[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR482.25]

[Page 488-489]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents
 
                   Subpart C_Basic Hospital Functions
 
Sec. 482.25  Condition of participation: Pharmaceutical services.

    The hospital must have pharmaceutical services that meet the needs 
of the patients. The institution must have a pharmacy directed by a 
registered pharmacist or a drug storage area under competent 
supervision. The medical staff is responsible for developing policies 
and procedures that minimize drug errors. This function may be delegated 
to the hospital's organized pharmaceutical service.
    (a) Standard: Pharmacy management and administration. The pharmacy 
or drug storage area must be administered in accordance with accepted 
professional principles.
    (1) A full-time, part-time, or consulting pharmacist must be 
responsible

[[Page 489]]

for developing, supervising, and coordinating all the activities of the 
pharmacy services.
    (2) The pharmaceutical service must have an adequate number of 
personnel to ensure quality pharmaceutical services, including emergency 
services.
    (3) Current and accurate records must be kept of the receipt and 
disposition of all scheduled drugs.
    (b) Standard: Delivery of services. In order to provide patient 
safety, drugs and biologicals must be controlled and distributed in 
accordance with applicable standards of practice, consistent with 
Federal and State law.
    (1) All compounding, packaging, and dispensing of drugs and 
biologicals must be under the supervision of a pharmacist and performed 
consistent with State and Federal laws.
    (2) Drugs and biologicals must be kept in a locked storage area.
    (3) Outdated, mislabeled, or otherwise unusable drugs and 
biologicals must not be available for patient use.
    (4) When a pharmacist is not available, drugs and biologicals must 
be removed from the pharmacy or storage area only by personnel 
designated in the policies of the medical staff and pharmaceutical 
service, in accordance with Federal and State law.
    (5) Drugs and biologicals not specifically prescribed as to time or 
number of doses must automatically be stopped after a reasonable time 
that is predetermined by the medical staff.
    (6) Drug administration errors, adverse drug reactions, and 
incompatibilities must be immediately reported to the attending 
physician and, if appropriate, to the hospital-wide quality assurance 
program.
    (7) Abuses and losses of controlled substances must be reported, in 
accordance with applicable Federal and State laws, to the individual 
responsible for the pharmaceutical service, and to the chief executive 
officer, as appropriate.
    (8) Information relating to drug interactions and information of 
drug therapy, side effects, toxicology, dosage, indications for use, and 
routes of administration must be available to the professional staff.
    (9) A formulary system must be established by the medical staff to 
assure quality pharmaceuticals at reasonable costs.

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]