Texas Administrative Code
Title 22 - EXAMINING BOARDS
Part 15 - TEXAS STATE BOARD OF PHARMACY
Chapter 291 - PHARMACIES
Subchapter G - SERVICES PROVIDED BY PHARMACIES
Section 291.121 - Remote Pharmacy Services
Universal Citation: 22 TX Admin Code § 291.121
Current through Reg. 49, No. 52; December 27, 2024
(a) Remote pharmacy services using automated pharmacy 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 facility that is not at the same location as the Class A
or Class C pharmacy through an automated pharmacy system as outlined in
§562.109 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.
(A) Automated
pharmacy system--A mechanical system that dispenses prescription drugs and
maintains related transaction information.
(B) Prepackaging--The act of repackaging and
relabeling quantities of drug products from a manufacturer's original
commercial container, or quantities of unit dosed drugs, into another cartridge
or container for dispensing by a pharmacist using an automated pharmacy
system.
(C) Provider pharmacy--The
community pharmacy (Class A) or the institutional pharmacy (Class C) providing
remote pharmacy services.
(D)
Remote pharmacy service--The provision of pharmacy services, including the
storage and dispensing of prescription drugs, in remote sites.
(E) Remote site--A facility not located at
the same location as a Class A or Class C pharmacy, at which remote pharmacy
services are provided using an automated pharmacy dispensing system.
(F) Unit dose--An amount of a drug packaged
in a dosage form ready for administration to a particular patient, by the
prescribed route at the prescribed time, and properly labeled with name,
strength, and expiration date of the drug.
(3) General requirements.
(A) A provider pharmacy may provide remote
pharmacy services using an automated pharmacy system to a jail or prison
operated by or for the State of Texas, a jail or prison operated by local
government or a healthcare facility regulated under Chapter 142, 241, 242, 247,
252, 464, 534, or 577, Health and Safety Code, provided drugs are administered
by a licensed healthcare professional working in the jail, prison, or
healthcare facility.
(B) A provider
pharmacy may provide remote pharmacy services at more than one remote
site.
(C) Before providing remote
pharmacy services, the automated pharmacy system at the remote site must be
tested by the provider pharmacy and found to dispense accurately. The provider
pharmacy shall make the results of such testing available to the board upon
request.
(D) A provider pharmacy
which is licensed as an institutional (Class C) pharmacy is required to comply
with the provisions of §§
291.31-
291.34 of this title (relating to
Definitions, Personnel, Operational Standards, and Records, respectively) and
this section.
(E) The
pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy
operations involving the automated pharmacy system located at the remote site
including supervision of the automated pharmacy system and compliance with this
section.
(F) A pharmacist from the
provider pharmacy shall be accessible at all times to respond to patients' or
other health professionals' questions and needs pertaining to drugs dispensed
through the use of the automated pharmacy system. Such access may be through a
24 hour pager service or telephone which is answered 24 hours a day.
(4) Operational standards.
(A) Application for permission to provide
pharmacy services using an automated pharmacy system.
(i) A Class A or Class C Pharmacy shall file
a completed application containing all information required by the board to
provide remote pharmacy services using an automated pharmacy system and pay the
application fee specified in §
291.6(e)(1) of
this title (relating to Pharmacy License Fees).
(ii) Such application shall be resubmitted
every two years in conjunction with the application for renewal of the provider
pharmacy's license.
(iii) Upon
approval of the application, the provider pharmacy will be issued a certificate
which must be displayed at the remote site.
(B) Notification requirements.
(i) A provider pharmacy shall notify the
board in writing within ten days of a discontinuance of service, or closure of:
(I) a remote site where an automated pharmacy
system is operated by the pharmacy; or
(II) a remote pharmacy service at a remote
site.
(ii) A provider
pharmacy shall comply with appropriate federal and state controlled substance
registrations for each remote site if controlled substances are maintained
within an automated pharmacy system at the facility.
(iii) A provider pharmacy shall file a change
of location and/or name of a remote site as specified in §
291.3 of this title (relating to
Notifications).
(C)
Environment/Security.
(i) A provider pharmacy
shall only store drugs at a remote site within an automated pharmacy system
which is locked by key, combination or other mechanical or electronic means so
as to prohibit access by unauthorized personnel.
(ii) An automated pharmacy system shall be
under the continuous supervision of a provider pharmacy pharmacist. To qualify
as continuous supervision, the pharmacist is not required to be physically
present at the site of the automated pharmacy system if the system is
supervised electronically by a pharmacist.
(iii) Automated pharmacy systems shall have
adequate security and procedures to:
(I)
comply with federal and state laws and regulations; and
(II) maintain patient
confidentiality.
(iv)
Access to the automated pharmacy system shall be limited to pharmacists or
personnel who:
(I) are designated in writing
by the pharmacist-in-charge; and
(II) have completed documented training
concerning their duties associated with the automated pharmacy
system.
