| (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;
Cont'd... |
