22 Tex. Admin. Code § 291.129 - Satellite Pharmacy
(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 issued 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
(iv)
Federal Controlled Substances Act and rules (or official publication describing
the requirements of the Federal Controlled Substances Act and rules);
(B) at least one current or
updated reference from each of the following categories:
(i) patient information:
(I) United States Pharmacopeia Dispensing
Information, Volume II (Advice to the Patient); or
(II) a reference text or information leaflets
which provide patient information;
(ii) drug interactions: a reference text on
drug interactions, such as Drug Interaction Facts. A separate reference is not
required if other references maintained by the satellite pharmacy contain drug
interaction information including information needed to determine severity or
significance of the interaction and appropriate recommendations or actions to
be taken;
(iii) a general
information reference text, such as:
(I)
Facts and Comparisons with current supplements;
(II) United States Pharmacopeia Dispensing
Information Volume I (Drug Information for the Healthcare Provider);
(III) Clinical Pharmacology;
(IV) American Hospital Formulary Service with
current supplements; or
(V)
Remington's Pharmaceutical Sciences; and
(C) basic antidote information and the
telephone number of the nearest Regional Poison Control Center.
(f) Records.
(1) Maintenance of records.
(A) Every record required to be kept under
§
291.34 of this title and under
this section shall be:
(i) kept by the
provider pharmacy and be available, for at least two years from the date of
such inventory or record, 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
board. 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.
(B) Records, except
when specifically required to be maintained in original or hard-copy form, may
be maintained in an alternative data retention system, such as a data
processing system or direct imaging system provided:
(i) the records maintained in the alternative
system contain all of the information required on the manual record;
and
(ii) the data processing system
is capable of producing a hard copy of the record upon the request of the
board, its representative, or other authorized local, state, or federal law
enforcement or regulatory agencies.
(C) Prescription drug orders shall be
maintained by the provider pharmacy in the manner required by §
291.34(d) or (e)
of this title.
(2)
Prescriptions.
(A) Prescription drug orders
shall meet the requirements of §
291.34(b) of
this title.
(B) The provider
pharmacy must maintain appropriate records to identify the name(s), initials,
or identification code(s) and specific activity(ies) of each pharmacist,
pharmacy technician, or pharmacy technician trainee who performed any
processing at the satellite pharmacy.
(C) A provider pharmacy shall keep a record
of all prescriptions sent and returned between the pharmacies separate from the
records of the provider pharmacy and from any other satellite pharmacy's
records.
(D) A satellite pharmacy
shall keep a record of all prescriptions received and returned between the
pharmacies.
Notes
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