(v) Drugs shall
be stored in compliance with the provisions of §
291.15 of this title (relating to
Storage of Drugs) and §
291.33(f)(2) of
this title including the requirements for temperature and handling of outdated
drugs.
(D) Prescription
dispensing and delivery.
(i) Drugs shall only
be dispensed at a remote site through an automated pharmacy system after
receipt of an original prescription drug order by a pharmacist at the provider
pharmacy in a manner authorized by §
291.34(b) of this
title.
(ii) A pharmacist at the
provider pharmacy shall control all operations of the automated pharmacy system
and approve the release of the initial dose of a prescription drug order.
Subsequent doses from an approved prescription drug order may be removed from
the automated medication system after this initial approval. Any change made in
the prescription drug order shall require a new approval by a pharmacist to
release the drug.
(iii) A
pharmacist at the provider pharmacy shall conduct a drug regimen review as
specified in §
291.33(c) of this
title prior to releasing a prescription drug order to the automated pharmacy
system.
(iv) Drugs dispensed by the
provider pharmacy through an automated pharmacy system shall comply with the
labeling or labeling alternatives specified in §
291.33(c) of this
title.
(v) An automated pharmacy
system used to meet the emergency medication needs for residents of a remote
site must comply with the requirements for emergency medication kits in
subsection (b) of this section.
(E) Drugs.
(i) Drugs for use in an automated pharmacy
system shall be packaged in the original manufacturer's container or be
prepackaged in the provider pharmacy and labeled in compliance with the board's
prepackaging requirements for the class of pharmacy.
(ii) Drugs dispensed from the automated
pharmacy system may be returned to the pharmacy for reuse provided the drugs
are in sealed, tamper evident packaging which has not been opened.
(F) Stocking an automated pharmacy
system.
(i) Stocking of drugs in an automated
pharmacy system shall be completed by a pharmacist, pharmacy technician, or
pharmacy technician trainee under the direct supervision of a pharmacist,
except as provided in clause (ii) of this subparagraph.
(ii) If the automated pharmacy system uses
removable cartridges or containers to hold drugs, the prepackaging of the
cartridges or containers shall occur at the provider pharmacy unless provided
by an FDA approved repackager. The prepackaged cartridges or containers may be
sent to the remote site to be loaded into the machine by personnel designated
by the pharmacist-in-charge provided:
(I) a
pharmacist verifies the cartridge or container has been properly filled and
labeled;
(II) the individual
cartridges or containers are transported to the remote site in a secure,
tamper-evident container; and
(III)
the automated pharmacy system uses bar-coding, microchip, or other technologies
to ensure that the containers are accurately loaded in the automated pharmacy
system.
(iii) All drugs
to be stocked in the automated pharmacy system shall be delivered to the remote
site by the provider pharmacy.
(G) Quality assurance program. A pharmacy
that provides pharmacy services through an automated pharmacy system at a
remote site shall operate according to a written program for quality assurance
of the automated pharmacy system which:
(i)
requires continuous supervision of the automated pharmacy system; and
(ii) establishes mechanisms and procedures to
routinely test the accuracy of the automated pharmacy system at a minimum of
every six months and whenever any upgrade or change is made to the system and
documents each such activity.
(H) Policies and procedures of operation.
(i) A pharmacy that provides pharmacy
services through an automated pharmacy system at a remote site shall operate
according to written policies and procedures. The policy and procedure manual
shall include, but not be limited to, the following:
(I) a current list of the name and address of
the pharmacist-in-charge and personnel designated by the pharmacist-in-charge
to have access to the drugs stored in the automated pharmacy system;
(II) duties which may only be performed by a
pharmacist;
(III) a copy of the
portion 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 relating to the operation of the automated
pharmacy system in fulfilling the terms of the contract in compliance with
federal and state laws and regulations;
(IV) date of last review/revision of the
policy and procedure manual; and
(V) policies and procedures for:
(-a-) security;
(-b-) operation of the automated pharmacy
system;
(-c-) preventative
maintenance of the 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 automated pharmacy system 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 automated pharmacy system shall maintain a written plan for
recovery from an event which interrupts the ability of the automated pharmacy
system to dispense prescription drugs. 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 automated
pharmacy system in compliance with §
291.34(b) of this
title.
(iii) if prescription drug
records are maintained in a data processing system, the system shall have a
workable (electronic) data retention system which can produce a separate audit
trail of drug usage by the provider pharmacy and each remote site for the
preceding two years as specified in §
291.34(e) 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) The automated pharmacy system
shall electronically record all transactions involving drugs stored in,
removed, or dispensed from the system.
(ii) Records of dispensing from an automated
pharmacy system for a patient shall be maintained by the providing pharmacy and
include the:
(I) identity of the system
accessed;
(II) identification of
the individual accessing the system;
(III) date of transaction;
(IV) name, strength, dosage form, and
quantity of drug accessed; and
(V)
name of the patient for whom the drug was accessed.
