22 Tex. Admin. Code § 291.104 - Operational Standards
(a) Licensing
requirements.
(1) A Class E pharmacy shall
register with the board on a pharmacy license application provided by the
board, following the procedures specified in §
291.1 of this title (relating to
Pharmacy License Application).
(2)
On initial application, the pharmacy shall follow the procedures specified in
§
291.1 of this title and then
provide the following additional information specified in §560.052(c) and
(f) of the Act (relating to Qualifications):
(A) evidence that the applicant holds a
pharmacy license, registration, or permit issued by the state in which the
pharmacy is located;
(B) the name
of the owner and pharmacist-in-charge of the pharmacy for service of
process;
(C) evidence of the
applicant's ability to provide to the board a record of a prescription drug
order dispensed by the applicant to a resident of this state not later than 72
hours after the time the board requests the record;
(D) an affidavit by the pharmacist-in-charge
which states that the pharmacist has read and understands the laws and rules
relating to a Class E pharmacy;
(E)
proof of creditworthiness; and
(F)
an inspection report issued not more than two years before the date the license
application is received and conducted by the pharmacy licensing board in the
state of the pharmacy's physical location.
(i) A Class E pharmacy may submit an
inspection report issued by an entity other than the pharmacy licensing board
of the state in which the pharmacy is physically located if the state's
licensing board does not conduct inspections as follows:
(I) an individual approved by the board who
is not employed by the pharmacy but acting as a consultant to inspect the
pharmacy;
(II) an agent of the
National Association of Boards of Pharmacy;
(III) an agent of another State Board of
Pharmacy; or
(IV) an agent of an
accrediting body, such as the Joint Commission on Accreditation of Healthcare
Organizations.
(ii) The
inspection must be substantively equivalent to an inspection conducted by the
board.
(3) On
renewal of a license, the pharmacy shall complete the renewal application
provided by the board and, as specified in §561.0031 of the Act, provide
an inspection report issued not more than three years before the date the
renewal application is received and conducted by the pharmacy licensing board
in the state of the pharmacy's physical location.
(A) A Class E pharmacy may submit an
inspection report issued by an entity other than the pharmacy licensing board
of the state in which the pharmacy is physically located if the state's
licensing board does not conduct inspections as follows:
(i) an individual approved by the board who
is not employed by the pharmacy but acting as a consultant to inspect the
pharmacy;
(ii) an agent of the
National Association of Boards of Pharmacy;
(iii) an agent of another State Board of
Pharmacy; or
(iv) an agent of an
accrediting body, such as the Joint Commission on Accreditation of Healthcare
Organizations.
(B) The
inspection must be substantively equivalent to an inspection conducted by the
board.
(4) A Class E
pharmacy which changes ownership shall notify the board within ten days of the
change of ownership and apply for a new and separate license as specified in
§
291.3 of this title (relating to
Required Notifications).
(5) A
Class E pharmacy which changes location and/or name shall notify the board of
the change as specified in §
291.3 of this title.
(6) A Class E pharmacy owned by a partnership
or corporation which changes managing officers shall notify the board in
writing of the names of the new managing officers within ten days of the
change, following the procedures in §
291.3 of this title.
(7) A Class E pharmacy shall notify the board
in writing within ten days of closing.
(8) A separate license is required for each
principal place of business and only one pharmacy license may be issued to a
specific location.
(9) A fee as
specified in §
291.6 of this title (relating to
Pharmacy License Fees) will be charged for the issuance and renewal of a
license and the issuance of an amended license.
(10) The board may grant an exemption from
the licensing requirements of this Act on the application of a pharmacy located
in a state of the United States other than this state that restricts its
dispensing of prescription drugs or devices to residents of this state to
isolated transactions.
(11) A Class
E pharmacy engaged in the centralized dispensing of prescription drug or
medication orders or outsourcing of prescription drug order dispensing to a
central fill pharmacy shall comply with the provisions of §
291.125 of this title (relating to
Centralized Prescription Dispensing).
(12) A Class E pharmacy engaged in central
processing of prescription drug or medication orders shall comply with the
provisions of §
291.123 of this title (relating to
Central Prescription or Medication Order Processing).
(13) A Class E pharmacy engaged in the
compounding of non-sterile preparations shall comply with the provisions of
§
291.131 of this title (relating to
Pharmacies Compounding Non-Sterile Preparations).
(14) Class E pharmacy personnel shall not
compound sterile preparations unless the pharmacy has applied for and obtained
a Class E-S pharmacy license.
