N.J. Admin. Code § 8:37-6.3

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

Section 8:37-6.3 - Storage of medications

(a) The licensee shall provide an appropriate and safe medication storage area in a common area for all resident medications.

1. Resident medications shall not be stored or kept in individual resident rooms.

2. The storage area requirement may be satisfied through the use of a locked medication cart.

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

4. The storage area shall be used only for storage of medications and medical supplies.

5. The key to the storage area shall be kept on the person of the employee on duty who is responsible for medication supervision.

6. 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.

7. Medications shall be stored in accordance with manufacturer's instructions and with United States Pharmacopoeia (USP) requirements at USP 39, NF 34, published by U.S. Pharmacopoeia Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, www.usp.org, 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, prescribing health care practitioner'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.

i. If a generic substitute is used, the drug shall be labeled according to the requirements at N.J.S.A. 24:6E-9.

ii. Required information appearing on individually packaged, single dose drugs, or within an automated 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 USP requirements set forth in (a)7 above.

i. 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 Department in writing from the Certificate of Need and Healthcare Facility Licensure Program, to which the facility shall direct the request to maintain a stock supply of prescription medications.

(e) The licensee shall ensure that discontinued or expired medications are destroyed within 30 days in the facility, or, if unopened and properly labeled, returned to the pharmacy for credit, if allowable, and in conformance with N.J.A.C. 13:39 and all applicable State and Federal laws, rules, and regulations.

N.J. Admin. Code § 8:37-6.3

Adopted by 49 N.J.R. 461(a), effective 2/7/2017

Amended by 49 N.J.R. 3981(a), effective 12/18/2017