42 CFR § 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 § 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—
(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.
(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.
(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]