(15)
A Class E pharmacy, which operates as a community type of pharmacy which would
otherwise be required to be licensed under the Act §560.051(a)(1)
(Community Pharmacy (Class A)), shall comply with the provisions of §
291.31 of this title (relating to
Definitions), §
291.32 of this title (relating to
Personnel), §
291.33 of this title (relating to
Operational Standards), §
291.34 of this title (relating to
Records), and §
291.35 of this title (relating to
Official Prescription Requirements), contained in Community Pharmacy (Class A);
or which operates as a nuclear type of pharmacy which would otherwise be
required to be licensed under the Act §560.051(a)(2) (Nuclear Pharmacy
(Class B)), shall comply with the provisions of §
291.51 of this title (relating to
Purpose), §
291.52 of this title (relating to
Definitions), §
291.53 of this title (relating to
Personnel), §
291.54 of this title (relating to
Operational Standards), and §
291.55 of this title (relating to
Records), contained in Nuclear Pharmacy (Class B), to the extent such sections
are applicable to the operation of the pharmacy.
(b) Prescription dispensing and delivery.
(1) General.
(A) All prescription drugs and/or devices
shall be dispensed and delivered safely and accurately as prescribed.
(B) The pharmacy shall maintain adequate
storage or shipment containers and use shipping processes to ensure drug
stability and potency. Such shipping processes shall include the use of
packaging material and devices to ensure that the drug is maintained at an
appropriate temperature range to maintain the integrity of the medication
throughout the delivery process.
(C) The pharmacy shall utilize a delivery
system which is designed to assure that the drugs are delivered to the
appropriate patient.
(D) All
pharmacists shall exercise sound professional judgment with respect to the
accuracy and authenticity of any prescription drug order they dispense. If the
pharmacist questions the accuracy or authenticity of a prescription drug order,
he/she shall verify the order with the practitioner prior to
dispensing.
(E) Prior to dispensing
a prescription, pharmacists shall determine, in the exercise of sound
professional judgment, that the prescription is a valid prescription. A
pharmacist may not dispense a prescription drug if the pharmacist knows or
should have known that the prescription was issued on the basis of an
Internet-based or telephonic consultation without a valid patient-practitioner
relationship.
(F) Subparagraph (E)
of this paragraph does not prohibit a pharmacist from dispensing a prescription
when a valid patient-practitioner relationship is not present in an emergency
situation (e.g. a practitioner taking calls for the patient's regular
practitioner).
(2) Drug
regimen review.
(A) For the purpose of
promoting therapeutic appropriateness, a pharmacist shall, prior to or at the
time of dispensing a prescription drug order, review the patient's medication
record. Such review shall at a minimum identify clinically significant:
(i) inappropriate drug utilization;
(ii) therapeutic duplication;
(iii) drug-disease
contraindications;
(iv) drug-drug
interactions;
(v) incorrect drug
dosage or duration of drug treatment;
(vi) drug-allergy interactions; and
(vii) clinical abuse/misuse.
(B) Upon identifying any
clinically significant conditions, situations, or items listed in subparagraph
(A) of this paragraph, the pharmacist shall take appropriate steps to avoid or
resolve the problem including consultation with the prescribing practitioner.
The pharmacist shall document such occurrences.
(3) Patient counseling and provision of drug
information.
(A) To optimize drug therapy, a
pharmacist shall communicate to the patient or the patient's agent information
about the prescription drug or device which in the exercise of the pharmacist's
professional judgment the pharmacist deems significant, such as the following:
(i) the name and description of the drug or
device;
(ii) dosage form, dosage,
route of administration, and duration of drug therapy;
(iii) special directions and precautions for
preparation, administration, and use by the patient;
(iv) common severe side or adverse effects or
interactions and therapeutic contraindications that may be encountered,
including their avoidance and the action required if they occur;
(v) techniques for self-monitoring of drug
therapy;
(vi) proper
storage;
(vii) refill information;
and
(viii) action to be taken in
the event of a missed dose.
(B) Such communication shall be:
(i) provided to new and existing patients of
a pharmacy with each new prescription drug order. A new prescription drug order
is one that has not been dispensed by the pharmacy to the patient in the same
dosage and strength within the last year;
(ii) provided for any prescription drug order
dispensed by the pharmacy on the request of the patient or patient's
agent;
(iii) communicated orally in
person unless the patient or patient's agent is not at the pharmacy or a
specific communication barrier prohibits such oral communication; and
(iv) reinforced with written information. The
following is applicable concerning this written information:
(I) Written information must be in plain
language designed for the patient and printed in an easily readable font
comparable to but no smaller than ten-point Times Roman. This information may
be provided to the patient in an electronic format, such as by e-mail, if the
patient or patient's agent requests the information in an electronic format and
the pharmacy documents the request.
(II) When a compounded product is dispensed,
information shall be provided for the major active ingredient(s), if
available.
(III) For new drug
entities, if no written information is initially available, the pharmacist is
not required to provide information until such information is available,
provided:
(-a-) the pharmacist informs the
patient or the patient's agent that the product is a new drug entity and
written information is not available;
(-b-) the pharmacist documents the fact that
no written information was provided; and
(-c-) if the prescription is refilled after
written information is available, such information is provided to the patient
or patient's agent.
(IV)
The written information accompanying the prescription or the prescription label
shall contain the statement Do not flush unused medications or pour down a sink
or drain. A drug product on a list developed by the Federal Food and Drug
Administration of medicines recommended for disposal by flushing is not
required to bear this statement.
