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TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER HOTHER CLASSES OF PHARMACY
RULE §291.151Pharmacies Located in a Freestanding Emergency Medical Care Facility (Class F)

      (ix) loading drugs into an automated medication supply system. For the purpose of this clause, direct supervision may be accomplished by physically present supervision or electronic monitoring by a pharmacist.

    (C) Procedures.

      (i) Pharmacy technicians and pharmacy technician trainees shall handle medication orders in accordance with standard written procedures and guidelines.

      (ii) Pharmacy technicians and pharmacy technician trainees shall handle prescription drug orders in the same manner as pharmacy technicians or pharmacy technician trainees working in a Class A pharmacy.

    (D) Special requirements for compounding non-sterile preparations. All pharmacy technicians and pharmacy technician trainees engaged in compounding non-sterile preparations shall meet the training requirements specified in §291.131 of this title.

  (5) Owner. The owner of an FEMCF pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:

    (A) establishing policies for procurement of prescription drugs and devices and other products dispensed from the FEMCF pharmacy;

    (B) establishing and maintaining effective controls against the theft or diversion of prescription drugs;

    (C) if the pharmacy uses an automated medication supply system, reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;

    (D) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and

    (E) establishing policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.

  (6) Identification of pharmacy personnel. All pharmacy personnel shall be identified as follows:

    (A) Pharmacy technicians. All pharmacy technicians shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician.

    (B) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.

    (C) Pharmacist interns. All pharmacist interns shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist intern.

    (D) Pharmacists. All pharmacists shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist.

(d) Operational standards.

  (1) Licensing requirements.

    (A) An FEMCF pharmacy shall register annually or biennially 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).

    (B) An FEMCF pharmacy which changes ownership shall notify the board within 10 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).

    (C) An FEMCF pharmacy which changes location and/or name shall notify the board of the change within 10 days and file for an amended license as specified in §291.3 of this title.

    (D) A 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 10 days of the change, following the procedures in §291.3 of this title.

    (E) An FEMCF pharmacy shall notify the board in writing within 10 days of closing, following the procedures in §291.5 of this title (relating to Closing a Pharmacy).

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

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

    (H) An FEMCF pharmacy, which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(1), concerning community pharmacy (Class A), is not required to secure a license for the other type of pharmacy; provided, however, such license is required to 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), to the extent such sections are applicable to the operation of the pharmacy.

    (I) An FEMCF pharmacy engaged in the compounding of non-sterile preparations shall comply with the provisions of §291.131 of this title.

  (2) Environment.

    (A) General requirements.

      (i) Each FEMCF shall have a designated work area separate from patient areas, and which shall have space adequate for the size and scope of pharmaceutical services and shall have adequate space and security for the storage of drugs.

      (ii) The FEMCF pharmacy shall be arranged in an orderly fashion and shall be kept clean. All required equipment shall be clean and in good operating condition.

    (B) Special requirements.

      (i) The FEMCF pharmacy shall have locked storage for Schedule II controlled substances and other controlled drugs requiring additional security.

      (ii) The FEMCF pharmacy shall have a designated area for the storage of poisons and externals separate from drug storage areas.

    (C) Security.

      (i) The pharmacy and storage areas for prescription drugs and/or devices shall be enclosed and capable of being locked by key, combination, or other mechanical or electronic means, so as to prohibit access by unauthorized individuals. Only individuals authorized by the pharmacist-in-charge may enter the pharmacy or have access to storage areas for prescription drugs and/or devices.

      (ii) The pharmacist-in-charge shall consult with FEMCF personnel with respect to security of the drug storage areas, including provisions for adequate safeguards against theft or diversion of dangerous drugs, controlled substances, and records for such drugs.

      (iii) The pharmacy shall have locked storage for Schedule II controlled substances and other drugs requiring additional security.

  (3) Equipment and supplies. FEMCFs supplying drugs for outpatient use shall have the following equipment and supplies:

    (A) data processing system including a printer or comparable equipment;

    (B) adequate supply of child-resistant, moisture-proof, and light-proof containers; and

    (C) adequate supply of prescription labels and other applicable identification labels.

