| (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) 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) or Subchapter M, Chapter 431, Health
and Safety Code, or Chapter 442, Health and Safety Code. 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.
(9) Redistribution of Donated Prepackaged Prescription
Drugs.
(A) A participating provider may dispense to a recipient
donated prescription drugs that are prepackaged and labeled in accordance
with §442.0515, Health and Safety Code, and this paragraph.
(B) Drugs may be prepackaged in quantities suitable
for distribution to a recipient only by a pharmacist or by pharmacy
technicians or pharmacy technician trainees under the direction and
direct supervision of a pharmacist.
(C) The label of a prepackaged prescription drug a
participating provider dispenses to a recipient shall indicate:
(i) brand name and strength of the drug; or if no brand
name, then the generic name, strength, and name of the manufacturer
or distributor;
(ii) participating provider's lot number;
(iii) participating provider's beyond use date; and
(iv) quantity of the drug, if the quantity is greater
than one.
(D) Records of prepackaged prescription drugs dispensed
to a recipient shall be maintained to show:
(i) name of the drug, strength, and dosage form;
(ii) participating provider's lot number;
(iii) manufacturer or distributor;
(iv) manufacturer's lot number;
(v) manufacturer's expiration date;
(vi) quantity per prepackaged unit;
(vii) number of prepackaged units;
(viii) date packaged;
(ix) name, initials, or electronic signature of the
prepacker; and
(x) written or electronic signature of the responsible
pharmacist.
(E) Stock packages, repackaged units, and control records
shall be quarantined together until checked/released by the pharmacist.
(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
(6) metric-apothecary weight and measure conversion
charts.
(e) Library. A reference library shall be maintained
which includes the following in hard-copy or electronic format:
(1) current copies of the following:
(A) Texas Pharmacy Act and rules;
(B) Texas Dangerous Drug Act and rules;
(C) Texas Controlled Substances Act and rules; and
(D) Federal Controlled Substances Act and rules (or
official publication describing the requirements of the Federal Controlled
Substances Act and rules);
(2) at least one current or updated reference from
each of the following categories:
(A) a patient prescription drug information reference
text or leaflets which are designed for the patient and must be available
to the patient;
(B) at least one current or updated general drug information
reference which is required to contain drug interaction information
including information needed to determine severity or significance
of the interaction and appropriate recommendations or actions to be
taken; and
(C) if the pharmacy dispenses veterinary prescriptions,
a general reference text on veterinary drugs; and
(3) basic antidote information and the telephone number
of the nearest Regional Poison Control Center.
(f) Drugs.
(1) Procurement and storage.
(A) The pharmacist-in-charge shall have the responsibility
for the procurement and storage of drugs, but may receive input from
other appropriate staff relative to such responsibility.
(B) Prescription drugs and devices and nonprescription
Schedule V controlled substances shall be stored within the prescription
department or a locked storage area.
(C) All drugs shall be stored at the proper temperature,
as defined in the USP/NF and §291.15 of this title (relating
to Storage of Drugs).
(2) Out-of-date drugs or devices.
(A) Any drug or device bearing an expiration date shall
not be dispensed beyond the expiration date of the drug or device.
(B) Outdated drugs or devices shall be removed from
dispensing stock and shall be quarantined together until such drugs
or devices are disposed of properly.
(3) Nonprescription Schedule V controlled substances.
(A) Schedule V controlled substances containing codeine,
dihydrocodeine, or any of the salts of codeine or dihydrocodeine may
not be distributed without a prescription drug order from a practitioner.
Cont'd... |
