Current through Register Vol. 56, No. 18, September 16, 2024
(a)
For those residents who do not self-administer medications, the administrator
shall provide an appropriate and safe medication storage area, either in a
common area or in the resident's unit for the storage of medications. The
storage area requirement may be satisfied through the use of a locked
medication cart.
1. The storage area shall be
kept locked when not in use.
2. The
storage area shall be used only for storage of medications and medical
supplies.
3. The key to the storage
area shall be kept on the person of the employee on duty who is responsible for
resident supervision.
4. Each
resident's medications shall be kept separated within the storage area, with
the exception of large volume medications which may be labeled and stored
together in the storage area.
5.
Medications shall be stored in accordance with manufacturer's instructions and
with U.S.P. (United States Pharmacopoeia) requirements at USP 23, NF18,
published by U.S. Pharmacopoeia Convention, 12601 Twinbrook Parkway, Rockville,
MD 20852, incorporated herein by reference.
(b) All medications shall be kept in their
original containers and shall be properly labeled and identified.
1. The label of each resident's prescription
medication container shall be permanently affixed and contain the resident's
full name, physician's name, prescription number, name and strength of drug,
lot number, quantity, date of issue, expiration date, manufacturer's name if
generic, directions for use, and cautionary and/or accessory labels. If a
generic substitute is used, the drug shall be labeled according to the Drug
Utilization Review Council requirements at
24:6E-1 et seq. and N.J.A.C. 8:70.
Required information appearing on individually packaged drugs or within an
alternate medication delivery system need not be repeated on the
label.
2. All over-the-counter
(OTC) medications repackaged by the pharmacy shall be labeled with an
expiration date, name and strength of the drug, lot number, date of issue,
manufacturer's name if generic, and cautionary and/or accessory labels, in
accordance with U.S.P. requirements cited in (a)5 above. Original
manufacturer's containers shall be labeled with at least the resident's name,
and the name label shall not obstruct any of the aforementioned
information.
3. If a unit of use
drug distribution system is used, each dose of medication shall be individually
packaged in a hermetically sealed, tamper-proof container, and shall carry full
manufacturer's disclosure information on each discrete dose. Disclosure
information shall include, but not be limited to, the following: product name
and strength, lot number, expiration date, and manufacturer's or distributor's
name.
(c) Single use and
disposable items shall not be reused.
(d) No stock supply of prescription
medications shall be maintained, unless prior approval is obtained from the
Bureau.
(e) Discontinued or expired
medications shall be destroyed within 30 days in the facility, or, if unopened
and properly labeled, returned to the pharmacy. All medication destruction in
the facility shall be witnessed and documented by two persons, each of whom
shall be either the administrator, the registered nurse or the
pharmacist.