(iii) Records of stocking or removal from an
automated pharmacy system shall be maintained by the pharmacy and include the:
(I) date;
(II) name, strength, dosage form, and
quantity of drug stocked or removed;
(III) name, initials, or identification code
of the person stocking or removing drugs from the system; and
(IV) name, initials, or identification code
of the pharmacist who checks and verifies that the system has been accurately
filled.
(E)
Patient medication records. Patient medication records shall be created and
maintained by the provider pharmacy in the manner required by §
291.34(c) of this
title.
(F) 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 (relating to
Inventory Requirements) 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.
(b) Remote pharmacy services using emergency medication kits.
(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 facility that is not at the same location as
the Class A or Class C pharmacy through an emergency medication kit as outlined
in §562.108 of the Texas Pharmacy Act.
(2) Definitions. The following words and
terms, when used in this subsection, 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) Automated pharmacy system--A mechanical
system that dispenses prescription drugs and maintains related transaction
information.
(B) Emergency
medication kits--Controlled substances and dangerous drugs maintained by a
provider pharmacy to meet the emergency medication needs of a resident:
(i) at an institution licensed under Chapter
242 or 252, Health and Safety Code; or
(ii) at an institution licensed under Chapter
242, Health and Safety Code and that is a veterans home as defined by the
§
164.002,
Natural Resources Code, if the provider pharmacy is a United States Department
of Veterans Affairs pharmacy or another federally operated pharmacy.
(C) Prepackaging--The act of
repackaging and relabeling quantities of drug products from a manufacturer's
original commercial container, or quantities of unit dosed drugs, into another
cartridge or container for dispensing by a pharmacist using an emergency
medication kit.
(D) Provider
pharmacy--The community pharmacy (Class A), the institutional pharmacy (Class
C), the non-resident pharmacy (Class E) located not more than 20 miles from an
institution licensed under Chapter 242 or 252, Health and Safety Code, or the
United States Department of Veterans Affairs pharmacy or another federally
operated pharmacy providing remote pharmacy services.
(E) Remote pharmacy service--The provision of
pharmacy services, including the storage and dispensing of prescription drugs,
in remote sites.
(F) Remote site--A
facility not located at the same location as a Class A, Class C, Class E
pharmacy or a United States Department of Veterans Affairs pharmacy or another
federally operated pharmacy, at which remote pharmacy services are provided
using an emergency medication kit.
(3) General requirements.
(A) A provider pharmacy may provide remote
pharmacy services using an emergency medication kit to an institution regulated
under Chapter 242, or 252, Health and Safety Code.
(B) A provider pharmacy may provide remote
pharmacy services at more than one remote site.
(C) A provider pharmacy shall not place an
emergency medication kit in a remote site which already has a kit from another
provider pharmacy except as provided by paragraph (4)(B)(iii) of this
subsection.
(D) A provider pharmacy
which is licensed as an institutional (Class C) or a non-resident (Class E)
pharmacy is required to comply with the provisions of §§
291.31-
291.34 of this title and this
section.
(E) The
pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy
operations involving the emergency medication kit located at the remote site
including supervision of the emergency medication kit and compliance with this
section.
(4) Operational
standards.
(A) Application for permission to
provide pharmacy services using an emergency medication kit.
(i) A Class A, Class C, or Class E pharmacy
shall file a completed application containing all information required by the
board to provide remote pharmacy services using an emergency medication kit and
pay the application fee specified in §
291.6(e)(2) of
this title.
(ii) Such application
shall be resubmitted every two years in conjunction with the application for
renewal of the provider pharmacy's license.
(iii) Upon approval of the application, the
provider pharmacy will be issued a certificate which must be displayed at the
remote site.
(B)
Notification requirements.
(i) A provider
pharmacy shall notify the board in writing within ten days of a discontinuance
of service, or closure of:
(I) a remote site
where an emergency medication kit is operated by the pharmacy; or
(II) a remote pharmacy service at a remote
site.
(ii) A provider
pharmacy shall comply with appropriate federal and state controlled substance
registrations for each remote site if controlled substances are maintained
within an emergency medication kit at the facility.
(iii) If more than one provider pharmacy
provides an emergency kit to a remote site, the provider pharmacies must enter
into a written agreement as to the emergency medications supplied by each
pharmacy. The written agreement shall include reasons why an additional
pharmacy is required to meet the emergency medication needs of the residents of
the institution.
(iv) A provider
pharmacy shall file a change of location and/or name of a remote site as
specified in §
291.3 of this title.
(C) Environment/Security.
(i) Emergency medication kits shall have
adequate security and procedures to:
(I)
prohibit unauthorized access;
(II)
comply with federal and state laws and regulations; and
(III) maintain patient
confidentiality.
