N.J. Admin. Code § 8:36-11.7

Current through Register Vol. 56, No. 8, April 15, 2024

Section 8:36-11.7 - Storage and control of medications

(a) 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 that are not self-administered by the residents. 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/or pharmacy labels and/or directions, and/or United States Pharmacopeia Drug Information (USP DI) Volume I, Drug Information for the Health Care Professional, 2005, incorporated herein by reference, as amended and supplemented and USP DI Volume II: Advice for the Patient, incorporated herein by reference, as amended and supplemented. USP DI Volume I: Drug Information for the Health Care Professional and USP DI Volume II: Advice for the Patient can be obtained by contacting Thomson-Micromedex, 6200 S. Syracuse Way, Suite 300, Englewood, CO 80111, (303) 486-6400.

(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, prescriber's name, prescription number, name and strength of medication, lot number, quantity, date of issue, expiration date, manufacturer's name if generic, directions for use, and cautionary and/or accessory labels. Required information appearing on individually packaged medications or within an alternate medication delivery system need not be repeated on the label.

2. If a generic substitute is used, the drug shall be labeled according to N.J.A.C. 8:71 and/or the provisions identified in the publication of the Office of Generic Drugs in the Office of Pharmaceutical Science of the Center for Drug Evaluation and Research of the United States Department of Health and Human Services, "Approved Drug Products with Therapeutic Equivalence Evaluations," (March 20, 2020 Edition), incorporated herein by reference, as amended and supplemented, commonly known as the "Orange Book." The Orange Book can be obtained by contacting the Superintendent of Documents, Government Publishing Office, PO Box 371954, Pittsburgh, PA 15250-7954, (202) 512-1800 or toll-free (866) 512-1800, and is available on-line at http://www.fda.gov/media/136324/download .

3. All over-the-counter medications repackaged by the pharmacy shall be labeled with the name and strength of the medication, expiration date, lot number, date of issue, manufacturer's name, and cautionary and/or accessory labels, in accordance with (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.

4. For non-liquid prescription medications, where a unit-of-use drug distribution system shall be 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.

5. If a customized resident medication package is utilized, it shall conform with the provisions of USP DI Volume III, Approved Drug Products and Legal Requirements, 2005, incorporated herein by reference, as amended and supplemented. USP DI Volume III, Approved Drug Products and Legal Requirements can be obtained by contacting Thomson-Micromedex, 6200 S. Syracuse Way, Suite 300, Englewood, CO 80111, (303) 486-6400, under license granted by the United States Pharmacopeial Convention, Inc.

(c) Single use and disposable items shall not be reused.

(d) No stock supply of 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 for credit, if allowable, and in conformance with N.J.A.C. 13:39 and other State and Federal laws, codes, and regulations.

(f) All medication destruction in the facility shall be witnessed and documented by two individuals, each of whom shall be either the administrator, the registered professional nurse, the licensed practical nurse, or the provider or consultant pharmacist.

(g) The facility shall generate a crediting mechanism for medications dispensed in a unit-of-use medication distribution system, or other system that allows for the re-use of medications in accordance with all applicable State and Federal laws and regulations. The crediting system shall be monitored by the provider pharmacist and/or the consultant pharmacist and a facility representative.

(h) If the facility utilizes medications marked "sample," the provider pharmacist and/or consultant pharmacist, and the registered professional nurse, shall develop a mechanism for the control and limitation of these medications, in accordance with N.J.A.C. 13:35 and 13:39.

(i) Medication containers and carts shall be kept clean, and handled properly to prevent damage to the contents, and to prevent injury and harm to staff and/or residents.

(j) Needles and syringes shall be stored, used, and disposed of in accordance with N.J.S.A. 26:2H-5.10 et seq.;N.J.A.C. 8:43E-7 and 7:26-3A; and 29 CFR 1910 through 1930, and a record shall be maintained of the purchase, storage, and disposal of needles and syringes.

(k) Controlled dangerous substances shall be stored, and records shall be maintained, in accordance with the New Jersey Controlled Dangerous Substances Act, N.J.S.A. 24:21-1et seq., and all other Federal and State laws and regulations concerning the procurement, storage, dispensation, administration, and disposition of same., and all other Federal and State laws and regulations concerning the procurement, storage, dispensation, administration, and disposition of same.

(l) Any theft of Scheduled or Controlled Substances shall be reported to the New Jersey Department of Law and Public Safety, Enforcement Bureau of Professional Boards at (973) 648-4742, and/or to any other municipal, county, State, or Federal authority having jurisdiction over theft of such substances.

N.J. Admin. Code § 8:36-11.7

Amended by 54 N.J.R. 54(a), effective 1/3/2022