[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

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

[CITE: 42CFR483.60]



[Page 539]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 483_REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES--Table of

Contents

 

          Subpart B_Requirements for Long Term Care Facilities

 

Sec.  483.60  Pharmacy services.



    The facility must provide routine and emergency drugs and 

biologicals to its residents, or obtain them under an agreement 

described in Sec.  483.75(h) of this part. The facility may permit 

unlicensed personnel to administer drugs if State law permits, but only 

under the general supervision of a licensed nurse.

    (a) Procedures. A facility must provide pharmaceutical services 

(including procedures that assure the accurate acquiring, receiving, 

dispensing, and administering of all drugs and biologicals) to meet the 

needs of each resident.

    (b) Service consultation. The facility must employ or obtain the 

services of a licensed pharmacist who--

    (1) Provides consultation on all aspects of the provision of 

pharmacy services in the facility;

    (2) Establishes a system of records of receipt and disposition of 

all controlled drugs in sufficient detail to enable an accurate 

reconciliation; and

    (3) Determines that drug records are in order and that an account of 

all controlled drugs is maintained and periodically reconciled.

    (c) Drug regimen review. (1) The drug regimen of each resident must 

be reviewed at least once a month by a licensed pharmacist.

    (2) The pharmacist must report any irregularities to the attending 

physician and the director of nursing, and these reports must be acted 

upon.

    (d) Labeling of drugs and biologicals. Drugs and biologicals used in 

the facility must be labeled in accordance with currently accepted 

professional principles, and include the appropriate accessory and 

cautionary instructions, and the expiration date when applicable.

    (e) Storage of drugs and biologicals. (1) In accordance with State 

and Federal laws, the facility must store all drugs and biologicals in 

locked compartments under proper temperature controls, and permit only 

authorized personnel to have access to the keys.

    (2) The facility must provide separately locked, permanently affixed 

compartments for storage of controlled drugs listed in Schedule II of 

the Comprehensive Drug Abuse Prevention and Control Act of 1976 and 

other drugs subject to abuse, except when the facility uses single unit 

package drug distribution systems in which the quantity stored is 

minimal and a missing dose can be readily detected.



[56 FR 48875, Sept. 26, 1991, as amended at 57 FR 43925, Sept. 23, 1992]



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