(ii)
Access to the emergency medication kit shall be limited to pharmacists and
licensed healthcare personnel employed by the facility.
(iii) Drugs shall be stored in compliance
with the provisions of §
291.15 and §
291.33(f)(2) of
this title including the requirements for temperature and handling outdated
drugs.
(D) Prescription
dispensing and delivery.
(i) Drugs in the
emergency medication kit shall be accessed for administration to meet the
emergency medication needs of a resident of the remote site pursuant to an
order from a practitioner. The prescription drug order for the drugs used from
the emergency medication kit shall be forwarded to the provider pharmacy in a
manner authorized by §
291.34(b) of this
title.
(ii) The remote site shall
notify the provider pharmacy of each entry into an emergency medication kit.
Such notification shall meet the requirements of paragraph (5)(D)(ii) of this
subsection.
(E) Drugs.
(i) The contents of an emergency medication
kit:
(I) may consist of dangerous drugs and
controlled substances; and
(II)
shall be determined by the consultant pharmacist, pharmacist-in-charge of the
provider pharmacy, medical director, and the director of nurses and limited to
those drugs necessary to meet the resident's emergency medication needs. For
the purpose of this subsection, this shall mean a situation in which a drug
cannot be supplied by a pharmacy within a reasonable time period.
(ii) When deciding on the drugs to
be placed in the emergency medication kit, the consultant pharmacist,
pharmacist-in-charge of the provider pharmacy, medical director, and the
director of nurses must determine, select, and record a prudent number of drugs
for potential emergency incidents based on:
(I) clinical criteria applicable to each
facility's demographics;
(II) the
facility's census; and
(III) the
facility's healthcare environment.
(iii) A current list of the drugs stored in
each remote site's emergency medication kit shall be maintained by the provider
pharmacy and a copy kept with the emergency medication kit.
(iv) An automated pharmacy system may be used
as an emergency medication kit provided the system limits emergency access to
only those drugs approved for the emergency medication kit.
(v) Drugs for use in an emergency medication
kit shall be packaged in the original manufacturer's container or prepackaged
in the provider pharmacy and labeled in compliance with the board's
prepackaging requirements for the class of pharmacy.
(F) Stocking emergency medication kits.
(i) Stocking of drugs in an emergency
medication kit shall be completed at the provider pharmacy or remote site by a
pharmacist, pharmacy technician, or pharmacy technician trainee under the
direct supervision of a pharmacist, except as provided in clause (ii) of this
subparagraph.
(ii) If the emergency
medication kit is an automated pharmacy system which uses bar-coding,
microchip, or other technologies to ensure that the containers or unit dose
drugs are accurately loaded, the prepackaging of the containers or unit dose
drugs shall occur at the provider pharmacy unless provided by an FDA approved
repackager. The prepackaged containers or unit dose drugs may be sent to the
remote site to be loaded into the machine by personnel designated by the
pharmacist-in-charge provided:
(I) a
pharmacist verifies the container or unit dose drug has been properly filled
and labeled;
(II) the individual
containers or unit dose drugs are transported to the remote site in a secure,
tamper-evident container; and
(III)
the automated pharmacy system uses bar-coding, microchip, or other technologies
to ensure that the containers or unit dose drugs are accurately loaded in the
automated pharmacy system.
(iii) All drugs to be stocked in the
emergency medication kit shall be delivered to the remote site by the provider
pharmacy.
(G) Policies
and procedures of operation.
(i) A provider
pharmacy that provides pharmacy services through an emergency medication kit at
a remote site shall operate according to written policies and procedures. The
policy and procedure manual shall include, but not be limited to, the
following:
(I) duties which may only be
performed by a pharmacist;
(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
(ii) remote dispensing site.
(B) A provider pharmacy may not
provide remote pharmacy services at a remote healthcare site if a Class A or
Class C pharmacy that dispenses prescription drug orders to out-patients is
located in the same community, unless the remote healthcare site is a federally
qualified health center as defined by
42 U.S.C. Section
1396d(I)(2)(B). For the
purposes of this subsection a community is defined as:
(i) the census tract in which the remote site
is located, if the remote site is located in a Metropolitan Statistical Area
(MSA) as defined by the United States Census Bureau in the most recent U.S.
Census; or
(ii) within 10 miles of
the remote site, if the remote site is not located in an MSA.
(C) A provider pharmacy may not
provide remote pharmacy services at a remote dispensing site if a Class A
pharmacy is located within 22 miles by road of the remote dispensing
site.
(D) If a Class A or Class C
pharmacy is established in a community in which a remote healthcare site has
been located, the remote healthcare site may continue to operate.
(E) If a Class A pharmacy is established
within 22 miles by road of a remote dispensing site that is currently
operating, the remote dispensing site may continue to operate at that
location.
(F) Before providing
remote pharmacy services, the telepharmacy system at the remote site must be
tested by the provider pharmacy and found to operate properly. The provider
pharmacy shall make the results of such testing available to the board upon
request.
