N.J. Admin. Code § 8:43D-9.4

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:43D-9.4 - Storage of medications

(a) A facility's 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 or other secured locked areas.

1. The storage area shall be kept locked when not in use.

2. The storage areas 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 from the medications of other residents within the storage area, with the exception of large volume medications which may be labeled and stored together in the storage area or other secured location.

5. Medications shall be stored in accordance with manufacturer's instructions and with requirements of the United States Pharmacopeia and the National Formulary (USP-NF), incorporated herein by reference as amended and supplemented.

(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; the primary care provider's name; the prescription number; the name and strength of the drug; the lot number; the quantity; the date of issue; the expiration date; the manufacturer's name if generic; directions for use; cautionary and/or accessory labels or any other requirement under 13:39-7.12specific to labeling within the rules promulgated by the New Jersey Board of Pharmacy.

i. If a generic substitute is used, the drug shall be labeled according to the Drug Utilization Review Council requirements at 24:6E-1et seq.

ii. 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 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 dispensing 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: the product name and strength; the lot number; the beyond use date; and the manufacturer, distributor, or re-packager.

(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 Department.

(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 licensed nurse or the pharmaceutical services provider.

(f) The facility shall maintain Declining Inventory Sheets for scheduled or controlled substances.

N.J. Admin. Code § 8:43D-9.4

Amended by 48 N.J.R. 2336(a), effective 11/7/2016