(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.
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Source Note: The provisions of this §291.104 adopted to be effective September 1, 2000, 25 TexReg 2617; amended to be effective December 15, 2002, 27 TexReg 11541; amended to be effective June 23, 2003, 28 TexReg 4638; amended to be effective June 6, 2004, 29 TexReg 5397; amended to be effective June 12, 2005, 30 TexReg 3209; amended to be effective March 6, 2006, 31 TexReg 1441; amended to be effective September 18, 2007, 32 TexReg 6348; amended to be effective June 8, 2008, 33 TexReg 4307; amended to be effective December 6, 2009, 34 TexReg 8703; amended to be effective May 30, 2010, 35 TexReg 4178; amended to be effective September 12, 2011, 36 TexReg 5847; amended tobe effective December 5, 2012, 37 TexReg 9514; amended to be effective December 10, 2013, 38 TexReg 8866; amended to be effective June 11, 2015, 40 TexReg 3646; amended to be effective December 6, 2015, 40 TexReg 8779; amended to be effective September 11, 2016, 41 TexReg 6717; amended to be effective December 6, 2018, 43 TexReg 7784 |