(G) A provider pharmacy
which is licensed as a Class C pharmacy is required to comply with the
provisions of §§
291.31-
291.34 of this title and this
section.
(H) A provider pharmacy
can only provide pharmacy services at no more than two remote dispensing
sites.
(4) Personnel.
(A) The pharmacist-in-charge of the provider
pharmacy is responsible for all operations at the remote site including
supervision of the telepharmacy system and compliance with this
section.
(B) The provider pharmacy
shall have sufficient pharmacists on duty such that each pharmacist may
supervise no more than two remote sites that are simultaneously open to provide
services.
(C) The following duties
shall be performed only by a pharmacist at the provider pharmacy:
(i) receiving an oral prescription drug order
for a controlled substance;
(ii)
interpreting the prescription drug order;
(iii) verifying the accuracy of prescription
data entry;
(iv) selecting the drug
product to be stored and dispensed at the remote site;
(v) interpreting the patient's medication
record and conducting a drug regimen review;
(vi) authorizing the telepharmacy system to
print a prescription label at the remote site;
(vii) performing the final check of the
dispensed prescription to ensure that the prescription drug order has been
dispensed accurately as prescribed; and
(viii) counseling the patient.
(D) A pharmacy technician at the
remote site may receive an oral prescription drug order for a dangerous
drug.
(5) Operational
standards.
(A) Application to provide remote
pharmacy services using a telepharmacy system.
(i) A Class A or Class C pharmacy shall file
a completed application containing all information required by the board to
provide remote pharmacy services using a telepharmacy system and pay the
application fee specified in §
291.6(e)(3) of
this title.
(ii) Such application
shall be resubmitted every two years in conjunction with the renewal of the
provider pharmacy's license.
(iii)
On approval of the application, the provider pharmacy will be issued a license
for the remote site, which must be displayed at the remote site.
(iv) If the average number of prescriptions
dispensed each day at a remote dispensing site is open for business is more
than 125 prescriptions, as calculated each calendar year, the remote dispensing
site shall apply for a Class A pharmacy license as specified in §
291.1 of this title (relating to
Pharmacy License Application).
(B) Notification requirements.
(i) A provider pharmacy shall notify the
board in writing within ten days of a discontinuance of service, or closure of
a remote site where a telepharmacy system is operated by the
pharmacy.
(ii) A provider pharmacy
shall comply with appropriate federal and state controlled substance
registrations for each remote site, if controlled substances are
maintained.
(iii) A provider
pharmacy shall file a change of location and/or name of a remote site as
specified in §
291.3 of this title.
(C) Environment/Security.
(i) A remote site shall be under the
continuous supervision of a provider pharmacy pharmacist at all times the site
is open to provide pharmacy services. To qualify as continuous supervision, the
pharmacist is not required to be physically present at the remote site and
shall supervise electronically through the use of the following types of
technology:
(I) audio and video;
(II) still image capture; and
(III) store and forward.
(ii) Drugs shall be stored in compliance with
the provisions of §
291.15 and §
291.33(f)(2) of
this title including the requirements for temperature and handling of outdated
drugs.
(iii) Drugs for use in the
telepharmacy system at a remote healthcare site shall be stored in an area that
is:
(I) separate from any other drugs used by
the healthcare facility; and
(II)
locked by key, combination or other mechanical or electronic means, so as to
prohibit access by unauthorized personnel.
(iv) Drugs for use in the telepharmacy system
at a remote dispensing site shall be stored in an area that is locked by key,
combination, or other mechanical or electronic means, so as to prohibit access
by unauthorized personnel.
(v)
Access to the area where drugs are stored at the remote site and operation of
the telepharmacy system shall be limited to:
(I) pharmacists employed by the provider
pharmacy;
(II) licensed healthcare
providers, if the remote site is a remote healthcare site; and
(III) pharmacy technicians;
(vi) Individuals authorized to
access the remote site and operate the telepharmacy system shall:
(I) be designated in writing by the
pharmacist-in-charge; and
(II) have
completed documented training concerning their duties associated with the
telepharmacy pharmacy system.
(vii) Remote sites shall have adequate
security and procedures to:
(I) comply with
federal and state laws and regulations; and
(II) maintain patient
confidentiality.
(D) Prescription dispensing and delivery.
(i) A pharmacist at the provider pharmacy
shall conduct a drug regimen review as specified in §
291.33(c) of this
title prior to delivery of the dispensed prescription to the patient or
patient's agent.
(ii) The dispensed
prescription shall be labeled at the remote site with the information specified
in §
291.33(c) of this
title.
(iii) A pharmacist at the
provider pharmacy shall perform the final check of the dispensed prescription
before delivery to the patient to ensure that the prescription has been
dispensed accurately as prescribed. This final check shall be accomplished
through a visual check using electronic methods.
