| (A) As specified in §562.012 of the Act, a pharmacist
may dispense a dosage form of a drug product different from that prescribed,
such as a tablet instead of a capsule or liquid instead of tablets,
provided:
(i) the patient consents to the dosage form substitution;
and
(ii) the dosage form so dispensed:
(I) contains the identical amount of the active ingredients
as the dosage prescribed for the patient;
(II) is not an enteric-coated or time release product;
and
(III) does not alter desired clinical outcomes.
(B) Substitution of dosage form may not include the
substitution of a product that has been compounded by the pharmacist
unless the pharmacist contacts the practitioner prior to dispensing
and obtains permission to dispense the compounded product.
(5) 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 paragraph does not apply to generic substitution. For generic
substitution, see the requirements of paragraph (3) of this subsection.
(A) 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:
(i) a description of the change;
(ii) the reason for the change;
(iii) whom to notify with questions concerning the
change; and
(iv) instructions for return of the drug if not wanted
by the patient.
(B) The pharmacy shall maintain documentation of patient
notification of therapeutic drug interchange which shall include:
(i) the date of the notification;
(ii) the method of notification;
(iii) a description of the change; and
(iv) the reason for the change.
(C) The provisions of this paragraph do not apply to
prescriptions for patients in facilities where drugs are administered
to patients by a person required to do so by the laws of this state
if the practitioner issuing the prescription has agreed to use of
a formulary that includes a listing of therapeutic interchanges that
the practitioner has agreed to allow. The pharmacy must maintain a
copy of the formulary including a list of the practitioners that have
agreed to the formulary and the signatures of these practitioners.
(6) Prescription containers.
(A) A drug dispensed pursuant to a prescription drug
order shall be dispensed in a child-resistant container unless:
(i) the patient or the practitioner requests the prescription
not be dispensed in a child-resistant container; or
(ii) the product is exempted from requirements of the
Poison Prevention Packaging Act of 1970.
(B) A drug dispensed pursuant to a prescription drug
order shall be dispensed in an appropriate container as specified
on the manufacturer's container.
(C) Prescription containers or closures shall not be
re-used. However, if a patient or patient's agent has difficulty reading
or understanding a prescription label, a prescription container may
be reused provided:
(i) the container is designed to provide audio-recorded
information about the proper use of the prescription medication;
(ii) the container is reused for the same patient;
(iii) the container is cleaned; and
(iv) a new safety closure is used each time the prescription
container is reused.
(7) Labeling.
(A) At the time of delivery of the drug, the dispensing
container shall bear a label in plain language and printed in an easily
readable font size, unless otherwise specified, with at least the
following information:
(i) name, address and phone number of the pharmacy;
(ii) unique identification number of the prescription
that is printed in an easily readable font size comparable to but
no smaller than ten-point Times Roman;
(iii) date the prescription is dispensed;
(iv) initials or an identification code of the dispensing
pharmacist;
(v) name of the prescribing practitioner;
(vi) if the prescription was signed by a pharmacist,
the name of the pharmacist who signed the prescription for a dangerous
drug under delegated authority of a physician as specified in Subtitle
B, Chapter 157, Occupations Code;
(vii) name of the patient or if such drug was prescribed
for an animal, the species of the animal and the name of the owner
that is printed in an easily readable font size comparable to but
no smaller than ten-point Times Roman. The name of the patient's partner
or family member is not required to be on the label of a drug prescribed
for a partner for a sexually transmitted disease or for a patient's
family members if the patient has an illness determined by the Centers
for Disease Control and Prevention, the World Health Organization,
or the Governor's office to be pandemic;
(viii) instructions for use that are printed in an
easily readable font size comparable to but no smaller than ten-point
Times Roman;
(ix) quantity dispensed;
(x) appropriate ancillary instructions such as storage
instructions or cautionary statements such as warnings of potential
harmful effects of combining the drug product with any product containing
alcohol;
(xi) if the prescription is for a Schedule II - IV
controlled substance, the statement "Caution: Federal law prohibits
the transfer of this drug to any person other than the patient for
whom it was prescribed";
(xii) if the pharmacist has selected a generically
equivalent drug or interchangeable biological product pursuant to
the provisions of the Act, Chapter 562, the statement "Substituted
for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand
Name" is the actual name of the brand name product prescribed;
(xiii) the name and strength of the actual drug or
biological product dispensed that is printed in an easily readable
size comparable to but no smaller than ten-point Times Roman, unless
otherwise directed by the prescribing practitioner;
(I) The name shall be either:
(-a-) the brand name; or
(-b-) if no brand name, then the generic drug or interchangeable
biological product name and name of the manufacturer or distributor
of such generic drug or interchangeable biological product. (The name
of the manufacturer or distributor may be reduced to an abbreviation
or initials, provided the abbreviation or initials are sufficient
to identify the manufacturer or distributor. For combination drug
products or non-sterile compounded drug preparations having no brand
name, the principal active ingredients shall be indicated on the label).
(II) Except as provided in clause (xii) of this subparagraph,
the brand name of the prescribed drug or biological product shall
not appear on the prescription container label unless it is the drug
product actually dispensed.
(xiv) 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; and
(xv) 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.
(B) If the prescription label required in subparagraph
(A) of this paragraph is printed in a type size smaller than ten-point
Times Roman, the pharmacy shall provide the patient written information
containing the information as specified in subparagraph (A) of this
paragraph in an easily readable font size comparable to but no smaller
than ten-point Times Roman.
(C) The label is not required to include the initials
or identification code of the dispensing pharmacist as specified in
subparagraph (A) of this paragraph if the identity of the dispensing
pharmacist is recorded in the pharmacy's data processing system. The
record of the identity of the dispensing pharmacist shall not be altered
in the pharmacy's data processing system.
Cont'd... |
