(a) A
registered pharmacist shall be physically present during the hours of operation
of a prescription area.
(b) At any
time a registered pharmacist is not in the prescription area, (except in cases
of emergencies), the entire stock of prescription drugs shall be secured from
access to unauthorized persons and the means of access shall only be in the
control of the pharmacist.
(c) A
pharmacist in an institutional pharmacy shall ensure that written policies and
procedures have been established by the institutional facility for providing
drugs to the medical staff and other authorized personnel of the institutional
facility by use of night cabinets, and access to the institutional pharmacy and
emergency kits when the pharmacist is not in the area. A "night cabinet" is a
cabinet, room, or any other enclosure not located within the prescription area.
The written policies and procedures shall provide that a pharmacist shall be
"on call" during those periods when night cabinets are utilized and shall
provide policies and procedures regarding the following:
(1) Security of the night cabinet to ensure
that the night cabinet is sufficiently secured to deny access to unauthorized
persons by force or otherwise;
(2)
The development and maintenance of an inventory listing of all drugs included
in the cabinet and the requirement that the pharmacist ensures, at a minimum,
that:
(A) Drugs available therein are properly
labeled;
(B) Only prepackaged drugs
are available therein in amounts sufficient for immediate therapeutic
requirements; and
(C) An
appropriate practitioner's prescription regarding the dispensing of drugs
exists;
(3) Access to
the pharmacy. In the event a drug is not available from floor supplies or night
cabinets and the drug is required to treat the immediate needs of a patient
whose health would otherwise be jeopardized, the drug may be obtained from the
institutional pharmacy in accordance with this subsection. Authorized personnel
may remove drugs therefrom provided:
(A) The
authorized personnel are designated, in writing, by the institutional
facility;
(B) The authorized
personnel have been instructed by the pharmacist of the proper methods of
access, and the records and procedures regarding removal of the drugs;
and
(C) The authorized personnel
are required to complete a form which shall include the patient's name and room
number, the name of drug, drug strength, dosage, quantity of drug removed,
date, time, and the signature of the authorized personnel; and
(4) The prompt detection, removal,
disposal, handling, and replacement, if possible, of a drug that has been
recalled by the U.S. Food and Drug Administration or the manufacturer to ensure
that recalled drugs are removed from the pharmacy's inventory, emergency kit,
night cabinet, remote dispensing machine, or from the patient if deemed
necessary according to the federal and manufacturer's guidelines.
