Current through Register Vol. 56, No. 6, March 18, 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.
