| (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,
or 252, 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.
(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
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.
Cont'd... |