(iv) A pharmacist at the provider pharmacy
shall counsel the patient or patient's agent as specified in §
291.33(c) of this
title. This counseling may be performed using electronic methods.
Non-pharmacist personnel may not ask questions of a patient or patient's agent
which are intended to screen and/or limit interaction with the
pharmacist.
(v) If the remote site
has direct access to the provider pharmacy's data processing system, only a
pharmacist or pharmacy technician may enter prescription information into the
data processing system.
(vi) Drugs
which require reconstitution through the addition of a specified amount of
water may be dispensed by the remote site only if a pharmacy technician,
pharmacy technician trainee, or licensed healthcare provider reconstitutes the
product.
(vii) A telepharmacy
system located at a remote dispensing site may not dispense a schedule II
controlled substance.
(viii) Drugs
dispensed at the remote site through a telepharmacy system shall only be
delivered to the patient or patient's agent at the remote site.
(E) Quality assurance program. A
pharmacy that provides remote pharmacy services through a telepharmacy system
at a remote site shall operate according to a written program for quality
assurance of the telepharmacy system which:
(i) requires continuous supervision of the
telepharmacy system at all times the site is open to provide remote pharmacy
services; and
(ii) establishes
mechanisms and procedures to routinely test the operation of the telepharmacy
system at a minimum of every six months and whenever any upgrade or change is
made to the system and documents each such activity.
(F) Policies and procedures.
(i) A pharmacy that provides pharmacy
services through a telepharmacy system at a remote site shall operate according
to written policies and procedures. The policy and procedure manual shall
include, but not be limited to, the following:
(I) a current list of the name and address of
the pharmacist-in-charge and personnel designated by the pharmacist-in-charge
to have:
(-a-) access to the area where drugs
are stored at the remote site; and
(-b-) operate the telepharmacy
system;
(II) duties which
may only be performed by a pharmacist;
(III) if the remote site is located at a
remote healthcare site, a copy of the written contact or agreement between the
provider pharmacy and the healthcare facility which outlines the services to be
provided and the responsibilities and accountabilities of each party in
fulfilling the terms of the contract or agreement in compliance with federal
and state laws and regulations;
(IV) date of last review/revision of policy
and procedure manual; and
(V)
policies and procedures for:
(-a-)
security;
(-b-) operation of the
telepharmacy system;
(-c-)
sanitation;
(-d-) storage of
drugs;
(-e-) dispensing;
(-f-) supervision;
(-g-) drug and/or device
procurement;
(-h-) receiving of
drugs and/or devices;
(-i-) delivery
of drugs and/or devices; and
(-j-)
recordkeeping.
(ii) A pharmacy that provides remote pharmacy
services through a telepharmacy system 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 through a telepharmacy system shall
maintain a written plan for recovery from an event which interrupts the ability
of a pharmacist to electronically supervise the telepharmacy system and the
dispensing of prescription drugs at the remote site. The written plan for
recovery shall include:
(I) a statement that
prescription drugs shall not be dispensed at the remote site, if a pharmacist
is not able to electronically supervise the telepharmacy system and the
dispensing of prescription drugs;
(II) procedures for response when a
telepharmacy system is experiencing downtime; and
(III) procedures for the maintenance and
testing of the written plan for recovery.
(6) Additional operational
standards for remote dispensing sites.
(A) A
pharmacist employed by a provider pharmacy shall make at least monthly on-site
visits to a remote site. The remote site shall maintain documentation of the
visit.
(B) A pharmacist employed by
a provider pharmacy shall be physically present at a remote dispensing site
when the pharmacist is providing services requiring the physical presence of
the pharmacist, including immunizations.
(C) A remote dispensing site shall be staffed
by an on-site pharmacy technician who is under the continuous supervision of a
pharmacist employed by the provider pharmacy.
(D) All pharmacy technicians at a remote
dispensing site shall be counted for the purpose of establishing the
pharmacist-pharmacy technician ratio of the provider pharmacy which,
notwithstanding Section 568.006 of the Act, may not exceed three pharmacy
technicians for each pharmacist providing supervision.
(E) A pharmacy technician working at a remote
dispensing site must:
(i) have worked at least
one year at a retail pharmacy during the three years preceding the date the
pharmacy technician begins working at the remote dispensing site; and
(ii) have completed a training program on the
proper use of a telepharmacy system.
(F) A pharmacy technician at a remote
dispensing site may not perform sterile or nonsterile compounding. However, a
pharmacy technician may prepare commercially available medications for
dispensing, including the reconstitution of orally administered powder
antibiotics.
(7) Records.
(A) Maintenance of records.
(i) Every record required under this section
must be:
(I) accessible 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 remote site
shall maintain original prescription drug orders for medications dispensed from
a remote site using a telepharmacy system in the manner required by §
291.34(b) of this
title and the provider pharmacy shall have electronic access to all
prescription records.
