Federal Pharmacy Requirements for all states
§ 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—
(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] |
