| (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 emergency medical care facility
that is licensed by the Texas Department of State Health Services
or in a freestanding emergency medical care facility operated by a
hospital that is exempt from registration as provided by §254.052,
Health and Safety Code. Class F pharmacies located in a freestanding
emergency medical care facility shall comply with this section.
(b) Definitions. The following words and terms, when
used in this section, 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) 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.
(4) Board--The Texas State Board of Pharmacy.
(5) Consultant pharmacist--A pharmacist retained by
a facility on a routine basis to consult with the FEMCF in areas that
pertain to the practice of pharmacy.
(6) 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).
(7) 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.
(8) Distribute--The delivery of a prescription drug
or device other than by administering or dispensing.
(9) Downtime--Period of time during which a data processing
system is not operable.
(10) 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.
(11) Floor stock--Prescription drugs or devices not
labeled for a specific patient and maintained at a nursing station
or other FEMCF department (excluding the pharmacy) for the purpose
of administration to a patient of the FEMCF.
(12) Formulary--List of drugs approved for use in the
FEMCF by an appropriate committee of the FEMCF.
(13) Freestanding emergency medical care facility (FEMCF)--A
freestanding facility that is licensed by the Texas Department of
State Health Services pursuant to Chapter 254, Health and Safety Code,
to provide emergency care to patients.
(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 FEMCF, 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 FEMCF 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 FEMCF, subject to approval of the appropriate committee of
the FEMCF;
(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 FEMCF;
(vi) maintaining records of all transactions of the
FEMCF 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 FEMCF's
patient care evaluation program which relate to pharmaceutical material
utilization and effectiveness;
(viii) participating in teaching and/or research programs
in the FEMCF;
(ix) implementing the policies and decisions of the
appropriate committee(s) relating to pharmaceutical services of the
FEMCF;
(x) providing effective and efficient messenger and
delivery service to connect the FEMCF pharmacy with appropriate areas
of the FEMCF on a regular basis throughout the normal workday of the
FEMCF;
(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 section; and
(xiii) maintaining records in a data processing system
such that the data processing system is in compliance with the requirements
for an FEMCF; and
(xiv) ensuring that a pharmacist visits the FEMCF 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 FEMCF
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 FEMCF 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;
(vii) maintaining inventories of drug supplies;
(viii) maintaining pharmacy records; and
Cont'd... |
