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RULE §291.93Operational Standards

        (III) the total number of indigent patients served by the clinic during the previous fiscal year or calendar year;

        (IV) the percentage of clinic patients who are indigent, based upon the patient population during the previous fiscal year or calendar year;

        (V) the proposed formulary and the need for additional types of drugs based upon objectives of the clinic; and

        (VI) if the provision of any drugs on the proposed formulary require special monitoring, the clinic pharmacy shall submit relevant sections of the clinic's policy and procedure manual regarding the provision of drugs that require special monitoring.

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

        (I) Such renewal petition shall contain the documentation required in clause (i) of this subparagraph.

        (II) If at the time of renewal of the pharmacy license, the patient population for the previous fiscal year or calendar year is below 80% indigent patients, the clinic shall be required to submit an application for a Class A pharmacy license or shall limit the clinic formulary to those types of drugs and devices listed in subparagraph (B) of this paragraph.

      (iii) If a Class D pharmacy wishes to add additional drugs to the expanded formulary, the pharmacy shall petition the board in writing prior to adding such drugs to the formulary. The petition shall identify drugs to be added and the need for the additional drugs based upon objectives of the clinic as specified in clause (i) of this subparagraph.

      (iv) The following additional requirements shall be satisfied for clinic pharmacies with expanded formularies.

        (I) Supportive personnel who are providing drugs shall be licensed nurses or practitioners.

        (II) The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall make on-site visits to the clinic at least monthly.

        (III) If the pharmacy provides drugs which require special monitoring (i.e., drugs which require follow-up laboratory work or drugs which should not be discontinued abruptly), the pharmacy shall have policies and procedures for the provision of the prescription drugs to patients and the monitoring of patients who receive such drugs.

        (IV) The pharmacist-in-charge, consultant pharmacists, or staff pharmacists shall conduct retrospective drug regimen reviews of a random sample of patients of the clinic on at least a quarterly basis. The pharmacist-in-charge shall be responsible for ensuring that a report regarding the drug regimen review, including the number of patients reviewed, is submitted to the clinic's medical director and the pharmacy and therapeutics committee of the clinic.

        (V) If a pharmacy provides antipsychotic drugs:

          (-a-) a practitioner of the clinic shall initiate the therapy;

          (-b-) a practitioner shall monitor and order ongoing therapy; and

          (-c-) the patient shall be physically examined by the practitioner at least on a yearly basis.

      (v) The board may consider the following items in approving or disapproving a petition for an expanded formulary:

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

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

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

        (IV) the objectives of the clinic.

  (2) Storage.

    (A) Drugs and/or devices which bear the words "Caution, Federal Law Prohibits Dispensing without prescription" or "Rx only" shall be stored in secured storage areas.

    (B) All drugs shall be stored at the proper temperatures, as defined in §291.15 of this title (relating to Storage of Drugs).

    (C) Any drug or device bearing an expiration date may not be provided, dispensed, or administered beyond the expiration date of the drug or device.

    (D) Outdated drugs or devices shall be removed from stock and shall be quarantined together until such drugs or devices are disposed.

    (E) Controlled substances may not be stored at the Class D pharmacy.

  (3) Drug samples.

    (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.


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