0940-05-16-.08
Hospital Pharmacy Requirements
Cite as Tenn. Comp. R. & Regs. 0940-05-16-.08
(1)
All hospitals must have a licensed pharmacy. In hospitals up one hundred (100) beds the
pharmacy must be under the full-time or part-time supervision of a pharmacist licensed to
practice in the State of Tennessee. A pharmacy in a hospital of over one hundred (100) beds
must be under the supervision of a full-time pharmacist.
(2)
The full-time or part-time pharmacist is responsible for the control of all bulk drugs and
maintenance of records of their receipts and expenditures. The pharmacist must supervise all
dispensing of drugs from the bulk supply, properly label all bottles and make the medications
available to the appropriate licensed nursing staff.
(3)
The pharmacy must be operated in accordance with applicable Tennessee State Laws.
(4)
The pharmacy floor space must be allocated to assure that drugs are prepared in sanitary,
well-lighted and enclosed places.
(5)
Pharmacy equipment and physical facilities for the proper compounding, dispensing and
storage of drugs must be provided.
(6)
A library must be maintained with applicable reference books.
(7)
All designated areas for drug storage within the facility must be maintained in a sanitary
environment, appropriate temperature and ventilation, moisture control, segregation, security
and lighting. Refrigeration must be provided for thermolabile drugs in all hospital pharmacies.
(8)
The pharmacy must be kept securely locked and vacant if a pharmacist is not on duty.
Arrangements must be made in written policies for provision of drugs by use of night cabinets
and in emergency circumstances, by access to the Pharmacy during absence of a
pharmacist according to the rules of the Pharmacy Board.
(9)
Drugs may be provided by emergency kits provided that such kits meet requirements of the
Pharmacy Board.
(10) No drugs must be distributed by the use of the any mechanical device unless the device has
been approved by the Pharmacy Board. The approved device must be stocked with drugs
only by or under the supervision of a pharmacist.
(11) Drugs which are repacked in the pharmacy for use within the facility must be labeled
according to the Pharmacy Board’s requirements.
(12) The pharmacy must be responsible for the preparation, sterilization, labeling and dispensing
of parental medications within the facility.
(13) A pharmacist must receive, review and initial a direct copy or an electronic transmission
thereof of all medication orders before a drug is dispensed except in an emergency situation.
(14) Drugs dispensed to inpatients must be recorded on patient medication profiles in accordance
with standard pharmacy practice. Such records must be maintained as part of the medical
record. The institution must maintain a retrievable record of drugs dispensed for at least five
(5) years.
(15) All substances and legend drugs that have a potential for abuse must be dispensed and
recorded accordingly.
MINIMUM PROGRAM REQUIREMENTS FOR
CHAPTER 0940-05-16
MENTAL HEALTH HOSPITAL FACILITIES
(16) All drugs for patients who are leaving the facility must be dispensed and labeled by a
pharmacist.
(17) All discontinued, outdated, defective or deteriorated drugs; drug containers with illegible or
missing labels; and recalled drugs are to be returned to the pharmacy for proper disposition.
(18) Whenever patients bring drugs into a hospital facility, such drugs must not be administered
unless they can be identified and ordered to be given by a physician. If such drugs cannot be
administered, they must be delivered to the pharmacy, packaged, sealed and returned to an
adult member of patient’s immediate family or stored in the pharmacy and returned to the
patient upon discharge.
(19) A qualified pharmacist must make documented, monthly inspections of all drugs and
pharmaceutical materials kept in other areas of the hospital facility.