Texas Administrative Code › Title 22 - EXAMINING BOARDS › Part 15 - TEXAS STATE BOARD OF PHARMACY › Chapter 291 - PHARMACIES › Subchapter D - INSTITUTIONAL PHARMACY (CLASS C) › Section 291.76 - Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center

Current through Reg. 49, No. 28; July 12, 2024
(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.