(a) All hospitals having a licensed bed
capacity of 100 or more beds shall have a pharmacy on the premises licensed by
the California Board of Pharmacy. Those hospitals having fewer than 100
licensed beds shall have a pharmacy license issued by the Board of Pharmacy
pursuant to Section
of the Business and Professions Code.
(b) The responsibility and the accountability
of the pharmaceutical service to the medical staff and administration shall be
A pharmacy and
therapeutics committee, or a committee of equivalent composition, shall be
established. The committee shall consist of at least one physician, one
pharmacist, the director of nursing service or his or her representative and
the administrator or his or her representative.
(1) The committee shall develop written
policies and procedures for establishment of safe and effective systems for
procurement, storage, distribution, dispensing and use of drugs and chemicals.
The pharmacist in consultation with other appropriate health professionals and
administration shall be responsible for the development and implementations of
procedures. Policies shall be approved by the governing body. Procedures shall
be approved by the administration and medical staff where such is
(2) The committee
shall be responsible for the development and maintenance of a formulary of
drugs for use throughout the hospital.
(d) There shall be a system maintained
whereby no person other than a pharmacist or an individual under the direct
supervision of a pharmacist shall dispense medications for use beyond the
immediate needs of the patients.
(e) There shall be a system assuring the
availability of prescribed medications 24 hours a day.
Supplies of drugs for use in medical
emergencies only shall be immediately available at each nursing unit or service
area as required.
(1) Written policies and
procedures establishing the contents of the supply procedures for use,
restocking and sealing of the emergency drug supply shall be
(2) The emergency drug
supply shall be stored in a clearly marked portable container which is sealed
by the pharmacist in such a manner that a seal must be broken to gain access to
the drugs. The contents of the container shall be listed on the outside cover
and shall include the earliest expiration date of any drugs within.
(3) The supply shall be inspected by a
pharmacist at periodic intervals specified in written policies. Such
inspections shall occur no less frequently than every 30 days. Records of such
inspections shall be kept for at least three years.
No drugs shall be administered except by
licensed personnel authorized to administer drugs and upon the order of a
person lawfully authorized to prescribe or furnish. This shall not preclude the
administration of aerosol drugs by respiratory care practitioners. The order
shall include the name of the drug, the dosage and the frequency of
administration, the route of administration, if other than oral, and the date,
time and signature of the prescriber or furnisher. Orders for drugs should be
written or transmitted by the prescriber or furnisher. Verbal orders for drugs
shall be given only by a person lawfully authorized to prescribe or furnish and
shall be recorded promptly in the patient's medical record, noting the name of
the person giving the verbal order and the signature of the individual
receiving the order. The prescriber or furnisher shall countersign the order
within 48 hours.
(1) Verbal orders for
administration of medications shall be received and recorded only by those
health care professionals whose scope of licensure authorizes them to receive
orders for medication.
Medications and treatments shall be administered as ordered.
Standing orders for drugs may
be used for specified patents when authorized by a person licensed to
prescribe. A copy of standing orders for a specific patient shall be dated,
promptly signed by the prescriber and included in the patient's medical record.
These standing orders shall:
(1) Specify the
circumstances under which the drug is to be administered.
(2) Specify the types of medical conditions
of patients for whom the standing orders are intended.
(3) Be initially approved by the pharmacy and
therapeutics committee or its equivalent and be reviewed at least annually by
(4) Be specific as
to the drug, dosage, route and frequency of administration.
(i) An individual prescriber may
notify the hospital in writing of his or her own standing orders, the use of
which is subject to prior approval and periodic review by the pharmacy and
therapeutics committee or its equivalent.
(j) The hospital shall develop policies
limiting the duration of drug therapy in the absence of the prescriber's
specific indication of duration of drug therapy or under other circumstances
recommended by the pharmacy and therapeutics committee or its equivalent and
approved by the executive committee of the medical staff. The limitations shall
be established for classes of drugs and/or individual drug entities.
(k) If drugs are supplied through a pharmacy,
orders for drugs shall be transmitted to the pharmacy either by written
prescription of the prescriber, by an order form which produces a direct copy
of the order or by an electronically reproduced facsimile. When drugs are not
supplied through a pharmacy, such information shall be made available to the
(l) Medications shall not be
left at the patient's bedside unless the prescriber so orders. Such bedside
medications shall be kept in a cabinet, drawer or in possession of the patient.
Drugs shall not be left at the bedside which are listed in Schedules II, III
and IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of
1970 as amended. If the hospital permits bedside storage of medications,
written policies and procedures shall be established for the dispensing,
storage and records of use, of such medications.
