(II) a copy of the written contract or agreement between
the pharmacy and the facility which outlines the services to be provided
and the responsibilities and accountabilities of each party in fulfilling
the terms of the contract in compliance with federal and state laws
and regulations;
(III) date of last review/revision of the policy and
procedure manual; and
(IV) policies and procedures for:
(-a-) security;
(-b-) operation of the emergency medication kit;
(-c-) preventative maintenance of the automated pharmacy
system if the emergency medication kit is an automated pharmacy system;
(-d-) sanitation;
(-e-) storage of drugs;
(-f-) dispensing;
(-g-) supervision;
(-h-) drug procurement;
(-i-) receiving of drugs;
(-j-) delivery of drugs; and
(-k-) recordkeeping.
(ii) A pharmacy that provides pharmacy services through
an emergency medication kit at a remote site shall, at least annually,
review its written policies and procedures, revise them if necessary,
and document the review.
(iii) A pharmacy providing remote pharmacy services
using an emergency medication kit which is an automated pharmacy system
shall maintain a written plan for recovery from an event which interrupts
the ability of the automated pharmacy system to provide emergency
medications. The written plan for recovery shall include:
(I) planning and preparation for maintaining pharmacy
services when an automated pharmacy system is experiencing downtime;
(II) procedures for response when an automated pharmacy
system is experiencing downtime; and
(III) procedures for the maintenance and testing of
the written plan for recovery.
(5) Records.
(A) Maintenance of records.
(i) Every record required under this section must be:
(I) kept by the provider pharmacy and be available,
for at least two years, for inspecting and copying by the board or
its representative and to other authorized local, state, or federal
law enforcement agencies; and
(II) supplied by the provider pharmacy within 72 hours,
if requested by an authorized agent of the Texas State Board of Pharmacy.
If the pharmacy maintains the records in an electronic format, the
requested records must be provided in an electronic format if specifically
requested by the board or its representative. Failure to provide the
records set out in this section, either on site or within 72 hours,
constitutes prima facie evidence of failure to keep and maintain records
in violation of the Act.
(ii) The provider pharmacy shall maintain original
prescription drug orders for drugs dispensed from an emergency medication
kit in compliance with §291.34(b) of this title.
(B) Prescriptions. Prescription drug orders shall meet
the requirements of §291.34(b) of this title.
(C) Records of dispensing. Dispensing records for a
prescription drug order shall be maintained by the provider pharmacy
in the manner required by §291.34(d) or (e) of this title.
(D) Transaction information.
(i) A prescription drug order shall be maintained by
the provider pharmacy as the record of removal of a drug from an emergency
medication kit for administration to a patient.
(ii) The remote site shall notify the provider pharmacy
electronically or in writing of each entry into an emergency medication
kit. Such notification may be included on the prescription drug order
or a separate document and shall include the name, strength, and quantity
of the drug removed, the time of removal, and the name of the person
removing the drug.
(iii) A separate record of stocking, removal, or dispensing
for administration from an emergency medication kit shall be maintained
by the pharmacy and include the:
(I) date;
(II) name, strength, dosage form, and quantity of drug
stocked, removed, or dispensed for administration;
(III) name, initials, or identification code of the
person stocking, removing, or dispensing for administration, drugs
from the system;
(IV) name, initials, or identification code of the
pharmacist who checks and verifies that the system has been accurately
filled; and
(V) unique prescription number assigned to the prescription
drug order when the drug is administered to the patient.
(E) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs sent to and returned
from a remote site separate from the records of the provider pharmacy
and from any other remote site's records; and
(II) keep a perpetual inventory of controlled substances
and other drugs required to be inventoried under §291.17 of this
title, that are received and dispensed or distributed from each remote
site.
(ii) As specified in §291.17 of this title, a
provider pharmacy shall conduct an inventory at each remote site.
The following is applicable to this inventory.
(I) The inventory of each remote site and the provider
pharmacy shall be taken on the same day.
(II) The inventory of each remote site shall be included
with, but listed separately from, the drugs of other remote sites
and separately from the drugs of the provider pharmacy.
(c) Remote pharmacy services using telepharmacy systems.
(1) Purpose. The purpose of this section is to provide
standards for the provision of pharmacy services by a Class A or Class
C pharmacy in a healthcare facility that is not at the same location
as a Class A or Class C pharmacy through a telepharmacy system as
outlined in §562.110 of the Texas Pharmacy Act.
(2) Definitions. The following words and terms, when
used in this section, shall have the following meanings, unless the
context clearly indicates otherwise. All other words and terms shall
have the meanings defined in the Act or §291.31 of this title.
(A) Provider pharmacy--
(i) a Class A pharmacy that provides pharmacy services
through a telepharmacy system at a remote dispensing site or at a
healthcare facility that is regulated by this state or the United
States; or
(ii) a Class C pharmacy that provides pharmacy services
though a telepharmacy system at a healthcare facility that is regulated
by this state or the United States.
(B) Remote dispensing site--a location licensed as
a telepharmacy that is authorized by a provider pharmacy through a
telepharmacy system to store and dispense prescription drugs and devices,
including dangerous drugs and controlled substances.
(C) Remote healthcare site--a healthcare facility regulated
by this state or the United States that is a:
(i) rural health clinic regulated under 42 U.S.C. Section
1395x(aa);
(ii) health center as defined by 42 U.S.C. Section
254b;
(iii) healthcare facility located in a medically underserved
area as determined by the United States Department of Health and Human
Services;
(iv) healthcare facility located in a health professional
shortage area as determined by the United States Department of Health
and Human Services; or
(v) a federally qualified health center as defined
by 42 U.S.C. Section 1396d(I)(2)(B).
(D) Remote pharmacy service--The provision of pharmacy
services, including the storage and dispensing of prescription drugs,
drug regimen review, and patient counseling, at a remote site.
(E) Remote site--a remote healthcare site or a remote
dispensing site.
(F) Still image capture--A specific image captured
electronically from a video or other image capture device.
(G) Store and forward--A video or still image record
which is saved electronically for future review.
(H) Telepharmacy system--A system that monitors the
dispensing of prescription drugs and provides for related drug use
review and patient counseling services by an electronic method which
shall include the use of the following types of technology:
(i) audio and video;
(ii) still image capture; and
(iii) store and forward.
(3) General requirements.
(A) A provider pharmacy may provide remote pharmacy
services using a telepharmacy system at a:
(i) remote healthcare site; or
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