N.J. Admin. Code § 13:39-11.20

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

Section 13:39-11.20 - Documentation; audit trail

(a) The pharmacist shall ensure that compounded sterile preparations have been properly prepared, consistent with the assigned risk level of the preparation, labeled, controlled, stored, dispensed, and distributed in accordance with the provisions of this subchapter. The pharmacist shall be responsible for the accuracy and appropriateness of the compounded prescription. When more than one pharmacist is involved in the steps of the compounding process, the pharmacist shall be responsible for the accuracy and appropriateness of each step he or she performed or he or she approved and reviewed, and his or her unique and secure user identifier(s) shall be recorded in the audit trail.

(b) A pharmacy shall maintain an audit trail for all compounded sterile preparations consistent with the requirements of 13:39-7.6.

(c) A pharmacy shall maintain a compounding record for each compounded sterile preparation that contains the following information:

1. Selection of the drugs, container, and diluent prior to their being compounded, including documentation of lot numbers and expiration dates of the drugs, containers, and diluents, if applicable;

2. Verification that ingredients comply with the prescription or medication order;

3. Verification that the prescription or medication order label complies with the requirements of 13:39-11.21;

4. Verification that the compounded sterile preparation has been visually inspected to ensure the absence of particulate matter in solutions, the absence of leakage from vials and bags, and the accuracy and thoroughness of labeling; and

5. Verification that the prescription or medication order is complete and ready to be dispensed, including any necessary ancillary supplies.

N.J. Admin. Code § 13:39-11.20

Recodified from N.J.A.C. 13:39-11.4 and amended by R.1998 d.297, effective 6/15/1998.
See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).
Rewrote the section. Former N.J.A.C. 13:39-11.10, Patient profile records, was recodified to N.J.A.C. 13:39-11.16.
Recodified from N.J.A.C. 13:39-11.10 and amended by R.2005 d.25, effective 1/18/2005.
See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).
Rewrote the section. Former N.J.A.C. 13:39-11.9, Batch preparation, recodified to N.J.A.C. 13:39-11.8.
Amended by R.2009 d.305, effective 10/5/2009.
See: 40 N.J.R. 5170(a), 41 N.J.R. 3840(a).
Rewrote (c) and (e).
Recodified from N.J.A.C. 13:39-11.9 and amended by R.2013 d.084, effective 6/3/2013.
See: 45 N.J.R. 439(a), 45 N.J.R. 1400(b).
Section was "Documentation". Rewrote (a); deleted former (b) through (e); and added new (b) through (c). Former N.J.A.C. 13:39-11.20, Controlled environment for compounded sterile preparations: anteroom, recodified to N.J.A.C. 13:39-11.6.