(a) Purpose. The purpose of this section is to provide standards in the conduct, practice activities, and operation of a pharmacy located in a freestanding ambulatory surgical center that is licensed by the Texas Department of State Health Services. Class C pharmacies located in a freestanding ambulatory surgical center shall comply with this section, in lieu of §§291.71 - 291.75 of this title (relating to Purpose; Definitions; Personnel; Operational Standards; and Records).     
      (b) Definitions. The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.      
        (1) Act--The Texas Pharmacy Act, Occupations Code, Subtitle J, as amended.       
        (2) Administer--The direct application of a prescription drug by injection, inhalation, ingestion, or any other means to the body of a patient by:                  (A) a practitioner, an authorized agent under his supervision, or other person authorized by law; or                   (B) the patient at the direction of a practitioner.         
        (3) Ambulatory surgical center (ASC)--A freestanding facility that is licensed by the Texas Department of State Health Services that primarily provides surgical services to patients who do not require overnight hospitalization or extensive recovery, convalescent time, or observation. The planned total length of stay for an ASC patient shall not exceed 23 hours. Patient stays of greater than 23 hours shall be the result of an unanticipated medical condition and shall occur infrequently. The 23-hour period begins with the induction of anesthesia.       
        (4) Automated medication supply system--A mechanical system that performs operations or activities relative to the storage and distribution of medications for administration and which collects, controls, and maintains all transaction information.       
        (5) Board--The Texas State Board of Pharmacy.       
        (6) Consultant pharmacist--A pharmacist retained by a facility on a routine basis to consult with the ASC in areas that pertain to the practice of pharmacy.       
        (7) Controlled substance--A drug, immediate precursor, or other substance listed in Schedules I - V or Penalty Groups 1 - 4 of the Texas Controlled Substances Act, as amended, or a drug immediate precursor, or other substance included in Schedules I - V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513).       
        (8) Dispense--Preparing, packaging, compounding, or labeling for delivery a prescription drug or device in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner.       
        (9) Distribute--The delivery of a prescription drug or device other than by administering or dispensing.       
        (10) Downtime--Period of time during which a data processing system is not operable.       
        (11) Electronic signature--A unique security code or other identifier which specifically identifies the person entering information into a data processing system. A facility which utilizes electronic signatures must:                  (A) maintain a permanent list of the unique security codes assigned to persons authorized to use the data processing system; and                   (B) have an ongoing security program which is capable of identifying misuse and/or unauthorized use of electronic signatures.         
        (12) Floor stock--Prescription drugs or devices not labeled for a specific patient and maintained at a nursing station or other ASC department (excluding the pharmacy) for the purpose of administration to a patient of the ASC.       
        (13) Formulary--List of drugs approved for use in the ASC by an appropriate committee of the ambulatory surgical center.       
        (14) Hard copy--A physical document that is readable without the use of a special device (i.e., data processing system, computer, etc.).       
        (15) Investigational new drug--New drug intended for investigational use by experts qualified to evaluate the safety and effectiveness of the drug as authorized by the federal Food and Drug Administration.       
        (16) Medication order--An order from a practitioner or his authorized agent for administration of a drug or device.       
        (17) Pharmacist-in-charge--Pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy.       
        (18) Pharmacy--Area or areas in a facility, separate from patient care areas, where drugs are stored, bulk compounded, delivered, compounded, dispensed, and/or distributed to other areas or departments of the ASC, or dispensed to an ultimate user or his or her agent.       
        (19) Prescription drug--                  (A) A substance for which federal or state law requires a prescription before it may be legally dispensed to the public;                   (B) A drug or device that under federal law is required, prior to being dispensed or delivered, to be labeled with either of the following statements:                      (i) Caution: federal law prohibits dispensing without prescription or "Rx only" or another legend that complies with federal law; or                       (ii) Caution: federal law restricts this drug to use by or on order of a licensed veterinarian; or                     (C) A drug or device that is required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by a practitioner only.         
        (20) Prescription drug order--                  (A) An order from a practitioner or his authorized agent to a pharmacist for a drug or device to be dispensed; or                   (B) An order pursuant to Subtitle B, Chapter 157, Occupations Code.         
        (21) Full-time pharmacist--A pharmacist who works in a pharmacy from 30 to 40 hours per week or if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open.       
        (22) Part-time pharmacist--A pharmacist who works less than full-time.       
        (23) Pharmacy technician--An individual who is registered with the board as a pharmacy technician and whose responsibility in a pharmacy is to provide technical services that do not require professional judgment regarding preparing and distributing drugs and who works under the direct supervision of and is responsible to a pharmacist.       