Medications brought by or with the
patient to the hospital shall not be administered to the patient unless all of
the following conditions are met:
drugs have been ordered by a person lawfully authorized to give such an order
and the order entered in the patient's medical record.
(2) The medication containers are clearly and
(3) The contents
of the containers have been examined and positively identified, after arrival
at the hospital, by the patient's physician or the hospital
hospital shall establish a supply of medications which is accessible without
entering either the pharmacy or drug storage room during hours when the
pharmacist is not available. Access to the supply shall be limited to
designated registered nurses. Records of drugs taken from the supply shall be
maintained and the pharmacist shall be notified of such use. The records shall
include the name and strength of the drug, the amount taken, the date and time,
the name of the patient to whom the drug was administered and the signature of
the registered nurse. The pharmacist shall be responsible for maintenance of
the supply and assuring that all drugs are properly labeled and stored. The
drug supply shall contain that type and quantity of drugs necessary to meet the
immediate needs of patients as determined by the pharmacy and therapeutics
(o) Investigational drug
use shall be in accordance with applicable state and federal laws and
regulations and policies adopted by the hospital. Such drugs shall be used only
under the direct supervision of the principal investigator, who shall be a
member of the medical staff and be responsible for assuring that informed
consent is secured from the patient. Basic information concerning the dosage
form, route of administration, strength, actions, uses, side effects, adverse
effects, interactions and symptoms of toxicity of investigational drugs shall
be available at the nursing station where such drugs are being administered and
in the pharmacy. The pharmacist shall be responsible for the proper labeling,
storage and distribution of such drugs pursuant to the written order of the
(p) No drugs supplied
by the hospital shall be taken from the hospital unless a prescription or
medical record order has been written for the medication and the medication has
been properly labeled and prepared by the pharmacist in accordance with state
and federal laws, for use outside of the hospital.
Labeling and storage of drugs shall be
accomplished to meet the following requirements:
(1) Individual patient medications, except
those that have been left at the patient's bedside, may be returned to the
pharmacy for appropriate disposition.
(2) All drug labels must be legible and in
compliance with state and federal requirements.
(3) Drugs shall be labeled only by persons
legally authorized to prescribe or dispense or under the supervision of a
(4) Test agents,
germicides, disinfectants and other household substances shall be stored
separately from drugs.
use drugs in liquid, tablet, capsule or powder form shall be segregated from
drugs for internal use.
shall be stored at appropriate temperatures. Refrigerator temperature shall be
between 2.2oC (36oF) and
7.7oC (46oF) and room
temperature shall be between 15oC
(59oF) and 30oC
(7) Drugs shall be stored in an orderly
manner in well-lighted cabinets, shelves, drawers or carts of sufficient size
to prevent crowding.
shall be accessible only to responsible personnel designated by the hospital,
or to the patient as provided in 70263(l) above.
(9) Drugs shall not be kept in stock after
the expiration date on the label and no contaminated or deteriorated drugs
shall be available for use.
Drugs maintained on the nursing unit shall be inspected at least monthly by a
pharmacist. Any irregularities shall be reported to the director of nursing
service and as required by hospital policy.
Discontinued individual patient's drugs
not supplied by the hospital may be sent home with the patient. Those which
remain in the hospital after discharge that are not identified by lot number
shall be destroyed in the following manner:
(A) Drugs listed in Schedules II, III or IV
of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as
amended, shall be destroyed in the presence of two pharmacists or a pharmacist
and a registered nurse employed by the hospital. The name of the patient, the
name and strength of the drug, the prescription number, the amount destroyed,
the date of destruction and the signatures of the witnesses required above
shall be recorded in the patient's medical record or in a separate log. Such
log shall be retained for at least three years.
(B) Drugs not listed under Schedules II, III
or IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of
1970, as amended, shall be destroyed in the presence of a pharmacist.
(r) The pharmacist
shall develop and implement written quality control procedures for all drugs
which are prepackaged or compounded in the hospital including intravenous
solution additives. He or she shall develop and conduct an in-service training
program for the professional staff to assure compliance therewith.
(s) The pharmacist shall be consulted on
proper methods for repackaging and labeling of bulk cleaning agents, solvents,
chemicals and poisons used throughout the hospital.
(t) Periodically, the pharmacy and
therapeutics committee, or its equivalent, shall evaluate the services provided
and make appropriate recommendations to the executive committee of the medical
staff and administration.