N.J. Admin. Code § 13:39-11A.15

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

Section 13:39-11A.15 - Audit trail; compounding record documentation

(a) A pharmacy shall maintain an audit trail for all non-sterile compounded preparation prescriptions dispensed consistent with the requirements of 13:39-7.6.

(b) Except as provided in (c) below, a pharmacy shall maintain a compounding record for each compounded non-sterile preparation that contains the following information:

1. Selection of the ingredients and documentation of source, lot numbers, and expiration dates of all ingredients used;

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 13:39-11A.13;

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

5. Strength of preparation;

6. Date of preparation;

7. Name or personal identifier of the person(s) who performed each step of the compounding process and the compounding pharmacist(s) who verified the preparation;

8. Reference(s) for formulation, if available;

9. Total quantity;

10. Detailed steps of the compounding process to ensure that the exact same compound can be duplicated at a future date;

11. Type of dispensing container used when a drug has specific storage requirements;

12. Beyond-use date of the finished product consistent with the requirements in 13:39-11A.11;

13. The assigned internal identification number for the preparation or the prescription number; and

14. Instructions for use, storage, and handling of the compounded preparation.

(c) A compounding record shall not be required for:

1. Mixing, reconstituting, or assembling a drug according to the product's labeling or the manufacturer's directions; and

2. Product flavoring.

N.J. Admin. Code § 13:39-11A.15