Texas Register, Volume 16, Number 43, Pages 3093-3159, June 7, 1991 Page: 3,112
3093-3159 p. ; 28 cm.View a full description of this periodical.
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other source of such information, such as
patient information leaflets.
(ii) If a prescription drug
order is delivered to the patient or his or her
agent at the patient's residence or other
designated location, the following is appli-
cable.
(I) The pharmacist
shall place on the prescription container or
on a separate sheet delivered with the pre-
scription container in both English and
Spanish the statement: "A pharmacist is
available to answer questions concerning
your prescription." This clause does not ap-
ply to patients in institutions where drugs
are administered to patients by a person
authorized to do so by the laws of the state
(i.e., nursing homes).
(II) The pharmacist-
in-charge shall assure that:
(-a-) adequate stor-
age or shipment containers and shipping
processes are used to ensure drug stability
and potency; and
(-b-) the pharmacy
utilizes a delivery system which is designed
to assure that the drugs are delivered to the
appropriate patient.
(B) Prescription containers.
(i) 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 ex-
empted from requirements of the Poison
Prevention Packaging Act of 1970.
(ii) A drug dispensed
pursuant to a prescription drug order shall
be dispensed in an appropriate container as
follows.
(I) If a drug is suscep-
tible to light, the drug shall be dispensed in
a light-resistant container.
(II) If a drug is sus-
ceptible to moisture, the drug shall be dis-
pensed in a tight container.
(III) The container
should not interact physically or chemically
with the drug product placed in it so as to
alter the strength, quality, or purity of the
drug beyond the official requirements.(iii) Prescription contain-
ers or closures shall not be re-used.(C) Labeling. At the time of
delivery of the drug, the dispensing con-
tainer shall bear a label with at least the
following information:
(i) name, address, and
phone number of the pharmacy, including a
phone number which is answered 24 hours
a day;
(ii) date dispensed;
(iii) name of prescribing
practitioner;
(iv) name of patient;
(v) directions for use, in-
cluding infusion rate and directions to the
patient for the addition of additives, if ap-
plicable;
(vi) unique identification
number of the prescription;
(vii) name and amount of
the base solution and of each drug added
unless otherwise directed by the prescribing
practitioner.either:
name; or(I) The name shall be
(xiii) the name of the reg-
istered nurse or physician assistant, if the
prescription is carried out by a registered
nurse or physician assistant in compliance
with the Medical Practice Act, 3.06(d).
(4) Clinical services.
(A) A systematic ongoing
process of drug use review shall be de-
signed, followed, and documented to in-
crease the probability of desired patient
outcomes and decrease the probability of
undesired outcomes from drug therapy.
(B) There must be documen-
tation of ongoing drug therapy monitoring
and evaluation, including assessment of:
(i) the therapeutic appro-
priateness of the patient's drug regimen;
(ii) therapeutic duplica-
tion in the patient's drug regimen;
(iii) the appropriateness
of the delivery device, dose, frequency,
route of administration and compliance;(iv) potential drug, food,
or diagnostic test interactions or disease
(-a-) the brand limitations on drug use (or any combination
of these); and(-b-) if no brand
name, then the generic name and name of
the manufacturer or distributor of such ge-
neric drug. (The name of the manufacturer
or distributor may be reduced to an abbrevi-
ation or initials, provided the abbreviation
or initials are sufficient to identify the man-
ufacturer or distributor. For combination
drug products having no brand name, the
principal active ingredients shall be indi-
cated on the label.)
(II) The brand name
of the prescribed drug shall not appear on
the prescription container label unless it is
the drug product actually dispensed.
(viii) name or initials of
the person preparing the product and the
pharmacist who checked and released the
final product;
(ix) expiration date of the
preparation based on published data;
(x) appropriate ancillary
instructions such as storage instructions or
cautionary statements, including cytotox-
ic/biohazardous warning labels where appli-
cable;
(xi) if the prescription is
for a Schedule II-IV controlled substance,
the statement Caution: "Federal law prohib-
its 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
pursuant to the provisions of the Act, 40,
the statement "Substituted for Brand Pre-
scribed."(v) clinical laboratory or
clinical monitoring methods to monitor and
evaluate drug effectiveness, side effects,
toxicity, or adverse effects, and appropriate-
ness to continued use of the drug in its
current regimen..
(5) Patient, care guidelines.
(A) Primary provider. There
shall be a designated physician primarily
responsible for the patient's medical care.
There shall be a clear understanding be-
tween the physician, the patient, and the
pharmacy of the responsibilities of each in
the areas of the delivery of care, and the
monitoring of the patient. This shall be
documented in the patient medication re-
cord (PMR).
(B) Patient training. A phar-
macist must be responsible for assuring that
the patient and/or patient's caregiver re-
ceives information regarding drugs and
their safe and appropriate use, including
instruction regarding:
(i) appropriate disposi-
tion of hazardous solutions and ancillary
supplies;
(ii) proper disposition of
controlled substances in the home;
(iii) self-administration of
drugs, where appropriate;
(iv) emergency proce-
dures, including how to contact an appropri-
ate individual in the event of problems or
emergencies related to drug therapy; and16 TexReg 3112 June?, 1991 Texas RegL~ter .
%,
16 TexReg 3112 June 7, 1991
Texas Register
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Texas. Secretary of State. Texas Register, Volume 16, Number 43, Pages 3093-3159, June 7, 1991, periodical, June 7, 1991; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth193291/m1/20/: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.