        (24) Pharmacy technician trainee--An individual who is registered with the board as a pharmacy technician trainee and is authorized to participate in a pharmacy's technician training program.       
        (25) Texas Controlled Substances Act--The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended.       
      (c) Personnel.      
        (1) Pharmacist-in-charge.                  (A) General. Each ambulatory surgical center shall have one pharmacist-in-charge who is employed or under contract, at least on a consulting or part-time basis, but may be employed on a full-time basis.                   (B) Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following:                      (i) establishing specifications for procurement and storage of all materials, including drugs, chemicals, and biologicals;                       (ii) participating in the development of a formulary for the ASC, subject to approval of the appropriate committee of the ASC;                       (iii) distributing drugs to be administered to patients pursuant to the practitioner's medication order;                       (iv) filling and labeling all containers from which drugs are to be distributed or dispensed;                       (v) maintaining and making available a sufficient inventory of antidotes and other emergency drugs, both in the pharmacy and patient care areas, as well as current antidote information, telephone numbers of regional poison control center, and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the ASC;                       (vi) maintaining records of all transactions of the ASC pharmacy as may be required by applicable state and federal law, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials;                       (vii) participating in those aspects of the ASC's patient care evaluation program which relate to pharmaceutical material utilization and effectiveness;                       (viii) participating in teaching and/or research programs in the ASC;                       (ix) implementing the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the ASC;                       (x) providing effective and efficient messenger and delivery service to connect the ASC pharmacy with appropriate areas of the ASC on a regular basis throughout the normal workday of the ASC;                       (xi) labeling, storing, and distributing investigational new drugs, including maintaining information in the pharmacy and nursing station where such drugs are being administered, concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions, and symptoms of toxicity of investigational new drugs;                       (xii) meeting all inspection and other requirements of the Texas Pharmacy Act and this subsection;                       (xiii) maintaining records in a data processing system such that the data processing system is in compliance with the requirements for a Class C (institutional) pharmacy located in a freestanding ASC; and                       (xiv) ensuring that a pharmacist visits the ASC at least once each calendar week that the facility is open.           
        (2) Consultant pharmacist.                  (A) The consultant pharmacist may be the pharmacist-in-charge.                   (B) A written contract shall exist between the ASC and any consultant pharmacist, and a copy of the written contract shall be made available to the board upon request.         
        (3) Pharmacists.                  (A) General.                      (i) The pharmacist-in-charge shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the ASC pharmacy competently, safely, and adequately to meet the needs of the patients of the facility.                       (ii) All pharmacists shall assist the pharmacist-in-charge in meeting the responsibilities as outlined in paragraph (1)(B) of this subsection and in ordering, administering, and accounting for pharmaceutical materials.                       (iii) All pharmacists shall be responsible for any delegated act performed by pharmacy technicians or pharmacy technician trainees under his or her supervision.                       (iv) All pharmacists while on duty shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.                     (B) Duties. Duties of the pharmacist-in-charge and all other pharmacists shall include, but need not be limited to, the following:                      (i) receiving and interpreting prescription drug orders and oral medication orders and reducing these orders to writing either manually or electronically;                       (ii) selecting prescription drugs and/or devices and/or suppliers; and                       (iii) interpreting patient profiles.                     (C) Special requirements for compounding non-sterile preparations. All pharmacists engaged in compounding non-sterile preparations shall meet the training requirements specified in §291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations).         
        (4) Pharmacy technicians and pharmacy technician trainees.                  (A) General. All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).                   (B) Duties. Pharmacy technicians and pharmacy technician trainees may not perform any of the duties listed in paragraph (3)(B) of this subsection. Duties may include, but need not be limited to, the following functions, under the direct supervision of a pharmacist:                      (i) prepacking and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts a final check and affixes his or her name, initials, or electronic signature to the appropriate quality control records prior to distribution;                       (ii) preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders, provided a pharmacist supervises and checks the preparation;                       (iii) compounding non-sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees have completed the training specified in §291.131 of this title;                       (iv) bulk compounding, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her name, initials, or electronic signature to the appropriate quality control records prior to distribution;                       (v) distributing routine orders for stock supplies to patient care areas;                       (vi) entering medication order and drug distribution information into a data processing system, provided judgmental decisions are not required and a pharmacist checks the accuracy of the information entered into the system prior to releasing the order or in compliance with the absence of pharmacist requirements contained in subsection (d)(6)(D) and (E) of this section;                      Cont'd...