N.J. Admin. Code § 13:39-10.3

Current through Register Vol. 56, No. 11, June 3, 2024

Section 13:39-10.3 - Authority to use automated medication system

(a) Prior to use for the first time of an automated medication system, the pharmacy shall conduct and submit to the Board a self-inspection of the automated medication system documented on a form provided by the Board. After receipt of the self-inspection, the Board shall conduct an inspection of the automated medication system. The pharmacy shall not use the system until it receives Board approval.

(b) A pharmacy may use an automated medication system to fill prescriptions or medication orders provided that the pharmacy:

1. Conducts an annual self-inspection of the automated medication system documented on a form provided by the Board. The pharmacy shall make the self-inspection available to the Board upon request;

2. Tests the automated medication system consistent with N.J.A.C. 13:39-10.6. The pharmacy shall make the results of such testing available to the Board upon request; and

3. Makes the automated medication system available to the Board for the purpose of inspection, whereby the Board may validate the accuracy of the self-inspection and/or of the system.

(c) The pharmacist-in-charge shall be responsible for the following:

1. Supervision of the operation of the system, or in the case of an automated medication system utilized at a location with no on-site pharmacy, the pharmacist-in-charge of the provider pharmacy shall be responsible for the supervision of the operation of the system;

2. Ensuring that there are written policies and procedures, which are reviewed and approved by the pharmacist-in-charge for system operation, safety, security, accuracy, and access, patient confidentiality and prevention of unauthorized access and malfunction, and ensuring compliance with such policies and procedures;

3. Ensuring that the pharmacy conducts an annual self-inspection of the automated medication system documented on a form provided by the Board. Such inspection shall verify that the automated medication system has been tested by the pharmacy and found to dispense accurately;

4. Ensuring that medications in the automated medication system are inspected, at least once every two months, for expiration or use by date, misbranding and physical integrity, and ensuring that the automated medication system is inspected, at least once every two months, for security and accountability;

5. Assigning, discontinuing or changing personnel access to the automated medication system;

6. Ensuring that the automated medication system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation; and

7. Ensuring compliance with all applicable provisions of N.J.A.C. 13:39.

N.J. Admin. Code § 13:39-10.3

Amended by 49 N.J.R. 3761(a), effective 12/4/2017