| (a) Purpose. The purpose of this section is to create
a new class of pharmacy for the provision of pharmacy services by
a Class A or Class C pharmacy in a location that is not at the same
location as the Class A or Class C pharmacy through a satellite pharmacy
and to provide standards for the operation of this class of pharmacy
established under §560.053 of the Texas Pharmacy Act.
(b) 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 as defined in the Act or in §291.31 of this
title (relating to Definitions).
(1) Provider pharmacy--The Class A or Class C pharmacy
providing satellite pharmacy services.
(2) Satellite pharmacy--A facility not located at the
same location as a Class A or Class C pharmacy at which satellite
pharmacy services are provided.
(3) Satellite pharmacy services--The provision of pharmacy
services, including the storage and delivery of prescription drugs,
in an alternate location.
(c) General requirements.
(1) A Class A or Class C provider pharmacy may establish
a satellite pharmacy in a location that is not at the same location
as the Class A or Class C pharmacy.
(2) The pharmacist-in-charge of the provider pharmacy
is responsible for all pharmacy operations involving the satellite
pharmacy including supervision of satellite pharmacy personnel and
compliance with this section.
(3) A satellite pharmacy may not store bulk drugs and
may only store prescription medications that have been previously
verified and dispensed by the provider pharmacy.
(4) A Class C pharmacy that is a provider pharmacy
dispensing outpatient prescriptions for a satellite pharmacy shall
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.
(5) The provider pharmacy and the satellite pharmacy
must have:
(A) the same owner; and
(B) share a common electronic file or have appropriate
technology to allow access to sufficient information necessary or
required to process a non-dispensing function.
(d) Personnel.
(1) All individuals working at the satellite pharmacy
shall be employees of the provider pharmacy and must report their
employment to the board as such.
(2) A satellite pharmacy shall have sufficient pharmacists
on duty to operate the satellite pharmacy competently, safely, and
adequately to meet the needs of the patients of the pharmacy.
(3) Pharmacists are solely responsible for the direct
supervision of pharmacy technicians and pharmacy technician trainees
and for designating and delegating duties, other than those listed
in paragraph (7) of this subsection, to pharmacy technicians and pharmacy
technician trainees. Each pharmacist:
(A) shall verify the accuracy of all acts, tasks, and
functions performed by pharmacy technicians and pharmacy technician
trainees; and
(B) shall be responsible for any delegated act performed
by pharmacy technicians and pharmacy technician trainees under his
or her supervision.
(4) A pharmacist shall be physically present to directly
supervise a pharmacy technician or pharmacy technician trainee who
is entering prescription data into the data processing system. Each
prescription entered into the data processing system shall be verified
at the time of data entry.
(5) All pharmacists, while on duty, shall be responsible
for complying with all state and federal laws or rules governing the
practice of pharmacy.
(6) A pharmacist shall ensure that the drug is dispensed
and delivered safely and accurately as prescribed. A pharmacist shall
ensure the safety and accuracy of the portion of the process the pharmacist
is performing.
(7) Duties in a satellite pharmacy that may only be
performed by a pharmacist are as follows:
(A) receiving oral prescription drug orders for controlled
substances and reducing these orders to writing, either manually or
electronically;
(B) interpreting or clarifying prescription drug orders;
(C) communicating to the patient or patient's agent
information about the prescription drug or device, which in the exercise
of the pharmacist's professional judgment the pharmacist deems significant,
as specified in §291.33(c) of this title;
(D) communicating to the patient or the patient's agent
on his or her request for information concerning any prescription
drugs dispensed to the patient by the pharmacy;
(E) assuring that a reasonable effort is made to obtain,
record, and maintain patient medication records;
(F) interpreting patient medication records and performing
drug regimen reviews; and
(G) performing a specific act of drug therapy management
for a patient when delegated to a pharmacist by a written protocol
from a physician licensed in this state in compliance with the Medical
Practice Act.
(8) Pharmacy technicians and pharmacy technician trainees
may not perform any of the duties listed in paragraph (7) of this
subsection. However, a pharmacist may delegate to pharmacy technicians
and pharmacy technician trainees any nonjudgmental technical duty
associated with the preparation and distribution of prescription drugs
provided:
(A) a pharmacist verifies the accuracy of all acts,
tasks, and functions performed by pharmacy technicians and pharmacy
technician trainees; and
(B) pharmacy technicians and pharmacy technician trainees
are under the direct supervision of, and responsible to, a pharmacist.
(9) Pharmacy technicians and pharmacy technician trainees
in a satellite pharmacy may perform only nonjudgmental technical duties
associated with the preparation and distribution of prescription drugs
as follows:
(A) initiating and receiving refill authorization requests;
(B) entering prescription data into a data processing
system; and
(C) reconstituting medications.
(10) In addition to the duties listed above in paragraph
(9) of this subsection, pharmacy technicians may perform the following
nonjudgmental technical duties associated with the preparation and
distribution of prescription drugs:
(A) receiving oral prescription drug orders for dangerous
drugs and reducing these orders to writing, either manually or electronically;
and
(B) transferring or receiving a transfer of original
prescription information for a dangerous drug on behalf of a patient.
