| (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 storage
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 storage 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 storage and delivery system--A mechanical
system that delivers dispensed 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 storage and delivery
system.
(F) Remote pharmacy service--The provision of pharmacy
services, including the storage and delivery of prescription drugs,
in remote delivery sites.
(3) General requirements for a provider pharmacy to
provide remote pharmacy services using an automated storage and delivery
system to deliver a previously verified prescription that is dispensed
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
storage and delivery system located at the remote delivery site including
supervision of the automated storage 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
storage 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 previously dispensed 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 storage and distribution
system shall be stored at proper temperatures, as defined in the USP/NF
and §291.15 of this title (relating to Storage of Drugs).
(G) A provider pharmacy may only provide remote pharmacy
services using an automated storage 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 storage and delivery system at the remote delivery site
must be tested by the provider pharmacy and found to 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 (relating to Definitions, Personnel, Operational
Standards, and Records for Class A (Community) Pharmacies) and this
section.
(4) Operational standards.
(A) Application to provide remote pharmacy services
using an automated storage 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 storage and delivery system.
(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 sent 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
storage 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 (relating to Notifications).
(C) Environment/Security.
(i) A provider pharmacy shall only store dispensed
drugs at a remote delivery site within an automated storage and delivery
system which is locked by key, combination or other mechanical or
electronic means so as to prohibit access by unauthorized personnel.
Cont'd... |
