| (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.
(D) The dispensing container is not required to bear
the label as specified in subparagraph (A) of this paragraph if:
(i) the drug is prescribed for administration to an
ultimate user who is institutionalized in a licensed health care institution
(e.g., nursing home, hospice, hospital);
(ii) no more than a 90-day supply is dispensed at one
time;
(iii) the drug is not in the possession of the ultimate
user prior to administration;
(iv) the pharmacist-in-charge has determined that the
institution:
(I) maintains medication administration records which
include adequate directions for use for the drug(s) prescribed;
(II) maintains records of ordering, receipt, and administration
of the drug(s); and
(III) provides for appropriate safeguards for the control
and storage of the drug(s); and
(v) the dispensing container bears a label that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) unique identification number of the prescription;
(-c-) name and strength of the drug dispensed;
(-d-) name of the patient; and
(-e-) name of the prescribing practitioner or, if applicable,
the name of the pharmacist who signed the prescription drug order;
(II) if the drug is dispensed in a container other
than the manufacturer's original container, specifies 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
(III) sets forth the directions for use and cautionary
statements, if any, contained on the prescription drug order or required
by law.
(8) Returning Undelivered Medication to Stock.
(A) As specified in §431.021(w), Health and Safety
Code, a pharmacist may not accept an unused prescription or drug,
in whole or in part, for the purpose of resale or re-dispensing to
any person after the prescription or drug has been originally dispensed
or sold, except as provided in §291.8 of this title (relating
to Return of Prescription Drugs). Prescriptions that have not been
picked up by or delivered to the patient or patient's agent may be
returned to the pharmacy's stock for dispensing.
(B) A pharmacist shall evaluate the quality and safety
of the prescriptions to be returned to stock.
(C) Prescriptions returned to stock for dispensing
shall not be mixed within the manufacturer's container.
(D) Prescriptions returned to stock for dispensing
should be used as soon as possible and stored in the dispensing container.
The expiration date of the medication shall be the lesser of one year
from the dispensing date on the prescription label or the manufacturer's
expiration date if dispensed in the manufacturer's original container.
(E) At the time of dispensing, the prescription medication
shall be placed in a new prescription container and not dispensed
in the previously labeled container unless the label can be completely
removed. However, if the medication is in the manufacturer's original
container, the pharmacy label must be removed so that no confidential
patient information is released.
(d) Equipment and supplies. Class A pharmacies dispensing
prescription drug orders shall have the following equipment and supplies:
(1) data processing system including a printer or comparable
equipment;
(2) refrigerator;
(3) adequate supply of child-resistant, light-resistant,
tight, and if applicable, glass containers;
(4) adequate supply of prescription, poison, and other
applicable labels;
(5) appropriate equipment necessary for the proper
preparation of prescription drug orders; and
Cont'd... |