(11) All satellite pharmacy personnel shall wear identification
tags or badges that bear the person's name and identifies him or her
as a pharmacist, pharmacist intern, pharmacy technician, or pharmacy
technician trainee.
(e) Operational requirements.
(1) Application for permission to provide satellite
pharmacy services.
(A) A Class A or Class C pharmacy shall make an application
to the board to provide satellite pharmacy services. The application
shall include the following:
(i) the name, address, and license number of the provider
pharmacy;
(ii) the name and address of the facility where the
satellite pharmacy will be located;
(iii) the anticipated date of opening and hours of
operation; and
(iv) a copy of the lease agreement or, if the location
of the satellite pharmacy is owned by the applicant, a notarized statement
certifying such location ownership.
(B) A renewal application shall be resubmitted every
two years in conjunction with the application for renewal of the provider
pharmacy's license. The renewal application shall contain the documentation
required in subparagraph (A) of this paragraph.
(C) Upon approval of the application, the provider
pharmacy will be sent a certificate which must be displayed at the
satellite pharmacy.
(2) Notification requirements.
(A) A provider pharmacy shall notify the board in writing
within ten days of a change of location, discontinuance of service,
or closure of a satellite pharmacy that is operated by the pharmacy.
(B) A provider pharmacy shall comply with appropriate
federal and state controlled substance registrations for each satellite
pharmacy if controlled substances are maintained at the satellite
pharmacy.
(3) Environment.
(A) The satellite pharmacy shall be arranged in an
orderly fashion and kept clean. All required equipment shall be clean
and in good operating condition.
(B) A satellite pharmacy shall contain an area which
is suitable for confidential patient counseling.
(i) Such counseling area shall:
(I) be easily accessible to both the patient and pharmacists
and not allow patient access to prescription drugs; and
(II) be designed to maintain the confidentiality and
privacy of the pharmacist/patient communication.
(ii) In determining whether the area is suitable for
confidential patient counseling and designed to maintain the confidentiality
and privacy of the pharmacist/patient communication, the board may
consider factors such as the following:
(I) the proximity of the counseling area to the check-out
or cash register area;
(II) the volume of pedestrian traffic in and around
the counseling area;
(III) the presence of walls or other barriers between
the counseling area and other areas of the pharmacy; and
(IV) any evidence of confidential information being
overheard by persons other than the patient or patient's agent or
the pharmacist or agents of the pharmacist.
(C) The satellite pharmacy shall be properly lighted
and ventilated.
(D) The temperature of the satellite pharmacy shall
be maintained within a range compatible with the proper storage of
drugs in compliance with the provisions of §291.15 of this title
(relating to Storage of Drugs). The temperature of the refrigerator
shall be maintained within a range compatible with the proper storage
of drugs requiring refrigeration.
(E) Animals, including birds and reptiles, shall not
be kept within the pharmacy and in immediately adjacent areas under
the control of the pharmacy. This provision does not apply to fish
in aquariums, guide dogs accompanying disabled persons, or animals
for sale to the general public in a separate area that is inspected
by local health jurisdictions.
(4) Security.
(A) A satellite pharmacy shall be under the continuous,
physically present supervision of a pharmacist at all times the satellite
pharmacy is open to provide pharmacy services.
(B) The satellite pharmacy shall be enclosed by walls,
partitions or other means of floor-to-ceiling enclosure. In addition
to the security requirements outlined in §291.33(b)(2) of this
title, satellite pharmacies shall have adequate security and procedures
to:
(i) prohibit unauthorized access;
(ii) comply with federal and state regulations; and
(iii) maintain patient confidentiality.
(C) Access to the satellite pharmacy shall be limited
to pharmacists, pharmacy technicians, and pharmacy technician trainees
employed by the provider pharmacy and who are designated in writing
by the pharmacist-in-charge.
(D) The provider pharmacy shall have procedures that
specify that prescriptions may only be delivered to the satellite
pharmacy by the provider pharmacy and shall:
(i) be delivered in a sealed container with a list
of the prescriptions delivered;
(ii) be signed for on receipt by the pharmacist at
the satellite pharmacy; and
(iii) be checked by personnel designated by the pharmacist-in-charge
to verify that the prescriptions sent by the provider pharmacy were
actually received. The designated person who checks the order shall
document the verification by signing and dating the list of prescriptions
delivered.
(5) Prescription dispensing and delivery. A satellite
pharmacy shall comply with the requirements outlined in §291.33(c)
of this title with regard to prescription dispensing and delivery.
(6) Equipment and supplies. A satellite pharmacy shall
have the following equipment and supplies:
(A) typewriter or comparable equipment;
(B) refrigerator, if storing drugs requiring refrigeration;
and
(C) metric-apothecary weight and measure conversion
charts.
(7) Library. A reference library shall be maintained
by the satellite pharmacy that includes the following in hard-copy
or electronic format:
(A) current copies of the following:
(i) Texas Pharmacy Act and rules;
(ii) Texas Dangerous Drug Act and rules;
(iii) Texas Controlled Substances Act and rules; and
Cont'd... |
