shall be maintained according to §291.94(c) of this title (relating to Records).

  (5) Labeling for provision of drugs and/or devices in an original manufacturer's container.

    (A) Drugs and/or devices in an original manufacturer's container shall be labeled prior to provision with the information set out in paragraph (4)(C) of this subsection.

    (B) Drugs and/or devices in an original manufacturer's container may be labeled by:

      (i) a pharmacist in a pharmacy licensed by the board; or

      (ii) supportive personnel in a Class D pharmacy, provided the drugs and/or devices and control records required by §291.94(d) of this title are quarantined together until checked and released by a pharmacist.

    (C) Records of labeling for provision of drugs and/or devices in an original manufacturer's container shall be maintained according to §291.94(d) of this title.

  (6) Provision.

    (A) Drugs and devices may only be provided to patients of the clinic.

    (B) At the time of the initial provision, a licensed nurse or practitioner shall provide verbal and written information to the patient or patient's agent on side effects, interactions, and precautions concerning the drug or device provided. If the provision of subsequent drugs is delivered to the patient at the patient's residence or other designated location, the following is applicable:

      (i) Written information as specified in subparagraph (B) of this paragraph shall be delivered with the medication.

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

      (iii) The pharmacy shall use a delivery system which is designed to ensure that the drugs are delivered to the appropriate patient.

    (C) The provision of drugs or devices shall be under the continuous supervision of a pharmacist according to standing delegation orders or standing medical orders and in accordance with written policies and procedures and completion of the label as specified in subparagraph (G) of this paragraph.

    (D) Drugs and/or devices may only be provided in accordance with the system of control and accountability for drugs and/or devices provided by the clinic; such system shall be developed and supervised by the pharmacist-in-charge.

    (E) Only drugs and/or devices listed in the clinic formulary may be provided.

    (F) Drugs and/or devices may only be provided in prepackaged quantities in suitable containers and/or original manufacturer's containers which are appropriately labeled as set out in paragraphs (4) and (5) of this subsection.

    (G) Such drugs and/or devices shall be labeled by a pharmacist licensed by the board; however, when drugs and/or devices are provided under the supervision of a physician according to standing delegation orders or standing medical orders, supportive personnel may at the time of provision print on the label the following information or affix an ancillary label containing the following information:

      (i) patient's name; however, the patient's partner or family member is not required to be on the label of a drug prescribed for a partner for a sexually transmitted disease or for a patient's family members if the patient has an illness determined by the Centers for Disease Control and Prevention, the World Health Organization, or the Governor's office to be pandemic;

      (ii) any information necessary to complete the directions for use in accordance with paragraph (4)(C)(ii) of this subsection;

      (iii) date of provision; and

      (iv) practitioner's name.

    (H) Records of provision shall be maintained according to §291.94(e) of this title.

    (I) Controlled substances may not be provided or dispensed.

    (J) Non-sterile preparations may only be provided by the clinic pharmacy in accordance with §291.131 of this title (relating to Pharmacies Compounding Non-sterile Preparations).

  (7) Dispensing. Dangerous drugs may only be dispensed by a pharmacist pursuant to a prescription order in accordance with §§291.31 - 291.35 of this title (relating to Community Pharmacy (Class A)) and §291.131 of this title.

(f) Pharmacy and therapeutics committee.

  (1) The clinic pharmacy shall have a pharmacy and therapeutics committee, which shall be composed of at least three persons and shall include the pharmacist-in-charge, the medical director of the clinic, and a person who is responsible for provision of drugs and devices.

  (2) The pharmacy and therapeutics committee shall develop the policy and procedure manual.

  (3) The pharmacy and therapeutics committee shall meet at least annually to:

    (A) review and update the policy and procedure manual; and

    (B) review the retrospective drug utilization review reports submitted by the pharmacist-in-charge if the clinic pharmacy has an expanded formulary.

(g) Policies and procedures.

  (1) Written policies and procedures shall be developed by the pharmacy and therapeutics committee and implemented by the pharmacist-in-charge.

  (2) The policy and procedure manual shall include, but not be limited to, the following:

    (A) a current list of the names of the pharmacist-in-charge, consultant-pharmacist, staff pharmacist(s), supportive personnel designated to provide drugs or devices, and the supportive personnel designated to supervise the day-to-day pharmacy related operations of the clinic in the absence of the pharmacist;

    (B) functions of the pharmacist-in-charge, consultant pharmacist, staff pharmacist(s), and supportive personnel;

    (C) objectives of the clinic;

    (D) formulary;

    (E) a copy of written agreement between the pharmacist-in-charge and the clinic;

    (F) date of last review/revision of policy and procedure manual; and

    (G) policies and procedures for:

      (i) security;

      (ii) equipment;

      (iii) sanitation;

      (iv) licensing;

      (v) reference materials;

      (vi) storage;

      (vii) packaging-repackaging;

      (viii) dispensing;

      (ix) provision;

      (x) retrospective drug regimen review;

      (xi) supervision;

      (xii) labeling-relabeling;

      (xiii) samples;

      (xiv) drug destruction and returns;

      (xv) drug and device procuring;

      (xvi) receiving of drugs and devices;

      (xvii) delivery of drugs and devices;

      (xviii) recordkeeping; and

      (xix) inspection.

(h) Supervision. The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall personally visit the clinic on at least a monthly basis to ensure that the clinic is following established policies and procedures. However, clinics operated by state or local governments and clinics funded by government sources money may petition the board for an alternative visitation schedule under the following conditions.

  (1) Such petition shall contain an affidavit with the notarized signatures of the medical director, the pharmacist-in-charge, and the owner/chief executive officer of the clinic, which states that the clinic has a current policy and procedure manual on file, has adequate security to prevent diversion of dangerous drugs, and is in compliance with all rules governing Class D pharmacies.

  (2) The board may consider the following items in determining an alternative schedule:

    (A) the degree of compliance on past compliance inspections;

    (B) the size of the patient population of the clinic;

    (C) the number and types of drugs contained in the formulary; and

    (D) the objectives of the clinic.

  (3) Such petition shall be resubmitted every two years in conjunction with the application for renewal of the pharmacy license.

Source Note: The provisions of this §291.93 adopted to be effective January 7, 1987, 11 TexReg 5128; amended to be effective July 29, 1987, 12 TexReg 2339; amended to be effective February 17, 1988, 13 TexReg 613; amended to be effective September 14, 1988, 13 TexReg 4575; amended to be effective September 27, 1991, 16 TexReg 5071; amended to be effective January 29, 1992, 17 TexReg 324; amended to be effective March 25, 1999, 24 TexReg 2022; amended to be effective June 20, 2001, 26 TexReg 4513; amended to be effective March 12, 2003, 28 TexReg 2082; amended to be effective September 7, 2008, 33 TexReg 7242; amended to be effective September 9, 2012, 37 TexReg 6917;amendedtobe effective December 5, 2012, 37 TexReg 9513; amended to be effective March 19, 2017, 42 TexReg 1127; amended to be effective September 6, 2017, TexReg 4467

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