[Code of Federal Regulations]

[Title 42, Volume 3]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR482.25]



[Page 490-491]

 

                         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 491]]



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    (3) Outdated, mislabeled, or otherwise unusable drugs and 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]