(C) Only a pharmacist may orally provide drug
information to a patient or patient's agent and answer questions concerning
prescription drugs. Non-pharmacist personnel may not ask questions of a patient
or patient's agent which are intended to screen and/or limit interaction with
the pharmacist.
(D) If
prescriptions are routinely delivered outside the area covered by the
pharmacy's local telephone service, the pharmacy shall provide a toll-free
telephone line which is answered during normal business hours to enable
communication between the patient and a pharmacist.
(E) The pharmacist shall place on the
prescription container or on a separate sheet delivered with the prescription
container in both English and Spanish the local and toll-free telephone number
of the pharmacy and the statement: Written information about this prescription
has been provided for you. Please read this information before you take the
medication. If you have questions concerning this prescription, a pharmacist is
available during normal business hours to answer these questions at (insert the
pharmacy's local and toll-free telephone numbers).
(F) The provisions of this paragraph do not
apply to patients in facilities where drugs are administered to patients by a
person required to do so by the laws of the state (i.e., nursing
homes).
(G) Upon delivery of a
refill prescription, a pharmacist shall ensure that the patient or patient's
agent is offered information about the refilled prescription and that a
pharmacist is available to discuss the patient's prescription and provide
information.
(H) Nothing in this
subparagraph shall be construed as requiring a pharmacist to provide
consultation when a patient or patient's agent refuses such consultation. The
pharmacist shall document such refusal for consultation.
(4) Labeling. At the time of delivery, the
dispensing container shall bear a label that contains the following
information:
(A) the name, physical address,
and phone number of the pharmacy;
(B) if the drug is dispensed in a container
other than the manufacturer's original container, the date after which the
prescription should not be used or beyond-use-date. Unless otherwise specified
by the manufacturer, the beyond-use-date shall be one year from the date the
drug is dispensed or the manufacturer's expiration date, whichever is earlier.
The beyond-use-date may be placed on the prescription label or on a flag label
attached to the bottle. A beyond-use-date is not required on the label of a
prescription dispensed to a person at the time of release from prison or jail
if the prescription is for not more than a 10-day supply of
medication;
(C) either on the
prescription label or the written information accompanying the prescription,
the statement, Do not flush unused medications or pour down a sink or drain. A
drug product on a list developed by the Federal Food and Drug Administration of
medicines recommended for disposal by flushing is not required to bear this
statement; and
(D) any other
information that is required by the pharmacy or drug laws or rules in the state
in which the pharmacy is located.
(c) Substitution requirements.
(1) Unless compliance would violate the
pharmacy or drug laws or rules in the state in which the pharmacy is located a
pharmacist in a Class E pharmacy may dispense a generically equivalent drug or
interchangeable biological product and shall comply with the provisions of
§
309.3 of this title (relating to
Substitution Requirements) and §
309.7 of this title (relating to
Dispensing Responsibilities).
(2)
The pharmacy must include on the prescription order form completed by the
patient or the patient's agent information that clearly and conspicuously:
(A) states that if a less expensive
generically equivalent drug or interchangeable biological product is available
for the brand prescribed, the patient or the patient's agent may choose between
the generically equivalent drug or interchangeable biological product and the
brand prescribed; and
(B) allows
the patient or the patient's agent to indicate the choice of the generically
equivalent drug or interchangeable biological product or the brand
prescribed.
(d) Therapeutic Drug Interchange. A switch to
a drug providing a similar therapeutic response to the one prescribed shall not
be made without prior approval of the prescribing practitioner. This subsection
does not apply to generic substitution. For generic substitution, see the
requirements of subsection (c) of this section.
(1) The patient shall be notified of the
therapeutic drug interchange prior to, or upon delivery of, the dispensed
prescription to the patient. Such notification shall include:
(A) a description of the change;
(B) the reason for the change;
(C) whom to notify with questions concerning
the change; and
(D) instructions
for return of the drug if not wanted by the patient.
(2) The pharmacy shall maintain documentation
of patient notification of therapeutic drug interchange which shall include:
(A) the date of the notification;
(B) the method of notification;
(C) a description of the change;
and
(D) the reason for the
change.
(e)
Transfer of Prescription Drug Order Information. Unless compliance would
violate the pharmacy or drug laws or rules in the state in which the pharmacy
is located, a pharmacist in a Class E pharmacy may not refuse to transfer
prescriptions to another pharmacy that is making the transfer request on behalf
of the patient. The transfer of original prescription information must be done
within four business hours of the request.
(f) Prescriptions for Schedules II - V
controlled substances. Unless compliance would violate the pharmacy or drug
laws or rules in the state in which the pharmacy is located, a pharmacist in a
Class E pharmacy who dispenses a prescription for a Schedules II - V controlled
substance for a resident of Texas shall electronically send the prescription
information to the Texas State Board of Pharmacy as specified in §
315.6 of this title (relating to
Pharmacy Responsibility - Electronic Reporting) not later than the next
business day after the prescription is dispensed.
Notes
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