  (4) Library. A reference library shall be maintained that includes the following in hard copy or electronic format and that pharmacy personnel shall be capable of accessing at all times:

    (A) current copies of the following:

      (i) Texas Pharmacy Act and rules;

      (ii) Texas Dangerous Drug Act and rules;

      (iii) Texas Controlled Substances Act and rules; and

      (iv) Federal Controlled Substances Act and rules or official publication describing the requirements of the Federal Controlled Substances Act and rules;

    (B) at least one current or updated general drug information reference which is required to contain drug interaction information including information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken; and

    (C) basic antidote information and the telephone number of the nearest regional poison control center.

  (5) Drugs.

    (A) Procurement, preparation, and storage.

      (i) The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may receive input from other appropriate staff of the facility, relative to such responsibility.

      (ii) The pharmacist-in-charge shall have the responsibility for determining specifications of all drugs procured by the facility.

      (iii) FEMCF pharmacies may not sell, purchase, trade, or possess prescription drug samples, unless the pharmacy meets the requirements as specified in §291.16 of this title (relating to Samples).

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

      (v) Any drug bearing an expiration date may not be dispensed or distributed beyond the expiration date of the drug.

      (vi) Outdated drugs shall be removed from dispensing stock and shall be quarantined together until such drugs are disposed of.

    (B) Formulary.

      (i) A formulary may be developed by an appropriate committee of the FEMCF.

      (ii) The pharmacist-in-charge, consultant pharmacist, or designee shall be a full voting member of any committee which involves pharmaceutical services.

      (iii) A practitioner may grant approval for pharmacists at the FEMCF to interchange, in accordance with the facility's formulary, for the drugs on the practitioner's medication orders provided:

        (I) a formulary has been developed;

        (II) the formulary has been approved by the medical staff of the FEMCF;

        (III) there is a reasonable method for the practitioner to override any interchange; and

        (IV) the practitioner authorizes a pharmacist in the FEMCF to interchange on his/her medication orders in accordance with the facility's formulary through his/her written agreement to abide by the policies and procedures of the medical staff and facility.

    (C) Prepackaging and loading drugs into automated medication supply system.

      (i) Prepackaging of drugs.

        (I) Drugs may be prepackaged in quantities suitable for internal distribution only by a pharmacist or by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist.

        (II) The label of a prepackaged unit shall indicate:

          (-a-) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;

          (-b-) facility's lot number;

          (-c-) expiration date; and

          (-d-) quantity of the drug, if quantity is greater than one.

        (III) Records of prepackaging shall be maintained to show:

          (-a-) the name of the drug, strength, and dosage form;

          (-b-) facility's lot number;

          (-c-) manufacturer or distributor;

          (-d-) manufacturer's lot number;

          (-e-) expiration date;

          (-f-) quantity per prepackaged unit;

          (-g-) number of prepackaged units;

          (-h-) date packaged;

          (-i-) name, initials, or electronic signature of the prepacker; and

          (-j-) signature or electronic signature of the responsible pharmacist.

        (IV) Stock packages, repackaged units, and control records shall be quarantined together until checked/released by the pharmacist.

      (ii) Loading bulk unit of use drugs into automated medication supply systems. Automated medication supply systems may be loaded with bulk unit of use drugs only by a pharmacist, by pharmacy technicians or pharmacy technician trainees under the direction and direct supervision of a pharmacist, or by a licensed nurse who is authorized by the pharmacist to perform the loading of the automated medication supply system. For the purpose of this clause, direct supervision may be accomplished by physically present supervision or electronic monitoring by a pharmacist. In order for the pharmacist to electronically monitor, the medication supply system must allow for bar code scanning to verify the loading of drugs, and a record of the loading must be maintained by the system and accessible for electronic review by the pharmacist.

  (6) Medication orders.

    (A) Drugs may be administered to patients in FEMCFs only on the order of a practitioner. No change in the order for drugs may be made without the approval of a practitioner except as authorized by the practitioner in compliance with paragraph (5)(B) of this subsection.

    (B) Drugs may be distributed only pursuant to the copy of the practitioner's medication order.

Cont'd...

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