| (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
(III) date of transaction;
(IV) name, strength, dosage form, and quantity of drug
(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:
(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;
(IV) name, initials, or identification code of the
pharmacist who checks and verifies that the system has been accurately
(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.
(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 for All Classes of Pharmacies)
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
(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
(A) Automated pharmacy system--A mechanical system
that dispenses prescription drugs and maintains related transaction
(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
(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
(D) Provider pharmacy--The community pharmacy (Class
A), the institutional pharmacy (Class C), the non-resident (Class
E) pharmacy 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 Affairs pharmacy or another federally operated pharmacy,
at which remote pharmacy services are provided using an emergency
(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
(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
(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
(ii) Such application shall be resubmitted every two
years in conjunction with the application for renewal of the provider
(iii) Upon approval of the application, the provider
pharmacy will be sent a certificate which must be displayed at the
(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 provider pharmacies shall not duplicate drugs
stored in the emergency medication kits. 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.
(i) Emergency medication kits shall have adequate security
and procedures to:
(I) prohibit unauthorized access;
(II) comply with federal and state laws and regulations;
(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.
(i) The contents of an emergency medication kit:
(I) may consist of dangerous drugs and controlled substances;
(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
(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
(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 a 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
(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;
(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;