(iii) If
prescription drug records are maintained in a data processing system, the
system shall have a workable (electronic) data retention system which can
produce a separate audit trail of drug usage by the provider pharmacy and by
each remote site for the preceding two years as specified in §
291.34(e) of this
title.
(B) Prescriptions.
Prescription drug orders shall meet the requirements of §
291.34(b) of this
title.
(C) Patient medication
records. Patient medication records shall be created and maintained at the
remote site or provider pharmacy in the manner required by §
291.34(c) of this
title. If such records are maintained at the remote site, the provider pharmacy
shall have electronic access to those records.
(D) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs ordered and
dispensed by a remote site separate from the records of the provider pharmacy
and from any other remote site's records;
(II) keep a perpetual inventory of all
controlled substances that are received and dispensed or distributed from each
remote site. The perpetual inventory shall be reconciled, by a pharmacist
employed by the provider pharmacy, at least monthly.
(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 at the provider
pharmacy.
(III) A copy of the
inventory of the remote site shall be maintained at the remote site.
(d) Remote pharmacy services using automated dispensing and delivery 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 facility that is not at the same location as the Class A
or Class C pharmacy through an automated dispensing and delivery
system.
(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.
(A) Automated dispensing and delivery
system--A mechanical system that dispenses and delivers prescription drugs to
patients at a remote delivery site and maintains related transaction
information.
(B) Deliver or
delivery--The actual, constructive, or attempted transfer of a prescription
drug or device or controlled substance from one person to another, whether or
not for a consideration.
(C)
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.
(D) Provider
pharmacy--The community pharmacy (Class A) or the institutional pharmacy (Class
C) providing remote pharmacy services.
(E) Remote delivery site--A location at which
remote pharmacy services are provided using an automated dispensing and
delivery system.
(F) Remote
pharmacy service--The provision of pharmacy services, including the dispensing
and delivery of prescription drugs, in remote delivery sites.
(3) General requirements for a
provider pharmacy to provide remote pharmacy services using an automated
dispensing and delivery system to dispense and deliver a prescription that is
verified by the provider pharmacy to a patient or patient's agent.
(A) The pharmacist-in-charge of the provider
pharmacy is responsible for all pharmacy operations involving the automated
dispensing and delivery system located at the remote delivery site including
supervision of the automated dispensing and delivery system and compliance with
this section.
(B) The patient or
patient's agent shall receive counseling via a direct link to audio or video
communication by a Texas licensed pharmacist who has access to the complete
patient medication record (patient profile) maintained by the provider pharmacy
prior to the release of any new prescription released from the
system.
(C) A pharmacist shall be
accessible at all times to respond to patients' or other health professionals'
questions and needs pertaining to drugs delivered through the use of the
automated dispensing and delivery system. Such access may be through a 24 hour
pager service or telephone which is answered 24 hours a day.
(D) The patient or patient's agent shall be
given the option whether to use the system.
(E) An electronic notice shall be provided to
the patient or patient's agent at the remote delivery site with the following
information:
(i) the name and address of the
pharmacy that verified the prescription; and
(ii) a statement that a pharmacist is
available 24 hours a day, 7 days a week through the use of telephonic
communication.
(F) Drugs
stored in the automated dispensing and distribution system shall be stored at
proper temperatures, as defined in the USP/NF and §
291.15 of this title.
(G) A provider pharmacy may only provide
remote pharmacy services using an automated dispensing and delivery system to
patients at a board-approved remote delivery site.
(H) A provider pharmacy may provide remote
pharmacy services at more than one remote delivery site.
(I) Before providing remote pharmacy
services, the automated dispensing and delivery system at the remote delivery
site must be tested by the provider pharmacy and found to dispense and deliver
accurately. The provider pharmacy shall make the results of such testing
available to the board upon request.
(J) A provider pharmacy which is licensed as
an institutional (Class C) pharmacy is required to comply with the provisions
of §§
291.31-
291.34 of this title and this
section.
(4) Operational
standards.
(A) Application to provide remote
pharmacy services using an automated dispensing and delivery system.
(i) A community (Class A) or institutional
(Class C) pharmacy shall file a completed application containing all
information required by the board to provide remote pharmacy services using an
automated dispensing and delivery system and pay the application fee specified
in §
291.6(e)(4) of
this title.
(ii) Such application
shall be resubmitted every two years in conjunction with the application for
renewal of the provider pharmacy's license.
(iii) Upon approval of the application, the
provider pharmacy will be issued a certificate which must be displayed at the
provider pharmacy.
(B)
Notification requirements.
(i) A provider
pharmacy shall notify the board in writing within ten days of a discontinuance
of service.
(ii) A provider
pharmacy shall comply with appropriate controlled substance registrations for
each remote delivery site if dispensed controlled substances are maintained
within an automated dispensing and delivery system at the facility.
(iii) A provider pharmacy shall file an
application for change of location and/or name of a remote delivery site as
specified in §
291.3 of this title.
(C) Environment/Security.
(i) A provider pharmacy shall only store
prescription drugs at a remote delivery site within an automated dispensing and
delivery system which is locked by key, combination or other mechanical or
electronic means so as to prohibit access by unauthorized personnel.
(ii) Access to the automated dispensing and
delivery system shall be limited to pharmacists and pharmacy technicians or
pharmacy technician trainees under the direct supervision of a pharmacist who:
(I) are designated in writing by the
pharmacist-in-charge; and
(II) have
completed documented training concerning their duties associated with the
automated dispensing and delivery system.
(iii) Drugs shall be stored in compliance
with the provisions of §
291.15 of this title and §
291.33(c)(8) of
this title, including the requirements for temperature and the return of
undelivered medication to stock.
(iv) the automated dispensing and delivery
system must have an adequate security system, including security camera(s), to
prevent unauthorized access and to maintain patient confidentiality.
(D) Stocking an automated
dispensing and delivery system. Stocking of prescription drugs in an automated
dispensing and delivery system shall be completed under the supervision of a
pharmacist.
(E) Quality assurance
program. A pharmacy that provides pharmacy services through an automated
dispensing and delivery system at a remote delivery site shall operate
according to a written program for quality assurance of the automated
dispensing and delivery system which:
(i)
requires continuous supervision of the automated dispensing and delivery
system; and
(ii) establishes
mechanisms and procedures to routinely test the accuracy of the automated
dispensing and delivery system at a minimum of every six months and whenever
any upgrade or change is made to the system and documents each such
activity.
(F) Policies
and procedures of operation.
(i) A pharmacy
that provides pharmacy services through an automated dispensing and delivery
system at a remote delivery site shall operate according to written policies
and procedures. The policy and procedure manual shall include, but not be
limited to, the following:
(I) a current list
of the names and addresses of the pharmacist-in-charge and all personnel
designated by the pharmacist-in-charge to have access to the prescription drugs
stored in the automated dispensing and delivery system;
(II) duties which may only be performed by a
pharmacist;
(III) a copy of the
portion of the written contract or lease agreement between the pharmacy and the
remote delivery site location which outlines the services to be provided and
the responsibilities and accountabilities of each party relating to the
operation of the automated dispensing and delivery system in fulfilling the
terms of the contract in compliance with federal and state laws and
regulations;
(IV) date of last
review/revision of the policy and procedure manual; and
(V) policies and procedures for:
(-a-) security;
(-b-) operation of the automated dispensing
and delivery system;
(-c-)
preventative maintenance of the automated dispensing and delivery
system;
(-d-) sanitation;
(-e-) storage of prescription
drugs;
(-f-) supervision;
(-g-) delivery of prescription drugs;
and
(-h-) recordkeeping.
(ii) A pharmacy that
provides pharmacy services through an automated dispensing and delivery system
at a remote delivery 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 automated dispensing and delivery system shall maintain a
written plan for recovery from an event which interrupts the ability of the
automated dispensing and delivery system to dispense and deliver prescription
drugs. The written plan for recovery shall include:
(I) planning and preparation for maintaining
pharmacy services when an automated dispensing and delivery system is
experiencing downtime;
(II)
procedures for response when an automated dispensing and delivery 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 have a
workable (electronic) data retention system which can produce a separate audit
trail of drug delivery and retrieval transactions at each remote delivery site
for the preceding two years.
(B) Transaction information.
(i) The automated dispensing and delivery
system shall electronically record all transactions involving drugs stored in,
removed, or delivered from the system.
(ii) Records of delivery from an automated
dispensing and delivery system for a patient shall be maintained by the
provider pharmacy and include the:
(I)
identity of the system accessed;
(II) identification of the individual
accessing the system;
(III) date of
transaction;
(IV) prescription
number, drug name, strength, dosage form;
(V) number of prescriptions
retrieved;
(VI) name of the patient
for whom the prescription was retrieved;
(VII) name of prescribing practitioner;
and
(VIII) name of pharmacist
responsible for consultation with the patient, if required, and documentation
that the consultation was performed.
(iii) Records of stocking or removal from an
automated dispensing and delivery system shall be maintained by the pharmacy
and include the:
(I) count of bulk
prescription drugs stored or removed;
(II) number of dispensed prescription
packages removed;
(III) name,
initials, or identification code of the person stocking or removing
prescription drugs from the system; and
(IV) name, initials, or identification code
of the pharmacist who checks and verifies that the system has been accurately
filled.
(C) The
pharmacy shall make the automated dispensing and delivery system and any
records of the system, including testing records, available for inspection by
the board.
(D) The automated
dispensing and delivery system records a digital image of the individual
accessing the system to pick-up a prescription and such record is maintained by
the pharmacy for two years.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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